Download Shared care available

Shared Care Protocol –remains open to review in light of any new evidence
Amber = To be initiated and titrated to a stable dose in secondary care with follow up prescribing and monitoring by primary
care.
Parkinson’s Disease
Shared Care Guideline for the treatment of Parkinson’s Disease
This guideline has been subject to consultation with Consultant Neurologist Dr R Grunewauld and Dr A Khan.
This guideline has been subject to consultation and endorsement by:
 The Area Prescribing Committee on 14th January 2015
 The Local Medical Committee on 10th February 2015
The guidance was initially produced in September 2010 by Doncaster PCT. This has since been updated and
transposed onto the Barnsley template. The Guideline aims to support the consolidation of an effective and
patient-specific shared care agreement between the secondary care specialist and primary care GP.
Introduction
Parkinsonism describes a clinical syndrome that includes slowness of movement, stiffness and tremor,
the commonest cause of which is Idiopathic Parkinson’s Disease (IPD). While this document looks to
medications used in the treatment of Parkinson’s disease, not all drugs will be covered by a shared care
protocol for prescribing.
Traffic light system classification
Drug Class
Levodopa
Green
Red
Co-Beneldopa*
Co-Careldopa*
Dopamine receptor
agonists
MAO-B inhibitors
Amber
Apomorphine
Bromocriptine**
Cabergoline**
Pergolide**
Pramipexole
Ropinirole
Rotigotine
Selegiline*
Rasagiline***
COMT inhibitors
Entacapone
(including
‘Stalevo’ – combination
with Co-Careldopa)
Other
Amantadine
Tolcapone
* - see section 3 for NICE guidance regarding initiation. Initiation should be only after a consultant opinion
** -Bromocriptine, Cabergoline and Pergolide should be considered for second line therapy in patients who are
intolerant to or fail treatment with non-ergot dopamine receptor agonists. In view of the monitoring required with
ergot-derived dopamine agonists, a non-ergot derived agonist should be preferred in most cases.
*** -There is currently no proof that Rasagiline is superior to Selegiline, but there are theoretical reasons to suggest
that Rasagiline may cause less side-effects. Patients should therefore only be started on Rasagiline, if they were
previously unable to tolerate Selegiline
Parkinson’s Disease Shared care Guideline
Date Prepared: January 2015
Page 1 of 21
Review Date:January 2017
Shared Care Protocol –remains open to review in light of any new evidence
Amber = To be initiated and titrated to a stable dose in secondary care with follow up prescribing and monitoring by primary
care.
Procedure for Initiating Shared Care Arrangements
All practices will be asked to sign up to this shared care guideline in advance. Specialist education and
training and on-going advice and support is available from the Specialist Team.
Patients seen in the neurology clinic are provided with a personalised care plan outlined in the letter to
the GP and copied to the nurse specialist. Nurse specialists would normally assist in titration of
medication within limits recommended by the Consultant Neurologist. The Consultant Neurologist will
prescribe the first month’s medication for patients seen in the outpatient clinic. The nurse specialist will
support patients in titrating their doses until they are stable. Usually at three months, GPs will be asked
to continue prescribing. Changes in treatment (i.e.Prescribing of an alternative medication) advised by
the nurse specialists outside the outpatient clinic will be notified in writing to the GP and letters
countersigned by the Consultant Neurologist.
Sharing of care assumes communication between the specialist team, GP and patient and/or patient’s
carers. The shared care arrangements should be explained to the patient/carer and accepted by them.
The doctor who prescribes the medication legally assumes clinical responsibility for the drug and the
consequences of its use.
Responsibilities of the specialist initiating treatment
Summary

Diagnosis and assessment, ensuring there are no interactions with concurrent therapy or disease states.

Undertake baseline monitoring, if applicable, prior to the initiation of medication.

Ensure patient is fully informed of potential benefits and side effects of treatment.

Initiate treatment and provide one month supply of medication

Nurse Specialist will contact the patient by telephone or offer a clinic appointment/home visit for follow up
to assist in dose titration. The nurse specialist will support patients in taking their medication as
prescribed for the first three months. The GP will be notified of the outcome of follow up
discussions/appointments.

