Download BNF Chapter 2: Cardiovascular system

Prescribing Formulary
17th Edition –March 2014
Last amendment: March 23rd 2015
The Somerset CCG allows all information provided to be re-used free of charge in its original context. This may only be done by non-commercial
organisations/individuals using the information without profit. If you are a commercial, for profit organisation, or would like to re-use the information
provided in a context other than which it was given, you must apply for a Re-Use of Information licence using the following contact details.
Freedom of Information Team
Somerset Clinical Commissioning Group
Wynford House
Lufton Way
Yeovil
Somerset
BA22 8HR
Email: [email protected]
Somerset CCG - Prescribing Formulary
Introduction
This formulary has been developed and reviewed by the Somerset CCG Medicines Management team, in liaison with Secondary Care NHS Trusts.
It is intended to guide evidence-based and cost-effective prescribing across Somerset. Key points to note with regard to the formulary are:

It is intended to only cover first and in some cases second-line drug choices (other than where stated) in uncomplicated patients

It is expected that practices will find the options provided are appropriate for the treatment of most new patients

It is acknowledged that patients who are intolerant / unresponsive to formulary drugs, may require alternatives which are non-formulary

It is anticipated that medication reviews will provide an opportunity to transfer appropriate patients from non-formulary to formulary drugs

New products will by default be non-formulary initially and prescribers are thus asked to refrain from prescribing new drugs until they have been assessed and
approved for addition to the formulary either by the Prescribing Forum or Drugs and Therapeutics Committee.

Drugs which are classified as amber under the Somerset Traffic Light System are not generally included in the formulary. They should be initiated by (or on the
advice of) an appropriate specialist. There may be arrangements for Shared Care.

The formulary is primarily aimed at prescribing for adults, guidance on prescribing for children can be found in the BNF for children.

Full prescribing information about products in the formulary is available in the BNF, available online or as an app for many mobile devices.

Generally we do not support the use of combination products for oral medicines, normally on cost grounds. However it is appreciated that patient
choice and compliance may be the best option in some cases.
It is acknowledged that to be effective the formulary needs to be accessible and thus an electronic rather than paper format is preferred by many. To aid decision
support at the point of prescribing, this formulary will therefore be made available on general practice clinical systems. It is expected that this formulary will then be
set as the default for all users within practices, including partners, retained doctors, locums and non-medical prescribers.
The formulary will be reviewed at approximately six-monthly intervals, taking account of emerging evidence, product availability, and pricing. Prices quoted in this
edition are taken from the most recent editions of the Drug Tariff and Chemist & Druggist monthly price list.
There are often cost-effective alternatives to pharmaceutical specials, including crushing tablets or prescribing licensed liquid preparations of similar medicines.
Guidance on the use of pharmaceutical ‘specials’ is available on the Medicines Management web page. Prescribers may also contact the Prescribing & Medicines
Management Team with any queries.By rationalising the choice of drugs prescribed in Primary Care through adoption of the formulary, and by improving liaison with
Secondary Care, it is hoped that prescribing across the Somerset health community can become more rational, cost-effective and seamless. In further support of
this objective, the Out of Hours formulary is reproduced as an appendix to this document, and the Palliative Care handbook can be found here.
Somerset CCG Medicines Management Team
We believe the information in this document is correct at the time of production. Please notify the Medicines Management Team of any errors.
[email protected] Team Administrator
Introduction
Page 1
ADMISSION AND DISCHARGE PROCESSES
Poor communication of information at transition points is responsible for as many as 50% of all medication errors and up to 20% of adverse drug
events in hospital. Practices should have a process for medicines reconciliation before admission and after discharge from secondary care and a
means of identifying patients at high risk of medicines related adverse events.
Please see the following two NHS Somerset guidance documents: Provision of patient information on admissions from Primary Care
Reconciliation of patient information post-discharge
From Primary to Secondary Care
From Secondary to Primary care

Complete patient details

Complete patient details

The presenting condition plus co-morbidities

The diagnosis of the presenting condition plus co-morbidities

A list of all the medicines currently prescribed for the patient with
indications

Dose, frequency and route of all the medicines listed

Any OTC medicines or supplements the patient takes

Medicines stopped and started, with reasons

Dose, frequency and route of all the medicines listed

Length of courses where appropriate

An indication of any medicines that are not intended to be continued
(eg.acute prescriptions)

Details of increasing or decreasing regimes

Known allergies

Known allergies

Known previous side effects
Suggestions for Drug Monitoring in Adults in Primary Care
The monitoring parameters cited in the formulary are derived from a range of guidelines, reference sources, and expert opinion and must therefore be
considered suggestions only. Adherence to them will not ensure a successful outcome in every case. The ultimate judgement regarding a particular clinical
result must be made by the doctor in light of the clinical data presented by the patient and the diagnostic and treatment options available. Please see the
Suggestions for Drug Monitoring in Adults in Primary Care document.
Admission and discharge processes
Page 2
Contents
BNF Therapeutic Chapter
Page
Page
Chapter 1 Gastro-intestinal system
Dyspepsia & gastro-oesophageal reflux disease
Acute diarrhoea
Antispasmodics
Chronic bowel disorders
Antisecretory drugs
Guidance on assessing dehydration in children under 5 years
Proton pump inhibitors (PPI)
Laxatives
Proton pump inhibitors (PPI)
Local preparations for anal and rectal disorders
Helicobacter pylori eradication
Chapter 2 Cardiovascular system
Positive inotropic drugs
Guidelines for the Treatment of Chronic Stable Angina Pectoris
Diuretics
Oral anticoagulants
Anti-arrhythmic drugs
NOACs
Beta-adrenoreceptor blocking drugs
Stroke prevention in AF-patient decision aid
Drugs affecting the renin-angiotensin system
Summary of drug interactions for Dabigatran, Rivaroxaban &
Apixaban
Summary Drug Treatment for Hypertension
Decision aid for patients requiring stroke prevention in AF
NICE Care Pathway for Hypertension
Implementation priorities for Dabigatran & Rivaroxaban
Heart Failure Guidance
Antiplatelet drugs
Post MI secondary prevention
Lipid regulation
Calcium channel blockers – Dihydropyridines
Secondary prevention of CVD
Calcium channel blockers - Rate limiting
Drug – statin interactions
Other antianginal drugs
Lipid regulating drugs
Peripheral vasodilators
Heart Failure prescribing Guidelines flowchart
Nitrates, CCBs and potassium channel activators
Table of contents
Page 3
BNF Therapeutic Chapter
Chapter 3
Page
Page
Respiratory system
Safer use of inhaled corticosteroids
Asthma Step-down Guide: Combination MDIs
Bronchodilators
Asthma Step-down Guide: Combination DPIs
Corticosteroids
Guidance for managing COPD
Leukotriene receptor antagonists
Antihistamines
Adult and children asthma Inhaler pathway
Mucolytics
Chapter 4
Central nervous system
Hypnotics and anxiolytics
Neuropathic pain
Drugs used in psychoses and related disorders
Diagnosis of tension-type headache, migraine & cluster headache
Antimanic drugs
Medication Recommendations from NICE CG150: Headache
Bipolar disorder
Antidepressants
Citalopram maximum dose guidance
Escitalopram maximum dose guidance
CNS stimulants and drugs for ADHD
Antimigraine drugs
Epilepsy
Formulation switching of antiepileptic drugs
Drugs used in status epilepticus
Drugs used in substance dependence
Drugs used in the treatment of obesity
Smoking Cessation
Traffic light system for identifying risk of serious illness in children
Opioid dependence
Analgesics
Alcohol dependence
Opioid Conversion Table
Chapter 5
Drugs for dementia
Infections
Antibacterial drugs
Infection Management Guidance
Antifungal drugs
MRSA Decolonisation Policy
Antiviral drugs
Guidance on the management & treatment of C. difficile infection
Influenza vaccines
Table of contents
Page 4
BNF Therapeutic Chapter
Chapter 6
Page
Page
Endocrine system
Drugs used in diabetes
Guidance on Type 2 diabetes management
Sex Hormones
Hormone Replacement Therapy
Male sex hormones and antagonists
Hypothalamic and pituitary hormones and anti-oestrogens
Insulin therapy in Type 2 Diabetes
Posterior pituitary hormones and antagonists
HbA1c for Diagnosis of Diabetes Mellitus
NHS England Interim Gender Dysphoria Protocol and Service
Insulins
Drugs affecting bone metabolism
Hypodermic equipment
Primary prevention of osteoporosis in post-menopausal women
Drugs used in diabetes
Secondary prevention of osteoporosis in post-menopausal women
Guidance on the use of Blood Glucose Testing Strips
Breast cancer treatment - induced bone loss
Thyroid and anti-thyroid drugs
Osteoporosis in Men
Corticosteroids
Chapter 7
Obstetrics, gynaecology, and urinary-tract disorders
Treatment of vaginal and vulval conditions
Management of LUTS associated with BPH
Contraceptives
Drugs for urinary frequency, enuresis, and incontinence
Drugs for genito-urinary disorders
Drugs for erectile dysfunction
Anticholinergic load
Chapter 8
Malignant disease and immunosuppression
Sex hormones and hormone antagonists in malignant disease
Hormone antagonists
Chapter 9
Pre- or Postmenopausal women at high risk of breast cancer
Prostate cancer & Gonadorelin analogues
Nutrition and blood
Anaemias and some other blood disorders
Minerals
Fluids and electrolytes
Vitamins
Table of contents
Page 5
BNF Therapeutic Chapter
Chapter 10
Page
Musculoskeletal and joint diseases
Drugs used in rheumatic diseases and gout
Gout
Chapter 11
Page
Acute treatment and long-term management of gout
Guidance on the management of Osteoarthritis
Eye
Anti-infective eye preparations
Treatment of glaucoma
Corticosteroids and other anti-inflammatory preparations
Miscellaneous ophthalmic preparations
Mydriatics and cycloplegics
Ocular lubricants comparison table
Chapter. 12
Ear, nose and oropharynx
Drugs acting on the ear
Drugs acting on the oro-pharynx
Drugs acting on the nose
Nasal Allergy
Chapter 13
Skin
Emollient and barrier preparations guidance
Guidance on calcipotriol / betamethasone dipropionate use
Emollients
Topical preparations for acne
Emollient bath additives and shower preparations
Oral preparations for acne
Topical corticosteroids
Photodamage
Preparations for eczema and psoriasis
Anti-infective skin preparations
Chapter 15
Anaesthesia
Antagonists for central and respiratory depression
Appendix 1
Borderline substances
Food supplements
Suspicion of cow’s milk protein allergy (CMPA)– Breast fed infants
Gluten-free foods
Suspicion of cow’s milk protein allergy (CMPA) – Formula fed infants
MUST Nutritional Screening
Suggested feeding for formula fed infants
Table of contents
Page 6
BNF Therapeutic Chapter
Appendix 2
Page
Page
184
Dorset & Somerset Out of Hours Service
Somerset Community Pharmacies holding Palliative Care Drugs:
Minehead
Bridgwater
South Petherton
Cheddar
Taunton
Frome
Yeovil
Glastonbury
Dorset and Somerset Palliative Care Drug Stock List
Useful links

Prescribing & Medicines Management intranet pages

Traffic Light System

Palliative Care Handbook

Somerset Prescribing Forum

Drug & Therapeutics Committees

Prescribing & Medicines Management Group (PAMM)
Table of contents
Page 7
Therapeutic Area
Formulary
Choices
Cost for 28
Rationale for decision / comments
(unless otherwise stated)
BNF Chapter 1: Gastro-intestinal system
1.1
Top
Dyspepsia & gastro-oesophageal reflux disease Related guidance: NICE CG184 (2014):Dyspepsia
NICE encourages people who need long-term management of dyspepsia symptoms to reduce their use of prescribed medication stepwise: by using the
effective lowest dose, by trying 'as-needed' use when appropriate, and by returning to self-treatment with antacid and/or alginate therapy (unless there is
an underlying condition or co-medication that needs continuing treatment).
Advise people that it may be appropriate for them to return to self-treatment with antacid and/or alginate therapy (either prescribed or purchased over-thecounter and taken as needed).
Antacids
Mucogel
Suspension: £1.71
(500ml)
Low sodium and cost-effective treatment for dyspepsia.
At dose of 10-20ml tds & at bedtime provides equivalent magnesium intake required
for hypomagnesaemia as an alternative to magnesium glycerophosphate.
Alginates
Peptac
Aniseed and
peppermint flavour
Liquid: £1.95 (500ml)
Contains 3.1mmol of sodium per 5ml so should be avoided in patients where
restriction of sodium intake is desirable. Available OTC
Gaviscon
Advance Aniseed
and peppermint
Liquid: £5.12 (500ml)
Chewable tablets:
£3.07 (60)
Recommended dose: 10ml.
Contains 2.3mmol sodium & 1mmol potassium per 5ml dose
Severe hypomagnesaemia has been reported infrequently in patients treated with
PPIs, although the exact incidence is unknown.
Where this is a clinical concern prescribers may also decide to use a magnesium
containing product such as magnesium trisilicate or Gastrocote (with alginate).
NB: Magnesium salts tend to be laxative in effect.
1.2 Antispasmodics
Antispasmodics
Mebeverine
Gastro-intestinal System
135mg tablets: £4.43
(100)
Avoid prescribing as Colofac IBS® as this is the OTC pack and more expensive.
Page 8
Therapeutic Area
1.3
Formulary
Choices
Cost for 28
Rationale for decision / comments
(unless otherwise stated)
Antisecretory drugs
Related guidance: Related guidance: NICE CG184 (2014):Dyspepsia
H2 - receptor
antagonists
1.3.5
Ranitidine
150mg tablets: £1.96
Ranitidine is recommended as first line treatment for mild-moderate GORD in the
(60)
majority of patients.
300mg tablets: £1.63
Ranitidine is available OTC, but only as 75mg tablets
(30)
75mg/5ml S/F oral
solution: £7.79 (300ml)
Proton pump inhibitors (PPI)
Rebound acid hypersecretion and protracted dyspepsia may occur after stopping prolonged treatment with a PPI.

Prescribed for appropriate indications at the lowest effective dose for the shortest period.
 Review the need for long-term treatment periodically.
Severe hypomagnesaemia may occur in patients treated with PPIs, although the exact incidence is unknown.
Where this is a clinical concern prescribers may also decide to use a magnesium containing product such as magnesium hydroxide (not suitable
for patients with short bowel syndrome) or Mucogel (see previous page)
Proton-pump
inhibitors
Lansoprazole
capsules
15mg capsules: £1.20
30mg capsules: £1.61
Only use Lansoprazole orodispersible tablets (Zoton FasTabs®) as an alternative to
costly special liquid formulations.
NICE Dosage
information on proton
pump inhibitors
Omeprazole
capsules
10mg capsules: £1.27
20mg capsules: £1.26
As Mepradec®
10mg capsules: £1.13
(28)
20mg capsules: £1.13
(28)
Only use Omeprazole dispersible tablets (Losec MUPS®) as an alternative to costly
special liquid formulations and where lansoprazole orodispersible tablets are not an
acceptable alternative.
Where Omeprazole 20mg once-daily is not effective, increasing dose to 2x20mg daily
(not 1x40mg) or using Lansoprazole 30mg daily is recommended.
Pantoprazole
tablets
20mg tablets: £1.20
40mg tablets: £1.60
Pantoprazole has been included for circumstances where a tablet formulation is
necessary.
For patients currently taking Nexium® tablets who are unable to change to
omeprazole, lansoprazole or pantoprazole, product should be prescribed as Emozul®
capsules (esomeprazole capsules 20mg and 40mg)
Gastro-intestinal System
Page 9
Therapeutic Area
Helicobacter pylori
eradication
First line:
or
Second line:
Formulary
Choices
Cost for 28
Rationale for decision / comments
(unless otherwise stated)
Please refer to Infection Management Guidance
PPI (as opposite)
+ Metronidazole
+ Clarithromycin
all for 7 days
400mg BD
250mg BD
PPI (as opposite)
+ Amoxicillin
+ Clarithromycin
all for 7 days
1g BD
500mg BD
Helicobacter pylori eradication is indicated in GU, DU and MALT lymphoma, whereas
evidence of value in GORD and NUD is inconsistent. Recommended PPI regimes
for H. pylori eradication are either Omeprazole capsules 20mg bd or
Lansoprazole capsules 30mg bd.
The combination of a PPI + Clarithromycin and Metronidazole is now a recommended
as first line therapy for H. pylori eradication. However the use of Clarithromycin or
Metronidazole should be avoided if they have been used in the previous year for the
treatment of any other infections as this significantly increases the likelihood of
H.pylori being resistant.
NB. Different doses of Clarithromycin indicated in the two regimes.
See opposite or
seek specialist
advice
Where patients require a second course of eradication, a regime should be chosen
which does not include antibiotics given previously, see BNF for guidance or seek
specialist advice.
1.4 Acute diarrhoea
Avoid anti-motility agents in children. See page 10 for assessment of dehydration in under 5s in line with NICE CG84
Oral rehydration
Electrolade
£1.97 (6 sachet)
£4.99 (20 sachet)
Available as multipack containing mixed flavours, less expensive than Dioralyte®.
Available OTC.
Antimotility agents
Loperamide
tablets
2mg tablets: £2.15
(30)
Available OTC as generic loperamide, various own-brand products and as Imodium.
Do not prescribe as branded version owing to high cost.
Codeine
15mg tablets: £1.27
30mg tablets: £1.41
Just three days of codeine containing medicines can lead to addiction – The CCG
strongly recommends that prescribers discuss the risk of addiction when initiating new
patients on any opioid containing medication and that this discussion is recorded in the
patient notes.
Watch for increasing frequency of requests for prescriptions
Gastro-intestinal System
Page 10
Therapeutic Area
Formulary
Choices
Cost for 28
Rationale for decision / comments
(unless otherwise stated)
1.5 Chronic bowel disorders
Related guidance: NICE CG 166 Ulcerative colitis: management in adults, children and young people
Aminosalicylates
Patients receiving aminosalicylates should be advised to report any unexplained bleeding, bruising, purpura, sore throat, fever or
malaise that occurs during treatment. A blood count should be performed and the drug stopped immediately if there is suspicion of a
blood dyscrasia.
In line with national guidance it is recommended that Mesalazine is prescribed by brand, however recent data suggests that Asacol
MR and Octasa MR have very similar biovailability and could be switched and patient monitored for changes in symptoms. UKMI
For all mesalazine preparations monitor renal function as recommended in SmPC.
First line:
Second line:
Mesalazine
as Octasa MR
400mg tablets:
£19.50 (90)
as PentasacSR®
500mg tablets £30.74
(100)
1g tablets £36.89 (60)
as Salofalk
500mg sachets:
Salofalk sachets: 1.5g equivalent to 2g pentasa or 2.4g Octasa® or Asacol®
£28.74 (100)
3g equivalent to 4g Pentasa or 4.8g Octasa® or Asacol®
1g sachets £28.74 (50)
1.5g sachets £48.85
(60)
Oral therapy alone is not as effective as a topical salicylate alone or a combined
3g sachets £97.70 (60) oral/topical combined treatment
500mg suppositories
£14.81 (28)
2g/59ml enema £29.92
(7)
Mesalazine
as Mezavant® XL
Gastro-intestinal System
Where 400mg tablets are required Octasa® tablets are recommended as first line as
they are considered to be bioequivalent to the original product Asacol (see above)
but at a lower cost. 800mg Octasa® cost more than 2 x 400mg so for cost-effective
dose we recommend using 400mg tabs
1.2g tablets: £62.44
(60)
Where 500mg tablets are required Pentasa® tablets are recommended.
Consultant initiation only (AMBER prescribing). All patients should have evaluation of
renal function prior to initiation and at least twice yearly whilst on treatment.
Page 11
Therapeutic Area
Corticosteroids
Formulary
Choices
Cost for 28
Budesonide
as Budenofalk

Beclometasone
dipropionate
as Clipper®
Gastro-intestinal System
Rationale for decision / comments
(unless otherwise stated)
3mg capsules £77.05
(100)
2mg/100ml Rectal
Foam: £57.11 (14)
9mg GR granules
sachets:£135 (60)
5mg tablets: £56.56
(30)
Capsules enclose enteric coated granules which release budesonide into the ileum
and ascending colon.
Extraintestinal symptoms, e.g. involving the skin, eyes or joints, are unlikely to respond
to Budenofalk 3mg because of its local action.
Initial dose is 3mg tds for a maximum of 8 weeks. During week 7, dose should be
reduced to two capsules daily and in week 8, reduce to one capsule daily.
9mg sachet dose is one per day spinkled onto tongue 30 mins before breakfast
Budesonide (and conventional glucocorticosteroid) should not be used to maintain
remission NICE CG152
On consultant recommendation only: To induce remission of left-sided or extensive
ulcerative colitis as add-on therapy to 5-ASA containing drugs in accordance with
NICE CG166 (Jun-13). Maximum course of treatment is four weeks.
Page 12
Assessing dehydration in children under 5 years for use during remote and face-to-face assessments
Adapted from ‘Diarrhoea and vomiting in children’ (NICE clinical guideline 84). The quick reference guide and full guidance are available from: www.nice.org.uk/CG84
Increasing severity of dehydration
Clinical dehydration
Signs
(face-to-face assessments)
Symptoms
(remote and face-toface assessments)
No clinically detectable
dehydration
may indicate children at
increased risk of progression
to shock
Risk Factors for Dehydration:
Clinical shock (one or more
signs/symptoms present.
(-) features do not specifically
indicate shock

Children younger than 1 year, especially those younger than
6 months

infants who were of low birth weight

children who have passed six or more diarrhoeal stools in the
past 24 hours

children who have vomited three times or more in the past
24 hours
children who have not been offered or have not been able to
tolerate supplementary fluids before presentation
Appears well
Appears to be unwell or
deteriorating
–
Alert and responsive
Altered responsiveness (for
example, irritable, lethargic)
Decreased level of
consciousness

Normal urine output
Decreased urine output
–

infants who have stopped breastfeeding during the illness

children with signs of malnutrition.
Skin colour unchanged
Skin colour unchanged
Pale or mottled skin
Warm extremities
Warm extremities
Cold extremities
Alert and responsive
Altered responsiveness (for
example, irritable, lethargic)
Decreased level of
consciousness
Skin colour unchanged
Skin colour unchanged
Pale or mottled skin
Warm extremities
Warm extremities
Cold extremities
Eyes not sunken
Sunken eyes
Moist mucous membranes
(except after a drink)
Dry mucous membranes
(except for ‘mouth breather')
X Box 1 x
Suspect hypernatraemic dehydration if there are any of the
following:

jittery movements

increased muscle tone

hyperreflexia
–

convulsions
–
 drowsiness or coma.
Laboratory investigations:
Normal heart rate
Tachycardia
Tachycardia

Do not routinely perform blood biochemistry.
Normal breathing pattern
Tachypnoea
Tachypnoea

Measure plasma sodium, potassium, urea, creatinine and
glucose concentrations if:
- intravenous fluid therapy is required or
Normal peripheral pulses
Normal peripheral pulses
Weak peripheral pulses
Normal capillary refill time
Normal capillary refill time
Prolonged capillary refill time
Normal skin turgor
Normal blood pressure
Reduced skin turgor
Normal blood pressure
–
Hypotension (decompensated
shock)
- there are symptoms or signs suggesting hypernatraemia.
Measure venous blood acid–base status and chloride
concentration if shock is suspected or confirmed.
Interpret symptoms and signs taking into account risk factors for dehydration (see box 1).
Gastro-intestinal System
Page 13
Therapeutic Area
Formulary Choices
Cost for 28
Rationale for decision / comments
(unless otherwise stated)
1.6
Laxatives
Related guidance: NICE Clinical Guideline CG99 (2010): Constipation in children and young people
NICE Technical Appraisal TA211 Constipation (women) - prucalopride
Bulk-forming
laxatives
Stimulant laxatives
First line:
Second line
Ispaghula Husk
3.5g sachets: £2.20 (30)
Prescribe generically. Available OTC.
3.4g sachets (e.g. Regulan) are more expensive at £2.44 per 30
Bisacodyl
Senna
Glycerol
suppositories
Osmotic laxatives
Gastro-intestinal System
5mg tablets: £2.47 (60)
10mg suppositories: £3.52
(12)
7.5mg tablets: £12.64 (60)
7.5mg/5ml SF liquid: £2.69
(500ml)
Available OTC.
1g: £0.88 (12)
2g: £0.88(12)
4g: £4.02 (12)
All available OTC
Glycerin suppository sizes:
 1g = infant
 2g = child
 4g = adult
Available OTC.
NICE Cochrane QP review in June 2010 concluded that polyethylene glycol
(macrogol) should be used in preference to lactulose for chronic constipation.
Using polyethylene glycol in preference to lactulose is likely to improve the
quality of patient care by reducing the use of a less effective treatment.
Course of treatment for chronic constipation not normally > 2 weeks.
A stimulant laxative should be added if disimpaction is not achieved after 2
weeks.
Efficacy requires adequate fluid intake. Contains Na+, care in patients with
hypertension / heart failure. Laxido® replaces Movicol® as lower cost brand
equivalent.
Page 14
Therapeutic Area
Formulary Choices
Cost for 28
Rationale for decision / comments
(unless otherwise stated)
First line:
Macrogol
as Laxido
Orange
Sugar-free
as Cosmocol
Orange sugarfree
As sugar free lemon/lime alternative to Laxido orange
as Cosmocol
Paediatric
Sachets £2.99 (30)
For children 2-11
Lactulose
3.35g/5ml solution: £3.09
(500ml)
Takes 2 to 3 days to exert effect, “prn” use ineffective; should be taken with
additional fluid. Therapeutic dose for adults 15ml twice daily. Available OTC.
Prucalopride
1mg tablets:£38.69 (28)
2mg tablets:£59.52 (28)
Lubiprostone
24mcg capsule: £29.68 (28)
£53.48 (56)
As per NICE TA211 2010, for chronic constipation in women only for whom
treatment with at least two laxatives from different classes, at the highest
tolerated recommended doses for at least 6 months, has failed to provide
adequate relief and invasive treatment is being considered. Re-evaluate after 4
weeks treatment.
As per NICE TA318 2014, for treating chronic idiopathic constipation, that is,
for adults in whom treatment with at least 2 laxatives from different classes, at
the highest tolerated recommended doses for at least 6 months, has failed to
provide adequate relief and for whom invasive treatment for constipation is
being considered.Re-examine after 2 weeks treatment.
as Cosmocol Half
Other drugs used in
constipation
Sachets £3.99 (30)
Lemon/lime Sachets: £5.34
(30)
Orange/lemon/lime:£3.99
(30)
Sachets £2.99 (30)
as Cosmocol
Second line
Sachets:£4.27 (30)
NICE says prescribe oral macrogols as first-line treatment for children and
young people with newly diagnosed idiopathic constipation.
Gastro-intestinal System
Half the dose of standard (minimum 12 years age)
Page 15
Therapeutic Area
Formulary Choices
Cost for 28
Rationale for decision / comments
(unless otherwise stated)
Pre-op Bowel
Cleansing Solutions
N/A
Peripheral opioidreceptor antagonist
Methylnaltrexone
Injection
12mg/0.6ml
Bowel cleansing medicine may modify the absorption of regularly prescribed
medications. Urea and Electrolytes should be checked in all patients to
minimise the risk of electrolyte imbalance particularly patients taking the
following medications:
Diuretics, corticosteroids, cardiac glycosides, NSAIDs, tricyclics, SSRIs,
antipsychotics, carbamazepine.
See NPSA Alert and local guidelines for details.
£21.05 (single vial)
£147.35 (7 vial pack)
Injection for opioid-induced constipation in terminally ill patients, when
response to other laxatives is inadequate. Used in addition to existing laxative
therapy.
Not licensed for use in any other circumstance.
1.7 Local preparations for anal and rectal disorders
Rectal soothing
agents
Anusol
Cream: £2.32 (23g)
Ointment: £2.32 (25g)
Suppositories: £2.14 (12)
Available as cream, ointment and suppositories.
Available OTC.
Rectal
corticosteroids
Scheriproct
Ointment: £2.94 (30g)
Suppositories: £1.38 (12)
Scheriproct® is recommended over the traditionally widely used Proctosedyl®,
as the latter is one of the most costly preparations of its type at £10.34 per
tube.
Preparations for anal
fissures
Rectogesic
(Glyceryl Trinitrate
Ointment 0.4%)
Ointment: £39.30 (30g)
Glyceryl Trinitrate for the management of anal fissure should be prescribed as
Rectogesic®, which is the only available licensed product for this indication.
Prescriptions for other strengths will require the dispensing of “specials” which
are unlicensed, often have a short shelf life and usually cost in excess of £100
per pack.
Maximum duration of use: 8 weeks
All external preparations of diltiazem are unlicensed specials and are
non-formulary. Acute trust commissioned to provide full treatment
course.
Gastro-intestinal System
Page 16
Therapeutic Area
Formulary Choices
Cost for 28
Rationale for decision / comments
(unless otherwise stated)
BNF Chapter 2: Cardiovascular system
Related guidance:
NICE Clinical Guideline CG127 (2011): Hypertension: Clinical management of primary hypertension in adults
NICE Clinical Guideline CG180 (2014): Atrial fibrillation
NICE Clinical Guideline CG172 (2013): MI: secondary prevention
NICE Clinical Guideline CG107 (2010): Hypertension in pregnancy
NICE Clinical Guideline CG108 (2010): Chronic heart failure
NICE Technology Appraisal TAG210 (2010): Clopidogrel and modified-release dipyridamole
Top
Given the wide overlap between many drug groups and clinical indications and vice-versa, the indications for which each drug is included in the formulary are
clearly stated in the comments section. Recommendations and local guidelines for the management of specific cardiovascular conditions are provided as inserts.
2.1

Hypertension

Heart Failure

Primary Care Guidelines for the Treatment of Chronic Stable Angina Pectoris

Management of anticoagulant-induced haemorrhage

Primary Prevention of CVD

Secondary Prevention of CVD

Drug – statin interactions table
Positive inotropic drugs
Cardiac glycosides
Cardiovascular system
Digoxin
62.5mcg tablets: £1.41
125mcg tablets: £1.05
250mcg tablets: £1.01
Digoxin is included in the formulary for use:

Atrial fibrillation: but not paroxysmal AF

Heart failure: where symptoms persist (due to LVSD) despite optimum
therapy including ACEIs, B-Blockers and diuretics.
U&Es should be checked at least 6-monthly, or when drug treatment is
changed. Monitoring serum potassium is particularly important in patients’
taking digoxin or an aldosterone antagonist. A serum digoxin level should be
measured within 8-12 hours of the latest dose only if toxicity or non-adherence
is suspected.
Doses of greater than 250mcg per day in adults and greater than 125mcg in
patients over 70years should rarely be seen.
Page 17
Therapeutic Area
Formulary Choices
Cost for 28
Rationale for decision / comments
(unless otherwise stated)
2.2
Diuretics
Thiazides and
related diuretics
Indapamide
2.5mg tablets: £3.88
1.5mg MR tablets: £3.40 (30)

Hypertension: indapamide 2.5mg daily is considered the optimal dose
for hypertension.
Low dose indapamide 1.5mg SR has been shown to control hypertension as
effectively as 2.5mg (IR) with lower incidence of hypokalaemia.
http://www.ncbi.nlm.nih.gov/pubmed/8572850
Bendroflumethiazide
NB People treated with bendroflumethiazide whose blood pressure is
stable & well controlled should continue on bendroflumethiazide
2.5mg tablets £0.82

Loop diuretics
Aldosterone
Antagonists
Metolazone
2.5mg tablets
5mg tablets
No longer marketed in UK but remains on formulary for consultant
recommendation (Amber drug in the TLG.)
Furosemide
20mg tablets:£0.82
40mg tablets: £0.82
Furosemide is included in the formulary for use
Spironolactone
Eplerenone
Cardiovascular system
Heart failure: bendroflumethiazide may have a limited role in mild heart
failure or where patients are intolerant of loop diuretics.
25mg tablets: £1.33
50mg tablets: £1.80
25mg tablets: £42.72
50mg tablets: £42.72

Heart failure: to provide relief of symptoms. Patients’ who do not
respond to 80mg/day will require further specialist advice.

Hypertension: For treatment of resistant hypertension at Step 4 where
BP remains sub-optimally controlled despite standard therapies.
Spironolactone is included in the formulary for:

Heart failure: for patients with NHYA Grade III-IV who remain
symptomatic despite optimisation of therapies such as ACE inhibitors
and Beta-blockers. Spironolactone is the aldosterone antagonist of
choice in this situation; Eplenerone is considered an alternative only for
specialist initiation.

Hypertension: For treatment of resistant hypertension at step 4 if blood
potassium is ≤ 4.5mmol/l

Regular monitoring (maintenance): U&E at 6, 9 & 12 months,
thereafter every 6 months.
Used, in addition to standard therapy, to reduce the risk of cardiovascular
mortality and morbidity after recent myocardial infarction in stable patients with
left ventricular dysfunction and clinical evidence of heart failure, as an
alternative to spironolactone, where sex hormone mediated adverse effects
experienced.
Page 18
Therapeutic Area
Formulary Choices
Cost for 28
Rationale for decision / comments
(unless otherwise stated)
2.3
Anti-arrhythmic drugs
Drugs for
arrythmias
Amiodarone
100mg tablets: £1.36
200mg tablets: £1.77
Treatment should only be initiated by a hospital specialist and only for the
treatment of severe rhythm disorders not responding to other therapies.
Prescribing at initial loading dose should be limited to 2 weeks.
Amiodarone therapy requires monitoring of:

LFTs and TFTs at baseline and then every 6 months.
 Ophthalmic examination at baseline and then twelve-monthly
The long half-life of amiodarone (~50 days) means the therapeutic and adverse
effects persist for long periods after discontinuation of therapy.
WARNING Do not exceed Simvastatin 20mg in patients taking amiodarone
and monitor lipid levels to ensure lowest dose necessary of simvastatin is
used.
Dronedarone
400mg tablets: £67.50 (60)
Although effective in treating atrial fibrillation and flutter, dronedarone is not as
effective as amiodarone. However, the different side effect profile has led to its
use in patients for whom amiodarone may be contraindicated or otherwise
unsuitable. See the Shared Care Agreement or NICE TAG
What issues should be considered regarding drug induced QT prolongation?
Prolongation of the QT interval can lead to a life threatening ventricular arrhythmia known as torsades de pointes which can result in sudden cardiac death.
Recently there have been warnings relating to drug-induced QT prolongation for three commonly used drugs – citalopram, domperidone and ondansetron.
There are also a number of other widely used drugs which are known to cause QT prolongation and there are a number of drug interactions which can increase
the risk of this adverse effect occurring.
Full list of medicines that prolong QT interval
Cardiovascular system
Page 19
Therapeutic Area
Formulary Choices
Cost for 28
Rationale for decision / comments
(unless otherwise stated)
2.4
Beta-adrenoreceptor blocking drugs
Beta blockers may be considered as initial therapy for hypertension particularly if intolerant or C/I to ACEI/ARB for:

younger people (under 55)

women of childbearing age

people with evidence of increased sympathetic drive

at Step 4 if further diuretic therapy is not tolerated, C/I or ineffective
Evidence suggests the combination of beta-blocker and thiazide increases risk of Type 2 DM and this is generally considered to be dose related.
Cardioselective beta-blockers may be used in well-controlled asthmatic patients, or COPD without significant reversible component for Heart Failure or following
an MI. Treatment should be initiated at a low-dose & the patient monitored carefully for adverse effects.
Recent evidence-based guidance for angina states that beta-blockers should be the first line therapy for the long-term prevention of angina.
Patients with heart failure should only be prescribed with beta-blockers licensed for this indication.
Beta-blockers
Bisoprolol
Atenolol
Metoprolol
Cardiovascular system
1.25mg tablets: £1.23
2.5mg tablets: £1.18
3.75mg tablets: £1.81
5mg tablets: £0.98
7.5mg tablets: £4.32
10mg tablets: £1.06
25mg tablets: £0.92
50mg tablets: £0.95
100mg tablets: £1.12
50mg tablets: £1.03
100mg tablets: £1.15
Bisoprolol is included in the formulary for:

Heart failure: Patients’ with heart failure should be prescribed a betablocker licensed for heart failure. Bisoprolol is first line drug, initiated at
1.25mg and titrated according to guidelines.

Hypertension: in line with NICE guidance. Alternative to Atenolol or
Metoprolol

Angina: as alternative to Metoprolol

Post-MI: as alternative to Metoprolol
Atenolol is included in the formulary for:

Hypertension: in line with NICE guidance. Atenolol dose for
hypertension should not normally exceed 50mg daily.

Angina: for prophylaxis of symptoms, some additional benefit may be
obtained by increasing the dose to 100mg.
Metoprolol is included in the formulary for:

Hypertension: in line with NICE guidance. Alternative to Atenolol or
Bisoprolol

Angina: as alternative to Bisoprolol

Post-MI: as alternative to Bisoprolol
Page 20
Therapeutic Area
Formulary Choices
Cost for 28
Rationale for decision / comments
(unless otherwise stated)
2.5
Drugs affecting the renin-angiotensin system and other antihypertensives
ACE-inhibitors (ACEIs) should be used in line with NICE / CCG guidance for hypertension and heart failure. All should be prescribed in a single daily dose where
possible. Lisinopril and Ramipril are the recommended first line options. Monitoring requirements U+Es at baseline, repeated 1-2 weeks after each dose increase
for heart failure and after final dose increase in hypertension, annually thereafter.
Patients exhibiting ACE cough on first choice ACEI should trial a second choice ACEI before an ARB.
ACE-inhibitors
or
Cardiovascular system
Lisinopril
Ramipril capsules
2.5mg tablets: £1.15
5mg tablets: £1.12
10mg tablets: £1.11
20mg tablets: £1.15
1.25mg capsules:£1.06
2.5mg capsules: £1.14
5mg capsules: £1.22
10mg capsules: £1.45
Lisinopril is included in the formulary for:

Hypertension: in line with NICE guidance. Usual dose range
2.5mg-20mg daily. May be commenced at dose of 10mg daily in
patients without renal impairment and not on diuretics.

Post-MI: titrated to 5-10mg daily if possible

Heart failure: as guidelines, titrated to 35mg if possible

Diabetic nephropathy: initially 2.5mg once daily, adjusted to achieve
sitting diastolic BP of <75mmHg in normotensive IDDM and
<90mm Hg in hypertensive NIDDM, usual range 10-20mg once daily
Ramipril is included in the formulary for:

Hypertension: 1.25mg to 10mg daily, in line with NICE guidance.

Post-MI: titrated to 10mg daily if possible

Heart failure: as guidelines, titrated to 10mg if possible
Page 21
Therapeutic Area
Formulary Choices
Cost for 28
Rationale for decision / comments
(unless otherwise stated)
ARBs should only be used in patients with persistent troublesome ACEI induced cough. The percentage of patients’ reporting a cough was between 2-10% in
randomised controlled trials. ACEIs have a better evidence base and are more cost-effective.
ARBs should be used in line with NICE / CCG guidance for hypertension and heart failure.
Angiotensin-II
receptor blockers
(ARBs)
First line:
Patients exhibiting ACE cough on first choice ACEI should trial a second choice ACEI before switching to an ARB.
Dual therapy ACEI+ARB is not recommended for any indication, other than under specific conditions for patients with heart
failure. (NICE CG108 (2010): Chronic heart failure)
Losartan
Following
consideration of
available evidence
at Somerset
Prescribing Forum
March 2010 it was
agreed that generic
versions of losartan
may be used for all
indications
Second line:
Third line:
Cardiovascular system
Candesartan
Valsartan capsules
25mg tablets: £1.18
50mg tablets: £1.21
100mg tablets: £1.37
Losartan is included in the formulary for:

Hypertension: (where intolerant to ACEI except for people of African or
Caribbean origin at step 2where ARB are oreferred to ACE) in line with
NICE guidance, dose range 25-100mg once daily

Renal protection in Type 2 DM with nephropathy: (where intolerant to
ACEI) initially 50mg daily, increased after one month to 100mg daily
according to blood pressure

Heart failure: (>60 yrs; ACE intolerant; LVEF <40% & clinically stable).
Patients with heart failure who have been stabilised with an ACE
inhibitor should not be switched to losartan. Initially 12.5mg, titrated at
weekly intervals to usual maintenance dose of 50mg, as tolerated by
patient.
2mg tablets:£2.72 (7)
4mg tablets:£0.89 (7)
8mg tablets:£1.72
16mg tablets: £2.12
32mg tablets: £3.05
Candesartan is included in the formulary for:
40mg capsules:£1.49
80mg capsules:£1.89
160mg capsules:£2.58
Valsartan is only included in the formulary for:

Hypertension: (where intolerant to ACEI) in line with NICE guidance,
dose range 2-16mg daily

Heart failure: (where intolerant to ACEI) as per guidelines, titrated to
32mg daily if possible.

Post-MI: (where symptomatic heart failure and intolerant to ACEI),
initially 20mg bd, titrated to 160mg bd where tolerated

Not included for hypertension
Page 22
Therapeutic Area
Formulary Choices
Cost for 28
Rationale for decision / comments
(unless otherwise stated)
Centrally acting
antihypertensive
drugs
Methyldopa
Moxonidine
Alpha-blockers
Doxazosin
as Doxadura®
Cardiovascular system
125mg tablets: £55.79 (56)
250mg tablets: £6.33 (56)
500mg tablets: £9.39 (56)
Methyldopa is included in the formulary for:
200mcg tablets: £2.47
300mcg tablets: £2.67
400mcg tablets: £2.80
Moxonidine is included in the formulary for:
1mg tablets: £0.90
2mg tablets: £0.94
4mg tablets: £1.09
Doxazosin is included in the formulary for:
1mg tablets: £0.81
2mg tablets: £0.84
4mg tablets: £1.03
 Benign prostatic hyperplasia: See section 7
NB. Doxazosin MR (Cardura XL®) tablets are specifically not recommended for
maintenance in hypertension and maximum licensed dose for other indications
is 8mg. Stabilised hypertensive patients on Doxazosin MR tablets should be
switched to standard 4mg tablets:



Hypertension in pregnancy
Hypertension: For treatment of resistant hypertension at Step 4 where
BP remains sub-optimally controlled despite standard therapies.
Hypertension: For treatment of resistant hypertension at Step 4 where
BP remains sub-optimally controlled despite standard therapies.

Doxazosin MR 4mg one daily → Doxazosin 4mg one daily

Doxazosin MR 8mg one daily → Doxazosin 4mg two daily
Page 23
Summary of
Antihypertensive
Drug Treatments
Step 1
Aged under 55 years
Step 3
Step 4
Resistant
hypertension
Cardiovascular system
(NICE CG127)
ACE inhibitor or ARB
(sartan)
Calcium channel blocker (CCB)
(Choose a low cost ARB)
(a CCB is preferred but consider a thiazide-like diuretic if CCB
not tolerated or person has oedema, evidence of HF or high risk
of HF) [New 2011]
*If choosing an ARB (sartan)
Step 2
Aged over 55 years or black
person of African or
Caribbean origin of any age
ACE inhibitor or ARB (sartan)
+ Calcium channel blocker
(CCB)
ACE inhibitor or ARB (sartan)
+ Calcium channel blocker
(CCB)
+ Thiazide-like diuretic
ACE inhibitor or ARB (sartan)
+ Calcium channel blocker (CCB)
+ Thiazide-like diuretic
+ consider further diuretic or alphablocker or beta-blocker
Consider seeking expert advice
For black people of African or Caribbean
origin, consider an ARB (sartan) in preference
to an ACEI, in combination with CCB [new
2011]
If diuretic treatment is to be initiated or
changed, offer a thiazide-like diuretic such as
indapamide 1.5mg MR or 2.5mg daily in
preference to conventional thiazide diuretics
[new 2011]
Consider a low dose of spironolactone (25mg once
daily) if blood K is ≤4.5mmol/l or higher doses of a
thiazide-like diuretic if >4.5mmol/l. [New 2011]
Spironolactone does not have a UK marketing license for
this indication.
Informed consent should be obtained and documented
Consider an α-blocker or β-blocker if further
diuretic therapy is not tolerated, or
contraindicated or ineffective
Page 24
Cardiovascular system
Page 25
Prescribing Guidelines for HEART FAILURE
This guidance is not intended to replace NICE CG108 Chronic heart failure (Aug-10), but provides primary care prescribers with a summary of key points
relevant in practice.
Aims of treatment
 To relieve symptoms
 To improve exercise tolerance
 To reduce incidence of acute exacerbations
 To reduce hospitalisations
 To reduce mortality
First-line treatment
Offer both angiotensin-converting enzyme (ACE) inhibitors and beta-blockers licensed for heart failure, to all patients with heart failure due to left ventricular
systolic dysfunction (LVSD). Clinical judgement should guide which drug to start first.
ACE Inhibitors (first-line treatment)
An ACE inhibitor is recommended for ALL patients with asymptomatic LVSD or symptomatic heart failure (unless contra- indicated).
Start with a low dose and titrate upwards at short intervals (e.g. not less than 2 weeks). Where possible, ACE inhibitor treatment should be titrated up to the
highest licensed dose which is tolerated. GPs considering initiating ACE inhibitor therapy should consider specialist supervision and/or particularly careful
monitoring for those patients:

receiving multiple or high dose
diuretics (≥ furosemide 80mg)

with hypovolaemia

with hyponatraemia (<130mmol/l)

with pre-existing hypotension
(systolic < 90mm Hg)

with unstable heart failure

with renal impairment (creatinine >
150mmol/l)

receiving high-dose vasoldilator
therapy

aged 70 years or more
NB: A small dose of an ACE inhibitor is better than no ACE inhibitor at all.
Because of the risk of hypotension, especially in patients with hypovolaemia, consideration should be given to withholding or reducing the dose of diuretics for
24 hours prior to commencement of an ACE inhibitor. Where possible all ACE inhibitors should be used in a single daily dose to aid compliance and costeffectiveness.
Formulary recommended ACE inhibitors;

LISINOPRIL initially 2.5-5mg ONCE DAILY, titrated up to 30-35mg ONCE DAILY, or

RAMIPRIL initially 2.5mg ONCE DAILY (1.25mg if already prescribed a diuretic), titrated up to 10mg ONCE DAILY
Monitoring: serum urea, creatinine, electrolytes and eGFR at initiation and after each dose increment
Cardiovascular system
Page 26
Beta-blockers (first-line treatment)
Offer beta-blockers licensed for heart failure to all patients with heart failure due to left ventricular systolic dysfunction, including:
•
•
older adults and
patients with:
o peripheral vascular disease
o erectile dysfunction
o diabetes mellitus
o interstitial pulmonary disease and
o chronic obstructive pulmonary disease (COPD) without reversibility.
Beta-blocker therapy should be initiated by those experienced in the management of heart failure and should commence at a very low dose and titrated up by
doubling doses at intervals of not less than two weeks. Heart rate, blood pressure and clinical status should be assessed after each titration. Symptoms may
deteriorate initially, calling for adjustment of concomitant therapy, such as temporary increase in dose of diuretics.
Stable patients who are already taking a beta-blocker for a comorbidity (for example, angina or hypertension), and who develop heart failure due to left
ventricular systolic dysfunction, should be switched to a beta-blocker licensed for heart failure.