All patients are provided with contact details of the Nurse Specialist so they can contact the service if
needed before the nurse contacts them.

Consultant Neurologist writes to GP within 10 days of initiating new medication, detailing individual patient
plan (dose and titration). The GP will be expected to take on prescribing after a minimum of 3 months
treatment.

Any dose changes once the patient is established on treatment will be conveyed in writing to the GP for
the GP to prescribe.

To inform the GP of any monitoring that is required, when to refer back and when and how to stop
treatment.

Monitor side effects of medication via routine out-patient visits

Report adverse events to the CHM/MHRA

Monitor patient’s response to treatment via routine out-patient visits

Initiation or modification of additional support treatment (pharmacological or other) if outside that agreed
with the GP

Management of acute relapses or disease related issues requiring specialist advice and care
Baseline Tests
See individual drugs in Appendix B.
Disease monitoring
The patient will be reviewed by the Specialist Team when necessary. The time interval will differ depending on
the patient.
Parkinson’s Disease Shared care Guideline
Date Prepared: January 2015
Page 2 of 21
Review Date:January 2017
Shared Care Protocol –remains open to review in light of any new evidence
Amber = To be initiated and titrated to a stable dose in secondary care with follow up prescribing and monitoring by primary
care.
Responsibilities of other prescribers
Acceptance of Responsibility by the Primary Care Clinician
It is optional for GPs to participate in taking on responsibility for shared care for the patient. GPs will take on
shared care only if they are willing and able.
Summary
 To prescribe and adjust the dose as recommended by the specialist.
 To ensure there are no interactions with any other medications initiated in primary care.
 To continue monitoring as agreed with secondary care. Opportunistic monitoring of the patient and
collection of relevant information from the patient/carer where appropriate.
 General monitoring of patient’s physical health and treatment of concurrent or on-going physical illness.
 To refer back to the specialist where appropriate. For example:
o
Patient or general practitioner is not comfortable to continue with the existing regime due to either
change in condition or drug side effects.
o
Advice in respect of concordance.
o
Special situations, (e.g. Pregnancy)
 Discontinue the drug as directed by the specialist if required
 To identify adverse events if the patient presents with any signs and liaise with the hospital specialist
where necessary. To report adverse events to the specialist and where appropriate the Commission on
Human Medicines/MHRA (Yellow card scheme).
Monitoring
See individual drugs in Appendix B.
Background information
Differential diagnosis






Symptoms that may be associated with use of certain drugs including anti-psychotic agents, antiemetics and drugs used in the treatment of vertigo.
Essential Tremor that is postural rather being visible at rest and often improved by alcohol, betablockers or primidone.
Multiple system atrophy, which may be indistinguishable from IPD initially, though often associated
with atypical features including autonomic failure and absence of tremor. Characteristically any initial
improvement with L-dopa is rapidly lost.
Progressive supranuclear palsy characterised by Parkinsonism and falls due to postural instability.
Patients have impaired vertical and later horizontal gaze and little responsiveness to L-dopa.
Cerebral ischaemia that may be distinguished from IPD using appropriate imaging and lack of
response to L-dopa.
Normal pressure hydrocephalus characterised by dementia, gait disturbance and urinary
incontinence.
Diagnostic criteria
Idiopathic Parkinson’s Disease is usually asymmetric in onset with impaired movements such as loss of
arm swinging whilst walking. Resting tremor and rigidity are typical features, but tremor is not present in
all patients with PD. Patients not infrequently complain of aching and stiffness leading to orthopaedic or
rheumatological referral. Medication with dopaminergic drugs can result in motor side effects such as
dyskinesias. These can be observed early in the disease course in some patients, but are more typical
to occur after the patient has been on dopaminergic medication for several years.
Parkinson’s Disease Shared care Guideline
Date Prepared: January 2015
Page 3 of 21
Review Date:January 2017
Shared Care Protocol –remains open to review in light of any new evidence
Amber = To be initiated and titrated to a stable dose in secondary care with follow up prescribing and monitoring by primary
care.
Depression and dementia, but also other neuropsychiatric problems such as visual hallucinations with or
without additional features indicating (drug-induced) psychosis can be part of the disorder. Autonomic
problems such as constipation and orthostatic hypotension may accompany the disorder as well.
Investigations
In the majority of cases the diagnosis is clinical. CT imaging should be undertaken to exclude stroke,
tumour and hydrocephalus, the results of which will be communicated to the GP.
Disease progression
Disease progression is unpredictable but as time progresses
 75% patients will experience a shortening of response (wearing off) to medication
 Peak dose dyskinesias may follow with increasingly short periods of useful response to
dopaminergic stimulation. Patients are often better in the morning than later in the day
 Fluctuations in response become increasingly common and severe, causing the on-off phenomenon
 Hypersalivation which may be treated with Botulinum toxin
 Drug induced hallucinations become more common
 Patients can also develop cognitive impairment, drug induced confusion and increasing falls
Mechanisms causing deterioration are unclear but may include nigral cell death, cortical involvement,
changes in dopamine receptor sensitivity and altered dopamine absorption and metabolism.
General Treatment
A multidisciplinary approach including the use of nurse specialists, physiotherapists and speech and
language therapists may help maintain independence.
The decision to start pharmacotherapy depends on the individual patient’s clinical state, circumstances
and wishes. In general early use of an effective dose of a dopaminergic agent does not worsen
prognosis and does improve functional ability.
The following general comments about the use of drugs apply:
 Anticholinergics cause significant side effects and are not now used.
 Beta-blockers are not efficacious in IPD.
 Other Parkinsonian syndromes such as multiple system atrophy (MSA) or progressive supranuclear
palsy (PSP) typically respond badly to dopaminergic drugs, but some patients certainly respond to
high dose L-Dopa medication. These patients also require a multidisciplinary rehabilitation approach.
 Surgery may have a part to play in the management of some patients but its use lies outside the
scope of this protocol.
NICE Guidance
Patients with suspected PD should be referred quickly and untreated to a specialist with expertise in the
differential diagnosis of this condition.
There is no single drug of choice in the initial pharmacotherapy of early PD. First choice options include
L-Dopa, dopamine agonists and MAO-B inhibitors.
Disease Monitoring
Useful aspects of the disease to assess in clinic include:
 General well-being
 Mobility, including fine finger movements and balance/falls (but also problems with mobility at
night)
 Hallucinosis and paranoia
 Pain
Parkinson’s Disease Shared care Guideline
Date Prepared: January 2015
Page 4 of 21
Review Date:January 2017
Shared Care Protocol –remains open to review in light of any new evidence
Amber = To be initiated and titrated to a stable dose in secondary care with follow up prescribing and monitoring by primary
care.