Formulary recommended
beta-blocker for heart failure;

BISOPROLOL initially 1.25mg ONCE DAILY, titrated according to response and tolerability to 10mg ONCE DAILY
Where an alternative to bisoprolol is required, for example where there is intolerance or concern that unopposed beta-blockade may be undesirable;
Carvedilol should be considered as the appropriate alternative beta-blocker for heart-failure patients. There is also a stronger evidence base for carvedilol in
those patients with higher grades of heart failure and its use may be preferred in this situation. Prescribers should be aware that carvedilol requires twice-daily
dosing and the implications of this for compliance with therapy should be taken into account when selecting a beta-blocker for heart failure.
NB. Although doses of beta-blockers should be titrated to the maximum tolerated, a small dose of a beta-blocker is better than no beta-blocker at all.
Second-line treatment
Seek specialist advice and consider adding one of the following if a patient remains symptomatic despite optimal therapy with an ACE inhibitor and a betablocker:
•
•
•
an aldosterone antagonist licensed for heart failure (especially if the patient has moderate to severe heart failure [NYHA class III–IV] or has had an MI
within the past month) or
an angiotensin II receptor antagonist (ARB) licensed for heart failure (especially if the patient has mild to moderate heart failure [NYHA class II–III]) or
hydralazine in combination with nitrate (especially if the patient is of African or Caribbean origin (not including mixed race) and has moderate to
severe heart failure [NYHA class III–IV])
Cardiovascular system
Page 27
Aldosterone antagonists (second-line treatment)
Formulary recommended aldosterone antagonist for heart failure;

SPIRONOLACTONE initially 25mg each morning, reducing to 12.5mg daily or 25mg on alternate days if necessary
Monitoring: serum potassium, creatinine, & eGFR required at baseline, week 2, week 4, and monthly thereafter
Although the doses of spironolactone recommended for use in heart failure are much lower than those used for ascites, there is still a significant risk of
electrolyte disturbance.
Patients who have had an acute MI and who have symptoms and/or signs of heart failure and LVSD, should be prescribed an aldosterone antagonist licensed
for post-MI treatment. This should be initiated within 3–14 days of the MI, preferably after ACE inhibitor therapy.
Formulary recommended aldosterone antagonist for signs or symptoms of heart failure post-MI;

EPLERENONE initially 25mg ONCE DAILY, increased within 4 weeks to 50mg ONCE DAILY
Monitoring: serum potassium, creatinine, & eGFR required at baseline, week 2, week 4, and monthly thereafter
Angiotensin Receptor Blockers (ARBs) (second-line or alternative first-line treatment)
The weight of evidence supporting use of ARBs in heart failure is not as robust as it is for use of ACE inhibitors and therefore an ARB can only be
recommended for those patients who are intolerant of ACE inhibitor therapy due to intractable cough.
On the basis of the currently available evidence, candesartan and losartan are the only ARBs licensed for use in heart failure.
The combination of an ACE-inhibitor, a potassium-sparing diuretic (e.g. spironolactone), and an ARB is not recommended and should be considered only
after careful consideration of the potential benefits and risks.
Formulary recommended ARB;


LOSARTAN initially 12.5mg ONCE DAILY, increased at 1 - 2 weekly intervals, to 50mg ONCE DAILY
CANDESARTAN initially 4mg ONCE DAILY, doubling the dose at intervals of no less than 2 weeks, to 32mg ONCE DAILY
Monitoring: serum potassium, creatinine, & eGFR required at baseline, week 2, week 4, and monthly thereafter
The triple combination of Valsartan, ACE inhibitor and beta-blocker should be avoided, based on current evidence.
As with ACE inhibitors, it is recommended to exert particular care when using ARBs in the patient groups who are at greater risk of complications and
consideration given to specialist input where appropriate.
Hydralazine in combination with a nitrate (alternative first-line treatment)
Hydralazine in combination with nitrate can be considered for patients with heart failure due to LVSD who are intolerant of ACE inhibitors and ARBs. Seek
specialist advice.
Cardiovascular system
Page 28
Third-line treatment
Digoxin is appropriate for patients with atrial fibrillation and any degree of heart failure. It is also recommended for those with worsening or severe heartfailure due to LVSD who remain symptomatic despite treatment with an ACE Inhibitor and a beta blocker.
Digoxin may improve symptoms, exercise tolerance and reduce hospitalisations. Digoxin has not been shown to reduce mortality. Hypokalaemia predisposes
to digoxin toxicity so careful monitoring of U&Es is required, especially where patients are also prescribed loop or thiazide diuretics, particularly if an ACE
inhibitor, ARB or spironolactone is not co-prescribed.
Formulary recommendation;

DIGOXIN 62.5mcg - 125mcg ONCE DAILY (higher doses are rarely appropriate in heart failure not associated with AF)
Monitoring: serum urea & electrolytes, particularly potassium, creatinine, & eGFR required
Diuretics
A diuretic is usually required by most patients with heart failure to reduce symptoms of fluid overload, reduce hospitalisation due to acute exacerbation and
increase exercise tolerance. The dose should be titrated (up and down) according to need following the initiation of subsequent heart failure therapies.
Formulary recommended loop diuretic;

FUROSEMIDE 20mg - 40mg ONCE DAILY (in the morning), titrated according to symptomatic response
Monitoring: serum urea & electrolytes, creatinine, & eGFR required
A thiazide diuretic may be of benefit in patients with mild heart failure and good renal function; however thiazides are ineffective in patients with poor renal
function.
Formulary recommended thiazide diuretic;

BENDROFLUMETHIAZIDE 2.5mg ONCE DAILY (in the morning)
Monitoring: serum urea & electrolytes, creatinine, & eGFR required
If diuresis with one diuretic is insufficient, a combination of loop diuretic and thiazide may be tried.
Metolazone may still be recommended but has been discontinued in the UK. AMBER in Traffic Light Guidance (TLG).
Indapamide combined with furosemide has been found to be effective in a small trial of patients with massive oedema although this is an unlicensed use.
(M. Tanaka et al. (2005) The Na+-excreting efficacy of indapamide in combination with furosemide in massive edema. Clinical and Experimental Nephrology,
9: 122-126)
Cardiovascular system
Page 29
Calcium channel blockers
No Calcium channel blocker is licensed for the treatment of heart failure.
The use of calcium channel blockers with a direct effect on cardiac contractility i.e. verapamil or diltiazem should be specifically avoided in heart failure.
For those patients who develop heart failure or are at high risk of heart failure NICE CG127 (Aug-11) recommends they should be changed to a thiazide-like
diuretic in place of a CCB.
Where continuation of a dihydropyridine calcium channel blocker is considered essential for control of hypertension or angina, this may be justified where use
of other therapies such as beta-blocker, ACE-inhibitor and diuretic has been optimised.
Ivabradine
Initiation only for patients on maximum therapy & with heart rate > 75 beats per minute
NICE TA267 Ivabradine for Treating Chronic heart failure - recommends ivabradine as a possible treatment for people with chronic heart failure provided the
following conditions are all met.

New York Heart Association (NYHA) class II to IV stable chronic heart failure with systolic dysfunction

who are in sinus rhythm with a heart rate of 75 beats per minute or more

who are given ivabradine in combination with standard therapy including beta-blocker therapy, angiotensin-converting enzyme (ACE) inhibitors
and aldosterone antagonists, or when beta-blocker therapy is contraindicated or not tolerated (after 4 week period of stabilisation on these meds)

with a left ventricular ejection fraction of 35% or less
Initiation may be by GP with special interest (GPwSI) or heart failure specialist nurse.
Cardiovascular system
Page 30
NHS SOMERSET: Heart Failure Prescribing Guidelines
Algorithm adapted from NICE CG108 by the Medicines Management team, October 2010
For further details please refer to the full CCG guidance above and to NICE Clinical Guideline 108: Chronic heart failure
STANDARD TREATMENT FOR
PATIENTS WITH HEART FAILURE
DUE TO LVSD
OR
WITH PRESERVED EJECTION
FRACTION
New diagnosis of heart failure
with preserved ejection fraction
New diagnosis of heart failure
due to left ventricular systolic dysfunction
Manage comorbid conditions such as
high blood pressure, ischaemic heart
disease and diabetes mellitus in line
with relevant NICE guidance
FIRST LINE TREATMENT
Start ACE-inhibitor OR beta-blocker licensed for heart failure
Clinical judgement should guide which to start first
e.g. Lisinopril or Bisoprolol, and titrate upwards
If ACE-inhibitor not tolerated, trial a second ACE-inhibitor
If second ACE-inhibitor not tolerated, considering an ARB (Losartan)
If ARB not tolerated, consider hydralazine plus a nitrate
Offer rehabilitation and education
Diuretics should be prescribed for
the relief of congestive symptoms
and fluid retention.
Start ACE-inhibitor OR beta-blocker licensed for heart failure
Which ever is not yet prescribed, and titrate upwards
The dose should be titrated up and
down according to the patients’
need following initial and
subsequent heart failure therapies
Ensure both therapies are prescribed at maximum tolerated dose
Specialist
assessment
Ivabradine – option
For consultant initiation only for
patients on maximum therapy &
with heart rate > 75 beats per
minute, in sinus rhythm – see
p.26
Cardiovascular system
SECOND LINE TREATMENT
If patient remains symptomatic, seek specialist advice and consider
adding spironolactone, an ARB (Losartan), or hydralazine plus a
nitrate.
THIRD LINE TREATMENT
If symptoms persist, consider digoxin
Page 31
Prescribing guideline post myocardial infarction -Drug therapy CG 172 secondary Prevention of MI
 Offer all people who have had an acute MI treatment with the following drugs:
o ACE (angiotensin-converting enzyme) inhibitor
o dual antiplatelet therapy (aspirin plus a second antiplatelet agent)
o beta-blocker
o statin.
 Offer an assessment of left ventricular function to all people who have had an MI.
 Titrate the ACE inhibitor dose upwards at short intervals (for example, every 12–24 hours) before the person leaves hospital until the
maximum tolerated or target dose is reached. If it is not possible to complete the titration during this time, it should be completed within 4–
6 weeks of hospital discharge.
 Communicate plans for titrating beta-blockers up to the maximum tolerated or target dose – for example, in the discharge summary.
Offer an ACEI and aspirin to patients who have had an MI >12 months ago and also a β blocker to patients with LVSD whether symptomatic or not
(new for 2013) ACE intolerant should be offered an ARB. Statins are recommended for all patients with established cardiovascular disease.
NICE does not specify preferred ACE and β blockers
Medicines with licence post MI
ACEI
Target dose
Max dose Cr Cl >60
ml/min
Max dose CrCl 30-60ml/min
Max dose CrCl 1030ml/min
Ramipril (with or without heart
10mg
10mg
5mg
5mg
Lisinopril
10mg
Licensed for short term (6 week) use in Post MI
Perindopril
8mg
4mg
Captopril (only with LV failure)
100mg
License is 4 weeks
failure)
2mg
2mg alternate days
No data
No data
ARB
Valsartan
Seek secondary care advice
β blocker
Bisoprolol
10mg
Metoprolol,propranolol,
timolol or atenolol
Seek secondary care advice
Cardiovascular system
No data
Page 32
Therapeutic Area
Formulary Choices
Cost for 28
Rationale for decision / comments
(unless otherwise stated)
2.6 Nitrates, calcium channel blockers and potassium channel activators
Nitrates
ISMN First line:
ISMN second line:
Glyceryl trinitrate
(GTN) spray
as Nitromin®
Isosorbide
mononitrate
Instant release
Glyceryl trinitrate is included in the formulary for:
400mcg: £3.44 (200 dose)
400mcg: £2.63 (180 dose)
10mg: £13.09 (56)
20mg: £14.08 (56)
40mg: £12.89 (56)
Sustained-release
as Tardisc XL
60mg tablets: £3.49 (28)
Current generic price:
£10.50 (28)
 Angina: for as required use for relief of symptoms
Note that GTN tablets are now significantly more costly than spray
Isosorbide Mononitrate is included in the formulary for:
Angina: for prophylaxis of symptoms as monotherapy where intolerance
or C/I to use of a beta-blocker or rate-limiting CCB. As combination
therapy with beta-blocker or CCB where monotherapy provides
insufficient control.
First line is to prescribe standard Isosorbide mononitrate tablets asymmetrically
to ensure a nitrate free period is maintained to reduce nitrate tolerance e.g.
20mg bd at 6-8am and 2-4pm.
If patients cannot comply with this regime, MR preparations should be
prescribed by brand (Tardisc XL for 60mg) and only given once-daily to
reduce nitrate tolerance.
Where Isosorbide mononitrate has been added to provide symptom control
pending angioplasty or CABG, consideration should be given to cautious
withdrawal after successful completion of and recovery from the procedure
ISOSORBIDE DINITRATE is NON-FORMULARY except where initiated by
a specialist for left ventricular failure
Cardiovascular system
Page 33
Primary Care Guidelines for the Drug Treatment of Chronic Stable Angina Pectoris
Preventing
and treating
episodes of
Angina
Stable angina for medical management
Short-acting sublingual spray or
buccal nitrate prn
Disp Aspirin 75mg od (+/- PPI) plus
Atorvastatin 80mg. Target cholesterol
as per any co-morbidity (eg diabetes)
and relevant NICE guidance plus
Contraindication
(e.g. proven allergy to aspirin)
Clopidogrel 75mg od (+/-) Pantoprazole
Reduce dose of atorvastatin if
any interactions
or high risk of adverse effects
or patient choice
If patient is intolerant of atorvastatin, try
simvastatin, pravastatin or rosuvastatin
or (due to lack of evidence) final option
is ezetimibe
ACE (Ramipril or Lisinopril) in proven
CVD titrated to max tolerated dose
Treatment
aimed at relief
of symptoms
Version 5 October 2014
1ST Line - Beta-blocker (bisoprolol) or
Calcium antagonist (Amlodipine) titrate to
maximum tolerated dose
Symptoms not controlled
2nd
Line Beta blocker AND calcium antagonist
(amlodipine)
Symptoms controlled do not offer a third drug
Intolerant (e.g. fatigue) or
contraindication to 1st drug
Intolerant to both Beta-Blocker
and Calcium Antagonist
*Discontinue ivabradine if resting heart
rate becomes too low <60 bpm or
symptoms of bradychardia persist
Consider 3rd drug ONLY when symptoms not controlled on 2 drugs AND the person is waiting for
revascularisation or revascularisation is not considered appropriate or acceptable
MR nitrate (Tardisc XL £3.49) or
Nicorandil 20mg (£10.53) or
Ivabradine* (£40.17) or Ranolazine (£48.98) based
on CI, preference and cost
Cardiovascular system
DO NOT OFFER A
4th DRUG
Consider switch of 3rd Line
drug
Switch to other option as monotherapy
(Amlodipine)
Symptoms not controlled
MR nitrate (Tardisc XL £3.49) or
Nicorandil 20mg (£10.53) or
Ivabradine* (£40.17) or Ranolazine
(£48.98) based on CI, preference and cost
Symptoms controlled do not offer a third drug
ANGINA not responded to treatment
Re-evaluation and advice eg Skills to modify
cognitions and behaviours associated with pain
and self manage pain
Review drug treatment and revascularisation
Page 34
Therapeutic Area
Formulary Choices
Cost for 28
Rationale for decision / comments
(unless otherwise stated)
Calcium channel blockers – Dihydropyridines
First line:
Amlodipine
as Amlostin®
Second line:
Lercanidipine
5mg tablets: £0.89
10mg tablets: £0.94
NB. Avoid short-acting dihydropyridines in BP, CHD and CCF.
Amlodipine is first line CCB, with lercanidipine as a second line option for:
5mg tablets: £0.80
10mg tablets: £0.85
 Hypertension: in line with NICE guidance
10mg tablets: £1.55
20mg tablets: £1.86
 Angina: as monotherapy where intolerance or C/I to use of a beta-blocker
or rate-limiting CCB. As combination therapy with beta-blocker where
monotherapy provides insufficient control.
NB: When prescribing Amlodipine generically, this should be as plain
Amlodipine. Prescriptions for Amlodipine besilate will result in the supply of
Istin® and incur significantly greater costs.
Calcium channel blockers - Rate limiting
Prescribe by brand
Diltiazem
Modified-release
as Zemtard XL

Once daily dose
120mg m/r capsules: £6.10
180mg m/r capsules: £6.20
240mg m/r capsules: £6.30
300mg m/r capsules: £6.70
Verapamil
Immediaterelease
Prescribe by brand
 Angina: as monotherapy where intolerance or C/I to use of a beta-blocker.
In combination with a beta-blocker where monotherapy provides insufficient
control. NB: Caution required due to risk of bradycardia and heart-block.
 Hypertension: For treatment of resistant hypertension at Step 4 where BP
remains sub-optimally controlled despite standard therapies.
NB. Prescribing Diltiazem MR as the formulary preferred Zemtard XL brand
ensures continuity of supply, as recommended nationally.
Verapamil should not be combined with a beta-blocker for any indication due
to high risk of bradycardia and heart-block
40mg tablets: £1.66 (84)
80mg tablets: £2.10 (84)
Modified-release
Half-Securon SR 120mg m/r tablets: £7.71
Securon SR
240mg m/r tablets: £5.55
Cardiovascular system
Diltiazem XL (as Zemtard XL) is included in the formulary for:
Verapamil is included in the formulary for:
 Angina: as monotherapy where intolerance or C/I to use of a beta-blocker.
 Hypertension: For treatment of resistant hypertension at Step 4 where BP
remains sub-optimally controlled despite standard therapies.
Page 35
Therapeutic Area
Formulary Choices
Cost for 28
Rationale for decision / comments
(unless otherwise stated)
2.6.3
Other antianginal drugs
Potassium Channel
Activator
Nicorandil
10mg: £3.73 (60)
20mg: £7.33 (60)
Where Nicorandil has been added for symptom control pending angioplasty or
CABG, strong consideration should be given to cautious withdrawal after
successful completion of and recovery from the procedure.
Nicorandil is associated with oral, anal, gi & para-stomal ulceration & delayed
wound healing. Addition of a PPI is ineffective to promote healing – cessation
of the drug is needed.
Sinus Node
Regulator
Ivabradine*
5mg: £40.17
7.5mg: £40.17
GREEN for medical management of Stable angina: in line with NICE CG126
See guide p.34.
AMBER for management of heart failure (see guidelines page 26)
Other
2.6.4
Ranolazine
375mg: £48.98 (60)
500mg: £48.98 (60)
750mg: £48.98 (60)

QT prolongation may be exacerbated by heart rate reduction. The ue of
ivabradine with other drugs which prolong QT interval eg citalopram,
diltiazem, should be avoided.

If the combination appears necessary, close cardiac monitoring is needed.

Hypokalaemia and hypomagnesaemia can increase the risk of arrhythmia
especially in patients with long QT interval, whether congenital or
substance-induced eg with potassium-depleting diuretics (thiazide diuretics
and loop diuretics). Caution & careful monitoring is needed.
*Ivabradine: MHRA alert June 2014 emerging clinical trial evidence of
increased cardiovascular risk—carefully monitor for bradycardia
Included for medical management of Stable angina: in line with NICE CG126
See guide p.34
Peripheral vasodilators and related drugs
Related guidance: NICE Technology Appraisal TA223 (2011): Treatment of intermittent claudication in people with peripheral vascular disease
Vasodilators
Naftidrofuryl
100mg capsules: £6.58 (84)
Naftidrofuryl oxalate is recommended as an option for the treatment of
intermittent claudication in people with peripheral arterial disease for whom
vasodilator therapy is considered appropriate after taking into account other
treatment options (NICE TA223)
Cilostazol, pentoxifylline and inositol nicotinate are not recommended for the
treatment of intermittent claudication in people with peripheral arterial disease.
Cardiovascular system
Page 36
Therapeutic Area
Formulary Choices
Cost for 28
Rationale for decision / comments
(unless otherwise stated)
2.8 Anticoagulant drugs
Parenteral
anticoagulants
Related guidance: NICE Clinical Guideline CG92 (2010): Venous thromboembolism – reducing the risk
A Shared Care agreement is available for the use of Enoxaparin in pregnancy
Enoxaparin
Pre-filled syringes
20mg/0.2ml: £22.72 (10)
40mg/0.4ml: £30.27 (10)
60mg/0.6ml: £45.65 (10)
80mg/0.8ml: £64.86 (10)
100mg/1ml: £80.33 (10)
120mg/0.8ml: £97.70 (10)
150mg/1ml: £111.01 (10)
Enoxaparin is licensed for the prophylaxis and treatment of venous
thromboembolism; treatment of unstable angina, non-Q-wave myocardial
infarction, acute ST-segment elevation myocardial infarction (STEMI);
prevention of thrombus formation in the extracorporeal circulation during
haemodialysis.
NB. Dalteparin is licensed for treatment of symptomatic VTE and prevention of
its recurrence, in patients with solid tumours
Management of haemorrhage: haemorrhage is the main adverse effect of all oral anticoagulants. Checking the INR and omitting doses is essential. If the
anticoagulant is stopped but not reversed, the INR should be checked again after 2 to 3 days to ensure that it is falling. The following recommendations apply to
patients taking Warfarin and are based on the result of the INR and whether there is major or minor bleeding:
Major bleeding: stop Warfarin; give Phytomenadione (Vitamin K1) 5-10mg by slow intra-venous injection; give prothrombin complex concentrate (factirs II, VII,
IX and X) 30-50units/kg (or if no concentrate available) fresh frozen plasma 15ml/kg.
INR> 8.0, no bleeding or minor bleeding: stop Warfarin, re-start when INR < 5. If there are other risk factors for bleeding, give Phytomenadione (Vitamin K 1)
500mcg by slow intra-venous injection or 5mg by mouth, (for partial reversal of anticoagulation give smaller oral doses of Phytomenadione e.g.
0.5mg - 2.5mg, using the intravenous p reparation orally); repeat dose of Phytomenadione if INR still too high after 24 hours.
See Chapter 9 for details of Phytomenadione preparations on the formulary.
2.8.2
Oral anticoagulants
Coumarins
Management of patients on warfarin should be in line with the National Enhanced Service specification.
Refer to National Patient Safety Agency (NPSA) guidance on safe practices around use of anticoagulants.
Warfarin
Continued overleaf
Cardiovascular system
500mcg tablets: £1.40
1mg tablets: £0.89
3mg tablets: £0.93
5mg tablets: £0.98
Warfarin is included in the formulary for the following indications (with target
INRs):

Atrial fibrillation: target INR = 2.5

Treatment of DVT or PE: target INR = 2.5

Recurrent DVT or PE: target INR = 3.5

Mechanical prosthetic heart valves: target INR dependent on type and
location of valve. Generally a target INR of 3 is recommended for
mechanical aortic valves and a target INR of 3.5 for mechanical mitral
valves
Page 37
Therapeutic Area
Formulary Choices
Cost for 28
Rationale for decision / comments
(unless otherwise stated)
New Oral
Anticoagulants
(NOACs)
For primary care prescribing see NICE guidance on:

Dabigatran for the prevention of stroke and systemic embolism in atrial fibrillation – TA249

Dabigatran for the treatment and secondary prevention of deep vein thrombosis and/or pulmonary
embolism – TA327

Rivaroxaban – TA256, TA261, TA287
Apixaban – TA275
Primary prevention of venous thromboembolic events in adult patients after elective total hip replacement
surgery or total knee replacement surgery is hospital prescribing only: (see NICE TA157 Dabigatran,
NICE TA170 Rivaroxaban, and NICE TA245 Apixaban. The full course should be supplied when the procedure
is carried out & there should be no requirement to prescribe for either 10mg rivaroxaban or 75mg dabigatran in
primary care. (RED Indication in TLG)
Direct thrombin
Inhibitor
Cardiovascular system
Dabigatran
75mg capsules: £65.90 (60)
75mg only for after
elective knee & hip
surgery in some
patients – RED
110mg capsules:£65.90 (60)
150mg capsules:£65.90 (60)
Dabigatran is included for

Prevention of stroke & systemic embolism for people with non-valvular
atrial fibrillation where patients fit the criteria in NICE TA249. See
Implementation priorities.

Treatment of DVT and PE, and prevention of recurrent DVT and PE in
adults. TA327
See note above for use post elective hip & knee replacement (NICE TA157).
Page 38
Therapeutic Area
Formulary Choices
Cost for 28
Rationale for decision / comments
(unless otherwise stated)
Direct inhibitor of
activated Factor X
Rivaroxaban
10mg tablets: £63.00 (30)
10mg only for after
elective knee & hip
surgery – RED
15mg tablets: £58.80 (28)
20mg tablets: £58.80 (28)
 For the prevention of stroke & systemic embolism for people with nonvalvular atrial fibrillation in accordance with NICE TA256. See p50 for
implementation priorities
and;
 For treating and preventing deep vein thrombosis (DVT) and pulmonary
embolism (PE) in adults in accordance with NICE TA261
and;
 An option for treating pulmonary embolism and preventing recurrent deep
vein thrombosis and pulmonary embolism in adults in accordance with
NICE TA287
and;

As an option to treat signs and symptoms of DVT
and

15mg and 20mg strengths for prevention of cardiovascular disease in
patients with atrial fibrillation undergoing cardioversion
See note above for use post elective hip & knee replacement (NICE TA170)
Apixaban
Cardiovascular system
2.5mg tablets: £65.90 (60)
2.5mg only for after
elective knee & hip
surgery – RED
5mg tablets: £61.50 (56)
Apixaban is included for the prevention of stroke and systemic embolism in
adult patients with non-valvular atrial fibrillation, with one or more risk factors,
such as prior stroke or transient ischaemic attack (TIA); age ≥ 75 years;
See note above for use post elective hip & knee replacement (NICE TA245).
Apixaban has recently had licence extended to treatment of DVT and PE, and
prevention of recurrent DVT and PE in adults. Awaiting NICE approval on this.
Page 39
Drug interactions for Apixaban, Dabigatran & Rivaroxaban
Drug
Apixaban (APB)
Dabigatran (DBG)
Rivaroxaban (RVB)
Any other anticoagulants
Contraindicated (except when
switching treatments)
Contraindicated (except when
switching treatments)
Contraindicated (except when
switching treatments)
Antiplatelet agents – assess risk/need
balance
Increased risk of bleeding
Increased risk of bleeding
Increased risk of bleeding
Strong CYP34A Inducer
eg. Rifampicin, phenytoin,
carbamazepine, St Johns Wort
Caution ↓apixaban plasma levels
and increased bleeding risk
AVOID ↓dabigatran plasma levels
CAUTION ↓rivaroxaban plasma levels
Strong CYP34A and P-gp Inhibitors:
1. Systemic Azole-antimycotics (eg
itraconazole, ketoconazole)
Avoid ↑ bleeding risk
Contra-indicated
Avoid ↑ bleeding risk
2. HIV Protease Inhibitors
Avoid ↑ bleeding risk
Not studied – combination not
recommended
Avoid ↑ bleeding risk
3. Ciclosporin, tacrolimus
Contra-indicated
No data
Strong CYP3A4 and moderate P-gp
inhibitors
1. Clarithromycin, diltiazem, quinidine,
amiodarone, verapamil
No dose reduction.
Caution ↑dabigatran plasma levels
(especially in renal impairment)
Verapamil – reduce dose (see SPC
for detail)
↑rivaroxaban plasma levels, not
considered clinically relevant but
Caution if renal impairment
2. Dronedarone
No data in SPC
Contra-indicated
Avoid – limited clinical data
SSRIs/SNRIs/NSAID (including aspirin)
Increased risk of bleeding
Increased risk of bleeding
Increased risk of bleeding
All data sourced from SmPCs for APB, DBG, RVB
Cardiovascular system
Page 40
Decision aid for patients requiring stroke prevention in AF (there are no head-to-head trials between NOACS, and trials vs warfarin had
different entry criteria))
Rivaroxaban▼
Apixaban ▼
20mg OD
5mg BD
FXa inhibitor
FXa inhibitor
Treatment of deep vein thrombosis (DVT) and
pulmonary embolism (PE), and prevention of recurrent
DVT and PE in adults.
Prevention of stroke and systemic embolism in adults
with NVAF with ≥1 risk factor:
 Previous stroke, TIA, or systemic embolism (SEE)
 Left ventricular ejection fraction < 40 %
 Symptomatic heart failure, ≥ NYHA Class 2
 Age ≥ 75 years
 Age ≥ 65 years with diabetes mellitus, coronary
artery disease, or hypertension
Treatment of DVT and PE
Prevention of recurrent DVT and PE
in adults
Prevention of stroke and systemic
embolism in adults with NVAF with
≥1 risk factor:
 congestive heart failure,
 hypertension
 age ≥ 75 years
 diabetes mellitus
 prior stroke or TIA.
Prevention of cardiovascular
disease in AF patients undergoing
cardioversion
Treatment of deep vein thrombosis
(DVT) and pulmonary embolism (PE),
and prevention of recurrent DVT and
PE in adults.
Warfarin
Dabigatran
Dose
Variable OD
110mg BD
Class
Vitamin K antagonists (VKA)
Direct thrombin inhibitor
Licensed indications
(primary care prescribing)




Prophylaxis of systemic embolism
in rheumatic heart disease and AF
Prophylaxis after insertion of
prosthetic heart valves
Prophylaxis and treatment of VTE
and PE
Transient attacks of cerebral
ischaemia
150mg BD
Prevention of stroke and systemic
embolism in adults with NVAF, with ≥1
risk factor:
 prior stroke or TIA
 age≥ 75 years
 hypertension
 diabetes mellitus
 symptomatic heart failure ≥ NYHA
Class 2
Comparator
 NICE TA249
 NICE TA256
 NICE TA275
VTE tx and
prevention
Comparator
 NICE TA327
 NICE TA261

PE & recurrent VTE
Comparator
 NICE TA327
 NICE TA287

Stroke and systemic
embolism Risk
Comparator
Non‐inferior
Non‐inferior
Superior
Mortality
Comparator
No difference
No difference
Life‐ threatening
bleed / ICH & major /
minor bleeding
Comparator
 Lower risk (both strengths)
 Lower risk
 All‐cause mortality 11%
 Lower risk
Major bleed
Comparator
 Lower risk
Major GI bleeding
Comparator
No difference
Must take with food?
No
No
Dose frequency
OD
BD
OD
BD
Initiation
Variable
Stroke & SEE: no change
Stroke & SEE: no change
DVT & PE:
15mg BD 21/7
Stroke & SEE: no change
Elderly (>80 years)
INR dependent as for other age
groups
No dose change.
If also ≤ 60kg and / or serum
creatinine ≥1.5mg/dl (133μmole/l): 
dose (2.5mg BD)
Drug-drug interactions
CYP2C9
CYP1A2
CYP3A4 inhibitors
CYP3A4
P-glycoprotein
CYP3A4
P-glycoprotein
Bleeding risk
NICE
NVAF Stroke and
SEE prevention
Cardiovascular system
 Superior
No difference
No difference
Higher risk
Higher risk
Yes
 dose (110mg BD)
P-glycoprotein
 Lower risk
No difference
No
Page 41
Dose
Warfarin
Dabigatran
Variable OD
110mg BD
150mg BD
Rivaroxaban▼
Apixaban ▼
20mg OD
5mg BD
Can be added to MDS compliance
aids
Can be added to MDS compliance aids
Dietary vitamin K
Monitored Dosage System
(see RPS Guidance)
Not suitable for MDS compliance aids
Use with careful monitoring &
specialist advice
Contra‐indicated
Increased bleeding risk (Plasma
levels may be increased (
~ 1.6x )
Renal Impairment
CKD 4 and 5
Cr Cl <30ml/min
Not suitable for MDS compliance
aid inclusion unless NPSA
guidance followed
Cr Cl 15‐29ml/min –use with
caution - reduce to 15mg OD
Cr Cl 15‐29ml/min –reduce dose to
2.5mg bd
Cr Cl <15ml/min –not
recommended
Cr Cl <15ml/min –not
recommended
Advisable to use warfarin if Cr Cl 15‐29ml/min and renal function expected
to deteriorate further.
CKD 3
Cr Cl 30- 49ml/min
 Safe to use: dose INR dependent
Hepatic impairment
Monitor INR more frequently
Use 110mg dose if patient has a high bleeding risk
Reduce the dose to 15mg od.
No information available
Contraindicated in hepatic
disease associated with
coagulopathy and clinically
relevant bleeding risk including
cirrhotic patients with Child
Pugh B & C.
Liver enzymes >2x ULN: not recommended
 No dose adjustment needed
Contraindicated in hepatic
disease associated with
coagulopathy and clinically
relevant bleeding risk.
Not recommended in patients
with severe hepatic impairment
Use with caution in patients
with mild or moderate hepatic
impairment (Child Pugh A or B,
no dose adjustment needed).
Use with caution in patients with
elevated liver enzymes (ALT /
AST >2x ULN) or total bilirubin
≥1.5x ULN.
Antidote for haemorrhage
Vitamin K
No antidote
Supportive care only.
Potential problem where emergency surgery is needed
Not reversible. Early clinical trial
data suggests bleeding effects
completely reversed by Prothrombin
Complex Concentrate (PCC).
Supportive care only.
Potential problem where emergency
surgery needed.
Not reversible. If bleeding is
uncontrolled with supportive measures,
administration of recombinant factor
VIIa may be considered.
Potential problem where emergency
surgery needed.
Prescriber guides &
Patient alert cards








Safety alerts
NPSA: Actions that can make oral
anticoagulant therapy safer
NPSA management guidance
Yellow books available via SBS
(stationary order)
Pradaxa® education resources
Pradaxa® Patient Alert Card
Xarelto® resources
Xarelto® Patient Card
Eliquis® resources.
Eliquis® Patient Alert Card
EHRA / ESC AF Oral Anticoagulation Card for non-vitamin K anticoagulants
MHRA Drug Safety Update Oct 2013 - Revised contraindications for all NOACs
AF = atrial fibrillation; BD = twice daily; DVT = deep vein thrombosis; GI = gastro-intestinal; ICH = intracranial haemorrhage; NYHA = New York Heart Association; NVAF = non-valvular atrial fibrillation; OD = once
daily; PE = pulmonary embolism; SEE = systemic embolic event; TIA = transient ischaemic attack; ULN = upper limit of normal.
Cardiovascular system
Page 42
Reducing the risk of stroke in atrial fibrillation NICE CG180
Guide for health professionals
The NICE guideline recommends that anticoagulation should be considered for men with a CHA2DS2-VASc score of 1 or more and offered to men and women with
a CHA2DS2-VASc score of 2 or more, taking their bleeding risk into account. The guideline recommends that anticoagulation may be with apixaban, dabigatran
etexilate, rivaroxaban or a vitamin K antagonist, and includes the relevant technology appraisals for apixaban, dabigatran etexilate and rivaroxaban. It
recommends that the options for anticoagulation are discussed with the person and the choice based on their clinical features and preferences. The NICE guideline
makes no recommendations for using one anticoagulant over another and no analysis compared the efficacy and safety of apixaban, dabigatran or rivaroxaban
(the novel anticoagulants, or NOACs) with each other or with warfarin, so no similar comparisons have been made in this PDA. The NICE guideline recommends
against the use of aspirin monotherapy solely for stroke prevention to people with atrial fibrillation and makes no recommendations about use of dual antiplatelet
therapy, so these options are not discussed in the PDA.
Assessment of stroke and bleeding risks
Stroke risk
Use the CHA2DS2-VASc stroke risk score to assess stroke risk in people with any of the following:

symptomatic or asymptomatic paroxysmal, persistent or permanent atrial fibrillation

atrial flutter

a continuing risk of arrhythmia recurrence after cardioversion back to sinus rhythm.
Bleeding risk
Use the HAS-BLED score to assess the risk of bleeding in people who are starting or have started anticoagulation. Offer modification and monitoring of the
following risk factors:

uncontrolled hypertension

poor control of international normalised ratio (INR) ('labile INRs')

concurrent medication, for example concomitant use of aspirin or a non-steroidal anti-inflammatory drug (NSAID)

harmful alcohol consumption.
When discussing the benefits and risks of anticoagulation, explain to the person that:

for most people the benefit of anticoagulation outweighs the bleeding risk

for people with an increased risk of bleeding the benefit of anticoagulation may not always outweigh the bleeding risk, and careful monitoring of bleeding risk
is important.
Do not withhold anticoagulation solely because the person is at risk of having a fall.
Cardiovascular system
Page 43
Patient decision aid- please note this is not actual NICE guidance
Cardiovascular system
Page 44
Cardiovascular system
Page 45
Cardiovascular system
Page 46
Bleed risk-HAS-BLED There is little to support a patient decision aid with a HAS-BLED score of 0. The risk is very low whether they take an anticoagulant or not.
Cardiovascular system
Page 47
Cardiovascular system
Page 48
DABIGATRAN IMPLEMENTATION PRIORITIES: FOR PATIENTS WITH NON VALVULAR AF and 1 or more RISK FACTORS





RISK FACTORS
Previous stroke, TIA or systemic embolism
Left ventricular ejection fraction below 40%
Symptomatic heart failure of New York Association (NYHA)
class 2 or above
Age 75 Years or older
Age 65 years or older with one of Diabetes, Coronary
artery disease or hypertension
EXCLUSIONS
DABIGATRAN IS A POWERFUL ANTI-COAGULANT WHICH CAN’T BE REVERSED BY
VITAMIN K
BEFORE CONSIDERATION PATIENTS MUST HAVE AN UP TO DATE RENAL FUNCTION
TEST:
 Creatinine clearance <30ml/min (eGFR <30) =>
use of Dabigatran is contra-indicated do not proceed
 Contra-indicated with ketoconazole, cyclosporine, itraconazole and
tacrolimus (see SPC for full list)
An online eGFR calculator is available at: http://www.renal.org/eGFRcalc/GFR.pl
All new and existing Non Valvular AF patients should discuss with their clinician the risks and benefits of dabigatran compared to warfarin before initiation or switching
1st
2nd
3rd
4th
Patients newly diagnosed with Non Valvular AF – with good medicine
compliance. Dabigatran is NOT suitable for most MDS systems
because product must remain in original packaging.
Age < 80yrs 150mg BD
Age >80yrs 110mg BD
Patients fitting Criteria currently receiving no preventative treatment
Patients fitting Criteria receiving just aspirin – Aspirin offers little
protection against stroke in AF compared to warfarin or dabigatran
Patients with unstable INR on Warfarin or Phenindione. Starting with
those patients most commonly out of treatment range
House Bound
patients
requiring
remote
monitoring of
INR
When clinically relevant bleeding occurs,
treatment should be interrupted. Bleeding can
occur at any site during therapy with
dabigatran. An unexplained fall in haemoglobin
and/or haematocrit or blood pressure should
lead to a search for a bleeding site
Caution - Concomitant administration of
strong P-gp inhibitors (such as amiodarone,
verapamil, quinidine, ketoconazole and
clarithromycin) is expected to result in
increased dabigatran plasma concentrations
and potential increase in bleeding risk
Dabigatran can be given as soon as INR is < 2.0
5th
Patients with stable INR on Warfarin or Phenindione - the risks/
benefits of dabigatran compared to warfarin should be discussed as it
may be appropriate for stable patients to remain on warfarin
Cardiovascular system
FURTHER PRESCRIBER GUIDANCE: electronic Medicines Compendium
and information on renal function, tests & relationship between
creatinine clearance & eGFR here
Page 49
RIVAROXABAN IMPLEMENTATION PRIORITIES FOR PATIENTS WITH NON VALVULAR AF and 1 or more RISK FACTORS





RISK FACTORS
Previous stroke, TIA or systemic embolism
Left ventricular ejection fraction below 40%
Symptomatic heart failure of New York Association (NYHA) class
2 or above
Age 75 Years or older
Age 65 years or older with one of Diabetes, Coronary artery
disease or hypertension
EXCLUSIONS
RIVAROXABAN IS A POWERFUL ANTI-COAGULANT WHICH CAN’T EASILY BE
REVERSED (prothrombin complex concentrate is an option)
BEFORE CONSIDERATION PATIENTS MUST HAVE AN UP TO DATE RENAL FUNCTION
TEST:
 Creatinine clearance <15ml/min (eGFR <20) =>
use of Ribaroxaban is contra-indicated do not proceed
 Contra-indicated with ketoconazole, voriconazole, itraconazole and
dronedarone (see SPC for full list)
An online eGFR calculator is available at: http://www.renal.org/eGFRcalc/GFR.pl
All new and existing Non Valvular AF patients should discuss with their clinician the risks and benefits of rivaroxaban compared to warfarin before initiation or switching
1st
Patients newly diagnosed with Non Valvular AF – with good medicine
compliance. Rivaroxaban is suitable for patients using MDS systems
Dose 20mg ONCE DAILY for all ages
Dose 15mg ONCE DAILY if creatinine clearance 15-49 ml/min
2nd
Patients fitting Criteria currently receiving no preventative treatment
3rd
4th
Patients fitting Criteria receiving just aspirin – Aspirin offers little
protection against stroke in AF compared to warfarin or rivaroxaban
Patients with unstable INR on Warfarin or Phenindione. Start with
those patients most commonly out of treatment range.
House Bound
patients
requiring
remote
monitoring of
INR
If a dose is missed the patient should take
rivaroxaban immediately and continue on the
following day with the once daily intake as
recommended. The dose should not be doubled
within the same day to make up for a missed
dose.
Pregnancy
Safety and efficacy of rivaroxaban have not
been established in pregnant women. Studies
in animals have shown reproductive toxicity
and rivaroxaban passes the placenta.
Contraindicated during pregnancy
Rivaroxaban can be given as soon as INR is < 3.0
5th
Patients with stable INR on Warfarin or Phenindione - the risks/
benefits of rivaroxaban compared to warfarin should be discussed as
it may be appropriate for stable patients to remain on warfarin
Cardiovascular system
FURTHER PRESCRIBER GUIDANCE: electronic Medicines Compendium
and information on renal function, tests & relationship between
creatinine clearance & eGFR here
Page 50
Cardiovascular system
Page 51
Therapeutic Area
Formulary Choices
Cost for 28
Rationale for decision / comments
(unless otherwise stated)
2.9 Antiplatelet drugs
Related guidance: NICE Technology Appraisal TAG210 (2010): Clopidogrel and modified-release dipyridamole
Anti-platelet drugs
Aspirin
75mg dispersible tablets:
£0.80
ATT meta-analysis : Aspirin for primary prevention of CVD
Aspirin is not licensed for the primary prevention of vascular events but there
remains the possibility for particular sub-groups of individuals at higher CV risk
(including conditions such as diabetes) that the risk:benefit of aspirin is
favourable. Until more evidence is available, the use of Aspirin 75mg for
primary prevention should be based on an individual risk assessment.
Aspirin is included in the formulary for:

Secondary prevention of CV events: see notes regarding use in
combination with Dipyridamole or Clopidogrel below
NB There is evidence that:

Aspirin doses >75mg daily increase GI toxicity and general bleed risk
Enteric-coated Aspirin does not reduce GI events and may be less effective
Clopidogrel
Following
consideration of
available evidence
at Somerset
Prescribing Forum
Sep-09 it was
agreed that
generic versions
of clopidogrel may
be used for all
indications
75mg tablets: £1.74 (30)
Clopidogrel is recommended by NICE as an option to prevent occlusive
vascular events;

for people who have had an ischaemic stroke or who have peripheral
arterial disease or multivascular disease or TIA (by local agreement)
Clopidogrel is also included in the formulary for:

patients with true aspirin allergy who require secondary prevention of
cardiac or vascular disease

patients who have had an NSTEMI, regardless of treatment (up to 12
months)

patients who have had a STEMI and received a bare-metal or drugeluting stent for up to 12 months (new for 2013)

patients who have had a STEMI and medical management with or
without reperfusion treatment with a fibrinolytic agent. [new 2013]
(at least 1 month and up to 12 months)

Continued on next page
Cardiovascular system


alternative to aspirin in people who also have other clinical vascular
disease, in line with Clopidogrel and modified-release dipyridamole for
the prevention of occlusive vascular events (NICE TA 210), and who
have:
had an MI and stopped dual antiplatelet therapy or
had an MI more than 12 months ago. [new 2013]
Page 52
Therapeutic Area
Formulary Choices
Cost for 28
Rationale for decision / comments
(unless otherwise stated)
(Continued from previous page)
In all cases where Clopidogrel is initially used in combination with Aspirin,
when the Clopidogrel is stopped, anti-platelet therapy continues with Aspirin
75mg daily alone.
Patients requiring treatment with clopidogrel and PPI should avoid omeprazole
and esomeprazole which may reduce the effects of clopidogrel on platelet
function and lead to poorer long-term patient outcomes (death and
readmission). The effect of clopidogrel is also antagonised by calcium-channel
blockers and some statins.
Dipyridamole m/r
200mg m/r capsules: £10.06
(60)
Modified-release dipyridamole alone is recommended by NICE as an option to
prevent occlusive vascular events;
 for people who have had an ischaemic stroke only if aspirin and clopidogrel
are contraindicated or not tolerated or
 for people who have had a transient ischaemic attack only if aspirin is
contraindicated or not tolerated, or if clopidogrel (unlicensed use) has been
excluded
Dipyridamole m/r
(with Aspirin) as
Asasantin Retard
200/25mg m/r capsules:
£9.84 (60)
Modified-release dipyridamole in combination with aspirin (as Asasantin
Retard®) is recommended by NICE as an option to prevent occlusive vascular
events;
 for people who have had a transient ischaemic attack
or;
 for people who have had an ischaemic stroke only if clopidogrel is
contraindicated or not tolerated.
Non modified-release dipyridamole products, e.g. dipyridamole liquid,
should NOT be prescribed as evidence shows no clinical benefit.
Continued on next page
Cardiovascular system
Page 53
Therapeutic Area
Formulary Choices
Cost for 28
Rationale for decision / comments
(unless otherwise stated)
Anti-platelet drugs
Prasugrel
(Continued from previous page)
5mg tablets: £47.56
10mg tablets:£47.56
Prescribers should
ensure that all
prescriptions for
prasugrel have a
stop date and that
no repeats are
issued after that
date.
Ticagrelor
Prescribers should
ensure that all
prescriptions for
ticagrelor have a
stop date and that
no repeats are
issued after that
date.
Prasugrel 10mg in combination with aspirin is recommended as an option for
preventing atherothrombotic events in adults with acute coronary syndromes
having percutaneous coronary intervention, only when:
• immediate primary percutaneous coronary intervention for ST-segmentelevation myocardial infarction is necessary or
• stent thrombosis has occurred during clopidogrel treatment or
• the patient has diabetes mellitus.
Treatment should continue for 12 months unless discontinued earlier, e.g. for
side effects (NICE TA317: Acute coronary syndrome - prasugrel)
£54.60 (56)
Ticagrelor in combination with low-dose aspirin is recommended for up to 12
months as a treatment option in adults with acute coronary syndromes (ACS)
as follows:
 with ST-segment-elevation myocardial infarction (STEMI)
or;
 with non-ST-segment-elevation myocardial infarction (NSTEMI) or
admitted to hospital with unstable angina – defined as ST or T wave
changes on electrocardiogram suggestive of ischaemia plus one of the
characteristics defined in guidance.
Before ticagrelor is continued beyond the initial treatment, the diagnosis of
unstable angina should first be confirmed, ideally by a cardiologist.
See NICE TA236: Ticagrelor for the treatment of acute coronary syndromes
Hyperglycaemia in ACS
Hyperglycaemia is common in people admitted to hospital with ACS. Hyperglycaemia at the time of admission with ACS is a powerful predictor of poorer survival
and increased risk of complications while in hospital, regardless of whether or not the patient has diabetes.
All patients with hyperglycaemia after ACS and without known diabetes tests for should be tested for • HbA1c levels before discharge and • fasting blood glucose
levels no earlier than 4 days after the onset of ACS.
GPs should offer at least annual monitoring of HbA1c and fasting blood glucose levels to people without known diabetes who have had hyperglycaemia after an
episode of ACS
Cardiovascular system
Page 54
2.12
Lipid-regulation
Primary prevention of CVD (based on NICE Clinical Guideline CG181 (July 2014): Lipid modification)
 For primary prevention of CVD in primary care, a systematic strategy should be used to identify people aged 40–74 likely to be at high risk.
 People should be prioritised on the basis of an estimate of their CVD risk before a full formal risk assessment. Their CVD risk should be estimated using CVD
risk factors already recorded in primary care electronic medical records.
 The Framingham 1991 10-year risk equations1 should be used to assess CVD risk.
 People should be offered information about their absolute risk of CVD and about the absolute benefits and harms of an intervention over a 10-year period.
This information should be in a form that:
 presents individualised risk and benefit scenarios
 presents the absolute risk of events numerically
 uses appropriate diagrams and text (See www.npci.org.uk)
 Before offering lipid modification therapy for primary prevention, all other modifiable CVD risk factors should be considered and their management optimised if
possible. Baseline blood tests and clinical assessment should be performed, and comorbidities and secondary causes of dyslipidaemia should be treated.
Assessment should include:
 smoking status
 alcohol consumption
 blood pressure (see NICE CG127: Hypertension)
 body mass index or other measure of obesity (see NICE CG43: Obesity)
 fasting total cholesterol, LDL cholesterol, HDL cholesterol and triglycerides (if fasting levels are not already available)
 fasting blood glucose
 renal function
 liver function (transaminases)
 thyroid-stimulating hormone (TSH) if dyslipidaemia is present
 Statin therapy is recommended as part of the management strategy for the primary prevention of CVD for adults who have a 20% or greater 10-year risk of
developing CVD. This level of risk should be estimated using an appropriate risk calculator, or by clinical assessment for people for whom an appropriate risk
calculator is not available or appropriate (for example, older people, people with diabetes or CKD or people in high-risk ethnic groups) (see NICE TA94:
Cardiovascular disease – statins)
 Treatment for the primary prevention of CVD should be initiated with simvastatin 40 mg. If there are potential drug interactions, or simvastatin 40 mg is
contraindicated, a lower dose or alternative preparation such as pravastatin may be chosen.
1
Anderson KM, Odell PM, Wilson PW et al. (1991) Cardiovascular disease risk profiles. American Heart Journal 121: 293–8.
Cardiovascular system
Page 55
Secondary prevention of CVD (based on NICE Clinical Guideline CG67 (2008): Lipid modification)
 For secondary prevention, lipid modification therapy should be offered and should not be delayed by management of modifiable risk factors. Blood tests and
clinical assessment should be performed, and co-morbidities and secondary causes of dyslipidaemia should be treated. Assessment should include:
 smoking status
 alcohol consumption
 blood pressure (see NICE CG127: Hypertension)
 body mass index or other measure of obesity (see NICE CG43: Obesity)
 fasting total cholesterol, LDL cholesterol, HDL cholesterol and triglycerides (if fasting levels are not already available)
 fasting blood glucose (see NICE CG87: Type 2 diabetes – newer agents (a partial update of CG66)
 renal function (see NICE CG73: Chronic kidney disease)
 liver function (transaminases)
 thyroid-stimulating hormone (TSH) if dyslipidaemia is present
 Statin therapy is recommended for adults with clinical evidence of CVD (see NICE TA94: Cardiovascular disease – statins)
 Offer statins to people with CKD for secondary prevention of CVD irrespective of baseline lipid values
 Offer antiplatelet drugs to people with CKD for secondary prevention of CVD
 Treatment for the secondary prevention of CVD should be initiated with simvastatin 40 mg. If there are potential drug interactions, or simvastatin 40 mg is
contraindicated, a lower dose or alternative preparation such as pravastatin may be chosen.
 Any decision to offer a higher intensity statin should take into account informed preference, comorbidities, multiple drug therapy, and the benefit and risks of
treatment.
 There is an increased risk of myopathy associated with high-dose (80mg) simvastatin. The 80mg dose should be considered only in patients with severe
hypercholesterolaemia and high risk of cardiovascular complications who have not achieved their treatment goals on lower doses, when the benefits are
expected to outweigh the potential risks. (see MHRA Drug Safety Update May 2010; 3 (10))
 People with acute coronary syndrome should be treated with a higher intensity statin. Any decision to offer a higher intensity statin should take into account the
patient's informed preference, comorbidities, multiple drug therapy, and the benefits and risks of treatment.

‘Higher intensity statins’ are statins used in doses that produce greater cholesterol lowering than simvastatin 40 mg.
 For people with diabetes and existing or newly diagnosed CVD (or an increased albumin excretion rate) intensifying cholesterol lowering therapy with a more
effective statin (first line) or ezetimibe (second line) to achieve TC < 4 or LDL <2.
Cardiovascular system
Page 56
Drug – statin interactions
 No restriction
 Monitor
Atorvastatin (ATV)
Amiodarone
Monitor lipid levels to ensure lowest
dose ATV used

No interaction

No interaction

Recommended max dose
20mg SMV

Amlodipine
No interaction

No interaction

No interaction

Recommended max dose
20mg SMV

Ciclosporin
Recommended maximum dose
10mg ATV

Recommended start dose 20mg
PRV, titrate to max 40mg with
caution

Contraindicated

Recommended max dose
10mg SMV

Clarithromycin
If on 40mg or 80mg ATV: reduce
dose or temporarily suspend ATV

Monitor

No interaction

Contraindicated

Diltiazem
Monitor lipid levels to ensure lowest
dose ATV used

No interaction

No interaction

Recommended max dose
20mg SMV

Eslicarbazepine
No interaction

No interaction

Eslicarbazepine reduces systemic
exposure to RSV when
co administered

Eslicarbazepine reduces systemic
exposure to SMV when
co-administered

No interaction
May increase risk of myopathy

No interaction
May increase risk of myopathy
Rosuvastatin (RSV)
 Dosing restrictions
Drug
Ezetimibe
Pravastatin (PRV)
 Contraindicated / not recommended

No interaction
May increase risk of myopathy
Simvastatin (SMV)

No interaction

May increase risk of myopathy
Fusidic acid
Contraindicated – suspend ATV
Gemfibrozil
Recommended start dose 10mg
ATV and clinical monitoring

Not recommended

Recommended start dose 5mg
RSV, max dose 20mg

Recommended max dose
10mg SMV

Grapefruit juice
Large quantities of grapefruit juice
not recommended

No interaction

No interaction

Not recommended

Itraconazole
If on 80mg ATV: reduce dose or
temprorarily suspend ATV

No interaction

No dose restrictions recommended

Contraindicated

Protease inhibitors
Monitor lipid levels to ensure lowest
dose ATV used

No interaction

Not recommended

Contraindicated

Verapamil
Monitor lipid levels to ensure lowest
dose ATV used

No interaction

No interaction

Recommended max dose
20mg SMV

Warfarin
More frequent INR monitoring

No interaction (usual INR
monitoring)

More frequent INR monitoring

More frequent INR monitoring

No interaction
Contraindicated – suspend SMV
No interaction
All data sourced from SmPCs for ATV, PRV, RSV, and SMV. Ezetimibe information taken from Stockley’s Drug Interactions, accessed online on 28.10.2010.
Cardiovascular system
Page 57
Therapeutic Area
Formulary Choices
Cost for 28
Rationale for decision / comments
(unless otherwise stated)
2.12 Lipid-regulating drugs. Related guidance: Lipid modification: cardiovascular risk assessment and the modification of blood lipids for the
primary and secondary prevention of cardiovascular disease
Monitoring of statin treatment for primary and secondary prevention:
 People on a statin should be advised to seek medical advice if they develop muscle symptoms (pain, tenderness or weakness). If this occurs, creatine kinase
should be measured.
 Creatine kinase should not be routinely monitored in asymptomatic people who are being treated with a statin.
 Baseline liver enzymes should be measured before starting a statin. Liver function (transaminases) should be measured within 3 months of starting treatment
and at 12 months, but not again unless clinically indicated.
 People who have liver enzymes (transaminases) that are raised but are less than 3 times the upper limit of normal should not be routinely excluded from
statin therapy.
 If a person develops an unexplained peripheral neuropathy, statins should be discontinued and specialist advice sought.
It is recommended that atftempts should always be made to get patients to national cholesterol levels with statin monotherapy, using all formulary statins, before
consideration is given to adding in or changing to another agent.
A summary of drug –statins interactions is given on p.57
Statins
First line:
Atorvastatin
Simvastatin
as Simvador®
Continued on next page
Cardiovascular system
10mg tablets: £1.13
20mg tablets: £1.41
40mg tablets: £1.99
80mg tablets: £2.73
10mg tablets: £0.77
20mg tablets: £0.86
40mg tablets: £1.04
80mg tablets: £1.78
10mg tablets: £0.77
20mg tablets: £0.86
40mg tablets: £1.04
80mg tablets: £1.78
Atorvastatin is first line statin for all new patients unless contraindicated. It is included in the formulary for:
 Hypercholesterolaemia
 Primary prevention of cardiovascular events (where 10year CVD risk ≥
10%)
 Secondary prevention of CV events (give 80mg)
Please note:
 Simvastatin should be prescribed at night to optimise effect.
 Simvastatin 10mg should only be prescribed for patients who cannot
tolerate a higher evidence-based dose of statin therapy
 Simvastatin doses should not exceed 20mg for patients on Amiodarone,
Verapamil, Amlodipine or Diltiazem
 See BNF or SPC for further information on interactions
 There is an increased risk of myopathy associated with high-dose (80mg)
simvastatin. The 80mg dose should be considered only in patients with
severe hypercholesterolaemia and high risk of cardiovascular complications
who have not achieved their treatment goals on lower doses, when the
benefits are expected to outweigh the potential risks. (see MHRA Drug
Safety Update May 2010; 3 (10))
Page 58
Therapeutic Area
Formulary Choices
Cost for 28
Rationale for decision / comments
(unless otherwise stated)
Statins
Continued from previous page
2nd line:
Pravastatin
10mg tablets: £1.20
20mg tablets: £1.44
40mg tablets: £1.77
3rd line:
Rosuvastatin
5mg tablets: £18.03
10mg tablets: £18.03
20mg tablets: £26.02
40mg tablets: £29.69
It should be noted that the maximum reduction in total cholesterol which can be
expected from Pravastatin is 24%.
Higher intensity statins should not routinely be offered to people for the primary
prevention of CVD. A target for total or LDL cholesterol is not recommended
for people who are treated with a statin for primary prevention of CVD.
Pravastatin and Rosuvastatin have a different metabolic pathway so may be
tolerated when Simvastatin or Atorvastatin are not.
Cardiovascular system
Page 59
Therapeutic Area
Formulary Choices
Cost for 28
Rationale for decision / comments
(unless otherwise stated)
Other lipid lowering
drugs
In general, the evidence for an effect on outcomes is less robust than for statin therapy. Additional monitoring may be required,
particularly when Fibrates or Nicotinic Acid are used in combination with statins, due to increased risk of myopathy.
Ezetimibe
10mg tablets: £26.31
Ezetimibe is included in the formulary only for:

monotherapy for patients intolerant to any statin

in addition to a statin for patients not at target on statin monotherapy,
where higher doses of that statin and an alternative statin have been
tried and are not tolerated
Local specialist advice is to also consider check triglyceride levels & consider
fibrate.
The ENHANCE study showed the addition of Ezetimibe had no effect on
primary or secondary endpoints and emerging evidence contributes to
lack of positive cardiovascular outcomes with ezetimibe alone.
Fibrates
Fenofibrate
micronized
as Supralip
brand
200mg capsules: £2.56
160mg capsules: £6.69
Nicotinic acid
Bile acid
sequestrants
(Anionic exchange
resins)
Colestyramine
(Questran®)
Colesevelam
Colestipol
Specialist
recommendation ONLY
Consider use only in severe hypertriglyceridaemia. Do not routinely offer fibrates
for the prevention of CVD to any of the following:

people who are being treated for primary prevention

people who are being treated for secondary prevention

people with CKD

people with type 1 diabetes

people with type 2 diabetes.
These lipid lowering drugs are usually initiated in secondary care by clinical
biochemists for patients with complex dyslipidaemias.
Nicotinic acid and bile acid sequestrants : do not use as for fibrates above
Tredaptive (Nicotinic acid + laropiprant) withdrawn from market Jan 2013. HPS2-THRIVE trial failed to show reduced risk of
CV events & incidence of serious adverse events in the treatment group was higher.
Omega-3-acid ethyl esters (Omacor®) now non-formulary. NICE MI:secondary prevention (CG172) Nov 2013 says not to offer people omega 3 fatty acid
capsules or supplemented foods to prevent another MI. Similarly NICE CG 181 Lipid modification July 2014 does not recommend using omega-3 fatty acids to
help prevent CVD
Cardiovascular system
Page 60
Summary of NICE guidance on
the use of statins and
ezetimibe in adults
This summary is intended only as a guide to certain aspects of
the use of statins and ezetimibe. It is not a comprehensive
guide to all aspects of care. See the relevant NICE
guidance or NICE pathways for specific details, including who
should be offered treatment, additional or alternative treatment
options, referral and monitoring recommendations.
Cardiovascular system
Page 61
BNF Chapter 3: Respiratory System
Related guidance:
NICE Technology Appraisal TAG138 (2008): Asthma (in adults) - corticosteroids
BTS / SIGN Guideline 141 (October 2014): British Guideline on the Management of Asthma
Top
 Written personalised action plans as part of self-management education have been shown to improve health outcomes for people with asthma and
should be offered to all patients. Asthma Self Care Plan on NHS Somerset website
Note on inhaler devices
 Patients ability to use different devices varies; assessment of response to a prescribed treatment should include evaluation of inhaler technique as
demonstrated by the patient
 First line recommendation is an MDI plus spacer on grounds of cost
 Aerochamber Plus® spacer (medium-volume) has a flexible gasket & should fit all MDIs however SPC should be checked to ensure device is compatible
Correct inhaler technique is vital to ensure maximum benefit is obtained from inhaled therapies. Because the force of inhalation is different for MDI
and dry powder inhalers, where possible patients should have just one type of device i.e. all MDI or all DPI (see Types of Inhaler patient information
leaflet)
Safer use of inhaled corticosteroids (ICS)
 ALL patients on high dose ICS (ie > 1000mcg beclomethasone or equivalent daily) should be issued with a Steroid Card.
 ICS can have serious side effects: one study has shown an increased risk of diabetes onset and progression. The risk increased with higher doses – patients
on ICS doses of 1000mcg fluticasone/day or more (2000mcg beclometasone) had a 64% increased risk of developing diabetes compared to no ICS use.
 Stepping-down asthma therapy helps reduce the ICS dose and can be considered in patients with complete asthma control (for at least 12 weeks). For
patients on combination therapy the preferred approach is to reduce the ICS by approximately 50% while continuing LABA at the same dose initially. See the
asthma step-down guide for combination ICS/LABA inhalers p.70/55
 Different ICS have different potencies and the equivalent dose can also vary between devices. Standard practice is to express the dose equivalent to
beclometasone dipropionate in the old CFC-containing inhalers (and now in Clenil Modulite®) as shown below.
Weight for weight, the inhaled steroid in Qvar®, Fostair® and all fluticasone inhalers deliver a much higher steroid dose. REDUCE DOSE ACCORDINGLY IN
THESE PREPARATIONS.
400mcg Clenil Modulite®
=
400mcg BDP
200mcg Qvar
=
400-500mcg BDP
200mcg Fostair®
=
500mcg BDP
=
400mcg BDP
=
400mcg BDP
®
400mcg budesonide (Pulmicort®/Symbicort®/Easyhaler®)
®
®
®
200mcg fluticasone (Flixotide /Seretide /Flutiform )
Respiratory System – Bronchodilators
Page 62
Therapeutic Area
Formulary Choices
Cost per inhaler
Rationale for decision / comments
(unless otherwise stated)
3.1 Bronchodilators
Short acting
beta-2 agonist
bronchodilators
(SABAs)
First line:
A salbutamol inhaler contains 25 days supply at full dose ( 8 puffs/day)
Patients reliant on this dosage are poorly controlled and should be urgently reviewed. We would recommend that any patient using more
than 2 reliever inhalers in a year have their technique and compliance checked.
Salbutamol
CFC-free MDI
Second line:
100mcg/dose: £1.50
(200 dose inhaler)
First line: MDI (plus spacer if necessary) on grounds of cost
If patient cannot manage an MDI plus spacer, consider a breath-activated MDI
or a dry powder device.
Breath actuated
CFC-free MDI
as Airomir
Autohaler
100mcg/dose: £6.02
(200 dose)
as Salamol
Easi-breathe
100mcg/dose: £6.30
(200 dose)
or;
Dry powder inhaler
as Salbutamol
Easyhaler
Respiratory System – Bronchodilators
100mcg/dose: £3.31
(200 dose)
200mcg/dose: £6.63
(200 dose)
Page 63
Therapeutic Area
Formulary Choices
Cost per inhaler
Rationale for decision / comments
(unless otherwise stated)
Long acting
Beta-2 agonist
bronchodilators
(LABAs)
First line:
In asthma LABAs should only be added if regular use of a standard dose ICS has failed to control asthma adequately and
should be discontinued if there is no response to treatment. LABA should only be started in patients who are already on inhaled
corticosteroids, and the inhaled corticosteroid should be continued. Consider stopping LABAs in well-controlled patients once inhaled
corticosteroid dose has been reduced (see step-down guidance p70)
In COPD, LABAs should be used in line with the local COPD guidance (page 57) If no benefit after trial period, stop treatment
Formoterol
Dry powder inhaler
as Easyhaler
12mcg: £23.75 (120 dose)
Formoterol is the first line LABA as Easyhaler. Maintenance dose is 12mcg
once or twice daily.
as Oxis
Turbohaler
6mcg: £24.80 (60 dose)
Turbohaler formulation is second line Formoterol option. It costs 2-4 times per
dose more than an Easyhaler. 12mg and 6mg strengths cost the same so use 1x
12mcg bd rather than 2x6mcg bd. Licensed over age of 6 years.
12mcg: £30.06 (100 dose)
MDI version licensed for over age of 12 years
MDI
as Atimos
Second line:
Salmeterol
Salmeterol is the second line LABA
as CFC-free MDI
25mcg: £29.26 (120 dose
inhaler)
as Accuhaler
50mcg: £29.26
(60 dose inhaler)
Indacaterol
as Breezhaler®
Olodaterol
Usual maintenance dose of Salmeterol is 50mcg bd so the cost of the MDI and
Accuhaler is the same at this dose. Licensed over the age of 4 years.
300mcg: £29.26 (30 dose
inhaler)
Indacaterol is indicated for maintenance bronchodilator treatment of airflow
obstruction in adult patients with COPD.
This is a cost neutral alternative to established treatments and may be
appropriate for patients for whom once-daily administration is appropriate,
especially those not requiring inhaled corticosteroids. It has been approved by
the SMC.
2.5mcg:£26.35 (60 doses)
Adults over 18, 2 puffs twice a day
150mcg: £29.26 (30 dose
inhaler)
as Striverdi
Respimat®
Respiratory System – Bronchodilators
Page 64
Therapeutic Area
Formulary Choices
Cost per inhaler
Rationale for decision / comments
(unless otherwise stated)
Short acting
anticholinergic
bronchodilators
Ipratropium
as cfc-free MDI
Long acting
anticholinergic
bronchodilators
Aclidinium bromide
Dry powder inhaler
as Eklira
Genuair▼
Glycopyrronium
bromide
Dry powder inhaler
as Seebri
Breezhaler® ▼
Tiotropium
Dry powder inhaler
as Handihaler
Soft-mist inhaler
as Respimat ▼
Umeclidinium
Dry powder inhaler
as Incruse
Ellipta▼
Respiratory System – Bronchodilators
20mcg: £5.05 (200 dose
inhaler)
Do not co-prescribe Ipratropium with Tiotropium because of risk of increased
anticholingeric adverse effects.
400mcg: £28.60
(60 dose pack)
Aclidinium is licensed for the maintenance treatment of COPD. The dose is
400mcg bd. The device may be suitable for some patients who are unable to use
a Handihaler®.
NB. Each 400 mcg metered inhalation of aclidinium bromide delivers 322 mcg of
aclidinium
50mcg: £27.50 (30 capsules
plus device)
50mcg: £27.50 (30 dose refill
pack)
18mcg: £34.87 (30 dose
starter pack)
18mcg: £33.50 (30 dose refill
pack)
Glycopyrronium is licensed for the maintenance treatment of COPD. The dose is
50mcg od.
Each 50 microgram capsule delivers a dose of 44 micrograms of glycopyrronium
Tiotropium is only licensed for use in COPD and should be prescribed in line
with the local COPD guidance, which is consistent with the NICE guidance, see
p. 80 for more information.
If no benefit after trial period, stop treatment.
Repeat prescriptions should only be for refill packs owing to cost.
Tiotropium should not be combined with Ipratropium due to increased risk of
anticholinergic side-effects
2.5mcg: £33.50
(60 dose pack)
Tiotropium Respimat (soft-mist inhaler) was included in the formulary for patient
choice
55mcg:£27.50 (30 doses)
The recommended dose in adults (also the maximum dose) is one inhalation of
Incruse Ellipta once daily at the same time of the day each day.
Page 65
Therapeutic Area
Formulary Choices
Cost per inhaler
Rationale for decision / comments
(unless otherwise stated)
Theophylline
Reduce the dose of theophyline if macrolide or quinolones antibiotics (or other drugs known to interact) are prescribed to treat an
exacerbation.
Prescribe by brand.
Theophylline MR
as Nuelin SA®
175mg tablets: £6.38 (60)
250mg tablets: £8.92 (60)
as Slo-Phyllin®
60mg capsules: £2.76 (56)
125mg capsules: £3.48 (56)
250mg capsules: £4.34 (56)
as Uniphyllin
Continus®
200mg tablets: £2.95 (56)
300mg tablets: £4.77 (56)
400mg tablets: £5.65 (56)
The rate of absorption
from modified-release
preparations can vary
between brands. If a
brand name is not
specified on the
prescription,
pharmacists should
contact the prescriber
to establish which
brand is to be
dispensed.
Aminophylline
Aminophylline MR
as Phyllocontin
Continus®
Respiratory System – Bronchodilators
Offer theophylline only after trials of short- and long-acting bronchodilators, or to
people who cannot use inhaled therapy.
Theophylline can be used in combination with beta2 agonists and muscurinic
antagonists. Please note, the risk of hypokalaemia is increased when
theophylline is given in combination with a beta2 agonist.
Take care when prescribing theophylline to older people. Consider altered
pharmacokinetics, comorbidities, and interactions with other medicines;

Plasma theophylline level is increased in heart failure, hepatic
impairment, viral infections, in the elderly, and by drugs that inhibit its
metabolism.

Plasma theophylline level is decreased in smokers, by alcohol
consumption, and by drugs that induce its metabolism.
225mg tablets: £2.40 (56)
350mg tablets: £4.22 (56)
Page 66
Therapeutic Area
Formulary Choices
Cost per inhaler
Rationale for decision / comments
(unless otherwise stated)
3.2 Corticosteroids (See advice on safer use of inhaled corticosteroids p 62)
Inhaled
corticosteroids (ICS)
BTS / SIGN Guideline (141) on the management of asthma states: many children with recurrent episodes of viral-induced wheezing in
infancy do not develop chronic atopic asthma and do not require regular inhaled steroids.
NICE TAG138 states: for patients with chronic asthma in whom an ICS is appropriate, the least costly product that is suitable
for the individual, within its license, is recommended
Beclometasone
NB. Prescribe beclometasone MDIs by brand name to avoid confusion over the product intended. Clenil Modulite® and Qvar® are not
equipotent – see p62
CFC-free MDIs
as Clenil Modulite
as Qvar
Budesonide
50mcg: £3.70 (200 dose)
100mcg: £7.42 (200 dose)
200mcg: £16.17 (200 dose)
250mcg: £16.29 (200 dose)
Children up to age 15 should use these products with a Volumatic®
50mcg: £7.87 (200 dose)
100mcg: £17.21 (200 dose)
Qvar is not licensed in patients under 12yrs.
Dry powder
as Easyhaler®
200mcg: £14.93 (200 dose)
Breath-actuated
CFC-free MDI as
Qvar Easi-breathe
50mcg: £7.74 (200 dose)
100mcg: £16.95 (200 dose)
as Easyhaler
Respiratory System – Inhaled Corticosteroids
100mcg:£8.86 (200 dose)
200mcg £17.71 (200 dose)
400mcg: £17.71 (100 dose)
Licensed from age 6 years.
Page 67
Therapeutic Area
Formulary Choices
Cost per inhaler
Rationale for decision / comments
(unless otherwise stated)
Combination
long-acting
beta-agonist steroid
inhalers
NICE TAG 138 states that for patients with chronic asthma in whom an ICS and LABA is appropriate, the following apply:
-
Use of a combination device within license is recommended as an option to ensure that long-acting β2 agonists are not taken
without an inhaled steroid.
The decision to use combinations or separates should be made on an individual basis.
If a combination is chosen the least costly device that is suitable for the individual, within its license, is recommended
Flutiform ▼
(Fluticasone /
Formoterol)
CFC-free MDI
50mcg/5mcg £18.00
125mcg/5mcg £29.26
250mcg/10mcg:
non-formulary
Licensed for asthma only at Step 3 or above of the BTS / SIGN guidelines.
Flutiform 50mcg and 125mcg are licensed for adults and children over 12 years.
The 250mcg strength is non-formulary: licensed for over 18 years only and
limited indications for high dose fluticasone in asthma (estimated only 1%
asthma patients should need such a high dose combination.)
Fostair
(Beclomethasone /
Formeterol)
CFC-free MDI
100mcg/6mcg: £29.32
(120 dose inhaler)
OVER 18 YEARS ONLY
Fostair NEXThaler
(Beclomethasone /
Formeterol) ultrafine dry
powder inhaler
100mcg/6mcg: £29.32.
(Monthly cost of 1 puff bd=
£14.63)
(120 dose inhaler)
WARNING: beclomethasone 100mcg in Fostair is equivalent to 250mcg of
standard beclomethasone because of extra fine particle size. Patient should
receive specific training and information leaflet on this issue.
Asthma only. Fostair (MDI) is also licensed for use in COPD.
Beclometasone-formoterol as maintenance and reliever therapy (MART):
Patients over 18 years, at Step 3, who are poorly controlled may also use
Fostair® as a rescue medication (maximum 8 puffs per day - equivalent
2000mcg standard BDP), with no Salbutamol. Careful patient education is
required and quantity of inhalers used monitored.
NEXThaler has same BDP equivalent as Fostair MDI
Relvar® Ellipta® ▼
(Fluticasone
furoate/vilanterol) Dry
powder inhaler
Respiratory System – Inhaled Corticosteroids
92mcg/22mcg: £27.80
(30 dose)
184mcg/22mcg: £33.50
(30 dose)
Long acting once daily dosage due to the long acting furoate salt and LABA.
Dose equivalent to 500mcg daily fluticasone proprionate (1000mcg BDP)
Asthma: Both strengths licensed in adults and children >12years
NOTE: Licensed for new patients uncontrolled at step 2 i.e no license for
switching well controlled patients from another ICS/LABA combination.
Individual components not available in separate inhalers so step-down could
prove difficult
Only 92/22 strength is licensed for COPD if FEV1<70% predicted normal (postbronchodilator) with an exacerbation history despite regular bronchodilator
therapy.
Page 68
Therapeutic Area
Formulary Choices
Cost per inhaler
Rationale for decision / comments
(unless otherwise stated)
Duoresp® Spiromax
Budesonide/formoterol
Dry powder inhaler
Symbicort Turbohaler
(Budesonide/formoterol)
Dry-powder inhaler
Seretide Evohaler
(Fluticasone /
Salmeterol 25mcg)
CFC-free MDI
Seretide Accuhaler
(Fluticasone /
Salmeterol 50mcg)
Dry powder inhaler
Respiratory System – Inhaled Corticosteroids
160mcg/4.5mcg: £29.97
(120 doses)
320mcg/9mcg: £29.97 (60
doses)
100mcg/6mcg: £33.00
(120 doses)
200mcg/6mcg: £38.00
(120 doses)
400mcg/12mcg: £38.00
(60 doses)
Cost effective alternative to Symbicort Turbohaler. New legislation demands
that delivered dose is stated. 160/4.5 is comparative to Symbicort 200/6 and
320/9 is comparative to 400/12. Can be used as maintenance or maintenance
and reliever therapy. License in asthma and COPD (COPD 320/9mcg twice a
day dose). Not licensed in 12-17 year olds unlike Symbicort. SPC for Duoresp
suggests that stepdown from 160/4.5 may require separation into separate
inhalers but does not preclude single daily dose regimen if considered clinically
appropriate
Some dosing flexibility is possible with Symbicort, it is still not as flexible as
ICS and LABA prescribed separately. Symbicort is the preferred combination
as budesonide is equipotent to BDP and formoterol has a faster onset of
action. It is licensed in COPD. The 100/6 strength is now licensed in age
>6 years.
Symbicort Maintenance and Reliever Therapy (SMART): Patients over 18
years, at Step 3, who are poorly controlled may also use Symbicort 200/6 as
a rescue medication (maximum 12 puffs per day), with no Salbutamol. Careful
patient education is required and quantity of inhalers used monitored.
50mcg: £18.00 (120 doses)
125mcg: £35.00
(120 doses)
Seretide 50mcg & 125mcg Evohalers included for asthma: for patients at
Step 3 or above of the BTS / SIGN guidelines. Note that the 50mcg Evohaler 
is licensed for adults and children over 4 years and the 125mcg inhaler for
adults and children over 12 years. This change is based on NICE guidance on
inhaled corticosteroid for treatment of children with chronic asthma which
states that the choice of product should be based on suitability for the
individual child, licensed indication and cost.
250mcg: non-formulary
Seretide Evohaler 250mcg is non-formulary, due to cost and limited
need for high dose Fluticasone in asthma (estimated only 1% asthma
patients should need such high dose combination)
100mcg: £18.00 (60 dose)
250mcg: £35.00 (60 dose)
500mcg: £40.92 (60 dose)
Seretide 500mcg Accuhaler is included for moderate to severe COPD where
there is proven response to ICS. If no benefit after a trial period, stop
treatment.
Page 69
Therapeutic Area
Formulary Choices
Cost per inhaler
Rationale for decision / comments
(unless otherwise stated)
Combination long
acting muscarinic
antagonists (LAMA)
and long acting β
agonists (LABA)
Anoro Ellipta▼
(Umeclidinium/vilanterol
55/22) Dry powder
inhaler
£32.50 (30 doses- one
month)
Once daily dose. Maintenance bronchodilator treatment to relieve symptoms in
adult patients with chronic obstructive pulmonary disease (COPD)
Duaklir Genuair ▼
(aclidinium/formoterol
340/12) dry powder
inhaler
£32.50 (60 doses-one
month)
Twice daily dose. COPD only. Packaging is blue at present but will change to
orange in September 2015 to avoid confusion with reliever therapies.
£36.88 (30 doses –one
month)
Once daily dose. Indicated as a maintenance bronchodilator treatment to
relieve symptoms in adult patients with (COPD).Capsule has to be placed into
device, needs certain dexterity.
Ultibro Breezhaler▼
(glycopyrronium/indacat
erol 110/54 mcg) dry
powder inhaler
Spacer devices
Medium volume:
Large volume:
3.3.2
Patient’s ability to use different devices varies; assessment of response to a prescribed treatment should include evaluation of inhaler
technique as demonstrated by patient. First line recommended is MDI plus spacer on grounds of cost.
AeroChamber Plus
standard adult (blue)
£4.75 (1)
adult with mask (blue)
£7.92 (1)
infant with mask (orange)
£7.92 (1)
child with mask (yellow)
£7.92 (1)
Volumatic

£3.81 (1)
The AeroChamber Plus is recommended as the spacer device of choice, in
view of its portability and flexible inhaler orifice, which permits most MDIs to be
used with it. MHRA advise that deposition and therefore effectiveness and
adverse effects may differ from Volumatic
AeroChamber Plus spacer devices should fit ALL MDI devices (inhaler
mouthpiece fits into flexible gasket.) but prescribers should check SPC .
Volumatic® spacer device is only compatible with inhalers manufactured by
GSK or if mouthpiece has same specifications as inhalers manufactured by
GSK.
Leukotriene receptor antagonists
Leukotriene receptor
antagonists
Montelukast
Chewable tablets
Tablets
Granules
Zafirlukast
Respiratory System – Inhaled Corticosteroids
4mg tablets: £2.21 (28)
5mg tablets: £2.37 (28)
10mg tablets: £2.52 (28)
4mg granules: £4.02 (28)
Included for add-on therapy according to BTS & SIGN guidelines for the
management of chronic asthma (BNF) and
BTS/SIGN 141 October 2014
20mg tablets: £17.75 (56)
Page 70
Summary of recently introduced inhalers and their equivalents (Yellow=new)
Brand Name
Device
Drug
Company
Drugs
Strength
Adult Dose
No.
Puffs
per
inhaler
Licens
ed in
Asthm
a?
License
d in
COPD?
License
d in
Children
?
Price
Comments
LABA
Striverdi®
Respimat®solution
for inhalation
BI
Olodaterol
2.5mcg/puff
2 puffs OD
60
NO
YES
NO
Ellipta® DPI
GSK
Umeclidinium
55mcg/puff
1 puffs OD
30
NO
YES
NO
£26.35
COPD ONLY
LAMA
Incruse ®
Spiriva®
Respimat®solution
for inhalation
BI
Tiotropium
2.5mcg/puff
2 puffs OD
in asthma
and COPD
60
YES
YES
NO
£27.50
£33.50
Spiriva®
Handihaler®DPI
BI
Tiotropium
18mcg /dose
1 Dose OD
30
NO
YES
NO
Eklira®
Genuair® DPI
Almirall
400mcg/dose
1 Dose BD
60
NO
YES
NO
Seebri®
Breezhaler® DPI
Pfizer
Aclidinium
Glycopyrroniu
m
£34.87
Handihal
er £33.50
Refill
28.6
50 mcg /dose
1 Dose OD
30
NO
YES
NO
27.5
License recently extended
to cover asthma. add-on
maintenance
bronchodilator treatment
in adult patients with
asthma who are currently
treated with the
maintenance combination
of inhaled corticosteroids
(≥800 µg budesonide/day
or equivalent) and longacting β2 agonists and who
experienced one or more
severe exacerbations in the
previous year
COPD ONLY
COPD ONLY
COPD ONLY
LABA/ ICS
Respiratory System – Inhaled Corticosteroids
Page 71
Fostair®
Fostair®
NEXThaler® DPI
MDI
Cheisi
Cheisi
Beclometason
e/ formoterol
Beclometason
e/ formoterol
100/6mcg/puff
1-2 puffs
bd
120
YES
NO
NO
£29.32
100/6mcg/puff
1-2 puffs
bd (max 8
puffs/d in
maint and
reliever
therapy.)
120
YES
YES
NO
29.32
Relvar ®
Ellipta® DPI
GSK
Fluticasone/
Vilanterol
92/22 mcg /puff
1 puff OD
30
YES
YES
Relvar ®
Ellipta® DPI
GSK
Fluticasone/
Vilanterol
184/22 mcg /puff
1 puff OD
30
YES
NO
160/4.5 mcg /puff
Asthma 1-2
puffs BD.
(max 8
puffs/d in
maint and
reliever
therapy.)
COPD
2puffs BD
Duoresp ®
Spiromax ® DPI
TEVA
Budesonide/
Formoterol
Respiratory System – Inhaled Corticosteroids
120
YES
YES
YESAsthm
a
OVER
12 yrs
ONLY
YESAsthm
a
OVER
12 yrs
ONLY
NO
27.8
Patients not adequately
ctrld with ICS + PRN SABA
or those already ctrld on
ICS + LABA. N.B. 200mcg.
Fostair Equivalent to
500mcg BDP. NOT licensed
to treat astma attacks.
Patients not adequately
ctrld with ICS + PRN SABA
or those already ctrld on
ICS + LABA. Maintenance
and reliever therapy. N.B.
200mcg Fostair Equivalent
to 500mcg BDP
Recently licensed n COPD
where FEV1 < 50%
In COPD where FEV1 < 70%
OR Asthma at STEP 3
38.87
Asthma ONLY
29.97
Equivalent to Symbicort
Turbohaler 200/12mcg.
Can be used for
Maintenance and Reliever
Therapy in asthma. In
COPD where FEV1 < 50%
Page 72
Duoresp ®
Spiromax ® DPI
Teva
Budesonide/
Formoterol
320/9 mcg /puff
Symbicort®
Turbohaler® DPI
GSK
Budesonide/
Formoterol
100/6 mcg /puff
Symbicort®
Turbohaler® DPI
GSK
Budesonide/
Formoterol
200/6 mcg /puff
Symbicort®
Turbohaler® DPI
GSK
Anoro ®
Ellipta ® DPI
GSK
Duaklir®
Genuair® DPI
Almirall
Ultibro
Breezhaler® DPI
Pfizer
Budesonide/
Formoterol
Asthma 1-2
puffs BD
(max 8
puffs/d in
maint and
reliever
therapy.)
COPD 1puff
BD
Asthma 1-2
puffs BD.
(max 8
puffs/d in
SMART
therapy.)
COPD
2puffs BD
Asthma 1-2
puffs BD
(max 8
puffs/d in
SMART
therapy.)
COPD 1puff
BD
60
YES
YES
NO
120
NO
YES
YESAsthm
a
OVER
6yrs
ONLY
120
YES
YES
NO
29.97
Equivalent to Symbicort
Turbohaler 200/12mcg.
Asthma Maintenance
ONLY- NOT LICENSED FOR
Maintenance and reliever
therapy) .
In COPD where FEV1 < 50%
33
In COPD where FEV1 < 50%
38
In COPD where FEV1 <
50%
38
Maintenance ONLY- NOT
LICENSED FOR
Maintenance and reliever
therapy) In COPD where
FEV1 < 50%
400/12 mcg /puff
Asthma 1
puff BD
COPD 1puff
BD
60
YES
YES
NO
55/22 mcg /puff
1 puff OD
30
NO
YES
NO
£32.50
COPD ONLY
340/12 mcg/puff
1 puff BD
60
NO
YES
NO
£32.50
COPD ONLY
85/43mcg/puff
1 puff od
NO
YES
NO
£36.88
COPD ONLY. Capsule has to
be inserted into device
LAMA/ LABA
Umeclidinium
/ Vilanterol
Aclidinium/for
moterol
Glycopyrroniu
m/indacaterol
Respiratory System – Inhaled Corticosteroids
30
Page 73
Adult asthma inhaler pathway
December 2013
Daily
BDP
Dry powder
Daily
BDP
MDI
(beclometason
e dipropionate)
Step 1 Mild
intermittent
asthma
Step 2 Mild
persistent
asthma
preventer
therapy
SABA only
when needed
Reliever treatment
with short acting
bronchodilator
(SABA)
Salbutamol or
terbutaline
Salbutamol Easyhaler
100mcg/dose: £3.31
(200 dose)
200mcg/dose: £6.63
(200 dose)
Inhaled steroid
preventer
treatment. Up to
400mcg BDP/day
Beclometasone
Easyhaler
200mcg: £14.93
(200 dose)
1puff bd
-
£4.18/28d
Manufacturers vary in
their recommended
starting dose200mcg/day minimum
Budesonide
Easyhaler
200mcg £17.71
(200 dose)
Or 100mcg if want to
start lower £8.86
Step 3
Moderate
persistent
initial add on
therapy
Trial of LABA (4
weeks)
No response
Stop LABA
Increase steroid to
800mcg
Formoterol
Easyhaler
12mcg 120 dose
(£23.75)
Beclometasone
Easyhaler 200mcg
(200 dose)(£14.93)
Budesonide
Easyhaler
200mcg £17.71
(200 dose)
Respiratory System – Inhaled Corticosteroids
1 puff bd
£4.96/28d
1 puff bd
£2.48/28d
400mcg
200mcg
-
Clenil
Modulite
200mcg:
£16.17
(200 dose)
One puff bd
£4.53/28d
400mcg
50mcg
100mcg
2pbd £3.70/28d
1pbd £2.07/28d
200mcg
Qvar 100mcg:
£17.21
(200 dose)
1 puff bd
£4.82/28d
2pbd £2.20/d
50mcg
Plus spacer if necessary
800mcg
Qvar 100
(£17.21)
200 dose
2puffs bd
£9.64/28d
800mcg
Clenil 200
(16.17)
200 dose
2puffs bd
£9.05/28d
800mcg
800mcg
Breath
actuated MDIs
available
Airomir
Autohaler
Salamol EasiBreathe
~£6 each
Breath
actuated
CFC-free MDI as
Qvar Easibreathe
100mcg: £16.95
(200 dose)
Consider adding trial of
LABA BEFORE moving to
a higher steroid strength
Atimos licensed over 12
yrs only
Straight to
combination?
Seretide 50
evohaler or
Seretide 100
Accuhaler or
Symbicort 100/6
all 2 puffs bd
200mcg
1puff bd
£16.83/28d
£8.36/28d
2puffs bd
£9.92/28d
Using TWO or more
canisters of beta-2
agonist per year is an
indicator of poor control
400mcg
-------£11.08/28d
2puffs bd
Ventolin Evohaler
100mcg/dose: £1.50
(200 dose inhaler)
Formoterol
12mcg MDI
(Atimos)
(100 doses)
£30.06
1puff bd
Options
(beclometason
e dipropionate)
Plus spacer if necessary
400mcg
BTS/SIGN 141 October
2014
800mcgBDP = same
effects on serum
cortisol levels as 4mg
oral prednisolone
Breathactuated
CFC-free MDI as
Qvar Easibreathe
Page 74
Good Response
Partial
Response
Step 4
Persistent poor
control
Assess which type
of inhaler (DPI or
MDI) suits patient
best, stop
separate LABA and
use combination
inhaler
Seretide 100
Accuhaler
(60 dose)
(£18)
1puff bd
£16.80/28d
400mcg
Symbicort 100/6
(120 dose)
(£33)
2puffs bd
£30.80/28d
400mcg
Increase steroid to
800µg. Assess
which type of
inhaler (DPI or
MDI) suits patient
best
Duoresp
Spiromax
160/4.5(£29.97)
120 doses
2puffs bd
£27.97/28d
800mcg
Consider moving
up to 2000µg BDP
Seretide 250
Accuhaler (60
dose) £35
1 puff bd
£32.67/28d
Seretide 500
Accuhaler (60
dose) £40.92
1 puff bd
£38.19/28d
Oral steroid
Maintain at 2000mcg/day as above
Respiratory System – Inhaled Corticosteroids
2puffs bd
£16.80/28d
400mcg
Flutiform 50
(120 dose)
£18
2puffs bd
£16.80/28d
400mcg
Fostair 100/6
(£29.32)
120 doses
2puffs bd
£27.37/28d
1000mcg
Flutiform 125
(120 dose)
CFC-free MDI
125mg/5mcg
£29.26
2 puffs bd
£27.31/28d
1000mcg
Seretide 125
(120 dose)
£35
Non
formulary
Flutiform 250
2 puffs bd
£32.67/28d
800mcg
1000mcg
2000mcg
Step 5 Severe
persistent/contin
uous symptoms
Refer to
specialist
Seretide 50
Evohaler) 120
dose
£18
2 puffs bd
£42.52/28d
Seretide
2 puffs bd
Evohaler 250
£55.51/28d
Maintain at 2000mcg/day as
above
1000mcg
2000mcg
Symbicort 200/6 1puff
bd would be more cost
effective, but LABA
dose would be sub
therapeutic
£17.73/28d.
Fostair 100/6 could be
used 1 p bd but again
this may give sub
therapeutic dose of
LABA
Fostair is licensed for
over 18 yrs only.
Fostair only lasts 5
months out of the
fridge
Seretide Accuhaler at
500mcg bd dose
should be reserved for
severe asthmatics
only.
Doses over 1000µg
BDP equivalent/day
require a steroid
warning card.
2000mcg BDP=same
effect on serum
cortisol levels as 10mg
oral prednisolone
Note: 160mcg
Duoresp is
equivalent of
200mcg of BDP
Addition of a
fourth drug e.g
leukotriene
agonist,
theophylline
2000mcg
Page 75
Children age 5-12 asthma inhaler
pathway Jan 2014
Dry powder
Step 1 Mild
intermittent
asthma
Salbutamol Easyhaler
100mcg/dose: £3.31
(200 dose)
200mcg/dose: £6.63
(200 dose)
Age 4-11 up to 200mcg qds
Reliever treatment
with short acting
bronchodilator
(SABA)
BDP
-
Options
MDI
BDP
Ventolin Evohaler
100mcg/dose: £1.50
(200 dose inhaler)
-
Dose 100-200mcg up to qds
(age 1 month-18yrs)
Plus spacer always
Step 2 Mild
persistent
asthma
preventer
therapy
Inhaled steroid
preventer
treatment. 200400mcg BDP/day
200 is starting dose
Budesonide
Easyhaler
100mcg £8.86
200mcg £17.71
(200 dose)
Age 6 and above
1 puff bd
£2.48/28d
1 puff bd
£4.96/28d
200mcg
400mcg
SABA only when
needed
Step 3
Moderate
persistent
initial add on
therapy
Trial of LABA (4
weeks)
No response
Stop LABA
Increase steroid to
400mcg
Formoterol
Easyhaler
12mcg 120 dose
(£23.75)
Age 6 and above
Budesonide
Easyhaler
100mcg £8.86
200mcg £17.71
(200 dose)
Age 6 and above
Respiratory System – Inhaled Corticosteroids
1puff bd
-------£11.08/28d
Clenil
Modulite
One puff bd
50mcg:
£1.85/28d
£3.70 (200
dose)
100mcg:
£2.07/28d
£7.42 (200
dose)
Clenil
Modulite
One puff bd
200mcg:
£4.53/28d
£16.17
(200 dose)
Plus spacer if necessary
Salmeterol
MDI 25mcg
2puffs bd
(120 doses)
£27.31/28d
£29.26
Beclometasone
Easyhaler not
recommended
for children
100mcg
200mcg
Qvar not
licensed under
12 years
400mcg
Consider adding trial of
LABA BEFORE moving to a
higher steroid strength
400BDP = 2mg oral
prednisolone
Upto
2 puff bd
£4.96/28d
1 puff bd
£4.96/28d
Clenil 100
(£7.42)
200 dose
2puffs bd
£4.15/28d
400mcg
Clenil 200
(16.17)
200 dose
1puffs bd
£4.53/28d
400mcg
400mcg
Page 76
Good Response
Assess which type
of inhaler (DPI or
MDI) suits patient
best, stop separate
LABA and use
combination
inhaler
Seretide 100
Accuhaler
(60 dose)
(£18)
From 5 yrs
1puff bd
£16.80/28d
1 puff daily
£8.40/28d for
maintenance
only
Symbicort 100/6
(120 dose)
(£33)
From 6yrs
Max 2 puff bd
£30.80/28d
1 puff bd
£15.40/28d
400mcg
Seretide 50
Evohaler(£1
8) 120 dose
2puffs bd
£16.80/28d
400mcg
Clenil 100
(£7.42)
200 dose
2puffs bd
£4.15/28d
400mcg
Clenil 200
(16.17)
200 dose
1puffs bd
£4.53/28d
400mcg
200mcg
400mcg
200mcg
100mcg
Partial
Response
Step 4
Persistent poor
control
Step 5 Severe
persistent/conti
nuous
symptoms
Refer to
specialist
Continue LABA and
Increase steroid to
400mcg. Assess
which type of
inhaler (DPI or
MDI) suits patient
best
Consider moving
up to 800mcg BDP
Oral steroid
Symbicort 100/6
(£33) 120
doses
From 6yrs
Budesonide
Easyhaler
200mcg £17.71
(200 dose)
1 puff od
£7.70/28d for
maintenance
only
2puffs bd
£30.80/28d
2 puff bd
£9.91/28d
1 puff bd
£4.96/28d
Pulmicort Turbo
2 puff bd
200mcg £11.84
£13.26/28d
(100dose)
Age 6 and above
Maintain at 800mcg/day as above
Respiratory System – Inhaled Corticosteroids
400mcg
800mcg
MDI Beclometasone only
licensed upto 400mcg/day
400mcg
Refer to
respiratory
paediatrician if
uncontrolled at
this level
800mcg
Maintain at 800mcg/day as
above
Page 77
Asthma Step-down Guide: Combination MDIs: Note: all doses are for asthma maintenance therapy,
not asthma maintenance and reliever therapy
BTS/SIGN Step 4/5
Seretide
Evohaler
®
Flutiform
® inhaler
Seretide 250 Evohaler®
2 puffs bd
Seretide 125 Evohaler®
2 puffs bd
Seretide 50 Evohaler®
2 puffs bd
*(2000mcg/100mcg salmeterol)
NB. Non-formulary
*(1000mcg/100mcg salmeterol)
*(400mcg/100mcg salmeterol)
Flutiform®
250mcg/10mcg
2 puffs bd
*(2000mcg/40mcg formoterol)
NB. Non-formulary
BTS/SIGN Step 4
Fostair®
Inhaler
symbicort
/SIGN Step 3
Fostair® 100/6 Inhaler
2 puffs bd
*(1000mcg/ 24mcg formoterol)
Flutiform® 125mcg/5mcg
2 puffs bd
Flutiform® 50mcg/5mcg
2 puffs bd
*(1000mcg/20mcg formoterol)
*(400mcg/20mcg formoterol)
BTS/SIGN Step 3
Stepping down from Fostair is potentially problematic as there is only one
strength. Therefore either the device has to be changed or the LABA dose
reduced alongside the ICS.
OPTION 1:
Fostair® 100/6 Inhaler 1 puff bd
BTS/SIGN Step 2
Prescribe an MDI
equivalent to 400500mcg BDP/day:
Clenil Modulite® 100mcg
2 puffs bd
OR
Qvar Easi-Breathe®
50mcg
2 puffs bd
OR
Qvar® MDI 50mcg
2 puffs bd
OR
Fluticasone 50 Evohaler®
2 puffs bd
NB. Fluticasone inhalers
are non-formulary but are
included for comparison
*(500mcg/12mcg formoterol)
OPTION 2
Consider change to Flutiform® 50/5 2 puffs bd
Key (for both pages of step-down guide):
*(400mcg/20mcg formoterol)
*Total daily dose of inhaled corticosteroid, in terms of
beclometasone dipropionate (BDP) equivalent/ long
acting beta-agonist
OPTION 3
Consider change to separate corticosteroid and
LABA inhalers
Respiratory System – Inhaled Corticosteroids
Page 78
Asthma Step-down Guide – combination DPIs:
Note: all doses are for asthma maintenance therapy, not asthma maintenance and reliever therapy (e.g. not the SMART ® regime)
BTS/SIGN Step 3
Symbicort
Turbohaler®
400/12
Symbicort
Turbohaler®
200/6
BTS/SIGN Step 2
Symbicort 400/12 Turbohaler®
1 puff bd
Symbicort 100/6 Turbohaler®
2 puffs bd
*(800mcg/ 24mcg formoterol)
*(400mcg/24mcg formoterol
Prescribe a DPI
equivalent to 400500mcg BDP/day:
Symbicort 200/6 Turbohaler®
2 puffs bd
Symbicort 100/6 Turbohaler®
2 puffs bd
Easyhaler®
Beclometasone 200mcg
1 puff bd
OR
*(800mcg/ 24mcg formoterol)
*(400mcg/ 24mcg formoterol)
Easyhaler® Budesonide
200mcg
1 puff bd
OR
Symbicort 200/6 Turbohaler®
1 puff bd
*(400mcg/ 12mcg formoterol)
Symbicort
Turbohaler®
100/6
Symbicort 100/6 Turbohaler®
2 puffs bd
Fluticasone 100 Accuhaler®
1 puff bd
*(400mcg/ 24mcg formoterol)
BTS/SIGN Step 4/5
Seretide
Accuhaler®
Budesonide Turbohaler®
200mcg
1 puff bd
OR
BTS/SIGN Step 3
Seretide 500
Accuhaler®1 puff bd
Seretide 250
Accuhaler® 1 puff bd
Seretide 100 Accuhaler®
1 puff bd
*(2000mcg/100mcg salmeterol)
*(1000mcg/100mcg salmeterol)
*(400mcg/100mcg salmeterol)
Respiratory System – Inhaled Corticosteroids
NB. Fluticasone Accuhaler®
and budesonide Turbohaler®
are non-formulary but are
included here as some patients
on Seretide Accuhale® or
Symbicort Turbohaler® may
benefit from stepping down to
the same device. Use formulary
devices where possible.
Page 79
GUIDANCE FOR MANAGING COPD IN ACCORDANCE WITH NICE CLINICAL GUIDELINE CG101 (JUNE 2010)
ADAPTED BY SOMERSET CCG MEDICINES MANAGEMENT TEAM
FROM AN ORIGINAL PRODUCED BY SOMERSET LUNG CENTRE, MUSGROVE PARK, TAUNTON
CONSIDERATIONS
 STOP SMOKING, VACCINATIONS (pneumococcal, and annual influenza), THINK PULMONARY REHAB (MRC >3), PATIENT EDUCATION
 Remember, COPD is generally NOT a steroid-responsive disease, but:

There is evidence that some patients with more severe disease, or those who exacerbate frequently (more than twice a year), benefit from inhaled steroids. Trial
data shows an improvement in both exacerbation frequency and health status of these groups but patients are at increased risk of contracting pneumonia.