Sleep problems
Sexual dysfunction (including hypersexuality in men on dopaminergic treatment)
Other evidence for dopamine dysregulation syndrome, in particular pathological gambling
Skin lesions. Parkinson's disease, is associated with a higher risk of skin cancer (not exclusively
melanoma). Any suspicious skin lesion should be evaluated by a specialist.
Drug adverse effects (nausea, drowsiness, dizziness)
NB Specific attention should be paid to the CSM advice in relation to fibrotic reactions in patients
receiving treatment with the ergot derived dopamine receptor agonists Bromocriptine, Cabergoline and
Pergolide. Patients should be monitored for dyspnoea, persistent cough, chest pain, cardiac failure and
abdominal pain or tenderness
In addition general practitioners may occasionally need to undertake blood tests, e.g. in patients taking
ergot derivatives, but if so this will be recommended in writing in a letter from the clinic (see above). In all
cases it is the responsibility of the prescriber to ensure that appropriate monitoring is being carried out. If
patients develop new symptoms that require urgent treatment, e.g. hallucinations, the general
practitioner should seek telephone advice.
Dopaminergic medication (regardless whether L-Dopa or dopamine agonist) must not be abruptly
withdrawn since this carries the risk of neuroleptic malignant syndrome.
Communication
Specialist to GP
The specialist will inform the GP when they have initiated relevant medication. When the patient is near
completing the satisfactory initiation period, the specialist will write to the GP to request they take over
prescribing.
GP to specialist
If the GP has concerns over the prescribing of medication specified within this guideline, they will contact the
specialist as soon as possible.
Contact Details
Telephone number
Email
Dr Richard Grunewauld
01226 432046
[email protected]
Dr Aijaz Khan
01226 432386
[email protected]
Sue Slater (Parkinson’s Disease Nurse
Specialist)
01226 209885
[email protected]
Gillian Smith
Medicines Information Pharmacist, BHNFT
01226 432857
[email protected]
01226 433798
[email protected]
01226 434649
[email protected]
Chris Lawson, Head of Medicines Management,
NHS Barnsley CCG
Sarah Hudson, Lead Pharmacist, SWYPFT
Parkinson’s Disease Shared care Guideline
Date Prepared: January 2015
Page 5 of 21
Review Date:January 2017
Shared Care Protocol –remains open to review in light of any new evidence
Amber = To be initiated and titrated to a stable dose in secondary care with follow up prescribing and monitoring by primary
care.
Appendix A – Process for initiating Shared Care
Patient seen in outpatient neurology clinic.
Specialist makes the decision to prescribe.
Amber classification
(See Appendix B)
Patient provided with one month supply of medication.
Consultant writes to GP within 10 days of initiating new
medication, detailing individual patient plan (dose and
titration) and encloses a copy of the relevant drug summary
from the shared care guideline.
Red classification
(See Appendix B)
Patient to remain
under the care of
the Specialist
Team.
Patient followed up by Specialist Team and
dose titrated accordingly. GP notified of the
outcome. GP asked to take over the
prescribing at 3 months.
GP to add medication to the patient record in
preparation for future medication supply.
Patient not tolerating the medication
Specialist nurse will liaise with consultant to
decide on a suitable alternative medication
Is the drug suitable to be initiated by the GP?
Yes
No
Specialist to write to GP
informing them of the
change and providing
guidance on initiating the
new drug
Parkinson’s Disease Shared care Guideline
Date Prepared: January 2015
Page 6 of 21
Review Date:January 2017
Shared Care Protocol –remains open to review in light of any new evidence
Amber = To be initiated and titrated to a stable dose in secondary care with follow up prescribing and monitoring by primary
care.
Appendix B – Drug summaries
Drug class
Drug
Barnsley traffic light status
Levodopa and
associated drugs
Co-beneldopa
Apomorphine
Green – initiate on advice of specialist
only
Green - initiate on advice of specialist
only
Amber
Bromocriptine
Amber (*see note below)
Cabergoline
Amber (*see note below)
Pergolide
Amber (*see note below)
Pramipexole
Amber
Ropinirole
Amber