Do NOT use oral corticosteroids routinely for maintenance therapy

Do NOT use oral corticosteroid reversibility tests to identify patients who will benefit from inhaled corticosteroids (ICS).
 Smoking cessation MUST be offered at every opportunity to people with COPD who still smoke, regardless of age.
 Combivent was discontinued in June 2008. Options are separate salbutamol/ipratropium inhalers (non-persistent symptoms), or a trial of tiotropium (persistent symptoms).
 Don’t just assess on physiology. Use symptoms to determine inhaler benefit. Withdraw add on therapy if no benefit after trial.
Determining disease severity
Disability in COPD can be poorly reflected in the FEV1. A more comprehensive assessment should also include:

degree of airflow obstruction and disability

frequency of exacerbations

prognostic factors such as breathlessness (assessed using the Medical Research Council (MRC) scale, carbon monoxide lung transfer factor (TLCO), health status, exercise
capacity, BMI, partial pressure of oxygen in arterial blood (PaO2), and cor pulmonale.
Severity of airflow obstruction
Gold 1: Mild
≥ 80% predicted FEV1
Symptoms should be present to diagnose
COPD in people with mild airflow obstruction
Respiratory System – Inhaled Corticosteroids
Gold 2: Moderate
50-79% predicted FEV1
Gold 3: Severe
30-49% predicted FEV1
Gold 4: Very severe
< 30% predicted FEV1
Or FEV1 < 50% with respiratory failure
Page 80
Symptoms
Choice of inhaled therapy in COPD
SABA e.g. salbutamol or terbutaline, OR SAMA e.g. ipratropium as required.
SABA should continue through all stages of symptoms
Breathlessness
and/or exercise
limitation
FEV1 ≥ 50%
Exacerbations or
persistent
breathlessness
LABA
e.g. Formoterol, Salmeterol,
or Indacaterol
FEV1 < 50%
LAMA
e.g. Tiotropium
Aclidinium
Glycopyrronium
LABA + ICS
in a combination inhaler
Give LABA + LAMA if ICS
is declined or not tolerated.
Discontinue SAMA.
Give LAMA in preference
to regular SAMA.
Persistent
exacerbations or
breathlessness
LABA + ICS in a combination inhaler.
Discontinue SAMA.
Give LAMA in preference to
regular SAMA
LAMA
+
LABA + ICS in a combination inhaler.
Consider LABA + LAMA if ICS is declined or
not tolerated.
Definition of terms
LAMA
e.g. Tiotropium
Aclidinium
Glycopyrronium
Recommended product and daily dose
SABA
Short-acting beta2 agonist
Salbutamol (as Ventolin®) 100mcg PRN, or up to QDS (max: 400mcg daily)
SAMA
Short-acting muscurinic antagonist
Ipratropium 20mcg PRN, up to QDS (max: 80mcg daily)
LABA
Long-acting beta2 agonist
Formoterol 24mcg BD via Easyhaler® or Turbohaler®
or Salmeterol 50mcg BD via MDI and spacer
Recommended trial period
Continue throughout
Stop if LAMA introduced
2 weeks
or Indacaterol 150-300mcg OD via Breezhaler®
or Olodaterol 2.5mcg 2puffs daily via Striverdi Respimat®
LAMA
Long-acting muscurinic antagonist
Aclidinium 400mcg bd via DPI
6-8 weeks
Glycopyrronium 50mcg daily via DPI
Tiotropium 18mcg daily via Handihaler (when initiating, discontinue ipratropium).
Umeclidinium 55mcg daily via DPI
Respiratory System – Inhaled Corticosteroids
Page 81
LABA/LAMA
Combination of above
Anoro Ellipta® 1 actuation daily
(Umeclidinium/vilanterol)
Duaklir Genuair® 1 actuation bd
(Aclidinium/formoterol
Ultibro Breezhaler® 1 actuation od
(glycoprrronium / indacaterol)
LABA + ICS
Inhaled corticosteroid
Duoresp Spiromax
Symbicort Turbohaler® 400/12: 1-2 actuations BD
or Relvar® Ellipta®92mcg/22mcg: 1 actuation daily (if FEV<70% expected)
3 months
or Seretide Accuhaler® 500/50: 1 actuation BD
or Fostair® 100/6: 2 actuations BD
Delivery systems
Inhalers
Spacers
Nebulisers

Hand-held devices are usually best, with a spacer if appropriate

If a person cannot use a particular device, try another

Teach technique before prescribing and check regularly

Ensure the spacer is compatible with the inhaler (aerochamber fits most inhaler devices)

Individuals should make single actuations of the inhaler into the spacer, and inhale as soon as possible, repeating as needed

Tidal breathing is as effective as single breaths

Do not clean spacers more than once a month

Clean with water and washing-up liquid and allow to air dry

Consider a nebuliser for people with distressing or disabling breathlessness despite maximum therapy with inhalers

Assess the individual and/or carers ability to use the nebuliser before prescribing and arrange appropriate support and maintenance of equipment

Allow the patient to choose either a facemask or mouthpiece where possible

Continue nebuliser treatment only if there is an improvement of symptoms, daily living activities, exercise capacity or lung function
Oral therapies
Corticosteroids

Corticosteroids are not normally recommended for maintenance therapy, but may be of use in some people with advanced COPD where
corticosteroid treatment cannot be stopped after an exacerbation

Keep dose as low as possible, monitor for osteoporosis and offer prophylaxis
Respiratory System – Inhaled Corticosteroids
Page 82
Theophylline
Mucolytic therapy
Not Recommended

Theophylline should be considered only after trials of short- and long-acting bronchodilators, or in people who cannot use inhaled therapy

Theophylline can be used in combination with inhaled beta 2 agonists and muscurinic antagonists

Take care when prescribing to older people because of pharmacokinetics, comorbidities and interactions with other medications

Reduce theophylline dose if macrolide or flouroquinolone antibiotics (or other drugs known to interact) are prescribed to treat an exacerbation

Mucolytic therapy can be considered in people with chronic productive cough, and continued if symptoms improve

Do not routinely use to prevent exacerbations

Anti-oxidant therapy (alpha-tocopherol and beta-carotene supplements)

Anti-tussive therapy

Prophylactic antibiotic therapy
Assess symptoms or condition and manage as described below
Breathlessness and
exacerbations






Manage breathlessness and Fexercise limitation with inhaled therapy
For exacerbations or persistent breathlessness:
– use long-acting bronchodilators or LABA + ICS
– consider adding theophylline if still symptomatic
Offer pulmonary rehabilitation to all suitable people
Refer patients who are breathless, have a single large bulla on a CT scan and an FEV1 less than 50% predicted for consideration of bullectomy
Refer people with severe COPD for consideration of lung volume reduction surgery if they remain breathless with marked restrictions of their
activities of daily living, despite maximal medical therapy (including rehabilitation), and meet all of the following:
– FEV1 greater than 20% predicted
– PaCO2 less than 7.3 kPa
– upper lobe predominant emphysema
– TLCO greater than 20% predicted
Consider referring people with severe COPD for assessment for lung transplantation if they remain breathless with marked restrictions of their
activities of daily living despite maximal medical therapy. Considerations include:
– age
– FEV1
– PaCO2
– homogeneously distributed emphysema on CT scan
– elevated pulmonary artery pressures with progressive deterioration
– comorbidities
– local surgical protocols
Frequent exacerbations




Optimise inhaled therapy
Offer vaccinations and prophylaxis
Give self-management advice
Consider osteoporosis prophylaxis for people requiring frequent oral corticosteroids
Cor pulmonale





Consider in people who have peripheral oedema, a raised venous pressure, a systolic parasternal heave, a loud pulmonary second heart sound
Exclude other causes of peripheral oedema
Perform pulse oximetry, ECG and echocardiogram if features of cor pulmonale
Assess need for LTOT
Treat oedema with diuretic
Respiratory System – Inhaled Corticosteroids
Page 83


Angiotensin-converting enzyme inhibitors, calcium channel blockers, alpha-blockers are not recommended
Digoxin may be used where there is atrial fibrillation
Assess symptoms or condition and manage as described below (continued)
Respiratory failure


Assess for appropriate oxygen
Consider referral for assessment for long-term domiciliary NIV therapy
Abnormal BMI



Refer for dietetic advice
Offer nutritional supplements if the BMI is low
Pay attention to weight changes in older patients (especially > 3 kg)
Chronic productive cough

Consider mucolytic therapy
Anxiety and depression


Screen for anxiety and depression using validated tools in people who:
- are hypoxic
- are severely breathless or
- have recently been seen or treated at a hospital for an exacerbation
Refer to ‘Depression with a chronic physical health problem’ (NICE CG91).
Alpha-1 antitrypsin
deficiency


Offer referral to a specialist centre to discuss the clinical management of this condition
Alpha-1 antitrypsin replacement therapy is not recommended
Palliative setting

Opioids should be used when appropriate for the palliation of breathlessness in people with end-stage COPD unresponsive to other medical
therapy
Use benzodiazepines, tricyclic antidepressants, major tranquillisers and oxygen to treat breathlessness
Provide access to multidisciplinary palliative care teams and hospices


Respiratory System – Inhaled Corticosteroids
Page 84
Therapeutic Area
Formulary Choices
Cost for 28
Rationale for decision / comments
(unless otherwise stated)
3.4.1
Antihistamines
Non-sedating
antihistamines
For nasal allergy and treatment with corticosteroid nasal sprays, please see Chapter 15.
First- line:
Loratadine
10mg tablets: £1.06 (30)
5mg/5ml solution: £2.06
(100ml)
Loratadine is first line on basis of low rate of motor impairment and costeffectiveness. Loratadine is available OTC.
Second-line:
Cetirizine
10mg tablets: £1.02 (30)
5mg/5ml solution: £1.78
(200ml)
Cetirizine is second line as more likely to impair motor function than
Loratadine. Cetirizine is available OTC.
Third-line:
Desloratadine
tablets
5mg tablets: £1.73 (30)
As an option if first- and second-line choices are not tolerated or
contra-indicated.
Chlorphenamine
4mg tablets: £1.00
2mg/5ml SF solution: £2.60
(150ml)
Chlorphenamine is available OTC.
Sedating
antihistamines
3.7 Mucolytics
Mucolytics
Carbocisteine
as
Mucodyne®
Do not routinely use to prevent exacerbations.
375mg capsules:
£18.98(120)
125mg/5ml liquid: £5.08
(300ml)
250mg/5ml liquid: £6.99
(300ml)
Carbocistine can be considered in patients with COPD with copious of
tenacious sputum. Trial carbocysteine 750mg tds for 4 weeks and stop if
ineffective. If effective reduce to bd.
Dose: initially 2.25g daily in divided doses,
then 1.5g daily in divided doses as condition improves
Acetylcysteine is unlicensed in the UK and for specialist prescribing only.Red
drug classification
Erdocysteine is non-formulary
Respiratory System – Inhaled Corticosteroids
Page 85
Therapeutic Area
Formulary Choices
Cost for 28
Rationale for decision / comments
(unless otherwise stated)
BNF Chapter 4: Central nervous system
Top
4.1 Hypnotics and anxiolytics
Hypnotics
First line
Zaleplon
5mg tablets: £3.12
10mg tablets: £1.67
Zopiclone
3.75mg tablets: £1.32
7.5mg tablets:£1.32
2mg tablets: £0.86
5mg tablets: £0.89
Diazepam
Second line
Third line
Anxiolytics
Patients should be advised to adopt better sleep hygiene and other lifestyle
changes, where appropriate. A leaflet advising on sleep hygiene measures is
available on CCG website. The National Prescribing Centre also produced a
useful document, The Good Relaxation Guide, which contains information that
can be printed off for patients.
Initial prescriptions for hypnotics should be limited to 7-14 days supply and not
transferred to repeat without re-assessment of the patient. Tolerance can
develop within 3 to 14 days of continuous use and long term efficacy is not
assured.
Patients who do not benefit from a first Z-drug are unlikely to benefit from
another. Zaleplon has a half life of just 1 hour. Zolpidem 2.5 hours, zopiclone
3.5-6.5 hours. Different rules may apply to patients cared for by Somerset
Partnership NHS Foundation Trust.
Diazepam may be considered as an alternative especially when using as a
benzodiazepine withdrawal therapy.
Melatonin
As Circadin®
2mg P/R tablets £15.39
Zolpidem
10mg tablets: £3.76
5mg tablets:£1.64
Circadin® is indicated as monotherapy for the short-term treatment (up to 13
weeks) of primary insomnia characterised by poor quality of sleep in patients
who are aged 55 or over.Circadin may be of benefit to elderly patients at risk of
falling, or to patients who drive and are susceptible to next-day drowsiness of
z-drugs and benzodiazepines.
MHRA warned in May 2014 of the risk of morning drowsiness and reduced
driving ability with zolpidem.Link
Temazepam
10mg tablets: £23.77
20mg tablets: £22.61
Treatment should be limited to lowest dose for the shortest period of time.
Diazepam
Central Nervous System
2mg tablets: £0.86
5mg tablets: £0.89
Treatment should be limited to lowest dose for the shortest period of time.
Page 86
Therapeutic Area
Formulary Choices
Cost for 28
Rationale for decision / comments
(unless otherwise stated)
4.2
Drugs used in psychoses and related disorders
Related guidance: NICE CG 178 (February 2014) Psychosis and schizophrenia in adults: treatment and management
NICE Technology Appraisal TA213 (2011): Aripiprazole for the treatment of schizophrenia in people aged 15 to 17 years
Antipsychotics
Antipsychotics are usually initiated within secondary care, following Somerset Partnership guidelines.
Prescribing responsibility may then be transferred to primary care in accordance with a Shared Care Agreement.
All antipsychotics (except risperidone for short-term, <6 weeks, use – see below) are unlicensed for use in dementia and should only
be used when a person is a risk to themselves and others and all other methods have been tried. Prescribers are reminded that all
antipsychotics are associated with an increased risk of serious adverse reactions in elderly patients with dementia, (mortality, stroke,
TIA and possibly cognition).
The choice of antipsychotic medication should be made by the service user and healthcare professional together, taking into account
the views of the carer if the service user agrees. Provide information and discuss the likely benefits and possible side effects of each
drug, including:
 metabolic (including weight gain and diabetes)
 extrapyramidal (including akathisia, dyskinesia and dystonia)
 cardiovascular (including prolonging the QT interval)
 hormonal (including increasing plasma prolactin)
 other (including unpleasant subjective experiences).
Regular combined
treatment with two or
more antipsychotic
agents is not
recommended
Risperidone
1mg tablets: £0.99 (20)
2mg tablets: £2.06 (60)
3mg tablets: £2.35 (60)
4mg tablets: £2.26 (60)
Risperidone
25mg: £79.69 (1 pfs)
long-acting
37.5mg: £111.32 (1 pfs50mg:
injection
£142.76 (1 pfs)
NB Cold chain must
be maintained.
Central Nervous System
Risperidone is licensed for the short-term treatment, up to six-weeks, of
persistent aggression in patients with moderate to severe Alzheimer’s
dementia unresponsive to non-pharmacological approaches and when there is
a risk of harm to self or others.
NB Six-week restriction does not apply where risperidone is being
prescribed to treat acute or chronic psychoses or mania
Two-weekly injection as part of a shared-care arrangement.
Page 87
Therapeutic Area
Formulary Choices
Cost for 28
Rationale for decision / comments
(unless otherwise stated)
Paliperidone
long-acting
injection ▼
50mg: £183.92 (1 pfs)
75mg: £244.90 (1 pfs)
100mg: £314.07(1 pfs)
150mg: £392.59 (1 pfs)
Maintenance in schizophrenia in patients previously responsive to paliperidone
or risperidone in accordance with the shared care guidelines .Suitable for
patients who require antipsychotic medication and can be given as a long
acting injection for those patients that have not tolerated other typical depot
medications because of EPSE.
Paliperidone is an active metabolite of risperidone.
Olanzapine
2.5mg tablets: £1.04
5mg tablets: £1.23
7.5mg tablets: £1.35
10mg tablets: £1.67
15mg tablets: £2.14
20mg tablets: £2.43
See below
Aripiprazole
5mg tablets: £96.04
10mg tablets: £96.04
15mg tablets: £96.04
30mg tablets: £192.08
Aripiprazole is recommended as an option for the treatment of schizophrenia in
people aged 15 to 17 years who are intolerant of risperidone, or where
risperidone is contraindicated, or whose schizophrenia has not been
adequately controlled with risperidone (NICE TA213).
Generic aripiprazole is not licensed for bipolar disease. Use branded Abilify®
Quetiapine
25mg tablets: £1.61 (60)
100mg tablets: £2.66 (60)
150mg tablets: £3.27 (60)
200mg tablets: £3.72 (60)
300mg tablets: £5.07 (60)
50mg tablets: £29.45 (60)
150mg tablets:£49.45 (60)
200mg tablets: £49.45 (60)
300mg tablets: £74.45 (60)
400mg tablets: £98.95 (60)
Where quetiapine is prescribed, the standard release formulation is preferred
for long term use on cost grounds (approx. 15 price differences). This
approach is supported by Somerset Partnership NHS Foundation Trust Mental
Health Directorate.
General advice
Offer people with psychosis or schizophrenia who smoke help to stop smoking,
even if previous attempts have been unsuccessful. Be aware of the potential
significant impact of reducing cigarette smoking on the metabolism of other
drugs, particularly clozapine and olanzapine. [new 2014]
Extended release
as Biquelle XL® or
Zaluron XL®
Central Nervous System
For patients unable to take immediate release quetiapine, a once daily dose XL
preparation is available. Generically prescribed XL preparations are 50% or
more expensive than brands stated.
Page 88
Therapeutic Area
Formulary Choices
Cost for 28
Rationale for decision / comments
(unless otherwise stated)
4.2.3
Antimanic drugs
Bipolar Disorder
Initiation of lithium therapy is the responsibility of Somerset Partnership NHS Foundation Trust after which care may be transferred to general practice under
shared care guidance. All healthcare organisations in the NHS where lithium therapy is initiated, prescribed, dispensed and monitored are asked to ensure that
by 31 December 2010:

Patients prescribed lithium are monitored in accordance with NICE guidance.

There are reliable systems to ensure blood test results are communicated between laboratories and prescriber.

At the start of lithium therapy and throughout their treatment patients receive appropriate ongoing verbal and wrttten information and a record book to
track lithium blood levels and relevant clinical tests.

Prescribers and pharmacists check that blood tests are monitored regularly and is is safe to issue a repeat prescription and/or dispense the prescribed
lithium.
 Systems are in place to identify and deal with medicines that might adversely interact with lithium therapy.
Suplies of record books and alert cards are available from:
Somerset Partnership Support Services,
Mallard Court, Express Park, Bridgwater, TA6 4RN
 01278 726964
Lithium
Lithium carbonate
Preparations vary widely in bioavailability:
Lithium must be
prescribed by brand
for safety reasons
(in-line with national
guidance)
as Camcolit 250®
250mg: £3.22 (100)
Li+ 6.8mmol/tablet
as Camcolit 400®
400mg: £4.30 (100)
Modified-release.
Li+ 10.8mmol/tablet
as Liskonium® 450mg
450mg: £2.88 (60)
Modified-release.
Li+ 12.2mmol/tablet
NPSA ‘Safer Lithium
Therapy’ guidance
must be followed
as Priadel® 200mg
200mg: £2.30 (100)
Modified-release.
Li+ 5.4mmol/tablet
as Priadel® 400mg
400mg: £3.35 (100)
Modified-release.
Li+ 10.8mmol/tablet
Central Nervous System
Page 89
Therapeutic Area
Formulary Choices
Cost for 28
Rationale for decision / comments
(unless otherwise stated)
4.3
Antidepressants
Do not routinely prescribe antidepressants for initial treatment of mild depression or persistent subthreshold depressive symptoms.
Do NOT initiate Dosulepin
Selective serotonin
re-uptake inhibitors
(SSRI)
NB. SSRIs are known to increase risk of GI bleeds especially if co-prescribed with NSAIDs and in the very elderly.
Prescribers are reminded of the risk of serotonin syndrome with SSRI when combined with other antidepressants, triptans, and opioids
including tramadol.
Fluoxetine, citalopram and sertraline are all included as first-line options for SSRI. The long half-life of fluoxetine is a benefit on
withdrawal, but a drawback when switching drugs, e.g. to a TCA.
In elderly or with reduced hepatic function maximum dose of citalopam is 20mg and maximum dose of escitalopram is 10mg.
See flowchart p.91 & p93 for options
Fluoxetine
as Oxactin®
as Olena®
20mg capsules: £1.10 (30)
20mg capsules: £0.92 (30)
20mg dispersible tablets
£3.44 (28)
Less expensive than fluoxetine liquid for patients unable to swallow capsules
50mg tablets: £3.26
100mg tablets: £5.78
Joint First-line SSRI for the pharmacological treatment of social anxiety
disorder in accordance with NICE CG159.
Or
Sertraline
Or
Citalopram
10mg tablets: £0.97
20mg tablets: £0.96
40mg tablets: £1.11
Escitalopram
5mg tablets: £8.97
10mg tablets: £14.91
20mg tablets: £25.20
Joint First-line SSRI for the pharmacological treatment of social anxiety
disorder in accordance with NICE CG159.
See Somerset Partnership Guidance below (p.92)
NB: Maximum dose restrictions – see MHRA DSU (Dec-11) for details.
Central Nervous System
Page 90
Therapeutic Area
Formulary Choices
Cost for 28
Rationale for decision / comments
(unless otherwise stated)
Tricyclic and related
antidepressants
TCAs should be avoided for the treatment of depression in the elderly, due to increased risk of adverse effects, e.g. cardiac especially
in high doses.
First-line:
Lofepramine
70mg tablets: £5.90 (56)
Second-line:
Amitriptyline
10mg tablets: £0.89
25mg tablets: £0.90
50mg tablets: £0.98
Other
antidepressants
Mirtazapine
15mg tablets: £2.13
30mg tablets: £1.75
45mg tablets: £2.44
Oro-dispersible
tablets:
Venlafaxine
First-line:
Immediate release
Second-line:
Modified-release
as Vensir XL
Central Nervous System

Lofepramine is the drug of choice in this group as it is safer and produces
fewer adverse effects than traditional tricyclics.
NB: Lofepramine is now more expensive than Fluoxetine.
Mirtazapine is a second-line line option; sedating properties may be useful
where insomnia is a problem.
15mg tablets: £1.65 (30)
30mg tablets: £1.66 (30)
45mg tablets: £2.32 (30)
See MHRA guidance
37.5mg tablets: £2.37 (56)
75mg tablets: £2.69 (56)
75mg capsules: £2.60 (28)
150mg capsules: £3.90 (28)
as Viepax XL
75mg tablets: £11.20
150mg tablets: £18.70
as Venlalic XL
75mg tablets: £11.20 (30)
150mg tablets: £18.70 (30)
225mg tablets: £33.60 (30)
If modified release venlafaxine is prescribed, use tablets not capsules (on cost
grounds)
Viepax XL® or Venlalic XL® are cost-effective brands for modified release
tablets (but NOT the non-MR formulation)
There is no rationale for prescribing M/R products as a BD dose
Page 91
Citalopram maximum dose (new guidance from MHRA)
In October 2011 the MHRA issued new dose recommendations for citalopram due to the
risk of dose-dependent QT prolongation:
•
The maximum dose of citalopram is now 40mg/day in adults and 20mg/day in
the elderly and in patients with hepatic impairment.
•
Citalopram is contraindicated in known QT prolongation, congenital long QT
syndrome or taking other QT-prolonging medicines (Click here for a full list)
•
Caution with pre-existing risk factors for QT prolongation - such as significant
bradycardia, recent MI or decompensated heart failure..
Adult prescribed above 40mg/day:
Reduce dose stepwise to 40mg/day
Monitor for 3 months

Remains stable
If citalopram dose currently above new
recommendations:
Discuss with patient. Consider continued need for citalopram and
alternative therapies; switch if also taking any other medicines likely to
cause QTc prolongation
Elderly or hepatic impairment prescribed above
20mg/day:
Reduce dose stepwise to 20mg/day. Monitor for 3 months
Consider risk:benefit with patient.
Switch if possible
Relapses or deteriorates
If under 18 refer to CAMHS (unlicensed use).
If all other options exhausted consider maintaining previously effective dose [document unlicensed dose
and rationale in notes; evidence of informed consent from patients with capacity].
Reduce and monitor any risk factors. Monitor with regular ECG (e.g. initially, 6-monthly and after any
medicine or dose changes), U&Es and ask patient to report any abnormal heart rate or rhythm.
If significant QT prolongation detected, must seek specialist advice and/or switch
Switch to different SSRI (other
than escitalopram).
Consider non-pharmacological
therapies

Escitalopram:
Citalopram:
The MHRA have also issued a warning that
The MHRA have also issued a warning that
escitalopram has also been associated with
citalopram has also been associated with
dose dependent QT prolongation. New
dose dependent QT prolongation. New
recommendations for maximum doses of
recommendations for maximum doses of
escitalopram (in the elderly or patients with
citalopram, contraindications, cautions and
hepatic impairment), contraindications,
monitoring requirements have been issued
cautions and monitoring requirements have
(see separate flow chart).
been issued (see separate flow chart).
For further information please click here
For further information please click here
Medicine alternatives include:
Sertraline (optimum alternative as similar
indications, low interaction propensity, good
tolerability, generic, NICE approved)
Fluoxetine (beware of P450 interactions)
Mirtazapine (depression indication only)
Known to need above 40mg/day (adults) or
20mg/day (elderly or hepatic impairment)




There is no comparative data available on QTc
prolongation between other antidepressants/doses.
There is no single switch method:
Depending on citalopram dose, urgency, tolerability
and other medicines then “reduce, stop and switch” is
safest.
Abrupt switching is not recommended.
Please contact the pharmacy team on 01823 368265
with any questions.
Somerset Partnership NHS Foundation Trust. Drug & Therapeutics Group. Dec 2011. Review date Dec 2014
Adapted from Norfolk & Waveney and Suffolk Mental Health Foundation Trusts Guidelines
Central Nervous System
Page 92
Escitalopram maximum dose (new guidance from MHRA)
In December 2011 the MHRA issued new dose recommendations for escitalopram in the
elderly or in patients with hepatic impairment, due to the risk of a dose-dependent QT
prolongation:
•
The maximum dose in the elderly and patients with hepatic impairment has
been reduced to 10mg daily. (The maximum dose for adults remains 20mg
daily).
•
Escitalopram contraindicated in known QT prolongation, congenital long QT
syndrome or taking other QT prolonging medicines (Click here for a full list).
•
Caution with pre-existing risk factors for QT prolongation - such as significant
bradycardia, recent MI or decompensated heart failure.
Central Nervous System
Page 93
Therapeutic Area
Formulary Choices
Cost for 28
Rationale for decision / comments
(unless otherwise stated)
4.5
CNS stimulants and drugs used for attention defecit hyperactivity disorder
Treatment of ADHD
See NICE CG72 Attention deficit hyperactivity disorder: Diagnosis and management of ADHD in children, young people and adults
(Sep-08; last modified Mar-13).
AMBER prescribing only: Initiated by a suitable specialist for the treatment of ADHD in accordance with the shared care guideline.
Methylphenidate
Modified release
as Concerta XL®
as Equasym XL®
as Medikinet XL®
5mg tablet: £3.03 (30)
10mg tablet: £5.49 (30)
20mg tablet: £10.92 (30)
Brand as recommended by consultant:
18mg tablet: £31.19 (30)
27mg tablet: £36.81 (30)
36mg tablet: £42.45 (30)
10mg capsule: £25.00 (30)
20mg capsule: £30.00 (30)
30mg capsule: £35.00 (30)
5mg capsule: £24.04 (30)
10mg capsule: £24.04 (30)
20mg capsule: £28.86 (30)
30mg capsule: £33.66 (30)
40mg capsule: £57.72 (30)
Atomoxetine
10mg capsule: £62.46
18mg capsule: £62.46
25mg capsule: £62.46
10mg capsule: £62.46
40mg capsule: £62.46
60mg capsule: £62.46
80mg capsule: £83.28
100mg capsule: £83.28
Dexamfetamine
5mg tablet: £18.90
Lisdexamfetamine
30mg capsule: £58.24
50mg capsule: £68.60
70mg capsule: £83.16
Central Nervous System
 22% immediate-release + 78% modified release
 30% immediate-release + 70% modified release
 50% immediate-release + 50% modified release
Prodrug of dexamfetamine.
Unlicensed for treatment of adults over 18 years.
Page 94
Therapeutic Area
Formulary Choices
Cost for 28
Rationale for decision / comments
(unless otherwise stated)
4.5.1 Drugs used in the treatment of obesity
Lipid absorption
inhibitors
Orlistat
Central Nervous System
120mg: £30.43 (84)
Only to be prescribed in line with NICE guidance:

BMI > 30kg/m2 or > 28kg/m2 where other risk factors e.g. type 2 DM,
hypertension or hypercholesterolaemia

for patients who have lost ≥ 2.5kg by dietary control and increased physical
activity during previous month

only for individuals between 18 and 75 years

arrangements should exist for primary care staff (mostly practice nurses)
supported by community dieticians to offer advice, support and counselling
on diet, physical activity and behavioural strategies

treatment should continue beyond 3 months only if weight loss of >5%
from start of treatment

treatment should continue beyond 6 months only if weight loss is > 10%
from start of treatment

treatment should not usually continue beyond one year and never beyond
two years
Page 95
Traffic light system for identifying risk of serious illness in children*
Colour
Green
Amber
Red
– low risk
– intermediate risk
– high risk
 Normal colour
 Pallor reported by
parent/carer
 Pale / mottled / ashen /
blue
 Responds normally to
social cues
Content/smiles Stays
awake or awakens
quickly
 Not responding normally to
social cues
 No response to social
cues
 No smile
 Appears ill to a healthcare
professional
(of skin, lips or
tongue)
Activity
 Strong normal cry/not
crying
Respiratory
 Wakes only with
prolonged stimulation
 Decreased activity
 Does not wake or if roused
does not stay awake
 Nasal laring
 Grunting
 Tachypnoea:
- RR >50 breaths/
minute, age 6–12
months
- RR >40 breaths/
minute, age >12
months
 Tachypnoea:
RR >60 breaths/minute
 Weak, high-pitched or
continuous cry
 Moderate or severe chest
indrawing
 Oxygen saturation ≤95% in
air
 Crackles in the chest
Circulation
and
hydration
 Normal skin and
eyes
 Moist mucous
membranes
 Tachycardia:
- >160 beats/minute,
age <12 months
- >150 beats/minute,
age 12–24 months
- >140 beats/minute,
age 2–5 years
 Reduced skin turgor
 CRT ≥3 seconds
 Dry mucous membranes
Poor feeding in infants
Reduced urine output
Other
 None of the amber or red
symptoms or signs
 Age 3–6 months,
temperature ≥39°C
 Age <3 months,
temperature ≥38°C
 Fever for ≥5 days Rigors
 Non-blanching rash
 Swelling of a limb or joint
 Bulging fontanelle
 Non-weight bearing limb /
not using an extremity
 Neck stiffness
 Status epilepticus
 Focal neurological signs
 Focal seizures
CRT, capillary refill time; RR, respiratory rate
*
This traffic light table should be used in conjunction with the recommendations in the guideline
on investigations and initial management in children with fever.
See http://guidance.nice.org.uk/CG160 (update of NICE clinical guideline 47).
‘Feverish illness in children’, NICE clinical guideline 160 (May 2013)
© National Institute for Health and Care Excellence 2013. All rights reserved
Central Nervous System
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Rationale for decision / comments
(unless otherwise stated)
4.7 Analgesics:
Related guidance: CG177 Osteoarthritis: Care and management in adults Feb 2014
Avoid soluble formulations of Paracetamol and Co-Codamol because of high sodium content (the equivalent of up to 9g of salt per day at full dose) which may
contribute to or exacerbate hypertension or heart failure. These products are also more expensive.
Medication Overuse Headache All medications for treating headache can cause MOH in patients with a pre-existing primary headache disorder, even
if taking medicines for pain other than headache. Mean onest 1.7 years (triptans) to 4.8 years (analgesics)
Non-opioid
analgesics
First-line
Paracetamol
500mg tablets: £2.78 (100)
First choice drug in acute and chronic pain. If treatment is not effective check
that adequate dose is being used (i.e. 1g QDS) before adding other options.
Available OTC.
Paracetamol may be considered an option for treating agitation in people with
dementia where pain may be a factor. Husebo et al. (2011) Br Med J 343: d4065;
Husebo, Ballard, & Aarsland (2011) Int J Ger Psych 26: 1012-1018.
Weak opioid
analgesics
Buprenorphine Patches 5/10/20mg should NOT be prescribed. They are non-formulary as not a cost-effective use of NHS resources.
See note re effect of external heat sources p.70
The CCG strongly recommends that prescribers discuss the risk of addiction when initiating new patients on any opioid containing
medication and also on review. This discussion should be recorded in the patient notes.
Just three days of codeine or dihydrocodeine medicines can lead to addiction.
Codeine 30mg x 8/day
provides 240mg
codeine equivalent to
Morphine 30mg
Codeine
Continued overleaf
Central Nervous System
15mg tablets: £1.27
30mg tablets: £1.41
60mg tablets: £3.58
Note that around 10% of the caucasian population lack the enzyme to
metabolize Codeine so derive little benefit from it, but still suffer the side effects
Prescribing Paracetamol and Codeine separately enables more appropriate
dose titration and enables patients to take more control of their own pain
management, e.g. taking Paracetamol regularly and adding Codeine as
required. Codeine alone is not considered a particularly effective analgesic.
Combinations may be appropriate for patients where there is concern over risk
of opiate abuse or where a fixed combination is known to be required regularly,
is effective and tolerated.
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Rationale for decision / comments
(unless otherwise stated)
Continued from previous page
Tramadol
First-line:
Immediate release
capsules
Second-line:
Modified release
Combination
analgesics
50mg capsules: £3.67 (100)
Tramadol may be considered as an alternative to Codeine where its efficacy or
tolerability is poor. MHRA advise short-term or intermittent treatment; caution
where history of addiction or seizure
Tramadol may be most effective when given with full therapeutic doses of
Paracetamol (i.e. NOT as Tramacet which contains only 375mg paracetamol).
as Marol
(twice-daily dosing)
100mg tablets: £6.98 (60)
150mg tablets: £10.48 (60)
200mg tablets: £14.28 (60)
For patients with long term chronic pain responsive to tramadol but who suffer
significant side effects from the immediate release capsules a modified release
product may be prescribed.
as Tradorec XL
(once-daily
dosing)
100mg tablets: £14.10 (30)
200mg tablets: £14.98 (30)
300mg tablets: £22.47 (30)
For patients suffering long term chronic night time pain and pain on early
waking, Tradorec XL is a formulary option.
Maintenance dose for majority of patients is 200mg IN THE EVENING
Combination formulations that include tramadol as one of the ingredients (e.g. Tramacet) are non-formulary.
The CCG strongly recommends that prescribers discuss the risk of addiction when initiating new patients on any opioid containing
medication and also on review. This discussion should be recorded in the patient notes.
Just three days of codeine or dihydrocodeine medicines can lead to addiction.
Co-codamol 30/500 x
8/day provides 240mg
codeine equivalent to
Morphine 30mg
Co-Codamol
(Codeine /
Paracetamol)
8/500mg tablets: £3.97 (100)
as Zapain
30/500mg tablets: £3.03
(100)
(capsules are at >twice this
price)
Evidence that Co-Codamol 8/500 offers significantly better analgesia than
Paracetamol alone is poor and many patients, especially the elderly,
experience troublesome constipation.
Co-Codamol 8/500 is available OTC.
Co-Codamol 30/500 is a potent analgesic carrying the full range of opioid side
effects e.g. constipation and sedation, requiring particular care in the elderly –
see BNF warning.
Prescribe as separate components if possible. NB. Zapain is 40% cheaper
than generic (£2/100)
Management of opioid overdosage may require use of Naloxone: refer to Chapter 15 of the current BNF
Strong opioid
analgesics
For non-cancer pain, strong opioids should be considered only when they are used as part of a programme of supported rehabilitation,
with the goal of helping patients to manage pain-related disability.
There is no evidence of superior clinical analgesic effect of other opioids over morphine
Central Nervous System
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Therapeutic Area
Formulary Choices
Cost for 28
Rationale for decision / comments
(unless otherwise stated)
First-line:
Morphine
Solution
Strong opioid
analgesics
10mg/5ml solution: £5.45
(100ml)
Modified release
capsules as
Zomorph
Modified release
tablets as
Morphgesic SR
Second-line:
Fentanyl
10mg capsules: £3.47 (60)
30mg capsules: £8.30 (60)
60mg capsules: £16.20 (60)
100mg capsules: £25.65 (60)
200mg capsules: £51.30 (60)
Continued overleaf
Central Nervous System
Zomorph is the recommended modified-release morphine formulation.
Prescribe 12-hourly.
Subject to CD regulations.
Capsules can be opened and sprinkled on semi-solid food (e.g. yoghurt) or
given in water via NG tube.
10mg tablets: £3.85 (60)
30mg tablets: £9.24 (60)
60mg tablets: £18.04 (60)
100mg tablets: £28.54 (60)
Fentanyl is only included for patients where morphine is contra-indicated or not tolerated or where there is
specific need for a non-oral route. For non-cancer pain, 75mcg/hour should be the maximum dose, if
ineffective other causes for lack of response should be considered (eg. Primary anxiety or unrealistic
expectations of analgesia from patch).
Patches
as Matrifen
Use oral solution for initial dose titration and breakthrough pain. Doses not to
be given at intervals of less than one hour.
Typical time to onset of therapeutic level –
Oral morphine solution:
20 – 30 minutes
Oxycodone solution:
60 minutes
Morphine tablets:
90 minutes
NB. Morphine 10mg/5ml is not subject to CD handwriting regulations.

12mcg / hour: £8.87 (5)
25mcg / hour: £12.68 (5)
50mcg / hour: £23.69 (5)
75mcg / hour: £33.03 (5)
100mcg / hour: £40.71 (5)
See MHRA DSU Vol.2 Issue 2 (Sep-08): Fentanyl patches: serious and fatal
overdose from dosing errors, accidental exposure, and inappropriate use.
Increases in body temperature and external heat sources may lead to
potentially fatal rises in serum fentanyl levels.
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Therapeutic Area
Formulary Choices
Cost for 28
Rationale for decision / comments
(unless otherwise stated)
Continued from previous page
Central Nervous System
as Fencino®
12mcg / hour: £8.57(5)
25mcg / hour: £12.24 (5)
50mcg / hour: £22.87 (5)
75mcg / hour: £31.88 (5)
100mcg / hour: £39.29 (5)
Buprenorphine
patches
as Hapoctasin®
35mcg/hr : £9.48 (4)
50mcg/hr: £14.23 (4)
70mcg/hr: £18.96 (4)
As an option for patients with moderate to severe cancer pain for whom
fentanyl may be too potent.
Note: Hapoctasin® are 72 hour patches the same as fentanyl. Transtec®
have the same rate of drug delivery as Hapoctasin® but are 96 hour
patches.
Table of approximate dose equivalents fro British Pain Society
Page 100
Therapeutic Area
Formulary Choices
Cost for 28
Rationale for decision / comments
(unless otherwise stated)
Third-line:
Oxycodone
Oxycodone is included only for patients where morphine is contra-indicated or not tolerated. Available data
does not provide any evidence of oxycodone’s superiority to morphine.
The CQC have issued guidance on prescribing, supply and administration:
Safer Use of Controlled Drugs – Preventing Harm From Oral Oxycodone Medicines
Instant release
as Shortec®
5mg capsules £11.43 (56)
10mg capsules £22.86 (56)
20mg capsules £45.71 (56)
5mg/5ml SF solution: £9.71
(250ml)
Modified release
as Longtec
Fourth-line:
5mg tablets: £10.00 (28)
10mg tablets: £19.99 (56)
20mg tablets: £39.98 (56)
40mg tablets: £79.98 (56)
80mg tablets: £159.98 (56)
Tapentadol
Targinact is non-formulary: not a cost-effective use of NHS resources.
No long-term data, no comparison with other opioids with/without regular
laxatives.
Fourth-line strong opioid analgesic: Approved for relief of moderate to severe
pain in adults as an alternative to oxycodone
Instant release
50mg tablets: £12.46 (28)
75mg tablets: £18.68 (28)
Note: instant release product only licensed for acute pain and the slow release
preparation is only licensed for chronic pain.
Modified release
50mg tablets: £12.46 (28)
100mg tablets: £49.82 (56)
150mg tablets: £74.73 (56)
200mg tablets: £99.64 (56)
250mg tablets: £124.55 (56)
Procedures should be in place to prevent inadvertent prescribing errors
Buprenorphine Patches should NOT be prescribed. They are non-formulary as not a cost-effective use of NHS resources. There is a
lack of evidence of comparative efficacy with a clinically relevant treatment in the UK. The economic case has not been demonstrated.
Like other transdermal products, increases in body temperature (eg after bathing) and external heat sources may lead to increased
serum levels of active drug.
Central Nervous System
Page 101
OPIOID CONVERSION TABLE - St Margaret’s Hospice Guide to Opioid Dose Conversion
This is an approximate guide, comprehensive data are lacking and there is inter-individual variation.
In most cases, the calculated dose-equivalent of a new drug derived must be reduced by 25-50% to ensure safety. A dose reduction of at least 50% is
recommended when switching at high doses (ie. morphine or equivalent doses of 1g/24 hours or more), in elderly or frail patients, or because of intolerable
undesirable effects. A similar dose reduction is recommended when there has been a recent rapid escalation of the first opioid.
NB Reduction may not be appropriate if the original opioid failed to control pain.
The patient’s clinical condition must be taken into account and breakthrough ‘prn’ analgesia to make up any deficit while re-titrating to a satisfactory dose of the
new opioid.
(Converting from)
Current opioid
(Converting to)
New opioid and/or new route of administration
Divide 24 hour dose* of current opioid (col 1) by relevant figure below to
calculate initial 24 hour dose of new opioid and/or new route (column 2)
Example:
120mg oral morphine in 24 hours
subcutaneous diamorphine
Divide by 3
120mg/3 = 40mg subcutaneous diamorphine in 24 hours
ORAL TO ORAL ROUTE CONVERSIONS
oral codeine
oral morphine
oral tramadol
oral morphine
oral morphine
oral oxycodone
oral morphine
oral hydromorphone
ORAL TO TRANSDERMAL ROUTE CONVERSIONS
oral morphine
transdermal fentanyl
oral morphine
transdermal buprenorphine
ORAL TO SUBCUTANEOUS ROUTE CONVERSIONS
oral morphine
subcutaneous morphine
oral morphine
subcutaneous diamorphine
oral oxycodone
subcutaneous morphine
oral oxycodone
subcutaneous oxycodone
oral oxycodone
subcutaneous diamorphine
oral hydromorphone
subcutaneous hydromorphone
OTHER ROUTE CONVERSIONS (RARELY USED IN PALLIATIVE MEDICINE)
subcutaneous or intramuscular morphine
intravenous morphine
subcutaneous diamorphine
subcutaneous alfentanil
subcutaneous oxycodone
subcutaneous diamorphine
intravenous morphine
oral morphine
*
**
oral morphine
intramuscular morphine
Divide by 10
Divide by 7
Divide by 2
Divide by 7.5
Refer to manufacturer’s information**
Seek specialist palliative care advice
Divide by 2
Divide by 3
Divide by 1
Divide by 2
Divide by 1.5
Seek specialist palliative care advice
Divide by 1
Divide by 10 (specialist palliative care input: amber drug)
Divide by 1 – treat as equivalent up to doses of 60mg/24
hours – seek specialist advice
Multiply by 2
Divide by 2
The same units must be used for both opioids or routes, eg mg morphine to mg oxycodone
The conversion ratios of oral morphine : transdermal fentanyl specified by the manufacturer(s) vary from around 100:1 to 150:1
Central Nervous System
Page 102
Therapeutic Area
Formulary Choices
Cost for 28
Rationale for decision / comments
(unless otherwise stated)
4.7.3 Neuropathic pain
Related guidance: CG173 Neuropathic pain - pharmacological management: NICE guideline November 2013
NICE recommendation for the pharmacological management of neuropathic pain depends on diagnosed origin of the pain.