Rotigotine
Amber
MAO-B inhibitors
Selegiline
COMT inhibitors
Rasagiline – for patients unable to
tolerate selegiline
Entacapone.
Green - initiate on advice of specialist
only
Amber
Co-careldopa
Dopamine
reception
agonists
Other
Amber
Stalevo® (levodopa, carbidopa
and entacapone)
Tolcapone
Amber
Amantadine
Amber
Red
* Bromocriptine, Cabergoline and Pergolide
Parkinson’s Disease Shared care Guideline
Date Prepared: January 2015
Page 7 of 21
Review Date:January 2017
Shared Care Protocol –remains open to review in light of any new evidence
Amber = To be initiated and titrated to a stable dose in secondary care with follow up prescribing and monitoring by primary
care.
Co-beneldopa (benserazide plus levodopa)
SPC available at: http://www.medicines.org.uk/emc/medicine/1708
See BNF at: https://www.medicinescomplete.com/mc/bnf/current/PHP3089-levodopa.htm
Licensed Indications: Parkinson’s Disease
Dose: Initially 100mg of dopa once daily in dopa-naiive patients, increasing at weekly intervals
to 100mg tds. Further increase by 50-100mg daily or on alternate days according to response,
up to 800mg daily in divided doses.
Preparations available:
Capsules - co-beneldopa 12.5/50, co-beneldopa 25/100, co-beneldopa 50/200 (available as
generic or Madopar®)
Dispersible tablets (Madopar®) – co-beneldopa 12.5/50, co-beneldopa 25/100.
Madopar® CR – co-beneldopa m/r 25/100.
Switching from one preparation to another:
Immediate release to m/r – 1 capsule substituted for every 100mg of levodopa and given at
same dosage frequency. Increase every 2-3 days according to response. Average increase of
50% needed over previous levodopa dose and titration may take up to 4 weeks.
m/r to dispersible – Reduce dose by approx. 30%
Side Effects: Nausea and vomiting (rarely dose limiting). Drowsiness (including sudden onset
of sleep) may affect performance of skilled tasks. Patients who are affected should not drive
or undertake potentially dangerous activities
Cautions: Severe pulmonary or cardiovascular disease, psychiatric illness, endocrine
disorders, history of convulsions or peptic ulcer. Angle closure glaucoma, hepatic impairment,
renal impairment. Avoid abrupt withdrawal due to risk of neuroleptic malignant syndrome and
rhabdomyolysis.
Drug Interactions: MAOI antidepressants, Antipsychotics may antagonise the effects of
Levodopa however atypical antipsychotics are used to treat medication induced psychosis
Monitoring: None
Parkinson’s Disease Shared care Guideline
Date Prepared: January 2015
Page 8 of 21
Review Date:January 2017
Shared Care Protocol –remains open to review in light of any new evidence
Amber = To be initiated and titrated to a stable dose in secondary care with follow up prescribing and monitoring by primary
care.
Co-careldopa (carbidopa plus levodopa)
SPC available at: http://www.medicines.org.uk/emc/medicine/9647
See BNF at: https://www.medicinescomplete.com/mc/bnf/current/PHP3089-levodopa.htm
Licensed Indications: Parkinson’s Disease
Dose: Initially 100mg of dopa once daily in dopa-naiive patients, increasing at weekly intervals
to 100mg tds. Further increase by 50-100mg daily or on alternate days according to response,
up to 800mg daily in divided doses.
Preparations available:
Tablets – co-careldopa 10/100, co-careldopa 25/100, co-careldopa 25/250, Sinemet® 12.5/50,
Sinemet® 10/100, Sinemet® Plus 25/100 (provides an adequate dose of carbidopa when low
dose levodopa is required), Sinemet® 25/250
Modified Release – Caramet® CR (co-careldopa 25/100, co-careldopa 50/200), Half Sinemet®
CR (co-careldopa 25/100), Sinemet® CR (co-careldopa 50/200)
Combination with entacapone (see drug monograph for entacapone for specific information) –
Stalevo® (levodopa/carbidopa/entacapone) 50/12.5/200, 75/18.75/200, 100/25/200,
125/31.25/200, 150/37.5/200, 175/43.75/200, 200/50/200
Switching from one preparation to another:
Immediate release to m/r – Differs depending on the m/r preparation. See BNF and SPC for
details.
Side Effects: Nausea and vomiting (rarely dose limiting). Drowsiness (including sudden onset
of sleep) may affect performance of skilled tasks. Patients who are affected should not drive
or undertake potentially dangerous activities
Cautions: Severe pulmonary or cardiovascular disease, psychiatric illness, endocrine