There is no need to change existing treatments for people whose neuropathic pain is well controlled
All pharmacological treatments should be started at a low dose & titrated to maximum effective or tolerated dose
When switching to a new drug, consider overlapping treatments to avoid deterioration in pain control
When withdrawing, taper the dose to avoid discontinuation symptoms
If pain reduction is still unsatisfactory at maximum doses of first & second line treatments refer patient to a specialist pain and/or condition specific service
Do not start treatment with opioids (such as morphine or oxycodone) other than tramadol without an assessment by a specialist pain service or a
condition-specific service
Neuropathic pain
Amitriptyline
Gabapentin
Duloxetine
Pregabalin
10mg tablets: £0.89
25mg tablets: £0.90
50mg tablets: £0.98
100mg capsules: £2.90 (100)
300mg capsules: £4.49 (100)
400mg capsules £4.77 (100)
Offer a choice of amitriptyline, duloxetine, gabapentin or pregabalin as initial
treatment for neuropathic pain (except trigeminal neuralgia)
If the initial treatment is not effective or is not tolerated, offer one of the remaining 3
drugs, and consider switching again if the second and third drugs tried are also not
effective or not tolerated.
Consider tramadol only if acute rescue therapy is needed.Consider capsaicin
cream for people with localised neuropathic pain who wish to avoid, or who cannot
tolerate, oral treatments.
60mg capsules: £27.72
25mg capsules: £64.40 (56)
50mg capsules: £96.60 (84)
75mg capsules: £64.40 (56)
100mg capsules: £96.60 (84)
150mg capsules: £64.40 (56)
200mg capsules: £96.60 (84)
225mg capsules: £64.40 (56)
300mg capsules: £64.40 (56)
Because of price structure for pregabalin, ensure dose optimisation is carried out.
Pregabalin dose spread over two daily doses proved non-inferior to three times a day
dosing. http://www.update-software.com/BCP/WileyPDF/EN/CD007076.pdf
.
Central Nervous System
Page 103
Therapeutic Area
Formulary Choices
Cost for 28
Rationale for decision / comments
(unless otherwise stated)
Tramadol capsules
(immediate release)
50mg capsules: £3.67 (100)
Acute treatment as rescue, for short term use only
NB The combination of tramadol with amitriptyline or duloxetine is associated with a
low risk of serotonin syndrome.
Lignocaine
(Lidocaine) Patches
5% medicated plaster:
£72.40 (pack 30)
For the treatment of localised pain for people unable to take oral medication because
of medical conditions and/or disability.
Central Nervous System
Page 104
Diagnosis of tension-type headache, migraine & cluster headache
Adapted from ‘Headaches’ (NICE clinical guideline 150), available from http://www.nice.org.uk/CG150
Headache feature
Tension-type headache
Migraine (with or without aura)
Cluster headache
Pain location1
Bilateral
Unilateral or bilateral
Pain quality
Pressing/tightening (non-pulsating)
Pain intensity
Effect on
activities
Other symptoms
Mild or moderate
Not aggravated by routine activities of daily
living
None
Pulsating (throbbing or banging in young people
aged 12–17 years)
Moderate or severe
Aggravated by, or causes avoidance of, routine
activities of daily living
Unilateral (around the eye, above the eye and
along the side of the head/face)
Variable (can be sharp, boring, burning,
throbbing or tightening)
Severe or very severe
Restlessness or agitation
 Unusual sensitivity to light and/or sound or
nausea and/or vomiting.
 Aura2: symptoms can occur with or without
Duration of
headache
Frequency of
headache
30 minutes–continuous
< 15 days per month
≥ 15 days per month
for more than
3 months
headache and:
o
are fully reversible,
o
develop over at least 5 minutes,
o
last 5 - 60 minutes.
Typical aura symptoms include visual
symptoms such as flickering lights, spots or
lines and/or partial loss of vision; sensory
symptoms such as numbness and/or pins and
needles; and/or speech disturbance.
4–72 hours in adults 1–72 hours in young
people aged 12–17 years
< 15 days per month
≥ 15 days per month
for more than
3 months
Diagnosis
Episodic tensiontype headache
Chronic tension-type
headache2
Episodic migraine
(with or without aura)
Chronic migraine
(with or without aura)
On the same side as the headache:





Red and/or watery eye
Nasal congestion and/or runny nose
Swollen eyelid
Forehead and facial sweating
Constricted pupil and/or drooping eyelid
15–180 minutes
1 every other day to 8
per day3, with
remission4 >1 month
Episodic cluster
headache
1 every other day to
8 per day3 with a
continuous remission4
<1 month in a
12-month period
Chronic cluster
headache
1
Headache pain can be felt in the head, face or neck. 2 Chronic migraine and chronic tension-type headache commonly overlap. If there are any features of migraine, diagnose chronic
migraine. 3 Frequency of recurrent headaches during a cluster headache bout. 4 The pain-free period between cluster headache bouts. 5 Chronic migraine and chronic tension-type headache
commonly overlap. If there are any features of migraine, diagnose chronic migraine. 6 NICE has developed technology appraisal guidance on Botulinum toxin type A for theprevention of
headaches in adults with chronic migraine (headaches on at least 15 days permmonth of which at least 8 days are with migraine).
Central Nervous System
Page 105
Medication Recommendations from NICE CG 150: Headache (All recommendations - take account of preferences, comorbidities and risk of adverse events.
*
Formulary triptans: 1st line – sumatriptan; 2nd line – zolmitriptan. If these are consistently ineffective, try one or more alternative triptans.
Tension Type Headache
Migraine with or without aura
Acute treatment
Acute treatment
 Aspirin (not for<16 years association with Reye’s
Syndrome)
 Paracetamol
 NSAID
 Oral triptan* + NSAID or
 Oral triptan* + paracetamol
plus
 Anti-emetic even in absence
of nausea & vomiting
 Consider nasal triptan for 1217 year olds & non-oral antiemetic
DO NOT OFFER
DO NOT OFFER
Migraine associated with
Menstrual Cycle
Acute treatment
When standard treatment is
not effective:
 Frovatripan 2.5mg bd or
 Zolmitriptan 2.5mg two
or three times a day
on the days migraine is
expected
Migraine in Pregnancy
Cluster Headache
Acute treatment
Acute treatment
Oxygen 100% at flow rate at
least 12 litres/min with nonrebreathing face mask and/or
subcutaneous or nasal triptan
DO NOT OFFER
DO NOT OFFER
DO NOT OFFER
Prophylaxis
 Paracetamol
 NSAIDs
 Opioids
 Ergots
 Oral triptans
Prophylaxis
 Paracetamol
 Consider triptan after
discussing need for
treatment and risks
 Opioids


Prophylaxis
Prophylaxis

Review need to continue
N/A
 Verapamil
 Seek specialist advice
prophylaxis 6 months after
 Seek specialist advice if
starting
cluster headache does not
 Continue current regime for
respond to verapamil
people on existing effective
 Seek specialist advice for
migraine prophylaxis.
cluster headache during
 Propranolol or Topiramate
pregnancy
(patients <18) – ensure suitable
contraception for females of
child bearing age (risk of foetal
malformation)
 Second line:
o Acupuncture: up to 10
sessions over 5-8 weeks or
Use of medication in bold within this guidance is off-license for indication/age/dose given. These
o Gabapentin – up to 1200mg
were all approved for prescribing in Somerset at Prescribing Forum November 2012.
daily
Prescribers should follow relevant professional guidance & patient (or parent or carer) should
o Riboflavin 400mg once daily
provide informed consent, which should be documented)
may be effective to reduce
migraine frequency & intensity.
Acupuncture: up to10
sessions over 5-8 weeks
Central Nervous System
Ergots or derivatives
Opioids
 Routinely prescribe combined
hormonal oral contraceptive
Prophylaxis
Page 106
Therapeutic Area
Formulary Choices
Cost for 28
Rationale for decision / comments
(unless otherwise stated)
4.7.4
Antimigraine drugs
Acute management
of migraine
Simple analgesia
Aspirin
300mg dispersible tablets:
£11.90 (100)
Evidence supports the efficacy of Aspirin at a dose of 900mg for acute
migraine. Available OTC.
Ibuprofen
200mg tablets: £3.40 (84)
400mg tablets: £3.19 (84)
600mg tablets: £6.91 (84)
For severe headache 400mg dose recommended. 200mg and 400mg tablets
available OTC.
Paracetamol
500mg tablets: £2.78 (100)
Soluble preparations may have a role for occasional use but have high sodium
content. Available OTC. Recommended dose 1000mg.
As above plus
Price as above
Analgesic plus anti-emetic combinations are the second line therapy option
when simple analgesia alone has proved inadequate. Combination products
eg. Migramax are significantly more expensive than separate prescriptions,
one component of which is available OTC.
Domperidone
10mg tablets: £1.13 (30)
30mg suppositories: £3.06
(10)
Affects QT .Maximum dose10mg tds (30mg) in adults and adolescents
weighing 35k or more. Avoid in moderate-severe liver function and in patients
with severe underlying heart problems
http://www.mhra.gov.uk/NewsCentre/Pressreleases/CON409258
Metoclopramide
10mg tablets: £0.94
Metoclopramide causes more acute dystonic reactions than domperidone
particularly in younger patients. Maximum 5 day treatment period. MHRA
warning
Prochlorperazine
5mg tablets: £1.02 (28)
3mg buccal tabs: £6.49 (10)
Simple analgesia
plus anti-emetic
prescribed
separately
Triptans
First-line
Sumatriptan
50mg tablets: £1.55 (6)
100mg tablets: £1.90 (6)
Sumatripan is included as the most cost-effective triptan. Evidence suggests
little additional benefit from doses above 50mg. If patients have been initiated
on injectable forms, a trial of oral sumatriptan is recommended.
Second-line:
Central Nervous System
Page 107
Therapeutic Area
Formulary Choices
Cost for 28
Rationale for decision / comments
(unless otherwise stated)
Zolmitriptan
Prophylaxis of
migraine
First-line
2.5mg tablets: £1.42 (6)
2.5mg orodispersible tabs:
£1.74 (6)
5mg orodispersible tabs:
£12.88 (6)
Dose for migraine is 2.5mg – 5mg strength only for patients not achieving
satisfactory relief with 2.5mg dose.
There is no evidence that oro-dispersible formulations have a faster onset of
action than conventional tablets.
Zolmitriptan orodispersible a good cost effective alternative to rizatriptan
melts
Consider prophylaxis when more than one or two attacks occur per month. See BNF for details.
The need for continuing migraine prophylaxis should be reviewed 6 months after starting.
Induction of drug overuse headache is possible for all triptans.
Risk becomes significant at 12 days per month of triptan intake, mean onest occurs after 1.7 years use.
Propranolol
10mg tablets: £0.96
40mg tablets: £1.19
80mg tablets: £1.66
Propranolol is the recommended first line prophylactic therapy for migraine.
Avoid using Propranolol MR products as significantly higher cost: Inderal-LA
(£1.91 pack of 28) and Half-Inderal LA (£5.40 pack of 28).
Second-line:
Topiramate tablets
25mg tablets: £2.77 (60)
50mg tablets: £3.11 (60)
100mg tablets: £3.16 (60)
200mg tablets: £15.73 (60)
Topiramate is effective for migraine prophylaxis. Advise women & girls of
childbearing potential that topiramate is associated with a risk of foetal
malformations & can impair the effectiveness of hormonal contraceptives.
Ensure they are offered suitable contraception.
Prescribe as tablet formulation not capsule because of large price difference.
Third-line
Amitriptyline
10mg tablets: £0.89
25mg tablets: £0.90
50mg tablets: £0.98
NICE CG150 states that people whose migraine is well controlled with
amitriptyline should continue their current treatment.
Central Nervous System
Page 108
Therapeutic Area
Formulary Choices
Cost for 28
Rationale for decision / comments
(unless otherwise stated)
4.8.1 Epilepsy
Related guidance: NICE CG137 The Epilepsies: diagnosis and management in adults and children in primary and secondary care
Formulation switching of antiepileptic drugs
See MHRA / CHM Guidance on antieplileptic drugs issued Jul-13.
AED Categorisation
Problems related to small differences in bioavailability of different manufacturers products (branded, generic) are of concern for some drugs (most notably
phenytoin) but not for some others that have a wider therapeutic index and/or high solubility and permeability. In broad terms, three groups of AEDs are identified
regarding concerns of the potential risk related to switching between products:
Category
Guidance
AEDs affected
Category 1
For these drugs, doctors are advised to ensure that their patient is maintained on
a specific manufacturer’s product.
Phenytoin, carbamazepine, phenobarbital, primidone
Category 2
For these drugs the need for continued supply of a particular manufacturer’s
product should be based on clinical judgement and consultation with patient
and/or carer taking into account factors such as seizure frequency and treatment
history.
Valproate, lamotrigine, perampanel, retigabine,
rufinamide, clobazam, clonazepam, oxcarbazepine,
eslicarbazepine, zonisamide, topiramate
Category 3
For these drugs it is usually unnecessary to ensure that patients are maintained
on a specific manufacturer’s product unless there are specific concerns such as
patient anxiety, and risk of confusion or dosing errors.
Levetiracetam, lacosamide, tiagabine, gabapentin,
pregabalin, ethosuximide, vigabatrin
NICE CG137 recommends use of controlled release preparations when prescribing Carbamazepine.
4.8.2
Drugs used in status epilepticus
Midazolam
Buccal solution
as Buccolam
10mg/2ml
0.5ml syringe (2.5mg dose):
£82
1ml syringe (5mg dose):
£85.50
1.5ml syringe (7.5mg dose):
£89.00
2ml syringe (10mg dose):
£91.50
Note: Buccolamis currently the only licensed version of buccal midazolam and
should be the preferred product for new patients. Licensed in patients 18yrs
and under.
There may be a risk if existing patients are changed from ‘Epistatus®’ or other
unlicensed specials to Buccolam unless there has been clear communication
and training for the carer of the different strengths available
As Epistatus®
Price variable
(unlicensed product)
Central Nervous System
Page 109
Therapeutic Area
Formulary Choices
Cost for 28
Rationale for decision / comments
(unless otherwise stated)
4.10
Drugs used in substance dependence
Related information: NICE Tobacco Harm Reduction PH45 June 2013
Smoking Cessation
Nicotine
Replacement
Therapy (NRT)
Patches - various
Gum - various
Lozenges - various
Nasal spray
Inhalator
Quickmist
Bupropion
(Amfebutamone)
Prescribing for the management of nicotine addiction should be in line with
NICE guidance
Evidence for all aids to smoking cessation indicates that motivational support
increase likelihood of successful quit attempt.
Decisions around appropriate aids to smoking cessation should be made in
agreement with the patient.
Combinations of NRT, bupropion and varenicline for smoking cessation should
not be used.
Decisions around route of administration for NRT should be made in
agreement with the patient.
Combinations of NRT products should be considered for those with a high level
of nicotine dependency or where previous attempts to stop smoking have been
unsuccessful.
Prescriptions should normally be for a sufficient to last until 2 weeks after the
target stop date, subsequent prescriptions should only be given to people who
demonstrate that their quit attempt is continuing.
Bupropion should not be prescribed to patients with other risk factors for seizures unless the potential benefits
of smoking cessation clearly outweigh the risk. Factors increasing seizure risk include:
 Concomitant administration of drugs that lower seizure threshold eg. antidepressants, antimalarials,
antipsychotics, quinolones, sedating antihistamines, systemic corticosteroids, theophylline and tramadol,
stimulants and anorectics
 Alcohol abuse
 History of head trauma
 Diabetes
150mg tablets: £41.76 (60)
Central Nervous System
Prescribers should consider prescribing Bupropion a month at a time to
minimise waste and link with patients receiving ongoing behavioural support.
Bupropion should not be prescribed in pregnancy, lactation or to patients aged
<18 years
Bupropion is contra-indicated in patients with history of seizure, eating
disorders, CNS tumour, or thoser experiencing acute symptoms of
benzodiazepine or alcohol withdrawal
Page 110
Therapeutic Area
Formulary Choices
Cost for 28
Rationale for decision / comments
(unless otherwise stated)
Smoking Cessation (continued from previous page)
Varenicline▼
Varenicline (Champix) is a Black Triangle▼drug, consequently all adverse effects should be reported to the
MHRA via the Yellow Card scheme. Following reports of depression and suicidal ideation the MHRA advise:
 Smoking cessation with or without pharmacotherapy may be associated with an exacerbation of underlying
psychiatric illness, including depression. Care should be taken in such patients, who should be advised of
the risk
 Patients should be made aware of the possibility that trying to stop smoking might cause symptoms of
depression
 Patients who are taking varenicline who develop suicidal thoughts should stop their treatment and contact
their doctor immediately.
There are some concerns about cardiovascular risk with a warning from FDA issued in June 2011. Patients should be
instructed to notify their doctor of new or worsening cardiovascular symptoms. The risk appears to be similar with
bupropion
Central Nervous System
Starter pack: £27.30
0.5mg tablets (11)
1mg tablets (14)
0.5mg tablets: £54.60 (56)
1mg tablets: £27.30 (28),
£54.60 (56)
Varenicline is approved for prescribing in Primary Care with the following
advice. Varenicline should:
Special advice for certain
patients
Offer people with psychosis or schizophrenia who smoke help to stop smoking,
even if previous attempts have been unsuccessful. Be aware of the potential
significant impact of reducing cigarette smoking on the metabolism of other
drugs, particularly clozapine and olanzapine. [new 2014] Link
 only be prescribed within its licensed indications for smokers who have
expressed a desire to quit smoking
 normally only be prescribed as part of a programme of behavioural support
 not be prescribed in pregnancy, lactation or to patients aged <18 years
Prescribers should consider prescribing the 12 week course of Varenicline a
month at a time to minimise waste in patients and link in with patients receiving
ongoing behavioural support.
Page 111
Therapeutic Area
Formulary Choices
Cost for 28
Rationale for decision / comments
(unless otherwise stated)
Opioid dependence
Oral methadone and buprenorphine are recommended by NICE for maintenance therapy in the management of opioid dependence.
Patients should be committed to a supportive care programme including a flexible dosing regimen administered under supervision for at
least three months, until compliance is assured. In Somerset substance misuse services are provided by Turning Point Somerset
which offers a comprehensive program of supportive care through the central team and key workers.
Selection of methadone or buprenorphine should be made on a case by case basis, but methadone should be prescribed (as
Physeptone®) if both drugs are equally suitable.
Primary care prescribing of methadone 1mg/ml mixture or buprenorphine sublingual tablets for the treatment or maintenance of opioid
dependence is only recommended by GPs who undertaken the necessary RCGP training and in practices that have the relevant
shared-care arrangements in place with Turning Point Somerset.
Prescribing for the treatment or maintenance of drug addiction outside of shared-care arrangements is NOT recommended and could
lead to medico-legal implications for the prescriber in some circumstances.
Methadone
1mg/1ml mixture
as Physeptone®
Alcohol dependence
1mg/ml: £6.42 (500ml)
1mg/ml sugar-free: £6.42
(500ml)
Prescribing by brand is recommended as the most cost-effective option.
NB: Sugar-free methadone liquid is thought to have more abuse potential, as it
causes fewer complications if injected intra-venously by abusers. SF
methadone mixture should be considered second-line. There is no evidence of
SF preparations being beneficial in the prevention of dental problems in opioid
dependence – dental decay is more likely to be attributed to lifestyle factors
that effect dental hygiene and the depressant effect of opioids on salivary
secretion.
Buprenorphine
sugar-free
sublingual tablets
0.4mg: £1.60 (7)
2mg: £2.13 (7)
8mg: £3.94 (7)
Prescribing generically is recommended as the most cost-effective option.
Naltrexone
50mg tablets: £22.34 (28)
For alcohol dependence, oral naltrexone is an AMBER drug, to be initiated at
Turning Point and continued by general practice.
Somerset Prescribing Forum approved use of generic naltrexone for this
indication.
Central Nervous System
Page 112
Therapeutic Area
Formulary Choices
Cost for 28
Rationale for decision / comments
(unless otherwise stated)
4.11 Drugs for dementia
Related guidance: NICE Technology Appraisal TA217 (2011): Donepezil, galantamine, rivastigmine and memantine for Alzheimer’s disease
When assessing the severity of Alzheimer’s disease and the need for treatment, healthcare professionals should not rely solely on cognition scores in
circumstances in which it would be inappropriate to do so (see NICE TA217 for examples).
When using assessment scales to determine the severity of Alzheimer’s disease, healthcare professionals should take into account any physical, sensory or
learning disabilities, or communication difficulties that could affect the results and make adjustments they consider appropriate. Healthcare professionals should
also be mindful of the need to secure equality of access to treatment for patients from different ethnic groups, in particular those from different cultural
backgrounds.
These should only be initiated by specialists in the care of dementia (psychiatrists, neurologists and physicians specialising in the care of older people).
Treatment should be continued only when it is considered to be having a worthwhile effect on cognitive, global, functional or behavioural symptoms. Patients who
continue on treatment should be reviewed regularly by an appropriate specialist team, or according to the locally agreed Shared Care Protocol. Carer’s views on
the patients’ condition should be sought at baseline and during follow-up.
Acetylcholinesterase
inhibitors
Donepezil
Orodispersible
Galantamine
5mg tablets: £1.31 (28)
10mg tablets: £1.71 (28)
5mg tablets: £7.05 (28)
10mg tablets: £9.42 (28)
8mg tablets: £59.29 (56)
12mg tablets: £74.10 (56)
Modified release
as Gatalin XL
or
Luventa XL®
Rivastigmine
Transdermal
patches
as Alzest
Central Nervous System
8mg m/r capsules: £25.94 (28)
16mg m/r capsules: £32.45 (28)
24mg m/r capsules: £39.90 (28)
8mg m/r capsules: £25.42 (28)
16mg m/r capsules: £31.80 (28)
24mg m/r capsules: £39.10 (28)
The acetylcholinesterase (AChE) inhibitors: Donepezil, Galantamine and
Rivastigmine are recommended as options for mild to moderate Alzheimer’s
disease.
Treatment should be started with the drug of lowest acquisition cost. However,
an alternative agent could be prescribed if considered appropriate when taking
into account adverse event profile, expectations about adherence, medical comorbidity, possibility of drug interactions and dosing profiles.
Oral formulations should be used except where patient has poor swallow or
experiences side effects with oral treatment which would lead to discontinuing
treatment.
Avoid anticholinergic (antimuscarinic) drugs with acetylcholinesterase inhibitors
which have the potential to reverse their effects
1.5mg capsules: £4.38 (28)
3mg capsules: £4.44 (28)
4.5mg capsules: £17.86 (28)
6mg capsules: £17.62 (28)
4.6mg/24hr patch: £35.10 (30)
9.5mg/24hr patch: £35.10 (30)
Considered bioequivalent to Exelon
Page 113
Therapeutic Area
Formulary Choices
Cost for 28
Rationale for decision / comments
(unless otherwise stated)
NMDA-receptor
antagonist
Memantine
10mg tablets: £12.43 (28)
20mg tablets: £42.27 (28)
Memantine is recommended as an option for people with;
 Moderate Alzheimer’s disease who are intolerant or, or have a
contraindication to AChE inhibitors, or
 Severe Alzheimer’s disease.
Central Nervous System
Page 114
Therapeutic Area
Formulary Choices
Cost for 28
Rationale for decision / comments
(unless otherwise stated)
BNF Chapter 5: Infections
Related guidance: Somerset CCG Infection Management Guidance (2013/14)
Top
5.1 Antibacterial drugs
Penicillins
Phenoxymethylpenicillin
(Penicillin V)
250mg tablets: £1.44 (28)
125mg/5ml SF solution:
£14.73 (100ml)
250mg/5ml SF solution:
£14.66 (100ml)
See Infection management guidance for appropriate clinical indications.
Flucloxacillin
250mg capsules: £1.66 (28)
500mg capsules: £2.48 (28)
125mg/5ml suspension:
£21.37 (100ml)
125mg/5ml SF suspension:
£21.87 (100ml)
250mg/5ml suspension:
£26.03 (100ml)
250mg/5ml SF suspension:
£26.87 (100ml)
See Infection management guidance for appropriate clinical indications.
Amoxicillin
250mg capsules: £1.46 (21)
500mg capsules: £1.65 (21)
125mg/5ml SF suspension:
£1.33 (100ml)
250mg/5ml SF suspension:
£1.59 (100ml)
See Infection management guidance for appropriate clinical indications.
Co-amoxiclav
250/125mg tablets: £2.18 (21) See Infection management guidance for appropriate clinical indications.
500/125mg tablets: £3.38 (21)
Community use of Co-amoxiclav has been implicated in the causation of
125/31mg SF suspension:
Clostridium difficile in Somerset.
£1.73 (100ml)
250/62mg SF suspension:
£1.88 (100ml)
Management of infection
Page 115
Therapeutic Area
Formulary Choices
Cost for 28
Rationale for decision / comments
(unless otherwise stated)
Cephalosporins
Cefalexin
RESTRICTED USE
ADVISED
250mg capsules: £1.83 (28)
500mg capsules: £2.05 (21)
125mg/5ml suspension:
£1.40 (100ml)
250mg/5ml suspension:
£2.22 (100ml)
The Infection management guidance has a very limited role for
cephalosporins first line. Cefalexin is indicated for second line use in
UTIs where sensitivity is known and Trimethoprim or Nitrofurantoin are
not appropriate.
The spectrum of activity of Cefalexin and other oral cephalosproins
means they are generally inappropriate for RTIs and skin and soft tissue
infections.
Cephalosporins are commonly implicated in Clostridium difficile infection
Tetracyclines
Doxycycline
100mg capsules: £1.11 (8)
See Infection management guidance for appropriate clinical indications.
Oxytetracycline has been removed from this section given probability of poor
compliance with dosing requirements, together with clinical and costeffectiveness of Doxycycline as viable alternative.
Macrolides
Erythromycin
250mg e/c tablets: £1.74 (28)
per 100ml suspension:
125mg/5ml: £2.75
sugar free £3.18
250mg/5ml: £4.13
sugar free £4.31
500mg/5ml: £7.14
sugar free £12.05
See Infection management guidance for appropriate clinical indications.
NB. Erythromycin capsules (such as Erymax®) are approximately 10 times the
price of the standard ec tablets.
250mg tablets: £1.90 (14)
500mg tablets: £2.74 (14)
125mg/5ml SF
suspension:£4.51 (70ml)
250mg/5ml SF
suspension:£7.97 (70ml)
See Infection management guidance for appropriate clinical indications.
250mg tablets: £2.88 (4)
500mg tablets: £1.89 (3)
Azithromycin is recommended for treatment of Chlamydia where compliance
with other options may be poor.
AMBER (specialist initiation) for prevention of exacerbations of non-CF
bronchiectasis. ECG required before initiation & if prescribed continuously for
longer than 3 months, GP should consider periodic ECG to manage cardiac
risks.
Clarithromycin
Azithromycin
Management of infection
Erythromycin & Clarithromycin are known inhibitors of cytochrome P450
enzyme CYP3A4. Prescribers should be aware of the potential for drug
interactions with other medicines. Click on these links for more information.
Clarithromycin MR tablets are non formulary on grounds of higher cost.
Page 116
Therapeutic Area
Formulary Choices
Cost for 28
Rationale for decision / comments
(unless otherwise stated)
Trimethoprim and
sulphonamides
Trimethoprim
100mg tablets: £1.01 (28)
200mg tablets: £0.99 (14)
50mg/5ml SF suspension:
£1.96 (100ml)
See Infection management guidance for appropriate clinical indications.
Metronidazole and
tinidazole
Metronidazole
200mg tablets: £1.26 (21)
400mg tablets: £1.31 (21)
200mg/5ml suspension:
£25.11 (100ml)
See Infection management guidance for appropriate clinical indications.
Quinolones
Ciprofloxacin
250mg tablets: £0.91 (10)
500mg tablets: £1.10 (10)
750mg tablets: £8.00 (10)
See Infection management guidance for appropriate clinical indications.
Ciprofloxacin has very poor activity against common RTI pathogens and
therefore should only be used on specialist advice for these indications.
Quinolones are commonly implicated in Clostridium difficile infection.
Urinary tract
infections (UTI)
First-line:
Nitrofurantoin
100mg tablets: £8.81 (28)
50mg capsules: £13.92 (30)
100mg capsules: £6.50 (30)
100mg capsules MR: £9.50
(14)
See Infection management guidance for appropriate clinical indications.
Consider Nitrofurantoin as an alternative to Trimethoprim as first line treatment
for uncomplicated UTIs. 50mg is associated with significantly less nausea than
100mg.
Second-line:
Trimethoprim
As above
Uncomplicated UTI: 200mg BD for 3 days (women) or 7 days (men). See
Infection management guidance for UTI with complicating factors.
Catheter associated
UTI (CAUTIS)
Do not use prophylactic antibiotics for catheter changes unless history of
catheter-change-associated UTI or trauma during catheterisation.
Clostridium difficile
Stop unnecessary antibiotics and/or PPIs. Seek Microbiology advice.
First-line:
Metronidazole
As above
Mild and moderate CDI: 400mg TDS for 10-14 days
Second-line:
Vancomycin
125mg capsules: £132.47
Severe or 3rd episode of CDI: 125mg (oral) QDS for 10-14 days
Fidaxomicin
200mg tablets: £1350.00 (20)
Approved for primary care use on the advice of a consultant microbiologist
( AMBER ) in accordance with Public Health England (PHE) guidance to the
management of Clostridium difficile. Treatment restricted to 10 days (licensed
treatment duration.)
Management of infection
Page 117
Therapeutic Area
Formulary Choices
Cost for 28
Rationale for decision / comments
(unless otherwise stated)
Bacterial vaginosis
For treatment only. Preventative should be via self-care
- Lactic Acid Gel
as Balance Activ
BV®
5.2 Antifungal drugs
For topical antifungal preparations, please refer to Chapter 13: Skin
Antifungals
Fluconazole
See Infection management guidance for appropriate clinical indications.
Voriconazole –
RED drug. NOT for
primary care
prescribing.
50mg capsules: £1.12 (7)
150mg capsule: £1.08 (1)
Itraconazole
100mg capsules: £4.89 (15)
See Infection management guidance for appropriate clinical indications.
NB Transient or permanent hearing loss has been reported with itraconazole.
Terbinafine
5.3
250mg tablets: £1.65 (28)
See Infection management guidance for appropriate clinical indications.
Measure LFTs before treatment & after 4-6 weeks.
Antiviral drugs
For topical antivirals please refer to Chapter 13: Skin
Antivirals
Antiviral treatments for
HIV, and
Valganciclovir
are RED drugs and
not for primary care
prescribing.
First-line:
Aciclovir
Second- line:
Valaciclovir
Management of infection
See Infection management guidance for appropriate clinical indications.
200mg dispersible tablets:
£2.09 (25)
400mg tablets: £4.89 (56)
800mg tablets: £4.81 (35)
250mg tablets: £123.28 (60)
500mg tablets: £6.86 (10),
£86.30 (42)
Famciclovir is non-formulary, based on cost. Famciclovir 750mg daily costs
£148 per 7 day course i.e. around 16x higher than an equivalent course of
Aciclovir 800mg
Valaciclovir is included in the formulary only for genital herpes for second line
use when Aciclovir is not appropriate.
Page 118
Therapeutic Area
Formulary Choices
Cost for 28
Rationale for decision / comments
(unless otherwise stated)
Influenza vaccine
Tri-valent
intramuscular
injection
2013-14 season
2014-15 season
For active immunisation against the influenza infection as part of the UK
national immunisation programme
Companies offer a range of deals & discounts depending on service
package. The CCG has a duty to recommend that practices make best use of
the available NHS resources and purchase a vaccine that is both cost effective
and has a supplier who can provide sufficient practice support to ensure good
uptake by patients. Given the choice of the different vaccines Somerset CCG
sees no reason for a practice to choose a vaccine with an NHS price > £5.50
The Joint Committee on Vaccination and Immunisation states that vaccines
should only be administered within the licensed age range:
First line:
Fluvirin®
Enzira®
Influvac®
Fluarix®
£5.55 per dose
£5.25 per dose
£5.22 per dose
£5.39 per dose
-
First line:
Enzira®
Influvac®
£5.25 per dose (2013 price)
£5.22 per dose (2013 price)
- Licensed for adults and children from 5 years of age
- Licensed for adults and children from 6 months of age
Licensed for adults and children from 4 years of age
Licensed for adults and children from 5 years of age
Licensed for adults and children from 6 months of age
Licensed for adults and children from 6 months of age
Fluarix Tetra®▼ (tetravalent vaccine) is not recommended.
Nasal vaccine
Fluenz Tetra®▼
£180.00 (10)
For active immunisation against the influenza infection as part of the UK
national immunisation programme:
 All infants aged two years and three years (but not four years or older) on
1 September 2013, or;
 Children aged 4 to 17 years who are in a clinical risk group category listed
in Chapter 19 of the Immunisation Against Infectious Disease
Shingles Vaccine
(Varicella zoster
Vaccine)
Management of infection
Zostavax® is recommended for active immunisation of individuals aged 70
year or 79 years for the prevention of herpes zoster (“zoster” or shingles) and
herpes zoster-related post-herpetic neuralgia (PHN) as part of the UK national
immunisation programme:
Supply is limited & prescribing not currently recommended on NHS FP10.
Page 119
Management of Infection-Guidance for Primary Care -February 2015
Aims

to provide a simple, empirical approach to the treatment of common infections

to promote the safe, effective and economic use of antibiotics

to minimise the emergence of bacterial resistance in the community
Principles of Treatment
1. This guidance is based on best available evidence and should be used alongside references such as the BNF, BNFc , and SPCs.
2. Professional judgement should be used and patients should be involved in decisions about their treatment.
3. Unless otherwise stated, a dose and duration of treatment for adults is usually suggested, but may need modification for age, weight and renal
function. In severe or recurrent cases consider a larger dose or longer course. Please refer to BNF for further dosing and interaction information
(e.g. interaction between macrolides and statins) if needed and please check for hypersensitivity.
4. Prescribe an antibiotic only when there is likely to be a clear clinical benefit.
5. Lower threshold for antibiotics in immunocompromised or those with multiple morbidities; consider culture and seek advice.
6. Consider a NO, or back-up / delayed, antibiotic strategy for acute self-limiting mild UTI symptoms and upper respiratory tract infections including
sore throat, common cold, cough and sinusitis. (See No Antibiotic ‘Prescription’ Form).
7. Limit prescribing over the telephone to exceptional cases.
8. Use simple antibiotics prescribed generically whenever possible.
9. Avoid broad spectrum antibiotics (e.g. co-amoxiclav, quinolones and cephalosporins) when narrow spectrum antibiotics remain effective, as they
increase risk of Clostridium difficile, MRSA and resistant UTIs.
10. Avoid widespread use of topical antibiotics (especially those agents also available as systemic preparations, e.g. fusidic acid).
11. In pregnancy take specimens to inform treatment; where possible avoid tetracyclines, aminoglycosides, quinolones, high dose metronidazole (2 g
STAT) unless benefit outweighs risks. Short-term use of nitrofurantoin (at term, theoretical risk of neonatal haemolysis) is not expected to cause
fetal problems. Trimethoprim is also unlikely to cause problems unless poor dietary folate intake or taking another folate antagonist e.g.
antiepileptic.
12. Clarithromycin is recommended in place of erythromycin (except in pregnancy) as it has less side-effects, greater compliance (as twice rather
than four times daily), and generic tablets are similar cost. In children erythromycin may remain preferable as clarithromycin syrup is twice the
cost.
13. For further advice (i.e. empirical therapy failure, special circumstances, etc.) contact the Microbiologists at Musgrove Park Hospital, out of hours
via MPH switchboard  01823 333444.
14. This guidance should not be used in isolation, it should be supported with patient information about back-up/delayed antibiotics, infection severity
and usual duration, clinical staff education, and audits. Materials are available on the RCGP TARGET website.
Jump to the infection group you want by clicking on the link below
UPPER RESPIRATORY TRACT INFECTIONS
GENITAL TRACT INFECTIONS
LOWER RESPIRATORY TRACT INFECTIONS
SKIN INFECTIONS
MENINGITIS
DENTAL INFECTIONS
URINARY TRACT INFECTIONS
EYE INFECTIONS
GASTRO-INTESTINAL TRACT INFECTIONS
ILLNESS
COMMENTS
DRUG
ADULT DOSE (unless
otherwise stated)
DURATION OF
TREATMENT
UPPER RESPIRATORY TRACT INFECTIONS: Consider delayed antibiotic prescriptions
Annual vaccination is essential for all those at risk of influenza.
Influenza
Allowed on FP10 as SLS (winter season); status change to: treat ‘at risk’ patients, when influenza is circulating in the
PHE Influenza
community and ideally within 48 hours of onset (do not wait for lab report) or in a care home where influenza is likely. At risk:
NICE Influenza
pregnant (including up to two weeks post partum), 65 years or over, chronic respiratory disease (including COPD and asthma)
Treatment
significant cardiovascular disease (not hypertension), immunocompromised, diabetes mellitus, chronic neurological, renal or liver
NICE Influenza
disease, morbid obesity (BMI>=40). Use 5 days treatment with oseltamivir 75mg bd. If resistance to oseltamivir or severe
Prophylaxis
immunosuppression, use zanamivir 10mg BD (2 inhalations by diskhaler for up to 10 days) and seek advice. See PHE Influenza
guidance for treatment of patients under 13 years or in severe immunosuppression (and seek advice).
Acute Sore
Avoid Antibiotics as 90% resolve in 7 days
Phenoxymethylpenicillin
500 mg QDS
10 days
Throat
without, and pain only reduced by 16 hours
1G BD (QDS when severe)
CKS
If Centor score 3 or 4: (Lymphadenopathy; No
Cough; Fever; Tonsillar Exudate) consider 2 or
if allergic to penicillin:
3-day delayed or immediate antibiotics.
Clarithromycin
250-500mg BD
5 days
Antibiotics to prevent Quinsy NNT >4000
Antibiotics to prevent Otitis media NNT 200
10d penicillin lower relapse vs 7d in RCT in
<18yrs
Acute Otitis
Optimise analgesia and Target Antibiotics
Child doses
Media
60% are better in 24 hours, and 80% are better
Amoxicillin
Neonate 7-28 days
(child doses)
in 4 days without antibiotics. They only reduce
30mg/kg (max. 125mg)
pain at 2 days (NNT15) and do not prevent
TDS
CKS
deafness.
1mth-1yr 125mg TDS
BNFc
Consider 2 or 3-day delayed or immediate
1-5yrs 250mg TDS
All for
antibiotics for pain relief if:
5-18yrs 500mg TDS
5 days
 < 2yrs with bilateral AOM (NNT4) or
Penicillin allergy:
bulging membrane & ≥ 4 marked symptoms
< 2yrs 125mg QDS
Erythromycin
 All ages with otorrhoea NNT3
2-8yrs 250mg QDS
Abx to prevent Mastoiditis NNT >4000
8-18yrs 250-500mg QDS
Management of infection
Page 120
Management of Infection-Guidance for Primary Care -February 2015
ILLNESS
COMMENTS
DRUG
ADULT DOSE (unless
otherwise stated)
Acute Otitis
Externa
CKS
Acute
Rhinosinusitis
CKS
First use aural toilet (if available) & analgesia
Cure rates similar at 7 days for topical acetic
acid or antibiotic +/- steroid.
If cellulitis or disease extending outside ear
canal, start oral antibiotics and refer.
Avoid Antibiotics as 80% resolve in 14 days
without, and they only offer marginal benefit after
7 days (NNT15).
Use adequate analgesia
Consider 7-day delayed or immediate antibiotic
when purulent nasal discharge NNT8.
In persistent infection use an agent with antianaerobic activity e.g. co-amoxiclav
First line:
Acetic acid 2%
Second line:
Neomycin sulphate with
corticosteroid
Phenoxymethylpenicillin
or Amoxicillin
DURATION OF
TREATMENT
1 spray TDS
7 days
3 drops TDS
7 days min to 14
days max
500mg QDS
500mg TDS
1g if severe
Penicillin allergy:
Doxycycline
200mg stat/100mg OD
All for 7 days
For persistent symptoms:
Co-amoxiclav
625mg TDS
LOWER RESPIRATORY TRACT INFECTIONS
TOP
Low doses of penicillins are more likely to select out resistance. Do not use quinolone (ciprofloxacin, ofloxacin) first line due to poor pneumococcal
activity. Reserve all quinolones (including levofloxacin) for proven resistant organisms e.g. pseudomonas spp.
Acute cough,
Antibiotic little benefit if no co-morbidity.
Amoxicillin
500 mg TDS
All for 5 days
bronchitis
Consider 7 days delayed antibiotic with
or Doxycycline
200 mg stat/100 mg OD
CKS
symptomatic advice/leaflet.
NICE 69
Symptom resolution can take 3 weeks.
Consider immediate antibiotics if > 80yr and
ONE of: hospitalisation in past year, oral
steroids, diabetic, congestive heart failure OR >
65yrs with 2 of above.
Acute
Treat exacerbations promptly with antibiotics if
Doxycycline
200mg stat/100mg OD
purulent sputum and increased shortness of
exacerbation of
or Amoxicillin
500mg TDS
breath and/or increased sputum volume.
COPD
NICE 101
Penicillin allergy:
All for 5-7 days
Risk factors for antibiotic resistant organisms
Gold
Clarithromycin
500 mg BD
include co-morbid disease, severe COPD,
frequent exacerbations, antibiotics in last
2nd line/ if resistance
3months.
Co-trimoxazole
960mg BD
CommunityUse CRB65 score to help guide and review:
IF CRB65=0: Amoxicillin
500 mg TDS
7 days
acquired
Each CRB65 parameter scores 1:
or Clarithromycin
500 mg BD
7 days
pneumonia or Doxycycline
200 mg stat/100 mg OD
7 days
Confusion (AMT8);
treatment in the Respiratory rate ≥ 30/min;
community
BP systolic <90 or diastolic ≤ 60; Age ≥65;
If CRB65=1 & AT HOME
BTS 2009
Score 0: suitable for home treatment;
Guideline
Score 1-2: hospital assessment or admission
Amoxicillin
500 mg TDS
7-10 days
CKS
Score 3-4: urgent hospital admission
AND Clarithromycin
500 mg BD
NICE
Give immediate IM Benzylpenicillin if delayed
or Doxycycline alone
200 mg stat/100 mg OD
7-10 days
admission/life threatening, and seek risk factors
for Legionella and Staph. aureus infection.
Mycoplasma infection is rare in over 65s.
MENINGITIS NICE fever guidelines
Suspected
meningococcal
disease
PHE
Meningococcal
disease
Transfer all patients to hospital immediately.
IF time before admission, give IV
Benzylpenicillin or Cefotaxime, unless
hypersensitive i.e. history of difficulty breathing,
collapse, loss of consciousness, or rash.
TOP
IV or IM Benzylpenicillin
Or
(only give IM if
vein cannot be
found)
Age 12+ years 1g
Child <12 yrs 50mg/kg
Prevention of secondary case of meningitis: Only prescribe following advice from Devon, Cornwall and Somerset Health Protection Team, Tel:
0344 225 3557or out of hours via the Musgrove Park Hospital switchboard on 01823 333444.
URINARY TRACT INFECTIONS - refer to PHE UTI guidance for diagnosis information
TOP
As E. coli bacteraemia in the community is increasing ALWAYS safety net and consider risks for resistance
Amoxicillin resistance is common, therefore ONLY use if culture confirms susceptibility.
People > 65 years: do not treat asymptomatic bacteriuria as it is common (25% in ♀, 10% in ♂) but is not associated with increased morbidity.
Catheter in situ: antibiotics will not eradicate asymptomatic bacteriuria; only treat if systemically unwell or pyelonephritis likely.
Do not use prophylactic antibiotics for catheter changes unless history of catheter-change-associated UTI or trauma (NICE & SIGN guidance).
Treat women with severe/or ≥ 3 symptoms.
Uncomplicated UTI (no
UTI in
Women mild/or ≤ 2 symptoms AND
admission risk):
men & women
a) Urine NOT cloudy 97% negative predictive
1st line
(no fever or
value, do not treat unless other risk factors for
flank pain)
Trimethoprim
200mg BD
infection.
PHE UTI
Alternatives
b) If cloudy urine use dipstick to guide treatment.
SIGN
Nitrofurantoin or
100mg m/r BD
Nitrite plus blood or leucocytes has 92% positive
CKS Women
Pivmecillinam (3 days only)
400mg STAT then
predictive value; nitrite, leucocytes, blood all
CKS Men
200mg TDS
Management of infection
IV or IM Cefotaxime
Age 10+ years: 1200 mg
Children 1 - 9 yr: 600 mg
Children <1 yr: 300 mg
Page 121
Management of Infection-Guidance for Primary Care -February 2015
ILLNESS
COMMENTS
DRUG
ADULT DOSE (unless
otherwise stated)
RCGP UTI
Clinical module
SAPG UTI
negative 76% NPV4Ac) Consider a back-up / delayed antibiotic option.
Men: Consider prostatitis and send pretreatment MSU1,5C OR if symptoms mild/nonspecific, use negative dipstick to exclude UTI.6C
Always safety net.
In treatment failure: always perform culture.
Pivmecillinam is only licensed for a 72 hour
course and cannot be used in Penicillin allergy.
Amoxicillin resistance is common; only use if
susceptible (usual dose 500mg TDS, 3 days for
women and 7 days for men).
Pivmecillinam is first option for community
multi-resistant Extended-spectrum Betalactamase E. coli and Fosfomycin (women: 3g
stat; men: 3g stat plus 2nd 3g dose 72 hours
later) may be an option on advice of
microbiology, see Fosfomycin proforma (YDH &
MPH).
Recurrent UTI
in women
(not pregnant)
≥ 3 UTIs/year
UTI in
pregnancy
PHE UTI
CKS
UTI in children
PHE UTI
CKS
NICE
Review at 6 months or more often.
To reduce recurrence first advise simple
measures including hydration. Then standby or
post-coital antibiotics.
Nightly prophylaxis reduces UTIs but adverse
effects and long term compliance poor.
Nitrofurantoin 2nd line due to potential pulmonary
toxicity.
Methenamine hippurate (Hiprex™) has been
locally approved as an option. Note: patients
already taking prophylactic antibiotics should
only be switched if failure/ resistance in urinary
isolate/ drug intolerance or complication.
Send MSU for culture & sensitivity and start
empirical antibiotics
Short-term use of Nitrofurantoin in pregnancy is
unlikely to cause problems to the foetus
Avoid Trimethoprim if low folate status or on
folate antagonist (e.g. antiepileptic or proguanil)
Child <3 moths: refer urgently for assessment
Child ≥ 3 months: use positive nitrite to guide.
Start antibiotics, also send pre-treatment MSU
for all.
Imaging: only refer if child <6 months, or
recurrent or atypical UTI.
Acute
pyelonephritis
CKS
If previous or current MRGNO/ ESBL discuss
with microbiology or consider admission.
If admission not needed, send MSU for culture &
susceptibility and start antibiotics.
If no response within 24 hours, admit.
If ESBL risk and with microbiology advice
consider IV antibiotic via outpatients (OPAT).
GASTRO-INTESTINAL TRACT INFECTIONS
Treat all positives in known DU, GU or low grade
Eradication of
MALToma. In Non-Ulcer NNT is 14.
Helicobacter
Management of infection
Frail vulnerable with
associated comorbidity
GFR˃45ml/min:
1st line
Nitrofurantoin
Alternatives
Pivmecillinam (3 days only)
or
Trimethoprim
Frail vulnerable with
associated comorbidity
GFR<45ml/min:
1st line
Pivmecillinam (3 days only)
Alternative
Trimethoprim
DURATION OF
TREATMENT
Women 3 days
Men 7 days
100mg m/r BD
400mg STAT then
200mg TDS
200mg BD
(except
Pivmecillinam licensed for 3
days)
400mg STAT then
200mg TDS
200mg BD
Pivmecillinam is first option if previous history of Trimethoprim
resistance.
Second line: perform culture in all treatment failures.
Risk factors for increased resistance include: care home resident,
recurrent UTI, hospitalisation >7d in the last 6 months, unresolving urinary
symptoms, recent travel to a country with increased antimicrobial resistance
(outside Northern Europe and Australasia) especially health related, previous
known UTI resistant to trimethoprim, cephalosporins or quinolones.
If increased resistance risk, send culture for susceptibility testing & give
safety net advice.
Post coital stat
Trimethoprim
100 mg
(off-label)
or Nitrofurantoin (note: as
50–100 mg
per December 2014 100mg
Prophylaxis
(non-MR) 1x nocte is the
OD at night
most cost-effective option
for prophylaxis with
Nitrofurantoin.
or consider:
Methenamine hippurate
First line: Nitrofurantoin
or Trimethoprim
Give folic acid if first
trimester
Second line:
if susceptible, Amoxicillin
Third line: Cefalexin
Lower UTI: Trimethoprim
or Nitrofurantoin
If susceptible, Amoxicillin
Second line: Cefalexin
Upper UTI: Co-amoxiclav
Second line: Cefixime
Ciprofloxacin
or Co-amoxiclav
If susceptible:
Trimethoprim
1g
100 mg m/r BD
200mg BD (off-label)
Give folic acid if first
trimester
BD (may be
increased to TDS
if catheterised)
All for 7 days
500 mg TDS
500 mg BD
Lower UTI
3 days
See BNFc for dosage
Upper UTI
7-10 days
500 mg BD
500/125 mg TDS
7 days
14 days
200mg BD
14 days
TOP
Always use PPI TWICE DAILY: Esomeprazole 20mg, Lansoprazole 30mg,
Omeprazole 20-40mg, Pantoprazole 40mg or Rabeprazole 20mg
Page 122
Management of Infection-Guidance for Primary Care -February 2015
ILLNESS
COMMENTS
DRUG
ADULT DOSE (unless
otherwise stated)
pylori
NICE Dyspepsia
NICE PPI doses
NICE H.Pylori
PHE H.Pylori
CKS
Do not offer eradication for GORD.
First line treatment: choose the treatment
regimen with the lowest acquisition cost, and
take into account previous exposure to
clarithromycin or metronidazole.
Do not use Clarithromycin, Metronidazole or
Quinolone if used in past year for any infection.
Retest for H. pylori post DU/GU or relapse after
second line therapy: using breath or stool test
OR consider endoscopy for culture and
susceptibility.
Seek advice from a gastroenterologist if
eradication of H pylori is not successful with
second-line treatment.
First line
PPI & Amoxicillin + either
Clarithromycin
OR Metronidazole
1g BD
500mg BD
400mg BD
First line - Penicillin allergy
PPI & Amoxicillin &
Clarithromycin
1g BD
500mg BD
First line - Penicillin allergy
with previous exposure to
Clarithromycin
PPI & Bismuthate (De-nol
tab®) &
Metronidazole &
Tetracycline
Second line (still have
symptoms after 1st line
eradication):
PPI & Amoxicillin + either
Clarithromycin OR
Metronidazole (whichever
was not first line)
Second line - previous
exposure to Clarithromycin
& Metronidazole
PPI & Amoxicillin + either
Tetracycline OR
Levofloxacin
Second line - Penicillin
allergy without previous
exposure to Quinolone
PPI & Metronidazole &
Levofloxacin
Infectious
diarrhoea
CKS
Clostridium
difficile
DoH
PHE
Travellers’
diarrhoea
CKS
Threadworm
CKS
DURATION OF
TREATMENT
240mg BD
400mg BD
500mg QDS
All for
7 days
1g BD
500mg BD
400mg BD
1g BD
500mg QDS
250mg BD
(MALToma
14 days)
400mg BD
250mg BD
Second line - Penicillin
allergy with previous
exposure to Quinolone
240mg BD
PPI & Bismuthate (De-nol
tab®) &
400mg BD
Metronidazole &
500mg QDS
Tetracycline
Check travel, food, hospitalisation and antibiotic history (C. difficile is increasing). Fluid replacement is essential.
Refer previously healthy children with acute painful or bloody diarrhoea to exclude E. coli 0157 infection.
Antibiotic therapy usually not indicated unless systemically unwell.
If the patient is systemically unwell, or if pregnant, initiate treatment on advice of microbiologist.
If systemically unwell and campylobacter suspected (e.g. undercooked meat and abdominal pain), consider Clarithromycin
250-500 mg BD for 5–7 days if treated early (within 3 days).
Please send stool specimens from suspected cases of food poisoning and after antibiotic use. Please notify suspected cases of
food poisoning to, and seek advice from, Devon, Cornwall and Somerset Health Protection Team, Tel: 0344 225 3557or out of
hours via the Musgrove Park Hospital switchboard on 01823 333444.
Stop unnecessary antibiotics and/or PPIs.
1st episode
70% respond to MTZ in 5 days; 92% in 14days
metronidazole (MTZ)
400 mg oral TDS
10-14 days
Admit if severe: T >38.5; WCC >15, rising
2nd episode/severe/type 027
creatinine or signs/symptoms of severe colitis.
oral vancomycin
125mg oral QDS
10 -14 days
Avoid anti-motility anti-diarrhoeal agents such as Recurrent disease consider:
Loperamide or Codeine.
Fidaxomicin (AMBER on the 200mg oral BD
10 days
recommendation of a
microbiologist)
Only consider standby antibiotics for remote areas or people at high-risk of severe illness with travellers’ diarrhoea
If standby treatment appropriate give: Ciprofloxacin 500 mg twice a day for 3 days (private Rx). If quinolone resistance high (e.g.
south Asia): consider bismuth subsalicylate (Pepto Bismol®) 2 tablets QDS as prophylaxis or for 2 days treatment
Treat all household contacts at the same time
> 6 months: Mebendazole
100mg
stat
PLUS advise hygiene measures for 2 weeks
(‘off-label’ if < 2yrs)
(hand hygiene, pants at night, morning shower)
PLUS wash sleepwear, bed linen, dust, and
< 6mths: six weeks hygiene
vacuum on day one.
GENITAL TRACT INFECTIONS Contact UKTIS (Tel. 0844 892 0909 or use TOXBASE®), for information on foetal risks if
TOP
patient is pregnant
STI screening
People with risk factors should be screened for chlamydia, gonorrhoea, HIV, syphilis. Refer individual and partners to GUM clinic
or Sexual Health Clinic. Risk factors: < 25yrs, no condom use, recent (<12mth)/frequent change of partner, symptomatic partner,
BASHH
area of high HIV.
Management of infection
Page 123
Management of Infection-Guidance for Primary Care -February 2015
ILLNESS
COMMENTS
DRUG
ADULT DOSE (unless
otherwise stated)
Chlamydia
trachomatis/
urethritis
SIGN
BASHH
PHE
CKS
Opportunistically screen all aged 15-25yrs.
Treat partners and refer to GUM service.
Pregnancy or breastfeeding: Azithromycin is the
most effective option.
Due to lower cure rate in pregnancy, test for
cure 6 weeks after treatment.
For suspected epididymitis in men ˃ 35 years
with low risk of STI (High risk, refer to GUM).
Vaginal
candidiasis
BASHH
PHE
CKS
All topical and oral azoles give 75% cure.
Bacterial
vaginosis
BASHH
PHE
CKS
Oral metronidazole (MTZ) is as effective as
topical treatment but is cheaper.
Less relapse with 7 day than 2g stat at 4 wks.
Pregnant / breastfeeding: avoid 2g stat dose.
Treating partners does not reduce relapse.
Trichomoniasis
BASHH
PHE
CKS
Treat partners and refer to GUM service.
Pregnant/ breastfeeding: avoid 2g stat dose
MTZ. Consider Clotrimazole for symptom relief
(not cure) if MTZ declined.
Pelvic
Inflammatory
Disease
BASHH
CKS
Refer woman & contacts to GUM service.
Always culture for gonorrhoea & chlamydia.
28% of gonorrhoea isolates now resistant to
quinolones. If gonorrhoea likely (partner has it,
severe symptoms, sex abroad) use ceftriaxone
regimen or refer to GUM.
Low risk only
Metronidazole PLUS
Ofloxacin
If high risk or likely
gonorrhoea
Ceftriaxone PLUS
Metronidazole PLUS
Doxycycline
Send MSU for culture and start antibiotics.
4-wk course may prevent chronic prostatitis.
Quinolones achieve higher prostate levels.
Ciprofloxacin
Acute
prostatitis
CKS
Pregnancy: avoid oral azole and use intravaginal
for 7 days.
Doxycycline
or Azithromycin
Pregnant or breastfeeding:
Azithromycin
or Erythromycin
or Amoxicillin
Epididymitis: low STI risk:
Ofloxacin
Clotrimazole OR
oral Fluconazole
Pregnant:
Clotrimazole OR
Miconazole 2% cream 3A+
oral Metronidazole OR
MTZ 0.75% vag gel OR
Clindamycin 2% cream OR
Lactic Acid Gel (Balance
Activ BV®) used in place of
clindamycin for treatment
only (self-care and buy OTC
for prophylaxis)
Metronidazole (MTZ)
Clotrimazole
DURATION OF
TREATMENT
100mg BD
1g
7 days
stat
1g (off-label use)
500mg QDS
500mg TDS
stat
7 days
7 days
200mg BD
500mg pessary OR 10%
cream
150mg orally
14 days
stat
10 mg pessary at night
5g intravaginally BD
6 nights
7 days
7 days
stat
5 nights
7 nights
7 nights
400 mg BD
or 2g
5 g applicatorful at night
5 g applicatorful at night
one single use tube at
night
stat
400 mg BD
or 2g
5-7 days
stat
100mg pessary at night
6 nights
400mg BD
400mg BD
14 days
14 days
500mg IM
400mg BD
100mg BD
500 mg BD
stat
14 days
14 days
All for 28 days
2nd line
Trimethoprim
200mg BD
SKIN INFECTIONS
Scarlet Fever
PHE
CKS
TOP
Suspected scarlet fever can be confirmed by
taking a throat swab for culture of GAS, although
a negative throat swab does not exclude the
diagnosis. Consider taking a throat swab in
patients with clinically suspected scarlet fever
and in children with an undiagnosed febrile
illness without an obvious focus of infection.
Prescribe antibiotics without waiting for the
culture result if scarlet fever is clinically
suspected.
Advise exclusion from nursery / school / work for
24 hours after the commencement of
appropriate antibiotic treatment.
Notify Devon, Cornwall and Somerset Health
Protection Team, Tel: 0344 225 3557
or out of hours via the Musgrove Park Hospital
switchboard on 01823 333444.
First line:
Penicillin V
Alternative for children who
are unable to swallow
tablets, or where
compliance is a concern
Amoxicillin
Second line
(If penicillin allergy)
Azithromycin
Impetigo
PHE
CKS
Eczema
CKS
For extensive, severe, or bullous impetigo, use
oral antibiotics.
Reserve topical antibiotics for very localised
lesions to reduce the risk of resistance.
Reserve Mupirocin for MRSA.
<1mth 12.5mg/kg (max.
62.5mg) QDS
1mth-<1yr 62.5mg QDS
1-<6yrs 125mg QDS
6-<12yrs 250mg QDS
12-<18yrs 250-500mg
QDS
Adults 500mg QDS
10 days
50 mg/kg OD (max 1000
mg)
or alternatively
25 mg/kg (max 500 mg)
BD
6mths-<12yrs ‘off-label’
12mg/kg (max. 500mg)
OD
˃12yrs 500mg OD
500 mg QDS
5 days
oral Flucloxacillin
7 days
If penicillin allergic:
oral Clarithromycin
250-500 mg BD
7 days
Retapamulin
Topically BD
5 days
Mupirocin (MRSA only)
Topically BD
5 days
If no visible signs of infection, use of antibiotics (alone or with steroids) encourages resistance and does not improve healing. In
eczema with visible signs of infection, use treatment recommended in impetigo.
Management of infection
Page 124
Management of Infection-Guidance for Primary Care -February 2015
ILLNESS
COMMENTS
DRUG
ADULT DOSE (unless
otherwise stated)
Erythema
chronicum
migrans
CKS
PHE
Associated with Lyme disease.
Send clotted blood for Lyme serology and treat
empirically. Microbiology will advise on positive
results.
Cellulitis
CKS
“Guidelines for
the Management
of Cellulitis in
Adults in
Somerset”
(Appendix 1)
Leg ulcer
PHE
CKS
If patient afebrile and healthy other than
cellulitis, use oral flucloxacillin alone.
If river or sea water exposure, discuss with
microbiologist.
Refer to local guidance “Guidelines for the
Management of Cellulitis in Adults in
Somerset” (Appendix 1 to this document).
MRSA
Diabetic Foot
Infections
PVL S. aureus
PHE
Bites
Human:
CKS
Cat or dog:
Mastitis
CKS
Scabies
CKS
Fungal
infection – skin
CKS body &
groin
CKS foot
CKS scalp
Ulcers always colonized. Antibiotics do not
improve healing unless active infection.
If active infection, send pre-treatment swab.
Review antibiotics after culture results.
Do not use Clindamycin.
For active MRSA infection, confirmed by lab
results.
Use antibiotic sensitivities to guide treatment.
If severe infection or no response to
monotherapy after 24-48 hours, seek advice
from microbiologist.
For cellulitis refer to local guidance “Guidelines
for the Management of Cellulitis in Adults in
Somerset” (Appendix 1 to this document).
See PEDIS grading & Treatment Options
Grade 1: No antibiotics
Grade 2: treat as per guidelines
Grade 2 + evidence of ischaemia, and above:
refer to secondary care.
Doxycycline
Second line:
Amoxicillin
(especially for children,
pregnancy & breastfeeding)
Flucloxacillin
if allergic to penicillin:
Clarithromycin (caution in
elderly with heart disease)
or Doxycyline
facial: Co-amoxiclav
DURATION OF
TREATMENT
100mg BD
All for 14 days
500mg TDS
See BNFc for children
under 5 years.
1g QDS (reduce to
500mg QDS if intolerant)
500 mg BD
200mg STAT followed by
100mg OD
500/125 mg TDS
All for 7 days
(review days 4872hrs or as
appropriate)
Active infection if cellulitis/increased pain/pyrexia/purulent exudate/odour
For MRSA screening and suppression, see PHE MRSA Quick Reference
Guide
1g QDS (reduce to
Flucloxacillin
All for 7 days
500mg QDS if intolerant) (If severe
if allergic to penicillin:
500 mg BD
infection or no
Clarithromycin (caution in
response to
elderly with heart disease)
monotherapy
or Doxycyline
200mg STAT followed
after 24-48 hours,
by 100mg OD
seek advice from
500/125 mg TDS
facial: Co-amoxiclav
microbiologist.)
Flucloxacillin
500mg - 1G QDS
If allergic to penicillin
Doxycycline
All for 7-14 days
200mg STAT followed
by 100mg OD
If osteomyelitis is suspected, refer to secondary
care
Panton-Valentine Leukocidin (PVL) is a toxin produced by 4.9% of S. aureus from boils/abscesses. Can rarely cause severe
invasive infections in healthy people; if found suppression therapy should be given. Send swabs if recurrent boils/abscesses. At
risk: close contact in communities (e.g. nursing homes) or contact sport, sharing equipment, poor hygiene and eczema.
Thorough irrigation is important.
Prophylaxis or treatment:
Assess risk of tetanus, HIV, hepatitis B&C.
Co-amoxiclav
625 mg TDS
All for 7 days
Antibiotic prophylaxis is advised.
If penicillin allergic:
Assess risk of tetanus and rabies.
Metronidazole PLUS
400 mg TDS
Doxycycline (cat/dog/man)
Give prophylaxis if cat bite/puncture wound; bite
100 mg BD
to hand, foot, face, joint, tendon, ligament;
immunocompromised/diabetic/asplenic/
AND review at 24 & 48hrs
cirrhotic/presence of prosthetic valve or
prosthetic joint.
Antibiotics are not always required. Self-help
Flucloxacillin
500mg - 1G QDS
measures e.g. continuation of breastfeeding or
expressing will aid resolution of mastitis.
If allergic to penicillin:
Clarithromycin (if not
500mg BD
All for 14 days
breastfeeding)
OR
Doxycycline
200mg stat then 100mg
OD
2 applications
Treat all home & sexual contacts within 24h.
Permethrin
5% cream
1 week apart
Treat whole body from ear/chin downwards and
If allergy:
under nails.
malathion
0.5% aqueous liquid
If under 2 or elderly, also face and scalp.
Terbinafine is fungicidal, so treatment time
Topical Terbinafine
BD
1-2 weeks
shorter than with fungistatic imidazoles.
or topical imidazole
BD
for 1-2 wks after
If candida possible, use imidazole.
healing
If intractable: send skin scrapings. If infection
(i.e. 4-6wks)
confirmed, use oral terbinafine/itraconazole.
Scalp: discuss with specialist, oral therapy
indicated.
Management of infection
Page 125
Management of Infection-Guidance for Primary Care -February 2015
ILLNESS
COMMENTS
DRUG
ADULT DOSE (unless
otherwise stated)
Fungal
infection –
fingernail or
toenail
CKS
Varicella
zoster/
chicken pox
CKS
PHE
&
Herpes zoster/
shingles
CKS
Cold sores
Topical treatment for most fungal skin and nail
infections are low priority and suitable for self
care.
Take nail clippings: start therapy only if infection
is confirmed by laboratory.
Terbinafine is more effective than azoles.
Liver reactions rare with oral antifungals.
If candida or non-dermatophyte infection
confirmed, use oral itraconazole.
For children, seek specialist advice.
Pregnant/immunocompromised/neonate: seek
urgent specialist advice.
Chicken pox: IF onset of rash < 24hrs & >
14years or severe pain or dense/oral rash or 2°
household case or steroids or smoker consider
Aciclovir.
Shingles: treat if > 50 yrs and within 72 hrs of
rash (PHN rare if < 50yrs); or if active ophthalmic
or Ramsey Hunt or eczema.
Superficial only Amorolfine
5% nail lacquer
First line: Terbinafine
Second line: Itraconazole
If indicated:
Aciclovir
1-2x/weekly
DURATION OF
TREATMENT
fingers
toes
6 months
12 months
fingers
toes
6 – 12 weeks
3 – 6 months
fingers
toes
7 days monthly
2 courses
3 courses
250 mg OD
200 mg BD
800 mg five times a day
7 days
Cold sores resolve after 7–10 days without treatment. Topical antivirals applied prodromally reduce duration by 12-24hrs.
DENTAL INFECTIONS
Dental
Infections
TOP
The primary treatment of dental infections should be drainage of pus and removal of the source of infection. This will normally
require attention by a dental practitioner. Urgent appointments (usually within 24 hours) can be obtained through the dental
helpline  0300 123 7691. Antibiotics are of limited use and should not be prescribed except for patients who are systemically
unwell, or if there are signs of severe infection, e.g. fever, lymphadenopathy, cellulitis, or diffuse swelling.
Patients to seek dental advice if possible.
Dentists should follow local guidance.
Acute dental-alveolar infections:
Amoxicillin
500mg TDS
Up to 5 days
If allergic to penicillin:
Metronidazole
200mg TDS
Up to 3 days
Pericoronitis:
metronidazole
Most bacterial conjunctivitis is self-limiting.
Treat if severe, as most viral or self-limiting.
65% resolve on placebo by day five.
Red eye with yellow-white mucopurulent, not
watery discharge.
Usually unilateral but may spread.
If severe:
1st line
Chloramphenicol 0.5%
drops
200mg TDS
EYE INFECTIONS
Conjunctivitis
CKS
3 days
TOP
Fusidic acid gel eye drops has less Gramnegative activity than Chloramphenicol and is
not recommended locally due to rising
resistance and in cost.
If treatment failure with Chloramphenicol
consider referral to specialist.
Ofloxacin (Exocin®) is a cost-effective option in
severe conjunctivitis only when Chloramphenicol
not tolerated.
Management of infection
and 1% ointment
OR
1% ointment
1 drop 2 hourly for
2 days then 4 hourly
(whilst awake)
at night
All for 48 hours
after resolution
QDS
Page 126
Management of Infection-Guidance for Primary Care -February 2015
Appendix 2
Methicillin Resistant Staphylococcus Aureus (MRSA)
Decolonisation Policy (WG 05/08/14)
If clinical infection is suspected medical staff must discuss treatment options with a Consultant
Microbiologist.
Where there is clinical infection, decolonisation treatment should be undertaken in addition to any
systemic treatment given.
Topical decolonisation treatment must be commenced immediately, using nasal and skin
preparations as below.
This is used for 5 days (if using Naseptin® then this nasal cream must be continued for an
additional 5 days) then stopped for 2 days and the patient is re-screened on day 8 to determine if
the patient is still MRSA positive.
Mupirocin (Bactroban®) Nasal Ointment: twice daily to nostrils for at least 5 days (if
Mupirocin nasal treatment is unavailable the second line treatment is Neomycin sulphate &
chlorhexidine dihydrochloride (Naseptin®) Nasal Cream four times daily for 10 days)
PLUS
Skinsan®*: Once daily wash, include at least one hair wash daily
OR
Octenisan®*: Once daily wash, include at least one hair wash daily
* Although these may not be listed on all GP clinical system prescribing databases, they can be prescribed
on FP10.
If the patient remains positive after the first course of decolonisation a further course of topical
treatment should be carried out as above, followed by a further screen. If the second course of
decolonisation is unsuccessful, the NHS Somerset CCG Infection Control Team must be contacted
to discuss further options.
The issues associated with the treatment for decolonising wounds is complex and should be
discussed with a member of the Somerset CCG Infection Control Team.
For patients in community hospitals, decolonisation therapy must be prescribed and staff must
record decolonisation as per the Topical Therapy Chart.
The NHS Somerset CCG Infection Control Team can be contacted for further advice via the CCG
switchboard on 01935 384000.
Further advice (and documents, including topical therapy chart) is also available on the Infection
control page of the NHS Somerset CCG website http://www.somersetccg.nhs.uk
Management of infection
Page 127
Public Health England Updated guidance on the management and treatment of
Clostridium difficile infection (Jun-13)
Algorithm 1. 1st episode of Clostridium difficile infection (CDI)
Diarrhoea AND one of the following:
Positive C. difficile toxin test OR Results of C. difficile toxin test
pending AND clinical suspicion of CDI
If clinically appropriate discontinue non-C. difficile antibiotics
to allow normal intestinal flora to be re-established
Suspected cases must be isolated
Symptoms/signs: not severe CDI
(None of: WCC >15, acute rising
creatinine and/or colitis)
Oral metronidazole
400mg 8-hourly 10-14 days
Symptoms/signs: severe CDI
WCC >15, acute rising creatinine and/or colitis
Oral vancomycin 125 mg 6-hourly 10-14 days.
Consider oral fidaxomicin 200 mg 12-hourly 10 days in
patients with multiple co-morbidities who are
receiving concomitant antibiotics
DAILY ASSESSMENT
DAILY ASSESSMENT
Symptoms improving
Diarrhoea should resolve in 1-2 weeks
st
Recurrence occurs in ~20% after 1 episode;
50-60% after 2nd episode
Symptoms not improving or worsening
Should not normally be deemed a treatment
failure until day 7 of treatment.
However, if evidence of severe CDI continues or
worsens
Symptoms not improving or worsening
Should not normally be deemed a treatment
failure until until day 7 of treatment.
However, if evidence of severe CDI:
WCC >15, acute rising creatinine and/or
signs/symptoms of colitis
Switch to oral vancomycin 125 mg 6-hourly
10-14 days
Antimotility agents
should not be
prescribed in acute
CDI
Management of infection
Surgery / GI / Micro / ID consultation
AND, depending on degree of ileus/prior treatment
EITHER Vancomycin 125-500 mg PO/NG 6-hourly
+/- Metronidazole 500 mg IV 8-hourly x 10 days
OR Fidaxomicin 200 mg PO 12-hourly
PLUS CONSIDER Intracolonic vancomycin (500 mg
in 100–500 ml saline 4–12-hourly) given as retention
enema: 18 gauge Foley catheter with 30 ml balloon
inserted per rectum; vancomycin instilled; catheter
clamped for 60 minutes; deflate and remove
(Apisarnthanarak et al., 2002)
Further Surgery/GI/Micro/ID consultation
Depending on choice of therapy (see above) consider:
1. High dose oral/NG vancomycin (500mg PO 6-hourly)
2. IV Immunoglobulin 400mg/kg 1 dose, consider repeat
Page 128
Updated guidance
Algorithm
on the management
2 Recurrent
and treatment
Clostridium
of Clostridium
difficile
difficile infection
infection
(CDI)
Recurrent CDI occurs in ~15-30% of patients treated with metronidazole or vancomycin
Recurrence of diarrhoea (at least 3 consecutive type 5-7 stools) within
~30 days of a previous CDI episode AND positive C. difficile toxin test
Must discontinue non- C. difficile antibiotics if at all possible to allow
normal intestinal flora to be re-established
Review all drugs with gastrointestinal activity or side effects
(stop PPIs unless required acutely)
Suspected cases must be isolated
Symptoms/signs: not life-threatening CDI
Oral fidaxomicin 200 mg 12-hourly for 10 days
(efficacy of fidaxomicin in patients with multiple recurrences is unclear)
Depending on local cost-effectiveness decision making, Oral
vancomycin 125 mg 6-hourly 10-14 days is an alternative
Daily Assessment
(include review of severity markers, fluid/electrolytes)
Symptoms improving
Diarrhoea should resolve in 1-2 weeks
IF MULTIPLE RECURRENCES ESPECIALLY IF EVIDENCE OF
MALNUTRITION, WASTING, etc.
1. Review ALL antibiotic and other drug therapy (consider stopping PPIs
and/or other GI active drugs)
2. Consider supervised trial of anti-motility agents alone
(no abdominal symptoms or signs of severe CDI)
Also consider on discussion with microbiology:
3. Fidaxomicin (if not received previously) 200 mg 12-hourly for 10 days
4. Vancomycin tapering/pulse therapy (4-6 week regimen)
5. (Am J Gastroenterol 2002;97:1769-75)
6. IV immunoglobulin, especially if worsening albumin status (J Antimicrob
Chemother 2004:53:882-4)
7. Donor stool transplant (Clin Infect Dis 2011;53:994-1002.Van Nood et al.,
NEJM 2013)
Management of infection
Page 129
BNF Chapter 6: Endocrine System
Top
6.1 Drugs used in diabetes
Related guidance: NICE Clinical Guideline CG87 (2009): Type 2 diabetes
See summary chart on p.Error! Bookmark not defined.
Before any pharmacological interventions are considered there should be a 3 month period of diet & lifestyle interventions.

Education

Diet
provide individualised and ongoing specialist nutritional advice.

Lifestyle
encourage weight loss and exercise.
provide structured education to every patient and/or their carer at and around the time of diagnosis and review annually.
Blood Pressure Control Evidence from UKPDS indicates that control of blood pressure in people with hypertension & Type 2 diabetes achieves a clinically
important reduction in the risk of deaths related to diabetes, complications related to diabetes, progression of diabetic retinopathy, and deterioration in visual acuity.
Guidance on the use of Blood Glucose Testing Strips is on page 144
The VADT, ACCORD and ADVANCE trials show that tight control of blood glucose in long standing Type 2 diabetics (reducing HbA1c to below 7%) may be
harmful. CG 87 agrees with this view and recommends:

Involve the person in decisions about their individual HbA1c target which may be above the general target of 6.5% especially in long standing diabetes.

Offer lifestyle advice and medication to help achieve and maintain the HbA1c target.

Inform patients with a higher HbA1c that any reduction towards the agreed target is advantageous to their health.

Avoid pursuing highly intensive management to levels of <6.5%.
♦ Self-monitoring of blood glucose should be offered to a patient newly diagnosed with T2DM only as an integral part of his/her self- management education. Its
purpose should be discussed and there should be agreement how the results should be interpreted and acted upon.
♦ Eye and kidney damage should be screened annually.
NB DH require that HbA1c should always be measured in millimoles per mol (mmol/mol) as well as by percentage. HbA1c of 6.5% is equivalent to 48mmol/mol.
Guide to HbA1c values expressed as mmol/mol:
Endocrine System - Diabetes
DCCT- HbA1c %
IFCC-HbA1c mmol/mol
6.0
42
6.5
48
7.0
53
7.5
58
8.0
64
9.0
75
Page 130
3 month trial of lifestyle interventions
Error!HbA1c
Bookmark
not defined.
≥48mmol/mol
METFORMIN with active dose titration
and use of MR version if necessary to
minimise incidence of GI side effects.
Consider gliclazide if:
i. Not overweight (tailor weight
assessment to ethnic group) OR
ii. Rapid therapeutic response is
required owing to hyperglycaemic
symptoms OR
iii. Metformin CI or not tolerated
HbA1c
<48mmol/mol
Monitor for
deterioration
Metformin
HbA1c
≤48mmol/mol
Monitor for
deterioration
HbA1c
≥48mmol/mol
Metformin plus gliclazide
HbA1c
≤58mmol/mol
Monitor for
deterioration
HbA1c
≥58mmol/mol
Insulin + metformin + gliclazide
Adding insulin in preference to other oral
hypoglycaemics should be normal 3rd line
option unless there is a strong reason not
to, parrticularly if patient is markedly
hyperglycaemic
HbA1c
≤58mmol/mol
Monitor for
deterioration
HbA1c
≥58mmol/mol
Consider repaglinide before meals for
people with erratic lifestyle. Consider
substituting pioglitazone (1st line) or
gliptin/gliflozin for gliclazide if there is
significant risk of hypoglycaemia (or its
consequences) or if sulphonylurea is
CI or not tolerated
Consider adding pioglitazone or gliptin
instead of insulin if insulin is not
acceptable for (see note p.132)
Consider adding exenatide,
lixisenatide or liraglutide if:
 BMI≥ 35 kg/m2 in people of
European origin and there are
problems associated with high
weight
 BMI < 35 and insulin is
unacceptable because of
occupational implications andor
weight loss would benefit other
comorbidities
Increase insulin dose and intensify
regimen over time.
Consider pioglitazone with insulin if:
 Pioglitazone has previously had a
marked glucose-lowering effect or:
 Blood glucose control is inadequate
with high-dose insulin
Insulin+gliptin
Insulin+cana/dapa/empaglliflozin
Insulin+lixa/exenatide(bd dose only)/liraglutide
Endocrine System - Diabetes
For options i. and ii. consider Metformin
plus gliclazide
Gliclazide
HbA1c
≥48mmol/mol
+ pioglitazone
If metformin CI or not
tolerated:
Gliclazide + pioglitazone
or
Metformin + gliptin
(alogliptin 1st line)
or
Metformin +
canagliflozin/dapagliflozin/empagliflozin
HbA1c
<58mmol/mol
Monitor for
deterioration
HbA1c
≥58mmol/mol
or
Gliclazide + gliptin
(Alogliptin 1st line)
HbA1c
<58mmol/mol
Monitor for
deterioration
HbA1c
≥58mmol/mol
Metformin + gliclazide + pioglitazone
or
Metformin + gliclazide + gliptin or
Start
Insulin
Metformin + gliclazide + cana/dapa/empag
Or
Metformin +pioglitazone + canagliflozin
or
Metformin + gliclazide + lixisenatide or exenatide or
liraglutide (use injections last)
HbA1c
<58mmol/mol
Monitor for
deterioration
HbA1c
≥58mmol/mol
HbA1c
≥58mmol/mol
HbA1c
<58mmol/mol
Monitor for
deterioration
Page 131
Insulin therapy in Type 2 Diabetes (based on NICE CG87, Type 2 Diabetes, May 2009)
When other measures do not keep HbA1c to < 7.5% (or other higher level agreed with the individual), discuss the benefits and risks of insulin therapy. Start
insulin therapy if the person agrees.
Note: Insulin may be considered unacceptable for employment, social, recreational or other personal issues, or obesity.
When starting insulin therapy, use a structured programme employing active insulin dose titration that encompasses:

structured education

continuing telephone support

frequent self-monitoring

dose titration to target

dietary understanding

management of hypoglycaemia

management of acute changes in plasma glucose control

support from an appropriately trained and experienced healthcare professional.
First-line: Human NPH insulin (intermediate-acting insulin) at bedtime or twice daily
OR: Long-acting insulin analogue (insulin detemir, glargine) once daily if:
 lifestyle and compliance factors make more frequent injections inappropriate
 the patient is unable to self-inject NPH insulin
target HbA1c is not reached or lifestyle is restricted because of hypoglycaemia
 significant hypoglycaemia occurs with NPH insulin
Alternative Options:
Biphasic human insulin (pre-mix) once or twice-daily particularly where HbA1c is above 9.0%.
Biphasic human insulin analogues (pre-mix) if:
 immediate injection before a meal is preferred, or
 hypoglycaemia is a problem, or
 blood glucose levels rise markedly after meals .
Intensifying Insulin Therapy (HbA1c levels not controlled)
Monitor patients on:
NPH or long-acting insulin analogue to identify the need for injections of short-acting insulin before meals or pre-mixed insulin
Pre-mixed insulin once or twice daily to identify the need for injections of short-acting insulin before meals or a change to mealtime plus basal insulin
regime.
Endocrine System - Diabetes
Page 132
HbA1c for Diagnosis of Diabetes Mellitus
Alogrithm as approved by Somerset Clinical Commissioning Group
HbA1c is recognised by the WHO for the diagnosis of diabetes. The specialist diabetes services in
Somerset (Taunton, Yeovil and Bath) have recommended that the following algorithm is adopted.
More detail on the evidence and reasoning for this are given below.
This is for use in ADULT patients in NON-URGENT situations.
NICE Guidance on Prevention of Type 2 Diabetes
http://www.nice.org.uk/nicemedia/live/13791/59951/59951.pdf
Endocrine System - Diabetes
Page 133
Until recently, type 2 diabetes has been diagnosed using the following criteria:
2. In symptomatic individuals, a single diagnostic test is sufficient – either random (RBG) or
fasting glucose (FBG), or an oral glucose tolerance test (OGTT)
3. In asymptomatic individuals (the majority), a two-step process is performed. A screening test,
typically random or fasting glucose (but could be OGTT), is performed and in individuals testing
positive, a follow up test on a different day, typically FBG or
OGTT.
These tests and criteria still apply; HbA1c is an additional diagnostic test.
HbA1c (glycated haemoglobin) has long been used as tool for assessing blood glucose control in individuals
with diabetes. As a measure of integrated plasma glucose levels over 2-3 months it was felt to have utility in
the diagnosis of diabetes. This has been studied, and in 2011, the WHO produced a report recommending
the use of HbA1c in the diagnosis of diabetes http://www.who.int/diabetes/publications/reporthba1c_2011.pdf. The primary recommendations were:
1. HbA1c can be used as a diagnostic test for diabetes providing that stringent quality assurance tests
are in place and assays are standardised to criteria aligned to the international reference values,
and there are no conditions present which preclude its accurate measurement.
2. An HbA1c of 48 mmol/mol (6.5%) is recommended as the cut point for diagnosing diabetes. A
value of less than 48 mmol/mol does not exclude diabetes diagnosed
using glucose tests.
The algorithm for diagnosis of diabetes is based on one developed by the Association of British Clinical
Diabetologists (ABCD) and reflects joint national guidance
(http://www.acb.org.uk/docs/Article%20Summary%20Use%20of%20HbA1c%20WHO%20gu
idance%20251111[1].pdf).
Somerset Clinical Commissioning Group has approved HbA1c funding for primary care within their
priority setting process in August 2013.
Clinical information provided by Paul Lambert Consultant
Diabetologist
Taunton and Somerset NHS Foundation Trust
September 2013
Version 5
Endocrine System - Diabetes
Page 134
Therapeutic Area
Formulary Choices
Cost for 28
Rationale for decision / comments
(unless otherwise stated)
6.1.1
Insulins
Insulin Passport
Insulin Passports and patient information booklets should be offered to patients receiving insulin. The Insulin Passport provides a record of the patient’s current
insulin preparations and contains a section for emergency information. The patient information booklet provides advice on the safe use of insulin. They are
suppled either from the insulin manufacturers, or via the Somerset partnership.
Eli Lilly – Russell Pearce – 07825 990332 / Debbie Gilmore 07714 308537
Novo Nordisk – 01293 613555
Sanofi – Rob Bartlett [email protected] 07841 321709
Sompar team administrator on 01823 346191
Please read code patients
Insulin passport given 8CE02
Insulin passport completed 8BAi.
Informed dissent not to carry insulin passport 8BAj
Short acting:
Insulin aspart
NovoRapid

3ml cartridge: £28.31 (5)
10ml vial: £14.08 (1)
Prefilled pens are around £2-3 more expensive per 5 and should be used
only when patient choice demands.
Insulin lispro
Humalog
3ml cartridge: £28.31 (5)
10ml vial: £16.61 (1)
Soluble insulin
Human Actrapid
Insuman Rapid®
10ml vial: £7.48 (1)
3ml cartridge: £17.50 (5)
Insulin glulisine
Apidra
Continued on next page
Endocrine System - Diabetes
Solostar 3ml pf inj. device:
£28.30 (5)
3ml cartridge: £28.30 (5)
10ml vial: £16.00 (1)
Page 135
Therapeutic Area
Formulary Choices
Cost for 28
Rationale for decision / comments
(unless otherwise stated)
Intermediate acting:
Biphasic insulin
aspart
NovoMix 30
3ml cartridge: £28.79 (5)
Biphasic Insulin
lispro
Humalog Mix25
3ml cartridge: £29.46 (5)
Isophane insulin
Human Insulatard 3ml cartridge: £22.90 (5)
10ml vial: £7.48 (1)
®
3ml pf inj. device: £19.80 (5)
Insuman Basal
3ml cartridge: £17.50 (5)
5ml vial: £5.61 (1)
Biphasic isophane
insulin
Insuman Comb 15® 3ml cartridge: £17.50 (5)
Insuman Comb 25® 3ml pf inj. device: £19.80 (5)
3ml cartridge: £17.50 (5)
5ml vial: £5.61 (1)
®
Insuman Comb 50 3ml cartridge: £17.50 (5)
Long acting:
Insulin glargine
Lantus
3ml cartridge: £41.50(5)
10ml vial: £30.68 (1)
Insulin detemir
Levemir
Endocrine System - Diabetes
3ml cartridge :£42.00 (5)
Page 136
Therapeutic Area
Formulary Choices
Cost for 28
Rationale for decision / comments
(unless otherwise stated)
Hypodermic
equipment
Choice of needle & lancet may be governed by specific insulin prescribed and injection technique.
Insulin pen needles
There is no clinical reason for recommending needles longer than 8mm in adults or 6mm in children or
adolescents.
GlucoRx FinePoint®
4mm/31 gauge: £5.95 (100)
5mm/31 gauge: £5.95 (100)
6mm/31 gauge: £5.95 (100)
8mm/31 gauge: £5.95 (100)
Omnican Fine
4mm/31gauge:£5.95 (100)
6mm/31 gauge: £5.95 (100)
8mm/31 gauge: £5.95 (100)
BD Autoshield DUO
®
5mm/30 gauge: £30.08 (100)
GlucoRx FinePoint® represents a cost-effective choice of needle where
appropriate.
Only for patients who have their insulin administered by healthcare assistants,
nurses, carers etc to help prevent needlestick injuries:
 Shield automatically locks after injection to help prevent accidental
needlesticks
 Metal tabs provide visual confirmation that the safety feature is activated
This section specifically cover drugs used for management of blood glucose, however the majority of patients with diabetes should be considered to be at high
risk of CVD and hence should also be prescribed Simvastatin 40mg for primary prevention (unless C/I). For secondary prevention guidance see page 56
ATT meta-analysis : Aspirin for primary prevention of CVD
Aspirin is not licensed for the primary prevention of vascular events but there remains the possibility that for particular sub-groups of individuals at higher CV risk
(including conditions such as diabetes) the risk: benefit of aspirin is favourable. Until more evidence is available, the use of Aspirin 75mg for patients with
diabetes should be based on an individual risk assessment.
Endocrine System - Diabetes
Page 137
Therapeutic Area
Formulary Choices
Cost for 28
Rationale for decision / comments
(unless otherwise stated)
6.1.2
Drugs used in diabetes
Biguanides
Metformin
Metformin should be:
First-line:
Immediate-release 500mg tablets: £0.90
850mg tablets: £1.30 (56)
 First-line in Type 2 DM because of cardioprotective effect unless not
overweight, rapid therapeutic response required or metformin C/I
 Introduced at low dose and given with or after food to minimise GI adverse
effects e.g. 500mg daily and gradually titrated to 2g per day (or 3g under
specialist supervision).
 Continued in patients with Type 2 DM who require Insulin, as Metformin
reduces insulin requirements.
 Use with caution in those at risk of a sudden deterioration in kidney function
Sachets
Metformin sachets now discontinued, so for patients with swallowing difficulties
a ‘special’ liquid formulation is an expensive option
Second-line:
Modified release
as Diagemet XL
Generic
Sulphonylureas
Gliclazide

500mg m/r tablets: £1.75
Metformin MR is approved for patients who would otherwise stop metformin
therapy due to GI side effects.
750mg m/r tablets: £6.40
1000mg m/rtablets: £8.52
80mg tablets: £1.04
40mg tablets: £3.36
NICE CG87 recommends prescribing a sulfonylurea with a low acquisition cost
(but not glibenclamide) when a sulfonylurea is indicated.
Normal third line option, if HbA1c remains at ≥ 58mmol/mol HbA1c (or level agreed with individual) is to initiate insulin therapy (see page 132 in
addition to metformin and sulphonylurea (or other dual oral therapy) in preference to adding other drugs to control blood glucose unless there is
strong justification not to.
Endocrine System - Diabetes
Page 138
Therapeutic Area
Formulary Choices
Cost for 28
Rationale for decision / comments
(unless otherwise stated)
Glitazones (thiazolidinediones)
Prescribing of Pioglitazone should be in line with MHRA/EMEA advice (Oct-07, Dec-07, Jan-11, Aug-11) and NICE guidance (TA63 Aug-03, CG66 May-08,
CG87 May-09)

Pioglitazone should not be started in people who:

The incidence of heart failure is increased when Pioglitazone is combined with insulin

Inform patient of risk of oedema and what to do if this happens. Closely monitor patients during treatment with pioglitazone for signs and symptoms of
fluid retention. Discontinue pioglitazone if heart failure develops.

Following consideration at Somerset Prescribing Forum (Nov 2011) it was agreed that generic versions of pioglitazone may be used for all indications
○
○
are at higher risk of fracture
have evidence of heart failure
Thiazolidinediones
Pioglitazone
DPP-4 inhibitors
(Gliptins)
DPP-4 inhibitor may be preferable to a glitazone:
Continue gliptin only
if there is a reduction
of ≥0.5% points in
HbA1c in 6 months
(between 5 and 6
mmol/mol)
15mg tablets: £1.49
30mg tablets: £1.92
45mg tablets: £2.33
The PROACTIVE trial showed improvements in secondary outcomes.
Pioglitazone is licensed for use with insulin
Continue only if there is a reduction ≥ 0.5% points in HbA1c in 6 months
Pioglitazone might be preferable to a DPP-4 inhibitor if there is marked insulin
insensitivity, or if DPP-4 inhibitor is contraindicated or not tolerated.

To prevent weight gain

If the patient has not responded to, or not tolerated or has a contraindication to a glitazone
NB Group 2 (LGV/PCV) drivers are required to notify DVLA if taking combination of gliptin with sulphonylurea
Dose Adjustment in Renal Impairment
Sitagliptin
Mild – no dose adjustment needed
Moderate: creatinine clearance ≥30 to <50ml/min), use
sitagliptin 50mg once daily.
Saxagliptin
Reduce dose to 2.5mg in moderate to severe renal impairment
Linagliptin
No dose reduction required for linagliptin for patients with renal impairment
Vildagliptin
Reduce dose to 50mg once daily when CrCl <50ml/min
Alogliptin
Reduce dose to 12.5mg once daily when CrCl <50ml/min, 6.25mg once daily when CrCl <30ml/min
CrCl <30ml/min or with end-stage renal disease
requiring haemodialysis or peritoneal dialysis,
use sitagliptin 25mg once daily.
Continued overleaf
Endocrine System - Diabetes
Page 139
Therapeutic Area
Formulary Choices
Cost for 28
Rationale for decision / comments
(unless otherwise stated)
DPP-4 inhibitors
First line
Alogliptin
6.25mg tablets:£26.60
12.5mg tablets:£26.60
25mg tablets: £26.60
Second line
Linagliptin
5mg tablets: £33.26
Monotherapy if metformin intolerant or C/I.Dual therapy with metformin. Triple
therapy with SU and metformin. Can use with insulin with or without metformin
Saxagliptin
5mg tablets: £31.60
2.5mg tablets: £31.60
Saxagliptin is is licensed for triple therapy with metformin & sulphonylurea and
with insulin +/- metformin
Sitagliptin
100mg tablets: £33.26
50mg tablets: £33.26
25mg tablets: £33.26
Sitagliptin is licensed for triple therapy with metformin & sulphonylurea and with
insulin +/- metformin
Caution >75years
Vildagliptin
50mg tablets: £31.76 (56)
Twice daily dosing.In dual combination with a sulphonylurea, the
recommended dose of vildagliptin is reduced to 50mg once daily administered
in the morning.
In this patient population, vildagliptin 100mg daily was no more effective than
vildagliptin 50mg once daily
Repaglinide
500mcg tablets: £8.67 (90)
1mg tablets: £9.10 (90)
2mg tablets: £5.71 (90)
Repaglinide may have a role in patients who fail to achieve target HbA1c with
Metformin +/- Sulphonylurea, or when either of these two classes of drug are
contra-indicated or not tolerated.
Consideration should be given to a trial of Repaglinide before initiating a
glitazone.
Repaglinide may have a particular role in patients with an erratic lifestyle
/ irregular eating pattern. Repaglinide should be given in the 30 minute period
before a meal, up to TDS.
Acarbose
50mg tablets: £9.02 (90)
100mg tablets: £15.48 (90)
Acarbose may have a role for a person unable to use other oral glucose
lowering medications (contra-indicated or not tolerated) or in patients who fail
to achieve target HbA1c with Metformin +/- Sulphonylurea. Titrate dose slowly
to reduce incidence of GI adverse effects.
Other options:
Rapid acting
insulin
secretagogue
Endocrine System - Diabetes
As a dual therapy add-on to other agents including insulin. Please note that the
licence for alogliptin does not preclude any particular combination including
triple therapy with metformin and a sulphonylurea (SU), and the use within this
specific combination is not contraindicated. The safety and efficacy of alogliptin
when used as triple therapy with metformin and a sulphonylurea have not been
fully established.
Monotherapy would be considered “off license”
Page 140
Therapeutic Area
Formulary Choices
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Rationale for decision / comments
(unless otherwise stated)
Sodium-glucose
cotransporter-2
(SGLT-2) inhibitor
Dapagliflozin▼
5mg tablets: £36.59
10mg tablets: £36.59
SGLT-2 drugs are recommended by NICE as an add-on to metformin in a
similar way to DDP-4. So continue only if there is a reduction of ≥0.5%
points in HbA1c in 6 months (between 5 and 6 mmol/mol)
For the improvement of glycaemic control treatment of type 2 diabetes mellitus
of in adults in accordance with NICE TA288 (Jun-13):

Dapagliflozin in a dual therapy regimen in combination with metformin is
recommended as an option for treating type 2 diabetes, only if it is used
as described for DPP-4 inhibitors in NICE CG87 Mar-09 (Updated
Mar-10)

Dapagliflozin in combination with insulin with or without other antidiabetic
drugs is recommended as an option for treating type 2 diabetes
 Age limit 75 years
Not recommended with concurrent pioglitazone or eGFR
<60ml/min/1.73m2
Quadruple therapy with metformin, SU and DPP-4 has not been studied so
remains non-formulary
Canagliflozin▼
Endocrine System - Diabetes
100mg tablets:£39.20 (30)
300mg tablets:£49.99 (30)

Monotherapy when diet and exercise alone do not provide adequate
glycaemic control in patients for whom the use of metformin is
considered inappropriate due to intolerance or contraindications.

Add-on therapy with other glucose-lowering medicinal products
including insulin, when these, together with diet and exercise, do not
provide adequate glycaemic control

Age limit 85 years

Can be used as per NICE TA288 (Jun-13)

No initiatition if eGFR <60ml/min/1.73m2
Page 141
Therapeutic Area
Formulary Choices
Cost for 28
Rationale for decision / comments
(unless otherwise stated)
Empagliflozin▼
Endocrine System - Diabetes
10mg tablet: £36.59
25mg tablet: £36.59

Monotherapy when diet and exercise alone do not provide adequate
glycaemic control in patients for whom use of metformin is considered
inappropriate due to intolerance.

Add on with other glucose–lowering medicinal products including
insulin, when these, together with diet and exercise, do not provide
adequate glycaemic control

No age limit

Can be used as per NICE TA288 (Jun-13)

No initiatition if eGFR <60ml/min/1.73m2
Page 142
Therapeutic Area
Formulary Choices
Cost for 28
Rationale for decision / comments
(unless otherwise stated)
GLP-1 mimetic
(Glucagon-like
peptide-1 analogue)
First-line:
Dietary advice should be given before starting therapy with these agents.
For all dose regimens of lixisenatide, exenatide & liraglutide treatment should be continued only if:
 there is a reduction of ≥1.0% points in HbA1c in 6 months (between 10 and 11 mmol/mol)
AND
 3% loss of initial body weight in 6 months.
Lixisenatide▼
Treatment initiation pack:
£54.14
Once-daily dosing
10mcg prefilled pen: £27.07
(14 doses)
20mcg prefilled pen: £54.14
(2  14 doses)
Second-line:
or
Exenatide
Twice-daily dosing
5mcg pre-filled pen: £68.24
(60 doses)
10mcg pre-filled pen: £68.24
(60 doses)
Modified-release▼
Once-weekly
2mg vial : £73.36 (4)
dosing
2mg prefilled pen £73.36 (4)
Lixisenatide, exenatide and liraglutide administered either daily or weekly (at
appropriate dose) may be considered for triple therapy in addition to
metformin and a sulphonylurea in people whose HbA1c is above agreed
level if;
 BMI ≥ 35 kg/m2 in those of European descent (with appropriate adjustment
for other ethnic groups) & other specific psychological or medical problems
associated with high body weight, or
 BMI < 35 kg/m2 and insulin therapy would have significant occupational
implications, or where weight loss would benefit other significant comobidities such as sleep apnoea.
NB Group 2 (LGV/PCV) drivers are required to notify DVLA if taking
combination of exenatide with sulphonylurea.
Somerset Prescribing Forum approved the use of lixisenatide and
exenatide as adjunctive therapy to basal insulin (with or without
metformin and/or pioglitazone in adults with Type 2 diabetes) i.e. within
the respective licensed indications. Patients are expected to show 0.5%
(6mmol/mol) reduction in HbA1c after 6 months to justify continuation.
Patients where weight & HbA1c reduction stipulated by NICE have not been
achieved after 6 months on exenatide should have exenatide stopped as not
cost-effective.
or
Liraglutide
Once-daily dosing
6mg/ml pre-filled pen: £78.48
(2  3ml), £117.72 (3  3ml)
Liraglutide 1.2mg daily can be considered for dual therapy (in combination with
metformin or a sulphonylurea) only if either metformin or a sulphonylurea is
contraindicated or not tolerated, and a DPP-4 inhibitor is contraindicated or not
tolerated.
For triple therapy see above
Endocrine System - Diabetes
Page 143
Guidance on the use of Blood Glucose Testing Strips based on NICE CG87
NICE national guidelines for the management ofblood glucose levels in people with type 2 diabetes (May-08)
1.
In line with NICE guidelines, regular HbA1c testing (every two to six months) is the standard measurement. Pathology services in Somerset currently allow
a minimum interval of 3 months between tests. An individual target HbA1c should be set with every patient.
2.
Blood glucose testing strips are primarily intended for people with diabetes treated with insulin. The frequency of testing should be as agreed between the
health professional and the individual with diabetes. (Those converting to insulin need to test more frequently during the dose titration phase, which is
usually managed by diabetes specialist nurses. Those with type 1 diabetes may need to test 4 or more times daily).
2.
Self monitoring in patients with Type 2 diabetes, who are controlled by diet or oral hypoglycaemic agents, should only be instigated as an integral part of a
patient’s self-management plan. The purpose of self-monitoring should be discussed along with agreement about how the results should be interpreted and
acted upon e.g.:
To provide information on hypoglycaemia
To assess changes in glucose control resulting from medication and lifestyle changes
To monitor changes during illness
To ensure safety during activities such as driving
Urine glucose monitoring is an option if blood glucose monitoring is not acceptable.I
Frequency of self-testing is variable but is likely to be higher if a patient is unwell or titrating their medication.
One pack of 50 strips will be sufficient for 6-12 months for most patients in this group.
4.
5.
Practices should assess at least annually the continuing benefit of the intervention including:
-
Appropriate frequency of testing
-
Use made of results obtained
-
Impact on quality of life
-
Self-monitoring skills
Blood Glucose testing for Drivers when on insulin or oral medication carrying the risk of hypoglycaemia (DVLA)
Patients must not have had more than one episode of disabling hypoglycaemia within 12 months & must inform DVLA if they develop impaired awareness
of hypoglycaemia.
Cars & Motorcycles
For patients on sulphonylureas & gliptins there is no absolute requirement to test blood glucose. It may be appropriate to monitor blood glucose
regularly and at times relevant to driving depending on other patient factors.
Vocational Driving (Bus, coach & lorries)
Drivers should monitor blood glucose twice daily on their driving days, at times relevant to the driving they do.
Endocrine System - Diabetes
Page 144
Therapeutic Area
Formulary Choices
Cost for 28
Rationale for decision / comments
(unless otherwise stated)
6.2
Thyroid and anti-thyroid drugs
Thyroid hormones
Anti-thyroid
hormones
Levothyroxine
25mcg tablets: £2.83
50mcg tablets: £1.96
100mcg tablets: £1.95
100micrograms/5ml oral
solution sugar free: £77.03
(100ml)
Monitoring requirements are for TFTs annually
Carbimazole
5mg tablets: £41.93 (100)
20mg tablets: £103.62 (100)
New patients should be counselled regarding warning signs of haematological
toxicity. Monitoring requirements are for FBC, LFTS and TFTs annually
Propylthiouracil
50mg tablets: £53.94 (56)
Propylthiouracil is included only for patients intolerant to Carbimazole.
Monitoring requirements are for FBC, LFTS and TFTs annually
Liquid is lactose free.
Liothyronine (T3) is classified as not recommended for primary care
initiation and considered red when consultant requested
NB. Under no circumstances should Carbimazole and Propylthiouracil be
combined.
6.3
Corticosteroids
Glucocorticoid
therapy
Prednisolone
Prescribers are
advised to use plain
prednisolone.
Enteric-coated
prednisolone has
slower onset of
action, less
consistent blood
levels and no proven
evidence of GI
protective effect.
Thyroid and Anti-thyroid drugs
1mg tablets: £0.95 (28)
5mg tablets: £1.13 (28)
Patients on long-term oral corticosteroids, should be provided with a steroid
warning card, these are available for practices to requisition from supplies at:
Somerset Partnership Support Services
Mallard Court
Express Park
Bridgwater
TA6 4RN
 01278 726964
Page 145
Therapeutic Area
Formulary Choices
Cost for 28
Rationale for decision / comments
(unless otherwise stated)
6.4
Sex Hormones
6.4.1 Hormone Replacement Therapy (HRT)

HRT should no longer be used a first line intervention to prevent osteoporosis. Preparations marked with an asterisk are those licensed for
osteoporosis as well as relief of menopausal symptoms, all other preparations are only licensed for menopausal symptoms.
 In view of increasing evidence that HRT may have harmful effects on CVD, this should be carefully discussed with patients at commencement and
annually at review.
 Oral preparations recommended 1st line on cost, although transdermal route may be more appropriate for some patients e.g. diabetics
 HRT should be prescribed by brand name to avoid confusion
Unopposed
1mg tablets: £5.06 (84)
Elleste Solo tablets are first line on cost grounds.
Elleste Solo
oestrogen
2mg tablets: £5.06* (84)
Cyclical combined
Continuous
combined:
Transdermal patches 25mcg patch: £3.42 (8)
50mcg patch: £3.88* (8)
as Evorel
75mcg patch: £4.12* (8)
100mcg patch:£4.28* (8)
Evorel is recommended where a patch formulation is required, due to lower
cost, range of doses available and patient acceptability of matrix patches.
Elleste Duet
1mg tablets: £9.20 (84)
2mg tablets: £9.20* (84)
Elleste Duet tablets are first line on cost grounds.
Femoston
1/10mg tablets: £13.47* (84)
2/10mg tablets: £13.47* (84)
Femoston (Estradiol and Dydrogesterone) offers alternative with a C21
progestogen.
Kliovance
Tablets: £13.20* (84)
Continuous combined products should not be used until 12 months after the
menopause. Irregular bleeding patterns may occur for the first few months and
may persist for some women, requiring a move back to cyclical preparations
and/or investigation.
Kliovance has identical composition to Elleste Duet Conti, but at a lower cost
Kliofem
Tablets: £11.43* (84)
Femoston Conti
Tablets: £20.36* (84)
Tibolone is now non-formulary. It is expensive and benefits over HRT have not been demonstrated for menopausal symptoms. The
MHRA have advised of increased risk of stroke in older women (LIFT study) and in February 2009 noted the increased risk of recurrent
breast cancer when tibolone was used for vaso-motor symptoms in women with a history of breast cancer (LIBERATE trial).
Sex Hormones
Page 146
Therapeutic Area
Formulary Choices
Cost for 28
Rationale for decision / comments
(unless otherwise stated)
Progestogens
Sex Hormones
Norethisterone
5mg tablets: £2.24 (30)
Norethisterone (15mg/day from days 5 to 26 of menstrual cycle) is an option
for management of heavy menstrual bleeding, however it is not recommended
as first line by NICE Clinical Guideline No.44. Norethisterone may cause more
androgenic effects than some other progestogens.
Medroxyprogesterone
2.5mg tablets: £1.84 (30)
5mg tablets: £1.23 (10)
10mg tablets: £2.47 (10)
Medroxyprogesterone may produce less androgenic adverse effects than
Norethisterone.
Page 147
Therapeutic Area
Formulary Choices
Cost for 28
Rationale for decision / comments
(unless otherwise stated)
6.4.2
Male sex hormones and antagonists
Testosterone
First-line:
Sustanon 250
®
250mg/ml amp: £2.45 (1ml)
Second-line:
Testosterone
Enantate
250mg/ml amp: £58.86 (1ml)
Third-line:
Nebido®
250mg/ml amp: £80.00 (4ml)
Fourth-line:
Testogel®
50mg/5g gel sachet: £31.11
(30)
Testim®
50mg/5g gel: £32.00 (30g)
Tostran®
2% gel (10mg per
application): £26.67 (60g)
Striant SR®
30mg Mucoadhesive buccal
tablets: £28.00 (60)
Restandol®
40mg capsules: £8.55 (30)
(Temporary formulary
inclusion)
5-Alpha Reductase
Inhibitors (5-ARIs)
Hypothalamic and pituitary hormones and anti-oestrogens
6.5.2
Posterior pituitary hormones and antagonists
Sex Hormones
ALL Testosterone products are included (except Intrinsa®) are
included in the formulary for the duration of the national shortage of
injectable formulations.
For non-injectable alternatives please see BNF 62 6.4.2 or Choosing a
Testosterone Preparation information sheet for details.
Cross refer to section 7.4.1 for further details on the management of Lower Urinary Tract Symptoms (LUTS) associated with benign
prostatic hyperplasia (BPH), for which 5-ARIs are indicated.
Finasteride
5mg tablets: £1.54 (28)
Finasteride is the only recommended 5-ARI, due to the weight of clinical
evidence and cost-effectiveness.
Dutasteride (Avodart) is non-formulary following rejection by the T&ST
D&TC
6.5
Posterior pituitary
hormones
Intrinsa® for females remains NON-FORMULARY
Sustanon 250® is the testosterone injection of choice on grounds of costeffectiveness.
Second line is Testosterone Enantate 250mg given every 4 weeks. Trough
testosterone should be measured on the day of the 3rd Enantate injection to
make sure patients are not being overdosed – target is a testosterone in the
lower quartile of reference range, 8-13 nmol/l.
The Enantate dosing interval range of 3-6 weekly is longer than that for
Sustanon®, which is usually 3-4 weekly.
If neither is first- or second-line choices are available Nebido® injection lasts for
10-14 weeks - measuring trough testosterone weekly from 10 weeks will
enable the dosing interval to be determined using the target range above.
Nebido® should be given with the patient lying in prone position
Desmopressin
200mcg tablets: £9.84 (30)
Desmopressin tablets are included in the formulary only for the treatment of
nocturnal enuresis in line with NICE CG111: Nocturnal enuresis.
Page 148
NHS England Interim Gender Dysphoria Protocol and Service
Protocol Flowchart
Hormone Therapy as part of Gender Reassignment:
NHS England expects GPs to co-operate with their commissioned Gender Identity Clinics (GICs) and to prescribe
hormone therapy recommended for their patients by the GIC. They are also expected to co-operate with GICs in
patient safety monitoring, by providing basic physical examinations (within the competence of GPs) and blood tests
recommended by the GIC. The GIC is expected to assist GPs by providing relevant information and support,
including the interpretation of blood test results. Hormone therapy should be monitored at least 6 monthly in the first 3
years and yearly thereafter, dependant on clinical need.
From: NHS England. Interim Gender Dysphoria Protocol and Service Guideline 2013/14 (Oct-13)
Sex Hormones
Page 149
6.6
Drugs affecting bone metabolism
Lifestyle interventions:
Investigations:

Nutrition (especially Calcium and Vitamin D intake)

FBC

Weight bearing exercise

Plasma viscosity,

Smoking cessation

Calcium, LFTs, creatinine,

Avoid excess alcohol

TSH,

Gamma GT,

? radiology to exclude other # causes.

Testosterone in males (sex hormone + SHBG)
DEXA scanning: Fractures over the age of 75 should be treated without DEXA

Guidance on primary prevention of osteoporosis in postmenopausal women is provided in NICE TAG 160 See summary table p154

Guidance on secondary prevention of osteoporosis in postmenopausal women is provided by NICE TAG 161. See summary table p157

The March 2012 Somerset Prescribing Forum debated and then approved the off license use of Bisphosphonates (alendronate (1st) , risedronate(2nd)
or ibandronate(3rd):
o Patients who have sustained fragility fractures but currently excluded by NICE criteria
o Patients deemed by clinicians at high risk of fragility fractures (including patients with Osteopenia if at high # risk)

The evidence of benefit from Bisphosphonate therapy comes from trials which ensured patients had intake of therapeutic doses of Calcium and Vitamin
D, supplementation with Calcium and Vitamin D is therefore recommended for patients prescribed these drugs.

Where Calcium and Vitamin D is recommended, a formulation providing Calc.Carb. 1500mg and Vit D 400iu per tablet should be prescribed. A range of
products is included all now of similar price; the product chosen should be made according to patient preference & encourage concordance.

Preparations such as Calcichew D3 or Calcium & Ergocalciferol BP do not provide evidence-based doses of the constituents and should normally not
be prescribed.
 Calcium and Vitamin D should be considered for all women over age of 75 yrs
The optimal period of treatment with bisphosphonates is not known, evidence of benefit has been measured for up to 5 years. NICE recommends research
into the long-term effects and prescribers should be aware of the possible adverse effects on bone quality when bisphosphonates are taken for extended
periods.
Bisphosphonate ‘drug holidays’ No formal guidance exists on this topic which is advocated by some secondary care centres. Local policy is to follow MHRA
alert & assess people individually. The absolute numbers of atypical stress fractures in patients on long-term bisphosphonates is very low; it is not at all clear
whether these are because of BPP therapy or simply random events.
Drugs affecting Bone Metabolism
Page 150
Patient group
Formulary Choices
Cost
Rationale for decision / comments
(per pack size stated)
Primary prevention
of osteoporosis in
postmenopausal
women
First-line:
See Summary of NICE TA160 on page 154
Somerset Prescribing Forum (Jan-12) approved Denosumab as third-line treatment for primary prevention of osteoporotic fractures in
women
Raloxifene is not recommended as a treatment option for primary prevention of osteoporotic fractures.
Alendronic Acid
70mg tablets: £0.90 (4)
70mg/100ml solution: £22.80
(4x100ml)
Risedronate 35mg
35mg tablets: £1.16 (4)
Second-line:
Ibandronate 150mg
150mg tablet: £3.02 (1)
Third-line:
Denosumab*
60mg/ml prefilled syringe:
£183.00 (1)
120mg Injection (Xgeva®)
is NOT for treatment of
osteoporosis
Bisphosphonates - 1st alendronate, 2nd risedronate & 3rd ibandronate (where
compliance would otherwise prevent patients taking bisphosphonate) are
recommended first line for the primary prevention of osteoporotic fracture in
susceptible postmenopausal women where specified combinations of BMD;
age; independent risk factors or other indicator of low bone mineral density
apply.
The flow chart on p142 summarises the conditions.
Independent risk factors considered:
 Parental history of hip fracture
 Alcohol intake > 3 units daily
 Rheumatoid arthritis
Indicators of low bone mineral density :
 BMI <22 kg/m2
 Ankylosing spondylitis
 Crohn’s disease
 Prolonged immobility
 Untreated premature menopause
Osteoporosis confirmed by DEXA scan is expected except by local agreement
for women over 75.
Osteopenia: Only the lowest cost bisphosphonates are approved for patients
with osteopenia. This is an off-licence use & patients’ informed consent is
required.
*Also for men at increased risk of fracture
Denosumab is associated with a risk of osteonecrosis of the jaw (ONJ)
and with a risk of hypocalcaemia. MHRA September 2014
Before starting denosumab, a dental examination and appropriate
preventative dentistry recommended.
Drugs affecting Bone Metabolism
Page 151
Patient group
Formulary Choices
Cost
Rationale for decision / comments
(per pack size stated)
Fourth line
Strontium Ranelate
All with calcium
and vitamin D
supplement
Sachets 2G: £27.08 (28)
Strontium should be considered only for patients with severe osteoporosis in
post-menopausal women and men with a high risk of fracture, and only
prescribed to patients who do not have a history of heart problems and if the
patient is unable to take any of the above medicines
http://www.mhra.gov.uk/home/groups/commspo/documents/news/con382707.pdf
Calcium carbonate 1500 mg and 10 micrograms of colecalciferol (equivalent to 400 IU vitamin D3) tablets: See p.129 for full choice
ThieCal D3
chewable tablets
1000mg/880IU
£2.95 (30 tablets)
Once daily dose with or without food
Accrete D3 tablets
600mg/800IU
£2.95 (60)
Twice daily tablet
Drugs affecting Bone Metabolism
Page 152
Drugs affecting Bone Metabolism
Page 153
PRIMARY PREVENTION OF OSTEOPOROSIS IN
POSTMENOPAUSAL WOMEN
Based on NICE TA160 and NICE TA204
Clinical risk factors for fracture:
A. Parental history of # hip
B. Alcohol > 3 units daily (> 4 units if considering Denosumab)
C. Rheumatoid arthritis
AGE < 70 and 0 risk factors
DO NOT TREAT
AGE 75 +
Plus 2 risk factors
from A, B, C or other
indicator of low BMD
AGE 70 - 74
Plus 1 or more risk factors A, B or C or
indicator of low BMD
AGE 65 - 69
Plus 1 or more risk factors A, B or C
NO DEXA required
Refer for DEXA
T score – 2.5 or worse
Initiate weekly generic ALENDRONATE
Refer for DEXA
T score – 2.5 or worse
Initiate weekly generic ALENDRONATE
Alendronate C/I, intolerant or unable to
comply
Alendronate C/I, intolerant or unable to
comply
Initiate weekly
generic
ALENDRONATE
Alendronate C/I,
intolerant or unable to
comply – try
risedronate or
etidronate
C/I, intolerant or
unable to comply
with
bisphosphonates
REFER FOR
DEXA
T score- 4.0 or
worse OR -3.0 or
worse and 2 risk
factors try
Denosumab,
Zoledronate
NO risk factors
ONE risk factor
TWO risk factors
T score better
than - 3.5
DO NOT TREAT
T score - 3.0 or
worse try
risedronate or
etidronate
T score - 2.5 or
worse try
risedronate or
etidronate
NO risk
factors
DO NOT
TREAT
T score - 3.5 or
worse try
risedronate or
etidronate
C/I, intolerant or unable to comply with bisphosphonates
ONE risk
factor
T score -3.5
or worse try
risedronate
or
etidronate
NO risk factors
and T score - 4.5
or worse try
Denosumab,
Zoledronate
DO NOT TREAT
TWO risk
factors and T
score - 3.5 or
worse try
Denosumab,
Zoledronate
TWO risk
factors
T score
-3.0 or
worse try
risedronate
or
etidronate
C/I, intolerant or unable to comply with
bisphosphonates
NO risk factors
and T score > - 4.5
DO NOT TREAT
ONE risk
factor and T
score - 4.0 or
worse try
Denosumab,
Zoledronate
AGE < 65
Plus 1 risk factor from
A, B or C AND one
additional indicator of
low BMD
NO risk
factors
DO NOT
TREAT
ONE risk
factor and
T score - 4.5
or worse try
Denosumab,
Zoledronate
REFER FOR DEXA
T score – 2.5 or worse
Initiate weekly generic
alendronate
Alendronate C/I,
intolerant or unable to
comply
DO NOT TREAT
The NHS Somerset
Formulary allows
consideration of
monthly ibandronate
where compliance
issues would
otherwise prevent
patient taking
bisphosphonates
TWO risk
factors and
T score - 4.0 or
worse try
Denosumab,
Zoledronate
Page 154
Patient group
Formulary Choices
Cost
Rationale for decision / comments
(per pack size stated)
Secondary
prevention of
osteoporosis in
postmenopausal
women
First-line:
See Summary of NICE TA161 on p.157)
Somerset Prescribing Forum approved Zoledronic acid annual infusion (Sep-10) & Denosumab (Jan-12)
as third-line treatments for secondary prevention of osteoporosis
Raloxifene is not recommended as a treatment option for primary prevention of osteoporotic fractures.
Alendronic Acid
70mg tablets: £0.90 (4)
70mg/100ml solution: £22.80
(4x100ml)
Risedronate 35mg
35mg tablets: £1.16 (4)
Second-line:
Ibandronate 150mg
150mg tablet: £3.02 (1)
Third-line:
Denosumab*
60mg/ml prefilled syringe:
£183.00 (1)
120mg Injection (Xgeva®)
is NOT for treatment of
osteoporosis
Bisphosphonates (1st alendronate or risedronate, 2nd ibandronate) are
recommended first line for the secondary prevention of osteoporotic fracture in
women with confirmed osteoporosis who have also sustained a clinically
apparent osteoporotic fracture.
In addition, in March 2012, Somerset Prescribing Forum approved the off
license use of Bisphosphonates in patients with previous fragility fractures or
deemed by clinicians at high risk of fragility fractures for patients with
Osteopenia.
Where an oral bisphosphonate is not appropriate, denosumab and annual
infusion of zoledronic acid are approved by Somerset Prescribing Forum as 3rd
line treatments or raloxifene (subject to BMD, age & other risk factors).
Teriparetide is a treatment option following assessment in secondary care
where other therapies are not appropriate. Teriparetide is a RED drug under
the traffic light classification.
This information is summarised in the flow chart on p
The FRAX algorithm is a tool to calculate 10 year probablilty of hip and other
major osteoporotic fractures using the same risk factors as NICE plus
glucocorticoid use and smoking status

http://www.shef.ac.uk/FRAX/?lang=en
NB Local agreement for women aged over 75 years: DEXA not required.
*Also for men at increased risk of fracture
Denosumab is associated with a risk of osteonecrosis of the jaw (ONJ)
and with a risk of hypocalcaemia. MHRA September 2014
Before starting denosumab, a dental examination and appropriate
preventative dentistry recommended.
Drugs affecting Bone Metabolism
Page 155
Patient group
Formulary Choices
Cost
Rationale for decision / comments
(per pack size stated)
Raloxifene 60mg
60mg tablets: £14.15
or
All with calcium
and vitamin D
supplement
Calcium carbonate 1500 mg) and 10 micrograms of colecalciferol (equivalent to 400 IU vitamin D3) tablets: See p.129 for full choice
Accrete D3
Drugs affecting Bone Metabolism
£2.95 (60)
Jan 2013 – cost-effective product
Page 156
SECONDARY PREVENTION OF OSTEOPOROSIS
IN POSTMENOPAUSAL WOMEN
Clinical risk factors for fracture:
A. Parental history of # hip
B. Alcohol > 4 units daily
C. Rheumatoid arthritis
Based on NICE TAG161 and NICE TAG204 (Denosumab)
(1.6) Intolerance of alendronate, risedronate or etidronate is defined as persistent
upper GI disturbance occuring even though instructions for administration have
been followed correctly and sufficiently severe for treatment to be stopped.
Weekly generic Alendronate is recommended for
postmenopausal women who are confirmed to have
osteoporosis (central T score -2.5 or worse).
For women over 75 years DEXA not required.
(1.7) Intolerance of strontium is defined as persistent nausea or diarrhoea, either of
which warrants discontinuation of treatment.
(1.8) An unsatisfactory response is defined by a women having another fragility
fracture despite adhering fully to treatment for 1 year and there is evidence of a
decline in BMD below her pre-treatment baseline
If alendronate is not appropriate i.e.
contra- indicated, intolerant, unable to comply or
unsatisfactory response to treatment, options
depend on combination of age, T score and
independent clinical risk factors.
50 – 54
55 – 59
60 – 64
65 – 69
70 – 74
75 and
older
Refer for
DEXA
Refer for
DEXA
Refer for
DEXA
Refer for
DEXA
Refer for
DEXA
DEXA not
required
Alendronate not option: Treat
with other bisphosphonate
0 risk factor
1 risk
factor
2 risk
factors
Not
recommended
- 3.0
- 2.5
- 3.0
- 3.0
- 2.5
- 3.0
- 3.0
- 2.5
- 3.0
- 2.5
- 2.5
- 2.5
- 2.5
- 2.5
- 2.5
- 2.5
- 2.5
* DEXA not required if indicators for low BMD exist, including:
Consider Denosumab or Zoledronic acid
Age
If T-score
not
available
(2.6) A fragility fracture is defined as a fracture sustained as the result of a force
equivalent to the force of a fall from a height equal to, or less than, the height of an
ordinary chair.
Bisphosphonate and Denosumab
or Zoledronic acid not option:
Treat with raloxifene
Raloxifene not option: refer to
secondary care assessment for
teriparatide
2 fragility
fractures or
less
Not
recommended
Not
recommended
Not
recommended
0 risk factors
1 risk
factor
2 risk
factors
More than 2
fragility fractures
Not
recommended
- 3.5
- 3.5
- 4.0
- 3.5
- 3.5
- 4.0
- 3.5
- 3.5
- 4.0
- 3.5
- 3.0
- 4.0
- 3.5
- 3.0
- 3.0
- 2.5
- 4.0
- 3.5
- 3.0*
- 2.5
- 2.5
- 4.0
- 3.5
Not recommended
- 4.0
- 4.0
Low BMI (< 22kg/m2), inflammatory conditions such as ankylosing spondylitis or Crohn’s disease,
Conditions resulting in prolonged immobility, and untreated early menopause.
NHS Somerset Formulary allows consideration of monthly ibandronate where compliance issues would otherwise prevent patient taking bisphosphonates
Drugs affecting Bone Metabolism
Page 157
Patient group
Formulary Choices
Cost
Rationale for decision / comments
(per pack size stated)
Steroid induced
osteoporosis
(6 months at >7.5mg
Prednisolone
equivalent)
Plus calcium and
vitamin D
supplement:
Alendronic Acid
70mg tablets: £0.90 (4)
70mg/100ml solution: £22.80
(4x100ml)
Calcium carbonate
1500 mg) and 10
micrograms of
colecalciferol
(equivalent to 400 IU
vitamin D3) tablets:
See p.178 for full choice
Accrete D3
£2.95 (60)
cost-effective product:
To reduce the risk of osteoporosis doses of oral corticosteroids should be as
low as possible and courses of treatment as short as possible. The risk of
osteoporosis may be related to cumulative dose of corticosteroids; even
intermittent courses can therefore increase the risk. The greatest rate of bone
loss occurs during the first 6–12 months of corticosteroid use and so early
steps to prevent the development of osteoporosis are important. Long-term use
of high-dose inhaled corticosteroids may also contribute to corticosteroidinduced osteoporosis
Patients taking (or who are likely to take) an oral corticosteroid for 3 months or
longer should be assessed and where necessary given prophylactic treatment;
those aged over 65 years are at greater risk. Patients taking oral
corticosteroids who have sustained a low-trauma fracture should receive
treatment for osteoporosis. The therapeutic options for prophylaxis and
treatment of corticosteroid-induced osteoporosis are the same:
 a bisphosphonate
 calcitriol [unlicensed indication]
 hormone replacement: HRT in women, testosterone in men
[unlicensed indication]
Breast cancer
treatment - induced
bone loss:
See: ‘Guidance for the management of breast cancer treatment-induced bone loss: A consensus position statement from a
UK expert group (2008)’
Algorithm 1: Women who experience premature menopause – The development of treatment-induced menopause or planned
ovarian suppression before the age of 45 years are indications for evaluation of BMD by DEXA. c and any type of concomitant
endocrine treatment. Any patient with a documented vertebral fragility fracture or previous low trauma hip fracture should receive
prophylactic bisphosphonate treatment irrespective of baseline BMD (p.19 in consensus guidance)
Algorithm 2: Postmenopausal women – The use of an aromatase inhibitor is an indication for evaluation of BMD by DEXA.
Monitoring and treatment thereafter depends on baseline BMD, age & presence of any major risk factors for osteoporotic fracture.
For women over the age of 75 years with one or more major risk factors, bone protection therapy with a bisphosphonate treatment is
recommended irrespective of baseline BMD (p.21 in consensus guidance)
Drugs affecting Bone Metabolism
Page 158
Patient group
Formulary Choices
Cost
Rationale for decision / comments
(per pack size stated)
Osteoporosis in Men
First-line:
Second-line:
NB All young men with osteoporosis should be referred for specialist advice.
Alendronic Acid
70mg tablets: £0.90 (4)
70mg/100ml solution: £22.80
(4x100ml)
Risedronate 35mg
35mg tablets: £1.16 (4)
Denosumab
60mg/ml prefilled syringe:
£183.00 (1)
Somerset Prescribing Forum (Nov-11) approved use of denosumab in men
when NICE criteria are fulfilled. Prescribers should ensure that patients are
aware that the product is being used outside of its licence.
Denosumab is associated with a risk of osteonecrosis of the jaw (ONJ)
and with a risk of hypocalcaemia. MHRA September 2014
Before starting denosumab, a dental examination and appropriate
preventative dentistry recommended.
Plus calcium and
vitamin D
supplement:
Calcium and
vitamin D
supplement
Accrete D3
Primary Prevention
of osteoporosis:
Frail elderly
women
See p.178 for full choice
£2.95 (60)
As above
Calcium and Vitamin See p.178 for full choice
D supplement
Accrete D3
Drugs affecting Bone Metabolism
Calcium carbonate 1500 mg) and 10 micrograms of colecalciferol (equivalent
to 400 IU vitamin D3) tablets:
Indicated for those at increased fracture risk e.g. patients in Nursing or
residential homes.
Calcium carbonate 1500 mg) and 10 micrograms of colecalciferol (equivalent
to 400 IU vitamin D3) tablets
£2.95 (60)
Page 159
Therapeutic Area
Formulary Choices
Cost
Rationale for decision / comments
(per pack size stated)
BNF Chapter 7: Obstetrics, gynaecology, and urinary-tract disorders
7.2
Top
Treatment of vaginal and vulval conditions
Preparations for
vaginal atrophy
Estradiol
as Ovestin
0.1% cream £4.45 (15g)
as Vagifem
10mcg pessaries £16.72 (24)
Topical oestrogens should be used in the lowest effective amount to minimize
systemic absorption. Patients should be reviewed at least annually to reassess the need for continued treatment and to monitor for symptoms of
endometrial hyperplasia or carcinoma in women with a uterus.
Patients should have the opportunity to choose a product suited to them
although there is no evidence of difference in effect.
Long term treatment may be required as symptoms can recur on cessation of
therapy
Vagifem 25mcg pessaries were discontinued February 2013
Vaginal and vulval
infections
Fungal infections:
First line:
Fluconazole (oral)
150mg capsule: £1.08 (1)
Fluconazole is recommended as first line due to ease of use and costeffectiveness. Available as a generic
Second line:
Clotrimazole
(intra-vaginal and/or
topical)
500mg pessary: £3.38 (1)
2% cream / 500mg pessary
combi-pack: £5.21 (1)
1% Cream: £1.34 (20g)
Clotrimazole pessaries are second line due to higher cost.
NB: available OTC, often at cost lower than the NHS prescription charge.
Gynaecology and Urinary-tract Disorders
Page 160
Therapeutic Area
Formulary Choices
Cost
Rationale for decision / comments
(per pack size stated)
7.3
Contraceptives
Women requiring contraception should be given information about and offered a choice of all methods including LARC (long-acting reversible contraception).
Interactions
The effectiveness of combined oral contraceptives, progestogen-only oral contraceptives, contraceptive patches, and vaginal rings can be considerably reduced
by interaction with drugs that induce hepatic enzyme activity (e.g. carbamazepine, eslicarbazepine, modafinil, nelfinavir, nevirapine, oxcarbazepine,
phenytoin, phenobarbital, primidone, ritonavir, St John’s Wort, topiramate, and, above all, rifabutin and rifampicin).
Hormonal contraceptives and antibacterials that do not induce liver enzymes
Advice on interactions between combined hormonal contraceptives and antibacterials that do not induce liver enzymes has been updated to take into account
the recommendations of the Faculty of Sexual and Reproductive Healthcare Clinical Guidance: Drug Interactions with Hormonal Contraception (January 2011).
Additional contraceptive precautions are no longer necessary when antibacterials that do not induce liver enzymes are taken with combined oral contraceptives,
(unless diarrhoea or vomiting occurs), contraceptive patches or vaginal rings. Click here for more information.
Some other interactions of hormonal contraceptives have been updated in Appendix 1 of the BNF: Interactions (under Oestrogens and Progestogens)
Gynaecology and Urinary-tract Disorders
Page 161
Therapeutic Area
Formulary Choices
Cost
Rationale for decision / comments
(per pack size stated)
7.3.1 Combined
hormonal
contraceptives
Low strength
Ethinylestradiol /
norethisterone
as Loestrin 20
Standard strength:
Ethinylestradiol /
norgestrel
as Rigevidon®
as Ovranette

20mcg/1mg tablets: £2.70
(63)
30mcg/150mcg tablets:
£1.89 (63)
30mcg/150mcg tablets:
£2.20 (63)
Rigevidon® is a cost-effective alternative to Ovranette®.
Ethinylestradiol /
norgestimate
as Cilest
Ethinylestradiol /
gestodene
as Millinette® 30/7
as Femodene 5
35mcg/250mcg tablets: £7.16
(63)
NB: Third-generation COCs containing the progestogens gestodene or
desogestrel (e.g. Femodene®) are associated with a higher risk of VTE.
30mcg/75mcg tablets: £4.85
(63)
30mcg/75mcg tablets : £6.73
(63)
Millinette® 30/75 is a cost-effective alternative to Femodene®
Ethinylestradiol /
norethisterone
(tri-phasic)
as Tri-Novum
Gynaecology and Urinary-tract Disorders
35mcg/500mcg,
35mcg/750mcg, &
35mcg/1mg: £3.46 (63)
Page 162
Therapeutic Area
Formulary Choices
Cost
Rationale for decision / comments
(per pack size stated)
7.3.2 Progestogenonly contraceptives
(POPs)
Norethisterone
350mcg
7.3.2.3 Intra uterine
POP system
Mirena®
as Micronor
Jaydess®
Long-acting
reversible
contraception
(LARC)
T-shaped plastic frame
levonorgestrel
20 micrograms/24 hours, net
price = £88.00
13.5mg: £69.22
Five year use license
Smaller frame and smaller reservoir. Approved for use in the CASH service
where a coil is appropriate but Mirena is not suitable or not tolerated. Three
year life license. Contraception only
LARC methods are more cost-effective than COC pill even at one year. Please see NICE guidance on Features of the larc methods to
discuss with women (Sept 14) and Choice of method for different groups of women (Sept 14)
Medroxyprogesterone
as Depo-Provera®
Etonogestrel
as Nexplanon®
7.3.5 Emergency
Hormonal
Contraception (EHC)
Tablets: £2.11 (84)
Progestogens gestodene or desogestrel (e.g. Cerelle® ) are associated with a
higher risk of VTE.
Cerelle® 75mcg is a cost-effective alternative to Cerazette®
Levonorgestrel
1500mcg tablet
as Upostelle®
150mg/ml prefilled syringe:
£6.01 (1)
68mg implant: £79.46
1500mcg tablet: £5.20 (1)
Nexplanon® is bioequivalent to Implanon® (discontinued), it has the same
release rate and 3-year duration of action. Nexplanon® also has a different
application device and insertion technique. Please visit
http://www.nexplanontraining.co.uk/ or contact MSD directly for training.
Available via PGD through many pharmacies across Somerset, free of charge
to all.
Levonorgestrol 1500mcg is the first-line oral preparation for patients presenting
within 72 hours of UPSI or contraceptive failure.
DO NOT PRESCRIBE AS THE OTC PREPARATION: Levonelle One Step
(as over twice the cost of the POM product.)
Gynaecology and Urinary-tract Disorders
Page 163
Therapeutic Area
Formulary Choices
Cost
Rationale for decision / comments
(per pack size stated)
Ulipristal acetate
30mg tablet ▼
as EllaOne
Pre-operative
treatment of uterine
fibroids
Ulipristal acetate
5mg tablet
as Esmya
Gynaecology and Urinary-tract Disorders
30mg tablet: £16.95 (1)
5mg tablet: £ 113.14 (28)
Patients presenting between 72 hours and 120 hours may be offered the
choice of ulipristal acetate or intrauterine device and the risks and benefits of
each method should be discussed with the patient.
Ulipristal is licensed for emergency contraception within 120 hours (5 days)
after unprotected sexual intercourse (UPSI).
Pregnancy should be excluded before ulipristal is taken.
Ulipristal acetate is indicated for pre-operative treatment of moderate to severe
symptoms of uterine fibroids in adult women of reproductive age over the age
of 18.
Approved at Somerset Prescribing Forum as an AMBER drug for a maximum
of 3 months treatment only with the acute trust to supply the first month.
Pregnancy should be precluded prior to treatment and a non hormonal
contraceptive method is recommended during treatment
Page 164
Consilient Pill Equivalences and VTE risk
There is an increased risk of venous thromboembolic disease in users of combined hormonal contraceptives particularly during the first year and possibly after
restarting combined hormonal contraceptives following a break of four weeks or more. This risk is considerably smaller than that associated with pregnancy (about
60 cases of venous thromboembolic disease per 100 000 pregnancies). In all cases the risk of venous thromboembolism increases with age and in the presence of
other risk factors, such as obesity. The risk also varies depending on the type of progestogen, see the chart below for details.Provided that women are informed of
the relative risks of venous thromboembolism and accept them, the choice of oral contraceptive is for the woman together with the prescriber jointly to make in light
of her individual medical history and any contra-indication
Gynaecology and Urinary-tract Disorders
Page 165
Gynaecology and Urinary-tract Disorders
Page 166
7.4
Drugs for genito-urinary disorders
7.4.1
Drugs for urinary retention
Related guidance: NICE Clincal Guideline CG97 (2010): Lower urinary tract symptoms
Management of Lower Urinary Tract Symptoms (LUTS) associated with Benign Prostatic Hyperplasia (BPH) involves:

Alpha-blockers – as below, cross refer to CV section for recommendations on use of alpha-blockers in hypertension
 5-alpha reductase inhibitors – cross refer to section 6.4.2. for details
Evidence from the MTOPS study which combined Finasteride with Doxazosin showed that dual-therapy provides additional symptomatic benefit for patients and
delays the progression of BPH, compared to monotherapy. Further guidance on management of LUTS associated with BPH is available on CD-ROM from the
British Association of Urological Surgeons.
Alpha-blockers
First-line:
Doxazosin
as Modifiedrelease (MR) for
initiation only
as Doxadura®
4mg m/r tabs: £5.00 (28)
4mg m/r tabs £4.50
Instant-release
tablets for
continuation
as Doxadura®
4mg tablets: £1.09 (28)
4mg tablets: £1.03
Gynaecology and Urinary-tract Disorders
Patients should be initiated on the 4mg MR preparation and then
switched to the more cost-effective standard 4mg tablet once
stabilised e.g. after one to two months therapy.
Page 167
Second-line:
Tamsulosin MR
capsules
as Tabphyn MR®
400mcg m/r capsules: £5.71 (30)
400mcg m/r capsules: £4.39 (30)
Tamsulosin has greater selectivity for the alpha-receptors predominant
in the urinary tract; however the clinical significance of this remains
debateable. In view of this and its greater cost, Tamsulosin should only
be used where there is intolerance to Doxazosin.
Generic Tamsulosin capsules are now available.
Tamsulosin MR tablets (Flomaxtra XL) are not included in the
formulary
Gynaecology and Urinary-tract Disorders
Page 168
7.4.2
Drugs for urinary frequency, enuresis, and incontinence
Related guidance: NICE Clinical Guideline CG111 (2010): Nocturnal enuresis – the management of bedwetting in children and young people
NICE Clinical Guideline CG171 (2013): The management of urinary incontinence in women
Before initiating treatment a thorough investigation of the underlying cause of incontinence should be carried out and drug treatments should be reviewed 4
weeks after starting. If there is no or suboptimal improvement or intolerable adverse effects change the dose, or try an alternative antimuscarinic drug, and
review again 4 weeks later.
Thereafter, treatments should be reviewed annually.
First-line:
Second-line:
Oxybutynin
(immediate release)
2.5mg tablets: £1.97 (56)
5mg tablets: £3.17 (56)
Tolterodine
(immediate release)
1mg tablets: £2.94 (56)
2mg tablets: £3.07 (56)
Darifenacin
(once daily)
7.5mg tablets: £25.48 (28)
15mg tablets: £25.48 (28)
Oxybutynin MR
5mg m/r tablets: £13.77 (30)
10mg m/r tablets: £27.54
(30)
Tolterodine MR
as Neditol XL®
4mg m/r capsules: £12.89
(28)
Trospium
(immediate release)
as Flotros®
As per NICE guidance immediate release Oxybutynin is recommended as the
first line antimuscarinic for managing urinary incontinence as a result of
detrusor instability on the basis of its good efficacy and low cost.
Not recommended in frail, elderly women.
Research has shown that concordance after 3 years is less than 10%
regardless of class of drug use with little to differentiate treatment options
(Shamliyan T, et al. Benefits and harms of pharmacologic treatment for urinary
incontinence in women. A systemic review. Ann Intern Med 2012; 156:861-74)
NICE advises thatsome adverse effects are indications that treatment is having
effect and that they may not see full benefits for 4 weeks.
If first treatment for OAB or mixed UI is not effective or not tolerated, offer
another drug with the lowest acquisition cost.
Aim to avoid additional antimuscarinic drugs particularly in elderly and patients
with dementia due to risk of delirium. See muscarinic load below.
20mg tablets:£18.20 (60)
TrospiumMR
as Regurin XL®
60mg tablets: £23.05 (28)
Propiverine
(immediate release)
Propiverine MR
15mg tablets: £18.00 (56)
30mg capsules: £24.45 (28)
Continued overleaf
Gynaecology and Urinary-tract Disorders
Page 169
Continued from previous page
Third-line
Non oral therapy
Solifenacin
5mg tablets: £27.62 (30)
10mg tablets: £35.91 ( 30)
Fesoterodine
4mg m/r tablets: £25.78 (28)
8mg m/r tablets: £25.78 (28)
Mirabegron
25mg tablets: £29.00 (28)
50mg tablets: £29.00 (28)
To use as an option where antimuscarinic drugs are contra-indicated or
clinically ineffective or side-effects are unacceptable, before surgery or botox
therapy
Lower dose used where hepatic or renal impairment exists
Oxybutinin Patches
Oxybutinin 3.9mg/24 hours:
£27.20 (8)
Oxybutinin patches remain an option at any stage for those unable to tolerate
oral therapy or for patients with swallowing problems to avoid the need for
unlicensed liquid formulations.
Patches are applied twice weekly to clean, dry, unbroken skin on abdomen,
hips or buttocks.
Evidence indicated that higher dose of solifenacin is more likely to cause side
effects than tolterodine MR or Trospium MR
For the use of desmopressin in the treatment of nocturnal enuresis, please refer to section 6.5.2 Posterior pituitary hormones and antagonists
Gynaecology and Urinary-tract Disorders
Page 170
7.4.5
Drugs for erectile dysfunction
The drugs for the treatment of erectile dysfunction in men listed below are considered appropriate for initiation in general practice, where patients meet the
following criteria for NHS prescribing and are endorsed as “SLS”:

Diabetes mellitus

Single gene neurological disease

Multiple sclerosis

Spina Bifida

Parkinson's disease

Spinal cord injury

Poliomyelitis

Dialysis for renal failure

Prostate Cancer

Radical pelvic surgery, prostatectomy or kidney transplant

Were receiving Caverject®, Erecnos®, MUSE®, Viagra® or Viridal® for ED at NHS
expense on 14-09-1998
 Severe pelvic injury
Prescriptions need to be annotated “SLS” with the exception of
sildenafil from August 1st 2014
First-line
Sildenafil
25mg tablets: £1.24 (4)
50mg tablets: £1.41 (4)
100mg tablets: £1.45 (4)
All PDE5 inhibitors are contra-indicated in patients taking nitrates.
Prophylactic use after prostate surgery to improve recovery. Not licenced
for this indication, therefore treat as RED if recommended by a relevant
specialist for this indication.
Second-line:
Vardenafil
5mg tablets: £7.56 (4)
10mg tablets: £14.08 (4)
20mg tablets: £23.48 (4)
NICE CG66 states that all PDE5’s are effective and the evidence is not
sufficient to distinguish between them.
Avanafil
Gynaecology and Urinary-tract Disorders
50mg tablets: £10.94 (4)
£19.70 (8)
100mg tablets: £14.08 (4)
£26.26 (8)
200mg tablets: £21.90 (4)
£39.40 (8)
Page 171
Third-line:
Tadalafil
10mg tablets: £26.99 (4)
20mg tablets: £26.99 (4)
Tadalafil is offered as a third line option for patients who are intolerant or
unresponsive to Sildenafil and Vardenafil. It should not be used in patients
taking nitrates.
Cialis Once Daily is non-formulary
Non oral therapy
7.4.6
Alprostadil
as Vitaros®cream
4 doses: £40
An alternative to oral medication
30mg tablets: £14.71 (3)
30mg tablets: £26.48 (6)
60mg tablets: £19.12 (3)
60mg tablets: £34.42 (6)
Dapoxetine is a short-acting selective serotonin re-uptake inhibitor licensed for
use in the treatment of premature ejaculation in men (18 to 64 yrs) who meet
all the following criteria: poor control over ejaculation, a history of premature
ejaculation over the past 6 months, marked distress or interpersonal difficulty
as a consequence of premature ejaculation, and an intravaginal ejaculatory
latency time of less than two minutes. Maximum 6 tablets per month.
Drugs for premature ejaculation
Dapoxetine
Anticholinergic load
Gynaecology and Urinary-tract Disorders
Page 172
Gynaecology and Urinary-tract Disorders
Page 173
Therapeutic area
Formulary Choices
Cost
Rationale for decision / comments
(per pack size stated)
BNF Chapter 8: Malignant disease and immunosupression
8.3
Top
Sex hormones and hormone antagonists in malignant disease
Hormone
antagonists
Anastrazole
1mg tablets: £1.93 (28)
Anastrazole is recommended as an adjuvant to early oestrogen-receptorpositive breast cancer and is supported by a Shared Care Protocol.
Letrozole
2.5mg tablets: £1.76 (14),
£84.68 (28)
Anastrazole is recommended as an adjuvant to early oestrogen-receptorpositive breast cancer and is supported by a Shared Care Protocol.
Use of an aromatase inhibitor is an indeication for evaluation of BMD by DEXA
Pre- or
Postmenopausal
women at high
risk of breast
cancer
Tamoxifen
10mg tablets: £21.19 (30)
20mg tablets: £2.39 (30)
40mg tablets: £16.16 (30)
10mg/5ml oral solution:
£29.61 (150ml)
NICE CG164 Jun-13:
 for 5 years to premenopausal women at high risk of breast cancer unless
they have a past history or may be at increased risk of thromboembolic
disease or endometrial cancer
 for 5 years to postmenopausal women with or without a uterus and at high
risk of breast cancer unless they have a past history or may be at increased
risk of thromboembolic disease or endometrial cancer
Local agreement: Tamoxifen is approved for longterm use (>5 years)
Raloxifene
60mg tablets: £14.15 (28),
£59.59 (84)
Raloxifene (unlicensed use) for 5 years to postmenopausal women with a
uterus and at high risk of breast cancer unless they have a past history or may
be at increased risk of thromboembolic disease or endometrial cancer
(NICE CG164 Jun-13)
Prostate cancer &
Monthly injections of triptorelin and goserelin were approved at the March 2010 meeting of the Somerset prescribing Forum for use
Gonadorelin analogues within licensed indications re: Breast Cancer – endometriosis and uterine fibroids.
First-line:
Triptorelin
as Decapeptyl SR

3mg (4.2mg) vial: £69.00 (1)
11.25mg (15mg) vial: £207.00
(1)
22.5mg (28mg) vial: £414.00
(1)
Second-line:
Leuprorelin
as Prostap

Malignant Disease and Immunosuppression
3.75mg PFS: £75.24
11.25mgPFS:£225.72
Decapeptyl SR is recommended as the first line GnRH anaologue within its
licensed indications for prostate cancer.
Patients with a life expectancy of >12 months who do not requiring 3-monthly
reviews should be considered for a switch from the 3-monthly (15mg) to the 6monthly (28mg) preparation.
Administered every 13 weeks rather that 12 making it more cost effective than
goserelin
Page 174
Therapeutic area
Formulary Choices
Cost
Rationale for decision / comments
(per pack size stated)
Third line:
Goserelin
Malignant Disease and Immunosuppression
3.6mg PFS: £65.00 (1)
10.8mg PFS: £235.00 (1)
Goserelin is considered as third line GnRH analogue for use within its licensed
indications, where Decapeptyl and Triptorelin are not appropriate.
Goserelin is used in young women with breast cancer. It is used either to
protect their ovaries during chemotherapy or to suppress their ovaries following
treatment to reduce the chance of recurrence. The 10.8 mg 3 monthly implant
is not licensed in breast cancer so the 3.6 mg injection is given on a monthly
basis - usually for 18m to 2 years
Page 175
Therapeutic area
Formulary Choices
Cost
Rationale for decision / comments
(per pack size stated)
BNF Chapter 9: Nutrition and blood
9.1
Top
Anaemias and some other blood disorders
Iron deficiency
Ferrous fumarate
210mg tablets: £2.30 (100)
322mg tablets: £0.95 (28)
Syrup
as Fersamal
as Galfer
Megaloblastic
anaemia
9.2
140mg/5ml: £3.73 (200ml)
140mg/5ml £5.33 (300ml)
Folic acid
400mcg tablets: £2.71 (90)
5mg tablets: £0.99 (28)
Hydroxocobalamin
1mg/ml injection: £2.83 (5)
210mg Ferrous fumarate provides 68mg elemental iron, usual dose 210mg
tds.
322mg Ferrous fumarate provides 100mg elemental iron, usual dose 322mg
bd
Ferrous sulphate is no longer included in the formulary as Ferrous
fumarate provides equivalent at lower cost. For reference 200mg Ferrous
sulphate tablets provide 65mg elemental iron.
400mcg daily is indicated for prevention of neural tube defects
Fluids and electrolytes
Potassium Salts
Potassium chloride
600mg m/r tablets: £1.90 (100)
Oral rehydration
therapy
Electrolade
Sachets: £1.97 (6)
Sachets: £4.99 (20)
Nutrition and Blood
Electrolade offers a lower cost alternative to Dioralyte
Page 176
Therapeutic area
Formulary Choices
Cost
Rationale for decision / comments
(per pack size stated)
9.5
Minerals
Calcium
supplements
9.6
Calcium carbonate
Chewable tablets: £8.25
(100)
Evidence for efficacy of Calcium supplements is in combination with Vitamin D,
there should be few situations where Calcium alone is indicated.
800IU capsules: £3.60 (30)
There is no national guidance on use of plain Vit D. Vitamin D deficiency
can occur in people whose exposure to sunlight is limited and in those whose
diet is deficient in vitamin D but there is little agreement on what minimum blood
levels should be and evidence base for supplementation is poor (except
rickets). Levels will be reduced during winter months. Ergocalciferol or
colecalciferol may be given in a dose of 20mcg (800IU daily by mouth.
Capsules contain arachis oil and must not be taken by people with peanut
allergy, and gelatine
as Desunin
800IU tablets: £ 3.60 (30)
Tablet version of colecalciferol – included for option to capsules which may be
crushed for patients wih swallowing problems.
Dose equivalent to 20microgram vitamin D3
as Fultium D3
3200IU capsules £13.32 (30)
£39.96 (90)
20000IU capsules £17.04(15)
Fultium D3 3200IU is included in formulary for Vitamin D deficiency in adults
and the elderly (serum levels <25 nmol/l (<10 ng/ml)) for up to 12 weeks. For
higher doses see below.
Treatment, 40,000iu weekly for 7 weeks, preferably with food, then reduce to
maintenance dose equiv to 1400—2000iu/day (2—3 caps per month).
Prevention, 20,000iu every 4 weeks.
Agreed as an option when recommended and initiated by a consultant
as Adcal

Vitamins
Vitamin D
Colecalciferol 800IU
as Fultium D3

£29.00 (30)
as InVita D3
25,000IU Oral solution 3x1ml
ampoule: £4.45
High dose unlicensed Vitamin D (e.g. 20,000IU Dekristol® Capsules) remain
non-formulary.
Higher doses may be necessary for severe deficiency.If recommended by
secondary care there is an agreement that they will be responsible for supplying
the supplement for its whole duration (i.e. considered RED under the TLG)and
primary care should not be asked to prescribe.
When concordance is an issue there should be no restriction of choice
Nutrition and Blood
Page 177
Therapeutic area
Formulary Choices
Cost
Rationale for decision / comments
(per pack size stated)
Vitamin D
supplements with
Calcium
Calcium and vitamin D should be considered as an intervention to reduce fracture risk for all women over 75 years.
Calcium and
Vitamin D:
Calcium & Ergocalciferol tablets BP are non-formulary as they provide an inadequate dosage for most
patients.
A range of Calcium and Vitamin D products are included to provide a range of flavours & formulation to
encourage concordance.
First-line:
Accrete D3
Tablets: £2.95 (60)
Accrete D3is currently the most cost-effective choice however a range of
products is included for patient choice.
Second-line:
Adcal D3
Chewable tablets:£3.65 (56),
£7.30 (112)
Caplet: £3.65 (112)
Dose Adcal D3® caplets is 2bd
or
Adcal D3 Dissolve
or
Soluble tablets: £4.99 (56)
Calcichew D3 Forte Chewable tablets: £4.24 (60)
or
Chewable tablets: £3.58 (60)
Calceos
Calcichew D3®
Caplets: £7.43 (100)
Vitamin K1
Phytomenadione
10mg/ml ampoule: £3.78 (10) For use in the management of haemorrhage due to Warfarin, cross refer to
2mg/0.2ml ampoule: £4.71 (5) anticoagulant section of formulary.
MultiVitamin
Preparations
Dialyvit
Renavit
Nutrition and Blood
More costly than other products in the class & provides lower dose of
colecalciferol.
Approved at May-12 Prescribing Forum only for patients receiving renal dialysis.
Unlicensed in UK – order supplies from USA
Tablets: £12.50 (100)
Preparation of Vitamins B1, B2, B6, B12, C, Biotin, Folic acid, Nicotinamide, and
Pathothenic acid.
Approved at Nov-13 Prescribing Forum only for patients receiving renal dialysis.
Page 178
Therapeutic area
Formulary Choices
Cost
Rationale for decision / comments
(per pack size stated)
BNF Chapter 10: Musculoskeletal and joint diseases
10.1
Top
Drugs used in rheumatic diseases and gout
Related guidance: CG177 Osteoarthritis: Care and management in adults Feb 2014
Non-steroidal antiinflammatory drugs
(NSAIDs)
NICE recommends cytoprotection with PPIs for patients who require systemic NSAIDs. Recommended PPIs are:
Lansoprazole 15mg capsules; Omeprazole 20mg capsules or Pantoprazole 20mg tablets.
Risk of GI bleeds is higher for slow release formulations.
Note that all NSAIDs should be prescribed at the minimum effective dose for the minimum period in order to limit cardiovascular, renal
and GI toxicity.
Consider trial of topical NSAIDs before moving to systemic NSAID for Osteoarthritis.
First-line:
Ibuprofen
200mg tablets: £3.40 (84)
400mg tablets: £3.19 (84)
600mg tablets: £6.91 (84)
Ibuprofen is 1st choice on grounds of safety and cost
Second-line:
Naproxen
250mg tablets: £1.22 (28)
500mg tablets: £1.70 (28)
Naproxen EC tablets are non-formulary, evidence that EC reduces GI
events is poor and they are three times the price of standard tablets.
Diclofenac is now non-formulary after the EMEA / MHRA added new
contraindications and warnings after a Europe-wide review of
cardiovascular safety (Jun-13).
COX-2 selective
NSAIDs
NICE recommends cytoprotection with PPIs for patients who require systemic COX-2s. Recommended PPIs are:
Lansoprazole 15mg capsules or Omeprazole 20mg capsules
Note that all NSAIDs including COX-2s should be prescribed at the minimum effective dose for the minimum period in order to limit
cardiovascular, renal and GI toxicity. Consider trial of topical NSAIDs before moving to systemic COX-2 for Osteoarthritis.
First-line:
Meloxicam
7.5mg tablets: £1.04 (30)
15mg tablets: £1.33 (30)
NB: Etoricoxib & celecoxib are non-formulary (Celecoxib exception below)
Celecoxib
(named-patient basis only
– see comment right)
Musculoskeletal system
100mg capsules: £21.55 (60)
200mg capsules: £21.55 (30)
Named-patient basis only when recommended by Consultant Rheumatologist
when ibuprofen, naproxen and meloxicam are ineffective. Consider
risk-benefit compared to diclofenac.
Page 179
Therapeutic area
Formulary Choices
Cost
Rationale for decision / comments
(per pack size stated)
Rubefacients and
topical NSAIDs
Algesal
Cream: £1.21 (50g)
Transvasin
Cream: £1.55 (40g)
Ibuprofen
as Fenbid
Piroxicam
5% gel: £1.50 (100g)
10% gel £4.00 (100g)
0.5% gel: £5.77 (112g)
NICE CG59 advises that Paracetamol and/or Topical NSAIDs should be
considered AHEAD of oral NSAIDs for OSTEOARTHRITIS
Topical NSAIDs should be considered for use in addition to core treatment for
knee or hand inflammation.
For patients using large volumes of topical NSAIDs, Fenbid 5%gel is the
most cost-effective.
Topical ketoprofen is no longer recommended following a Drug Safety Update
warning about the risk of photosensitivity reactions after exposure to direct
sunlight, uv lamps, etc.
Felbinac (Traxam) and Diclofenac (Voltarol) gels / foams are
non-formulary
Capsaicin
Musculoskeletal system
0.025% cream £17.71 (45g),
0.075% cream £14.58 (45g)
Topical capsaicin should be considered as an adjunct to core treatment for
knee or hand osteoarthritis
Page 180
Therapeutic area
Formulary Choices
Cost
Rationale for decision / comments
(per pack size stated)
Gout
Guidelines on management of gout available from The British Society for Rheumatology and British Health Professionals in
Rheumatology: http://rheumatology.oxfordjournals.org/cgi/reprint/kem056av1
Acute attacks:
First-line:
Naproxen
250mg tablets: £1.22 (28)
500mg tablets: £1.70 (28)
Oral NSAIDs at maximum doses are the drugs of choice where there are no
contra-indications.
NICE recommends gastroprotection with PPIs for patients who require
systemic COX-2s. See above
Second-line:
Colchicine
500mcg tablets: £36.23 (100)
Colchicine can be an effective alternative to NSAIDs, but has a slower onset of
action. To reduce risk of diarrhoea it should be used in doses of 500mcg bd to
qds.
First-line
Allopurinol
100mg tablets: £0.97 (28)
300mg tablets: £1.08 (28)
Allopurinol is first line therapy for lowering uric acid. In uncomplicated gout,
therapy should be started if a second attack or further attacks occur within 1
year. Commence 1-2 weeks after inflammation of acute attack has settled.
Treatment should be initiated with 50-100mg/day and increased at 50-100mg
increments every few weeks, adjusted in necessary for renal function, until the
therapeutic target (Serum Uric Acid < 300mol/litre) is reached. Maximum in
severe conditions 900mg/day in divided doses.
If mild/moderate renal impairment: seek further advice.
Second-line:
Febuxostat
80mg tablets: £24.36 (28)
120mg tablets: £24.36 (28)
Febuxostat is recommended as an option for the management of chronic
hyperuricaemia in gout only when allopurinol is not tolerated at an effective
dose or for whom allopurinol is contra-indicated. NICE TA164
Sulfinpyrazone
100mg tablets: £41.25 (84)
200mg tablets: £79.00 (84)
Uricosuric therapy with Sulfinpyrazone (usually 200-600mg/day) may be an
appropriate second line option for patients with normal renal function who are
under-excretors of uric acid and those resistant to, or intolerant of, Allopurinol.
For those with mild/moderate renal impairment seek further advice.
Long term control:
Musculoskeletal system
Page 181
1,2
Consider
risk factors and clinical
presentations
GOUT TREATMENT
ALGORITHM
Likely diagnosis of gout (exclude septic arthritis)
Typical 1st MTP joint involvement
ACUTE TREATMENT
Suppress pain and reduce inflammation until acute flare has subsided. Use one of the following
Full-dose NSAID

Colchicine* (500 microgram 3-4 times daily reducing course) Avoid if eGFR<30 ml/min

Corticosteroid (intra-articular, intramuscular) oral (0.5mg/Kg for 5-10 days)

Advise patient to use an ice-pack
6-week
appointment:
sUA ≥ 360 micro
mol per litre
Reduce risk factors:
Switch thiazide/indapamide/loop diuretic to ACE or Losartan (uricosuric)
if possible
Reduce alcohol intake (beer especially)
Reduce intake fructose/corn syrup in food and drinks
Check fasting lipids
LONG-TERM TREATMENT
Initiate sUA-lowering therapy if patient has had ≥2 flares per year, based on
patient preference and clinical judgement.

Allopurinol 100mg - 200mg od AND

Add prophylactic low-dose colchicine (500 microgram twice daily) for up to
the first six months of treatment (3 months may be sufficient). Alternatives
NSAID (but not aspirin) if no contraindications or Prednisolone 10 mg od

Patient education - increased fluid intake
6-week appointment: sUA ≥ 0.36
mmol per litre
6-week appointment:
sUA < 360 micro mol
per litre
RECONSIDER DIAGNOSIS
Persistent symptoms without
definitive diagnosis should be
discussed with secondary care
6-week appointment: sUA < 0.36
mmol per litre
Increase allopurinol depending upon sUA
 Continue with sUA-lowering therapy
Moderately severe 300mg – 600mg
 Retest sUA every six months to one year
Severe 700mg – 900mg
 Stop colchicine 1 month after hyperuricaemia
corrected
prophylactic
colchicine
(500
microgram
 Maintain
If allopurinol
intolerant
(side
effects
sufficient to warrant discontinuation) or allergic to allopurinol initiate
twice daily)
.
Febuxostat
80 mg od. If sUA >0.36mmol/l after 2-4 weeks increase to 120MG od
Gout flares while taking
sUA lowering therapy
Suppress pain and reduce inflammation. Do not interrupt
sUA lowering therapy unless there is a clinical reason
In stable gout uric acid levels should be checked annually
*Colchicine is the preferred treatment for patients who have concomitant conditions and who are taking medications that contraindicate
the use of NSAIDs
+ Allopurinol dosage reduction in renal failure:/elderly: start low (1.5 mg per unit of eGFR) or 50 mg od
1. Zhang W, Doherty M, Pascual E et al. EULAR evidence based recommendations for gout. Part I: Diagnosis. Report of a task force of the
Standing Committee for International Clinical Studies Including Therapeutics (ESCISIT). Ann Rheum Dis 2006; 65: 1301–11. Part II:
Management. Report of a task force of the Standing Committee for International Clinical Studies Including Therapeutics (ESCISIT), Ann
Rheum Dis 2006; 65: 1312–24.
2. Jordan KM, Cameron JS, Snaith M et al. British Society for Rheumatology and British Health Professionals in Rheumatology guideline for
the management of gout. Rheumatology 2007; 46: 1372-4.
This treatment algorithm has been produced as an educational service by A. Menarini Pharma UK SRL.
Musculoskeletal system
Management of Osteoarthritis
Therapy options in CG177 Feb 2014 are unchanged from 2008 guidance
Therapy options for OA are summarised in the following:
oral NSAIDs
including COX-2
inhibitors
opioids
capsaicin
intra-articular
corticosteroid
injections
paracetamol
supports
and braces
topical
NSAIDs
education, advice,
information access
shockabsorbing
shoes or insoles
Oral analgesics
strengthening exercise
aerobic fitness training
local heat and
cold
assistive
devices
weight loss if
overweight/obese
Healthcare professionals should consider offering paracetamol
for pain relief in addition to core treatment (see figure 2); regular
dosing may be required. Paracetamol and/or topical nonsteroidal anti-inflammatory drugs (NSAIDs) should be
considered ahead of oral NSAIDs, cyclo-oxygenase 2 (COX-2)
inhibitors or opioids.
If paracetamol or topical NSAIDs are insufficient for pain relief
for people with osteoarthritis, the addition of opioid analgesics
should be considered with Tramadol considered first line. Risks
and benefits should be discussed, particularly in elderly people.
If a strong opioid is needed, its use should be relatively short
term pending surgical or other specialist referral. Regular
follow-up is needed to assess analgesic efficacy and minimise
unwanted effects.
Topical treatments
TENS
manual therapy
(manipulation and
stretching)
Musculoskeletal system
joint
arthroplasty
Healthcare professionals should consider offering topical
NSAIDs for pain relief in addition to core treatment (see
figure 2) for people with knee or hand osteoarthritis. Topical
NSAIDs and/or paracetamol should be considered ahead of oral
NSAIDs, COX-2 inhibitors or opioids.
Topical capsaicin should be considered as an adjunct to core
treatment for knee or hand osteoarthritis.
Rubefacients are not recommended for the treatment of
osteoarthritis.
Page 183
NSAIDs and highly selective COX-2 inhibitors
Although NSAIDs and COX-2 inhibitors may be regarded as a single drug class of ‘NSAIDs’, these recommendations continue to use the two terms for clarity, and
because of the differences in side-effect profile. The recommendations in this section are derived from extensive health-economic modelling, which included
December 2007 NHS drug tariff costs. This guideline replaces the osteoarthritis aspects only of NICE technology appraisal guidance 27. The guideline
recommendations are based on up-to-date evidence on efficacy and adverse events, current costs and an expanded health-economic analysis of cost effectiveness.
This has led to an increased role for COX-2 inhibitors, an increased awareness of all potential adverse events (gastrointestinal, liver and cardio-renal) and a
recommendation to co-prescribe a proton pump inhibitor (PPI).
Where paracetamol or topical NSAIDs are ineffective for pain relief for people with osteoarthritis, then substitution with an oral NSAID/COX-2 inhibitor should be
considered.
Where paracetamol or topical NSAIDs provide insufficient pain relief for people with osteoarthritis, then the addition of an oral NSAID/COX-2 inhibitor to paracetamol
should be considered.
Oral NSAIDs/COX-2 inhibitors should be used at the lowest effective dose for the shortest possible period of time.
When offering treatment with an oral NSAID/COX-2 inhibitor, the first choice should be either a standard NSAID or a COX-2 inhibitor (other than etoricoxib 60 mg).
In either case, these should be co-prescribed with a PPI, choosing the one with the lowest acquisition cost.
All oral NSAIDs/COX-2 inhibitors have analgesic effects of a similar magnitude but vary in their potential gastrointestinal, liver and cardio-renal toxicity; therefore,
when choosing the agent and dose, healthcare professionals should take into account individual patient risk factors, including age. When prescribing these drugs,
consideration should be given to appropriate assessment and/or ongoing monitoring of these risk factors.
If a person with osteoarthritis needs to take low-dose aspirin, healthcare professionals should consider other analgesics before substituting or adding an NSAID or
COX-2 inhibitor (with a PPI) if pain relief is ineffective or insufficient.
Nutraceuticals
The use of glucosamine or chondroitin products is not recommended for the treatment of osteoarthritis.
Intra-articular injections
Intra-articular corticosteroid injections should be considered as an adjunct to core treatment for the relief of moderate to severe pain in people with osteoarthritis.
Intra-articular hyaluronan injections are not recommended for the treatment of osteoarthritis.
Musculoskeletal system
Page 184
Therapeutic area
Formulary Choices
Cost
Rationale for decision / comments
(per pack size stated)
BNF Chapter 11: Eye
11.3
Anti-infective eye preparations
Antibacterials
Chloramphenicol
0.5% drops: £1.59 (10ml)
1% ointment: £1.60 (4g)
See Infection management guidance for appropriate clinical indications.
Chloramphenicol drops and ointment are now both available OTC at a cost
lower than NHS prescription charge but restrictions apply to sales.
Fusidic acid (Fucithalmic®) is non-formulary
Antivirals
11.4
Aciclovir
3% ointment: £9.34 (4.5g)
Corticosteroids and other anti-inflammatory preparations
Corticosteroids
As advised by secondary care
Other
anti-inflammatory
products
Sodium
cromoglicate
11.5
As advised by secondary care
Treatment of glaucoma
Glaucoma
As advised by
secondary care
First line:
Where a prostaglandin analogue is indicated for reducing IOP, Latanoprost is the recommended first line agent on grounds of cost
(generic form available) and ocular tolerability.
Patients currently using other forms of prostaglandin analogues may be reviewed when seen routinely by secondary care.
Latanoprost
Preservative-free
single use
as Monoprost®
Eyes
Prescribe 13.5ml size.
5ml and 10ml pack sizes are OTC products (and non-formulary), and are
more expensive when being used regularly.
Mydriatics and cycloplegics
Mydriatics and
cyloplegics
11.6
2% drops: £1.61 (13.5ml)
50mcg/ml: £1.99 (2.5ml)
50mcg/ml: £8.49 (30x0.2ml)
For the reduction of elevated intra-ocular pressure in patients with open-angle
glaucoma and ocular hypertension who have proven sensitivity to
benzalkonium chloride
Page 185
Therapeutic area
Formulary Choices
Cost
Rationale for decision / comments
(per pack size stated)
11.8
Miscellaneous ophthalmic preparations
Dry eyes:
Hypromellose
Preservative-free
single use
as Lumecare®
Eyes
0.3% drops £1.21 (10ml)
0.5% drops: £0.81 (10ml)
1% drops: £0.94 (10ml)
Treatment for dry eyes associated with tear deficiency should normally
commence with the least viscous agent e.g. Hypromellose 0.3% drops and
work through alternatives in increasing order of viscosity.
0.3% drops: £5.72 (30x0.5ml)
Treatment for dry eyes associated with tear deficiency in patients who have
proven sensitivity to benzalkonium chloride
Page 186
Lubricant
Carbomer 0.2% eye gel
Brand
Clinitas
Presentation
10g tube
Cost
Preservative free
Xailin Gel
10g tube
£3.25
Carmize 1%
30 x 0.4ml single dose unit
60 x 0.4ml single dose unit
£3.00 reuse up to 12 hrs
£6.00 reuse up to 12 hrs
£1.49
Expiry once open
28 days
Carmellose: 1% drops are less expensive
than 0.5%
If patients are able to re-use vials for more than one drop Xailin® Fresh is best option. If not Optive becomes a cost-effective option.
Xailin® Fresh (0.5%)
30 x 0.4ml single dose units
£3.84
Carmize 0.5%
30 x 0.4ml single dose unit
£5.75 reuse up to 12 hrs
90 x 0.4ml single dose unit
£15.53 reuse up to 12 hrs
Optive 0.5% (special container maintains
contents)
10ml
£7.49 up to 6 months
Hypromellose 0.5% eye drops (Pres)
Isopto Plain
10ml
£0.81
28 days
Hypromellose (Pres Free)
Lumecare Hypromellose 0.3% Eye Drops
30 x 0.5ml single dose unit
£5.72
reuse up to 12 hrs
Polyvinyl Alcohol 1.4% (Pres)
Polyvinyl Alcohol 1.4% (Pres-Free)
Sno-Tears
Liquifilm Tears
10ml
30 x 0.4ml
£1.06
£5.35
28 days
single use
Sodium Hyaluronate (Pres)
Blink Intensive Tears
Clinitas (where units are resealed after
use later that day)
10ml
£4.98
45 days
30 x 0.5ml single dose unit
£5.70
reuse up to 12 hrs
Sodium Hyaluronate (Pres-Free)
Cost is least using Clinitas SDU (£5.70) if patients are able to reuse vials for more than one drop. If not VisMed Multi becomes a cost-effective option.
Vismed Multi (special container
maintains contents)
10ml
£6.81
3m
Soft white paraffin 57.3% w/w, White
mineral oil 42.5% w/w, Lanolin
alcohols 0.2% w/w
Xailin Night
5g
£2.49
28 days
White Soft Paraffin with Liquid Paraffin
VitaPos
5g
£2.75
6m
Many of the preparations for dry eyes are classed as medical devices ie approved by private sector organisations called ‘Notified bodies’, rather than medicines
which are directly approved by the MHRA. When prescribing, the variation in cost of these preparations should be considered.
Eyes
Page 187
Therapeutic area
Formulary Choices
Cost
Rationale for decision / comments
(per pack size stated)
BNF Chapter 12: Ear, nose, and oropharynx
12.1
Top
Drugs acting on the ear
Otitis Externa
also see Chapter 5
First line:
Acetic acid
as EarCalm®
2% spray: £4.10 (5ml)
Second line:
Betamethasone
with Neomycin
Drops: £2.39 (10ml)
See Infection management guidance for appropriate clinical indications.
Available OTC
Cure rates similar at 7 days for topical acetic acid or antibiotic +/- steroid.
Otitis media
Topical products not recommended for Otitis media
Removal of wax
For all preparations used in removal of ear wax patients should be advised to lie with affected ear uppermost for 5 minutes after
administration to ensure penetration of the ear canal.
Simple oils such as Olive (or Almond) oil should be used first line.
Available OTC
Olive Oil
Docusate Sodium
See Infection management guidance for appropriate clinical indications.
0.5% drops: £1.81 (10ml)
Available OTC
as Waxsol
Ear, Nose and Throat
Page 188
Therapeutic area
Formulary Choices
Cost
Rationale for decision / comments
(per pack size stated)
12.2
Drugs acting on the nose
Nasal Allergy
Nasal steroids
First-line:
Second-line:
Symptoms of nasal allergy are usually controlled with nasal corticosteroids and / or oral antihistamines.
Beclometasone
as Beconase®
Budesonide
as Rhinacort
Aqua®
50mcg/spray: £2.19
(200 dose unit)
Beclometasone nasal sprays are available OTC, unbranded versions at less
than NHS prescription charge.
Do Not prescribe Beconase Hayfever or Beconase 180 dose preparations
as these are significantly more expensive.
64mcg/spray: £3.49 (120
dose unit)
Fluticasone Furoate
27.5mcg/spray: £6.44
(120 dose unit)
Mometasone
50mcg/spray: £7.68
(140 dose unit)
Triamcinolone
55mcg/spray: £7.39
(120dose unit)
Anticholinergics
Ipratropium
21mcg/spray: £5.45
(180 dose unit)
Use Ipratropium only if rhinorhoea is main problem.
Decolonisation of
nasal MRSA
Mupirocin
Nasal ointment 2%: £3.54
(3g)
For use in decolonisation of nasal MRSA, standard regime is BD nasal
application for 5 days. Where there is clinical infection, nasal decolonisation
treatment should be undertaken in addition to any systemic treatment given
Naseptin
(Neomycin 0.5% /
Chlorhexidine 0.1%)
Nasal cream £1.90 (15g)
Please refer to CCG Management of Infection Guidance and MRSA Policy for
further details (page189).
Ear, Nose and Throat
Note: Fluticasone propionate nasal sprays are non-formulary.
All patients currently prescribed Fluticasone propionate should be switched to
Fluticasone furoate nasal spray Avamys® as significantly more cost-effective.
Page 189
Therapeutic area
Formulary Choices
Cost
Rationale for decision / comments
(per pack size stated)
12.3 Drugs acting on the oro-pharynx
Oral ulceration and
inflammation
Oropharyngeal antiinfectives
Benzydamine
0.15% mouthwash: £6.46
(300ml)
May be diluted with water if stinging occurs.
Available OTC
Hydrocortisone
2.5mg pellets: £4.24 (20)
Available OTC
Preparations for oral candidiasis should be used after food and retained in the mouth for as along as is practical.
Oral candidiasis is often associated with the use of inhaled corticosteroids, use of spacer devices and rinsing the mouth with water after
using such inhalers may be helpful.
Miconazole
0.2% gel: £2.97 (15g),
£4.38 (80g)
Nystatin
as Nystan®
100,000u/ml suspension: £1.80
(30ml)
Mouthwashes
Chlorhexidine
0.2% mouthwash: £3.43
(300ml)
Available OTC.
Dry mouth
BioXtra
Gel Mouthspray: £3.94 (50ml)
Saliva replacement. Neutral pH. Gluten and sugar-free. Contains fluoride
(4.2mg/l). Contains porcine-derived gastric mucin.
Approved for NHS prescribing where they fulfil the borderline substances
criteria, for dry mouth caused by:
Miconazole gel is available OTC.
Use with caution if patient taking warfarin.

radiotherapy
 sicca syndrome
Prescriptions should accordingly be endorsed as ACBS.
Available OTC
Salivix
Toothpastes
Ear, Nose and Throat
Pastilles: £3.50 (50)
Saliva stimulation. Available OTC.
No longer subject to ACBS criteria.
Toothpastes should be considered as self care and are therefore nonformulary
Page 190
Therapeutic area
Formulary Choices
Cost
Rationale for decision / comments
(per pack size stated)
BNF Chapter 13: Dermatological preparations
Related guidance: NICE Clinical Guideline CG57: Atopic eczema in children
SIGN National Clinical Guideline 125: Management of atopic eczema in primary care
13.2
Top
Emollient and barrier preparations

Always ensure that sufficient quantities are prescribed: liberal twice daily application to the whole adult body will use at least 500g per week. Total quantity of
emollient per week (based on “bd” application) for an adult: Face: 15-30g, Trunk: 400g, Both arms / legs: 100-200g, Both hands: 25-50g, Groins and
genitalia: 15-25g, Scalp: 50-100g

The more greasy an emollient the more effective it is but this needs to be balanced against cosmetic acceptability and compliance

Emollient creams and emulsifying ointment can be used as soap substitutes as well as moisturisers

Emollients should be applied by smoothing onto the skin in direction of any hairs (not by rubbing)

Regular re-application, especially after washing, with drying by patting not rubbing, will increase the effectiveness of all emollient therapy
13.2.1 Emollients
Doublebase
Gels
Doublebase
Dayleve
Creams - soap
substitute
Gel:
£2.65 (100g)
£5.83 (500g pump)
£2.65 (100g)
£5.83 (500g pump)
Contains povidone which inhibits water evaporation, so should need to be used
less frequently
Epimax
Cream: £0.75 (100g)
£2.49 (500g tub)
Non-foaming soap substitute. SLS & lanolin free.
Aquamax Wash
Cream wash: £2.99 (250g)
Non-foaming soap substitute. SLS & lanolin free.
Aqueous cream is non-formulary: may cause skin irritation, particularly in
children with eczema, possibly due to sodium lauryl sulfate content. (MHRA
DSU Mar-13)
Creams
First line
Second line
Epimax
Aquamax
Ultrabase
Dermatology
Cream: £0.75 (100g)
£2.49 (500g tub)
Cream: £1.89 (100g)
£3.99 (500g)
Cream: £1.40 (50g)
£4.80 (500g pump)
SLS, Parabens & lanolin free. Most cost-effective preparation currently
available but not available in pump packs.
Page 191
Therapeutic area
Formulary Choices
Cost
Rationale for decision / comments
(per pack size stated)
Cetraben
Cream: £1.40 (50g)
£3.98 (150g)
£5.99 (500g) pump
E45, Oilatum & Cetraben pump-packs are associated with less waste
than other pump-packs presentations and are preferred first choice options on
grounds of cost-effectiveness.
E45
Cream: £1.61 (50g)
£2.91 (125g)
£4.85 (350g)
£5.62 (500g pump)
However patients should be encouraged to find a product they will use
regularly & achieve benefit from.
Oilatum
Cream: £2.46 (150g)
£4.99 (500ml)
Balneum
Cream: £2.85 (50g)
£9.97 (500g pump)
Contains 5% urea
Balneum Plus
Cream: £3.29 (100g), £14.99
(500g pump)
Contains 5% urea, 3% lauromacrogols
Diprobase
Cream: £1.28 (50g),
£6.32 (500g pump)
Hydromol
Cream: £2.04 (50g),
£3.80 (100g), £11.09 (500g)
Emulsifying
ointment
or
Ointment: £2.31 (500g)
White soft paraffin
Ointment: £3.11 (500g)
Liquid paraffin /
White soft paraffin
50/50
or
Ointment: £2.39 (500g)
Diprobase
Ointment: £1.28 (50g)
£5.99 (500g)
Hydromol
Ointment: £4.82 (500g)
Continued on next page
Emollients
(Continued from previous page)
Ointments
First-line:
Second-line:
Dermatology
Hydromol ointment has same ingredients as Epaderm and is cheaper.
Epaderm is non formulary.
Page 192
Therapeutic area
Formulary Choices
Cost
Rationale for decision / comments
(per pack size stated)
Emollients with
antimicrobials
Use preparations with antimicrobials only if infection present or strongly suspected
Eczmol®
Dermol Cream

Dermol 500
13.2.1.1
Cream: £3.70 (250ml)
Eczmol cream contains 1% chlorhexidine gluconate.
Cream £6.63 (500g)
Lotion: £6.04 (500ml)
Dermol contains 0.1% chlorhexidine dihydrochloride and 0.1% benzalkonium
chloride.
Emollient bath additives and shower preparations
Emollient bath
preparations
First-line:
Based on current evidence bath emollients may offer little or no benefit.
People who use them instead of directly applied emollients will unknowingly have substandard emollient therapy.
Dermalo
Bath emollient: £3.44 (500ml)
Dermalo is recommended first line as a cost-effective fragrance-free liquid
paraffin based bath additive.
Dermalo has similar constituents to Oilatum and is less costly,
Second-line:
Dermatology
Doublebase
Bath Emollient: £5.45 (500ml)
Shower Gel: £5.21 (200g)
E45
Emollient bath oil:
£3.19(250ml)
£5.11 (500ml)
Hydromol
Bath & Shower Emollient:
£3.61 (350ml)
£4.11 (500ml)
£8.19 (1 litre)
Oilatum
Bath additive: £2.75 (250ml)
£4.57 (500ml)
Page 193
Therapeutic area
Formulary Choices
Cost
Rationale for decision / comments
(per pack size stated)
Use preparations with antimicrobials only if infection present or strongly suspected
Emollient bath /
shower
preparations with
antimicrobials
Dermol 200
Shower emollient: £3.55
(200ml)
or
Dermol 600
Bath emollient: £7.55 (600ml)
or
Emulsiderm
Liquid emulsion: £3.85 (300ml)
Liquid emulsion: £12.00
(1000ml)
or
Oilatum Plus
Dermatology
Bath additive: £6.98 (500ml)
Page 194
Therapeutic area
Formulary Choices
Cost
Rationale for decision / comments
(per pack size stated)
13.4
Topical corticosteroids
Topical corticosteroids
The Finger Tip Unit (FTU) is useful means of calculating approximate quantities required, as follows (1 FTU = 0.5g)
Face and neck: 2.5 FTU , Trunk: 7 FTU (front) and 7 FTU (back), One arm: 3 FTU, One hand: 1 FTU, One leg: 6 FTU, One foot: 2 FTU
Total quantities of topical steroids required per week based on “bd” application for an adult:
Face and neck: 15-30g, Trunk: 100g, Both arms: 50g, both hands: 15-30g, Both legs: 100g, Groins and genitalia: 15-30g
General note: Avoid prescribing dermatologicals that need to be made extemporaneously owing to the excessive costs of ‘special’ items. This does
not apply to ready made dilutions such as Betnovate RD
Topical
corticosteroids
Mild
Moderate
Most available as creams and ointments.
Patients with atopic eczema should be advised to apply topical corticosteroids once daily (SIGN CG125).
Twice weekly maintenance therapy should be considered in frequently relapsing moderate to severe atopic eczema (SIGN CG125).
NB Potency of a steroid is a product of the formulation as well as the corticosteroid
Hydrocortisone 1%
Cream: £1.12 (15g),
£2.24 (30g)
Ointment: £2.54 (30g)
Caution: Hydrocortisone butyrate is a potent steroid (Locoid)
Clobetasone
butyrate 0.05%
as Eumovate
Cream/ointment: £1.86 (30g),
£5.44 (100g)
Betamethasone
valerate 0.025%
as Betnovate RD
Cream/ointment: £3.15 (100g)
Fludroxycortide
0.0125%
as Haelan
Dermatology
Cream/ointment: £3.26 (60g)
Page 195
Therapeutic area
Formulary Choices
Cost
Rationale for decision / comments
(per pack size stated)
Potent
First-line:
Potent topical steroids should not be prescribed on repeat prescriptions.
Betamethasone
valerate 0.1%
as Betnovate
Second-line:
Cream/ointment: £1.43 (30g),
£4.05 (100g)
Hydrocortisone
butyrate 0.1%
as Locoid
Cream/ointment: £1.60 (30g),
£4.93 (100g)
Mometasone
furoate 0.1%
as Elocon
Cream:
£4.36 (30g),
£12.58 (100g)
Ointment: £4.32 (30g),
£12.44 (100g)
Fluticasone
propionate 0.05%
as Cutivate
Cream 0.05%/ointment
0.005%: £2.27 (15g), £4.24
(30g)
Fluocinolone
acetonide 0.025%
as Synalar
Very potent
Very potent topical steroids should not be prescribed on repeat prescriptions.
Clobetasol
propionate 0.05%
as Dermovate
Dermatology
Cream/ointment: £4.14 (30g),
£11.75 (100g)
Cream/ointment: £2.69 (30g)
£7.90 (100g)
Page 196
Therapeutic area
Formulary Choices
Cost
Rationale for decision / comments
(per pack size stated)
13.5
Preparations for eczema and psoriasis
Vitamin D analogues
Calcipotriol
as Dovonex®
with betamethasone
as Dovobet®
Ointment: £5.78 (30g)
Ointment: £61.55 (120g)
Gel:
£33.08 (60g),
£61.43 (120g)
Dovonex® Cream was discontinued on Oct-11.
For the treatment of stable plaque psoriasis on the body.
For the treatment of mild to moderate scalp and “non-scalp” psoriasis in adults.
The gel is licensed for body and scalp application. UK market research
indicates the majority of patients prefer a gel formulation.
Regular emollient use may be considered to reduce fall of scales and help with
other symptoms, including itch.
Department of Dermatology Musgrove Park Hospital
Guidance for General Practitioners For patients prescribed calcipotriol / betamethasone dipropionate* preparations.
The recommended treatment period for Dovobet® Gel is 4 weeks for use on the scalp and 8 weeks for use on “non-scalp”. The recommended treatment period for
Dovobet® Ointment is 4 weeks. After these periods, treatment can be continued after medical review and under medical supervision.
Dovobet® Gel for body &
scalp psoriasis
Dovobet® Ointment for
body psoriasis
Clearance is defined as no active psoriasis (flat, smooth, non-scaly & non-itchy). Patients should stop treatment at this point. Any residual
redness will improve without further treatment.
Dermatology
Page 197
Therapeutic area
Formulary Choices
Cost
Rationale for decision / comments
(per pack size stated)
13.6
Acne and rosacea
13.6.1 Topical preparations for acne
Initial treatment should be based on whether the acne is predominantly inflammatory or comedonal, and its severity.
Keratolytics
Benzoyl Peroxide
as PanOxyl Aquagel
Topical antibacterials
Retinoids
Clindamycin 1%
with Zinc
as Zindaclin Gel
Tretinoin Gel

2.5% gel: £1.76 (40g)
5% gel: £1.92 (40g)
Gel: £8.66 (30g)
Benzoyl peroxide may be effective for both comedonal and inflammatory acne.
Treatment should start with lower strength preparations, in an aqueous base.
Topical antibiotics are best reserved for patients with inflammatory acne who do
not wish to take systemic antibiotics or who cannot tolerate them.
0.01% gel: £5.28 (60g)
0.025% gel: £5.28 (60g)
Retinoids are useful in treating comedonal acne. Skin irritation often occurs
during the first few weeks of treatment.
Retinoids are contra-indicated in pregnancy and women of child bearing age
should take adequate contraceptive precautions.
100mg capsules: £1.11 (8)
Oral antibiotic treatment should be reviewed after 3 months; however maximum
benefit may only be seen after 4 to 6 months.
Oxytetracycline has been removed from this section: possibility of poor
compliance with dosing requirements in long term use.
Lymecycline
408mg capsules: £6.22 (28),
£11.98 (56)
Minocycline is not recommended owing to safety concerns: requires LFT
monitoring when used >6 months.
Higher cost and lack of evidence of superiority over Lymecycline in acne.
Co-Cyprindiol
2000/35mcg tablets: £5.37
(63)
The risk of VTE with Co-Cyprindiol is higher than with conventional low-dose
COCPs and recommend that:
13.6.2 Oral preparations for acne
Antibacterials
Doxycycline
or
Hormonal
 it should only to be used after systemic antibiotics have failed or are not
tolerated
 it should only be used in licensed indication
 it should not be used solely for contraception
 it should be discontinued 3-4 months after resolution of symptoms
The evidence in favour of co-cyprindiol over other oral contraceptives in
reducing acne lesion counts is limited.
Dermatology
Page 198
Therapeutic area
Formulary Choices
Cost
Rationale for decision / comments
(per pack size stated)
13.8
Photodamage
Actinic keratosis
Ingenol
0.0015% gel £65.00 (3x0.47g) Applied once daily to face or scalp for 3 days only
0.05% gel £65.00 (2x0.47g)
Applied once daily to trunk or extremeties for 2 days only
13.10 Anti-infective skin preparations
Avoid widespread use of topical antibiotics, especially those agents also available as systemic preparations.
Refer to CCG Management of Infection guidelines for indications
Antibacterials
Antifungals
Antivirals
Dermatology
Retapamulin
1% ointment: £7.89 (5g)
Refer to CCG Management of Infection Guidance for indications.
Mupirocin
2% cream: £4.38 (15g)
Ointment £5.09 (15g)
Reserve for MRSA. For nasal use see Chapter 12.
Amorolfine
5% nail paint: £15.55(5ml)
Refer to CCG Management of Infection Guidance for indications.
Available OTC. Systemic treatment is more effective than topical for nail
infections BNF 13.10.2
Clotrimazole
1% cream: £1.34 (20g),
£3.35 (50g)
Refer to CCG Management of Infection Guidance for indications. Available OTC
Miconazole
2% cream: £1.82 (30g)
Refer to CCG Management of Infection Guidance for indications. Available OTC
Terbinafine
1% cream: £1.89 (15g),
£3.78 (30g)
Refer to CCG Management of Infection Guidance for indications. Available OTC
Aciclovir
5% cream: £0.99 (2g), £4.95
(10g)
For treatment of labial herpes simplex (cold sores), most effective if applied at
prodromal phase. Use 5x/day for 5 days Available OTC
Page 199
Therapeutic area
Formulary Choices
Cost
Rationale for decision / comments
(per pack size stated)
BNF Chapter 15: Anaesthesia
Top
15.1.7 Antagonists for central and respiratory depression
Opioid overdose
Naloxone
400mcg/ml ampoule: £4.10
(1ml)
1mg/ml PFS: £16.50 (2ml)
Antagonists for Central and Respiratory Depression
Refer to Emergency treatment of poisoning section of current BNF for
guidance on management of opioid overdose / respiratory depression.
Page 200
Therapeutic area
Formulary Choices
Cost
Rationale for decision / comments
(per pack size stated)
Appendix 1 Borderline substances
Food supplements
Standard ACBS
indications: shortbowel syndrome,
intractable
malabsorption, preoperative preparation
of under-nourished
patients, proven
inflammatory bowel
disease following total
Top
Assess nutritional status before starting use of food supplements and offer advice about enriching nutritional value of normal diet. Aim
of treatment should be recorded and record of weight kept.
Malnutrition Universal Screening Tool (MUST) is available on the Medicines Management section of the CCG intranet together with a
guide to developing a Nutrition Support Care Pathway (p.196) for patients in community & Care Home Settings.
A short leaflet produced by NHS Somerset dieticians is available advising on food fortification.
NAGE (Nutrition Advisory Group for Elderly People) produce a range of advice leaflets & posters – details available at:
www.bda.uk.com/Downloads/nage_updated_form_jan06.pdf or contact: NAGE, The British Dietetic Association, Cambertown House,
Commercial Road, Goldthorpe Industrial, Estate, Goldthorpe, Rotherham, South Yorkshire, S63 9BL. Helpline Number: 01709 889900
Fax Number: 01709 881673
Food supplements and Gluten-free foods
Page 201
Therapeutic area
Formulary Choices
Cost
Rationale for decision / comments
(per pack size stated)
gastrectomy, bowel
fistulas, or diseaserelated malnutrition
and dysphagia
General Practitioners
are reminded that the
ACBS recommends
products on the basis
that they may be
regarded as drugs for
the management of
specified conditions.
Aymes Shake
Available in:
Strawberry
Vanilla,
Chocolate,
Banana
Neutral
Fresubin Powder
Extra®
Available in:
Strawberry
Vanilla
Chocolate
Original
flavour
Ensure Shake®
Available in:
Strawberry
Vanilla,
Chocolate
Banana
Food supplements and Gluten-free foods
£5.46 (7x57g)
Can be made with milk or water
£5.60 (7 x 62g sachets)
(Sachets of powder
requiring preparation
with fresh whole milk.)
For patients who are able to add whole milk to a powder, or have a carer /
home staff.
Not suitable for lactose intolerant patients.
£5.46 (7x57g sachets)
(Sachets of powder
requiring preparation
with fresh whole milk.)
Page 202
Therapeutic area
Formulary Choices
Cost
Rationale for decision / comments
(per pack size stated)
Resource ®Thicken
Up Clear
£8.46 (125g)
Used to thicken food & liquid for patients with swallowing difficulties. Easier to
use & more palatable than starch based thickeners.
Main features are:
Remains fully transparent in clear liquids
No change in odour or taste; helps to maintain appetite
Thickens rapidly and does not continue to thicken over time
Dissolves readily without lumps.
Less powder required than conventional thickeners as has greater water
binding properties.
Gluten-free foods
The Prescribing Guide to Gluten Free foods indicating quantities of products appropriate for a range of people with coeliac disease is
available on the Medicines Management section of the CCG intranet. (The Coeliac Society )
Food supplements and Gluten-free foods
Page 203
Complete MUST Nutritional Screening
Develop a nutritional care plan considering the aims of the patient’s treatment
Must = 1 - Medium Risk
Must = 0 - Low Risk
Continue screening monthly or at
each review if patient is seen less
than monthly.
Continue screening
(as for low risk)
Ensure that patient has a tailored
nutritional care plan in place which
considers the patients preferences
and nutritional needs to provide an
optimal diet .
Follow pathway detailed for MUST
scoreof 1 for two weeks.
 Encourage regular meals and high
energy puddings
 Encourage 2-3 high energy snacks
per day
 Ensure patient receives food
fortification. Fortify foods using
butter, margarine, cream or
grated cheese
 Offer 2-3 glasses of full cream
milk/milky drinks (hot or cold)
Screen more frequently should there
be any clinical concerns, i.e.
unplanned weight loss (loose fitting
rings/clothes) impaired swallow,
altered bowel habit, prolonged
illness, ongoing poor appetite,
apathy or depression.
Improvement in nutritional
status after 1 month
Must = 2 or more - High Risk
If no improvement request a
prescription for Ist line Fresubin
Powder Extra or Aymes Shake twice
a day in between meals for 1
month.
Refer to Dietitian
2nd Line: Fresubin 2KCAL or Fresubin Jucy Drink for
patients who dislike or are intolerant to lactose.
For patients who have end stage kidney disease or
Dysphagia please seek advice from Somerset
Community Dietitians. Tel: 01278 447407.
No improvement in
nutritional status after 1
month
Request a prescription for: 1st Line: Fresubin Extra or Aymes
Shake twice a day between meals
2nd Line: Fresubin 2KCAL or Fresubin Jucy Drink for patients
who dislike or are intolerant to lactose. For patients who have
end stage kidney disease or Dysphagia please seek advice from
Somerset Community Dietitians. Tel: 01278 447407.
Food supplements and Gluten-free foods
Patient is unsafe
and/or unable to
feed orally then
consider
appropriateness of
non-oral feeding
e.g. Naso-gastric
tube
Monitor patient’s
compliance for 6
weeks. Monitor
progress and if no
improvement in
nutritional status
Referral to Somerset
Community Dietiitans
using the referral
form and faxing to
01278 431384 or
send to East Quay
Medical Centre
Bridgwater TA6 4GP
Page 204
Suspected cow’s milk protein allergy (CMPA) – Breast fed infants (January 2015)
Clinical assessment and family history of Cow’s milk allergy (CMPA)
Suspected mild to moderate CMPA
Suspicion of severe CMPA
One or more of the following:
Gastrointestinal: frequent regurgitation, vomiting, diarrhoea, constipation,
anaemia
Dermatological: atopic dermatitis,
General: persistent distress or colic more than 3 hours over more than 3 days
over more than 3 weeks
One or more of the following symptoms:
Gastrointestinal: failure to thrive due to chronic diarrhoea, or vomiting, blood in
stool, anaemia due to occult or macroscopic blood loss, protein losing
enteropathy (hypoalbuminaemia), endoscopic or histologically confirmed
enteropathy, severe ulcerative colitis
Dermatological: exudative or severe atopic dermatitis
Maternal milk free diet whilst breast feeding for 2-4 weeks. Maternal calcium
supplement will be required (1000mg calcium/day). Baby may require Extensively
Hydrolysed Formula (eHF) for use with weaning foods e.g. Similac Alimentum OR
Milupa Aptamil Pepti 1 or 2 OR Nutramigen 1 or 2 OR Althera (see overleaf).
Soya Infant formula not recommended for babies under 6 months of age.
Improvement?
YES
Challenge by reintroducing milk back
into maternal diet (or in weaning foods)
and check symptoms
If no symptoms
develop return to
normal diet
Referral to paediatrician plus maternal milk free diet whilst
breastfeeding continues. Calcium supplement for mother will be
required (1000mg calcium/day). Amino acid formula on
weaning e.g. Neocate LCP or Alfamino or Nutramigen AA.
Refer to paediatric dietitian for
specialist advice.
NO
Check maternal diet for sources of dairy. If
weaning, consider a 2-4 week trial of amino
acid formula (instead of eHF) such as Neocate
LCP or Alfamino or Nutramigen AA for use with
milk free weaning solids.
If symptoms return, restart
maternal milk free diet. Or
Consider eHF* for use with
weaning solids and milk
free weaning diet
Improvement?
YES
NO
Return to normal diet
and consider
paediatrician referral
Specialist individual allergy and
challenge plan to be developed.
After 12 months of age, may
continue to breast feed on a
maternal milk free diet or use
over the counter Alpro soya
Junior 1+ as main ‘milk’ drink if
cow’s milk still not tolerated.
Continue on milk free diet and at 1 year of age or
after 6 months symptom free undertake milk rechallenge at home as per written plan
Food supplements and Gluten-free foods
Page 205
Suspicion of cow’s milk protein allergy (CMPA) – Formula fed infants (January 2015)
Clinical assessment and family history of CMPA
Suspicion of mild to moderate CMPA
Suspicion of severe CMPA
One or more of the following:
One or more of the following symptoms:
Gastrointestinal: frequent regurgitation, vomiting, diarrhoea, constipation, anaemia
Respiratory: runny nose, chronic cough, wheeze (all unrelated to infection)
Gastrointestinal: failure to thrive due to chronic diarrhoea, or vomiting, blood
in stool, anaemia due to occult or macroscopic blood loss, protein losing
enteropathy (hypoalbuminaemia), endoscopic or histologically confirmed
enteropathy, severe ulcerative colitis.
General: persistent distress or colic more than 3 hours over more than 3 days over
more than 3 weeks)
Dermatological: urticaria, swelling (angioedema), exudative or severe atopic
dermatitis
Dermatological: atopic dermatitis, urticarial (unrelated to acute infections or drugs)
Respiratory: acute laryngoedema or bronchial obstruction with difficulty
breathing
Trial of extensively hydrolysed formula (eHF) for 2-4 weeks e.g.
Similac Alimentum or Milupa Aptamil Pepti 1 or 2 or Nutramigen
Lipil 1 or 2 or Althera (See notes overleaf). Soya infant formula is not
recommended as a first line treatment for babies under 6 months of
age.
Improvement?
YES
NO
Open challenge back on
cow’s milk formula
Consider trial of different eHF e.g. Similac Alimentum, Milupa
Aptamil Pepti 1 or 2, Nutramigen Lipil 1 or 2 or Althera
If no improvement on alternative eHF, try 2-4 week trial of
amino acid formula (AAF) such as Neocate LCP or
Nutramigen AA or Alfamino
Improvement?
YES
NO
If no
symptoms
develop,
return to
normal diet.
Systemic reactions: anaphylactic shock needs immediate hospital
management
Continue on eHF and avoid
milk for at least 6 months or
until over 1 year. Give milk
free dietary advice and
consider referral to
community paediatric
dietitian
Improvement?
YES
Re-challenge with
eHF after 2-4
week trial on AAF
Improvement?
YES
At 1 year of age or after 6 months symptom free
undertake milk re-challenge at home as per written plan
Food supplements and Gluten-free foods
NO
NO
Amino acid formula (AAF) e.g. Neocate LCP or
Nutramigen AA or Alfamino (and strict milk free diet if
weaning) for 2-4 weeks
Improvement?
YES
NO
Unlikely to be
CMPA. Return to
normal infant
formula and
consider referral to
paediatrician.
Refer to hospital paediatric
dietitian and hospital
paediatrician for specialist
advice.
Specialist individual allergy
and challenge plan to be
developed by hospital team
Continue on AAF
and avoid milk for
at least 6 months or
until over 1 year.
Give milk free diet
pack
eHF or AAF should be continued until the age of 1
year at which point the child can change onto ready
to drink milk substitutes: Alpro 1+ soya milk.
If concurrent milk and soya allergy, extrensively
hydrolysed formula or amino acid should be
continued until the age of 2 years
Paediatric
specialist
diagnostic
procedures
Page 206
Suggested feeding table. Birth-12 months
PRODUCTS
Amino acid
formula
(AAF)
Preparation for single feeds
Approximate
age of baby
Approx
weight of baby
Level
scoops
Cooled, freshly
boiled water
Feeds in 24
hours
Extensively hydrolysed formula (EHF)
Nutramigen *Nutramigen 1 Nutramigen 2 *Similac
or Puramino
Alimentum
Birth to 6
6 months – 12
months
months
Birth to 6
months
400g tins
400g tins
400g tins
400g tins
Similac Alimentum
6 months – 12 months
ml
fl. oz.
(approx)
3
90
3
6
6
6
Not suitable
6
Not suitable
9 1/4
4
120
4
6
8
8
Not suitable
8
Not suitable
4.7
10 1/4
5
150
5
5
8
8
Not suitable
8
Not suitable
4 months
6.5
14 1/4
7
210
7
5
11
11
Not suitable
11
Not suitable
6 months +
7.5
16 1/2
8
240
8
4
10
10
10
10
5
7 – 1 year
-
-
7
210
7
3
7
7
7
7
3
kg
lb
Birth - 2 wks
3.5
7 3/4
2 - 4 wks
4.2
2 months
SUGGESTED NUMBER OF TINS NEEDED PER MONTH
*Nutramigen 1 may be used from birth – 1 year, although generally, once the child is 6 months old, they are moved to the appropriate
follow-on formula, either Nutramigen 2 or Similac Alimentum
Appendix 2: Out of hours formulary
Page 207
Appendix 2.
OUT OF HOURS
Appendix 2: Out of hours formulary
Page 208
SOMERSET COMMUNITY PHARMACY ENHANCED SERVICE TO PROVIDE PALLIATIVE CARE DRUGS
Bridgwater
ASDA Pharmacy
ASDA Superstore, East Quay, Bridgwater, TA6 5AZ
 01278 720400
Pharmacy open:
8am – 10pm Monday to Friday
8am – 9pm Saturday
10am – 4pm Sunday
Cheddar
Tout’s Pharmacy
Budgens Cheddar, Roynon Way, Cheddar, Somerset, BS27 3RB
 01934 744546
Pharmacy open:
7am to 11pm Monday to Friday
8am to 10pm Saturday
10am to 4pm Sunday
Frome
Sainsbury’s Pharmacy
Wessex Fields, Marston Road, Frome, BA11 4DH
 01373 473284
Pharmacy open:
7am to 11pm Monday to Friday
7am to 10pm Saturday
10am to 4pm Sunday
ASDA Pharmacy
Warminster Road, Frome, BA11 5LA
 01373 475200
Pharmacy open:
8am to 11pm Monday
7am to 11pm Tuesday to Saturday
10am to 4pm Sunday
 01458 834986
Glastonbury
Glastonbury Pharmacy
Feversham Lane, Glastonbury, BA6 9LP
Pharmacy open:
7am to 11pm Monday to Friday
7am to 7pm Saturday
9am to 1pm and 1.30pm to 5.30pm Sunday
Appendix 2: Out of hours formulary
Page 209
Minehead
Boots the Chemist
14-16 The Parade, Minehead, TA24 5UG
 01643 702004
Pharmacy open:
8.30am to 1.30pm and 2.30pm to 5.30pm Monday to Saturday
10am to 4pm Sunday
South Petherton
South Petherton Pharmacy
(John Ware Ltd)
Bernard Way, South Petherton, TA13 5EF
 01469 242269
Pharmacy open:
7pm to 11.59pm Monday and Friday
Midnight to 10pm Tuesday and Saturday
7am to 10pm Wednesday & Thursday
Taunton
ASDA Pharmacy
Creechbarrow Road, Taunton, TA1 2AN
 01823 448010
Pharmacy open:
9.45am to 12.30 and 2.30pm to 5pm Monday to Saturday.
11am to1pm and 2pm to 4pm Sunday
Yeovil
Asda Pharmacy
Preston Road, Yeovil, BA20 2HB
Pharmacy open:
7:30am to 11pm Monday - Friday
7am to 9pm Saturday
10am to 4pm Sunday
Boots the Chemist
37, Middle Street, Yeovil BA20 1LG
Pharmacy open:
8am to 1pm and 2pm to 10pm Monday - Sunday
Appendix 2: Out of hours formulary
 01935 709510
 01935 426673
Page 210
Part 2: Dorset and Somerset Palliative Care Drug Stock List:
Drug
Form
Quantity
Cyclizine 50mg/ml
Injection
10 x 1ml
Dexamethasone 4mg/ml
Injection
10 x 2ml
Dexamethasone 2mg
Tablets
100
Diamorphine 10mg
Injection
5
Diamorphine 100mg
Injection
5
Diazepam 5mg/ml
Injection
10 x 2ml
Diazepam 10mg
Rectal Tubes
5
Diclofenac 100mg
Suppositories
10
Domperidone 30mg
Suppositories
10
Fentanyl 25mcg
Patches
1x5
Fentanyl 50mcg
Patches
1x5
Fentanyl 75mcg
Patches
1x5
Fentanyl 100mcg
Patches
1x5
Glycopyrronium bromide 200mcg/ml
Injection
10 x 1ml
Haloperidol 5mg/ml
Injection
5 x 2ml
Hyoscine butylbromide 20mg/ml
Injection
10 x 1ml
Hyoscine hydrobromide 400mcg/ml
Injection
10 x 1ml
Levomepromazine 25mg
Tablets
84
Levomepromazine 25mg/ml
Injection
10 x 1ml
Metoclopramide 5mg/ml
Injection
10 x 2ml
Midazolam 5mg/ml
Injection
10 x 2ml
Morphine sulphate 10mg/ml
Injection
40 x 1ml
Morphine sulphate 30mg/ml
Injection
40 x 1ml
Morphine sulphate
(Oramorph®)
10mg/5ml
Oral Solution
5 x 100ml
Morphine sulphate
(Oramorph®)
100mg/5ml
Concentrated Oral Solution
1 x 30ml
Oxycodone 10mg/ml
Injection
20 x 1ml
Prochlorperazine 25mg
Suppositories
10
Sodium chloride 0.9%
Injection
10 x 10ml
Water for Injection
Injection
20 x 10ml
Clexane® 2000 units
Pre-Filled Syringes
1 x 10 pfs
Clexane®
Pre-Filled Syringes
1 x 10 pfs
Clexane 6000 units
Pre-Filled Syringes
1 x 10 pfs
Clexane® 8000 units
Pre-Filled Syringes
1 x 10 pfs
Clexane ®10000 units
Pre-Filled Syringes
1 x 10 pfs
Tamiflu® 30mg
Capsules
1 x 10
Tamiflu®
45mg
Capsules
1 x 10
Tamiflu® 75mg
Capsules
1 x 10
Tamiflu® 30mg/5ml
Oral Suspension
1 pack
Relenza®
Dry Powder for inhalation
1 pack
4000 units
5mg
Appendix 2: Out of hours formulary
Page 211
Version 16 (Version date: XX January 2014)