disorders, history of convulsions or peptic ulcer. Angle closure glaucoma, hepatic impairment,
renal impairment. Avoid abrupt withdrawal due to risk of neuroleptic malignant syndrome and
rhabdomyolysis.
Drug Interactions: MAOI antidepressants, Antipsychotics may antagonise the effects of
Levodopa however atypical antipsychotics are used to treat medication induced psychosis
Monitoring: None
Parkinson’s Disease Shared care Guideline
Date Prepared: January 2015
Page 9 of 21
Review Date:January 2017
Shared Care Protocol –remains open to review in light of any new evidence
Amber = To be initiated and titrated to a stable dose in secondary care with follow up prescribing and monitoring by primary
care.
Apomorphine
SPC available at: http://www.medicines.org.uk/emc/medicine/12941
See BNF at: https://www.medicinescomplete.com/mc/bnf/current/PHP3064-apomorphine-nonproprietary.htm?q=apomorphine&t=search&ss=text&p=1#PHP3064-apomorphine-nonproprietary
Licensed Indications: Refractory motor fluctuations in Parkinson’s Disease (‘off’ episodes)
inadequately controlled by co-beneldopa or co-careldopa or other dopaminergics.
Dose: The dose of Apomorphine is carefully titrated on an individual basis. Usual range is 330mg daily by intermittent subcutaneous injection. For those requiring 10 doses or more each
day a subcutaneous infusion may be preferred. Usual maximum daily dose by either route (or
combined routes) is 100mg.
Preparations available:
Injection – 10mg/ml (available in 2ml amp and 5ml amp)
Pen injector – 10mg/ml (3ml pen injector)
Prefilled syringe – 5mg/ml (10ml prefilled syringe)
Side Effects: Apomorphine is a strong emetic. Patients with no contraindications to
domperidone should be started on 20mg TDS three days prior to initiation that can be slowly
withdrawn over several weeks. Drowsiness (including sudden onset of sleep) may affect
performance of skilled tasks. Patients who are affected should not drive or undertake
potentially dangerous activities
Cautions: Pulmonary or cardiovascular disease, history of postural hypotension, susceptibility
to QT interval prolongation, neuropsychiatric conditions. Avoid in hepatic impairment and use
with caution in renal impairment.
Drug Interactions: Antipsychotics may antagonise the effects of Apomorphine, however
atypical antipsychotics are used to treat medication induced psychosis
Monitoring:
GP: Injection site reactions.
Specialist: 6 monthly FBC, LFT, U&Es
Parkinson’s Disease Shared care Guideline
Date Prepared: January 2015
Page 10 of 21
Review Date:January 2017
Shared Care Protocol –remains open to review in light of any new evidence
Amber = To be initiated and titrated to a stable dose in secondary care with follow up prescribing and monitoring by primary
care.
Bromocriptine
SPC available at: http://www.medicines.org.uk/emc/medicine/28129
See BNF at: https://www.medicinescomplete.com/mc/bnf/current/PHP3066bromocriptine.htm?q=bromocriptine&t=search&ss=text&p=1#_hit
Licensed Indications: Parkinson’s Disease
Dose: Initially 1mg to 1.25mg at night for week 1, then 2mg to 2.5mg at night for week 2, then
2.5mg BD for week 3, then 2.5mg TDS for week 4, increasing up to a usual dose range of
10mg to 40mg daily in divided doses, taken with food.
Preparations available:
Tablets – 1mg tablets, 2.5mg tablets
Capsules (Parlodel®) – 5mg capsules, 10mg capsules
Side Effects: Hypotensive reactions in some patients may be disturbing in the first few days of
treatment. Particular care should be exercised when driving or operating machinery. Tolerance
may be reduced by alcohol. Drowsiness (including sudden onset of sleep) may affect
performance of skilled tasks. Patients who are affected should not drive or undertake
potentially dangerous activities. May cause retroperitoneal and pleural fibrosis. See Drug
Safety Update July 2008. Available at: http://www.mhra.gov.uk/home/groups/plp/documents/publication/con020567.pdf
Cautions: History of peptic ulcer, Raynaud’s syndrome, cardiovascular disease, history of
serious mental health disease, acute porphyria.
Drug Interactions: Antipsychotics may antagonise the effects of dopamine agonists however
atypical antipsychotics are used to treat medication induced psychosis.
Monitoring:
GP: Unexplained malaise, breathlessness
Specialist:
•
May cause retro peritoneal and pleural fibrosis
•
Baseline chest x-ray, ECG, ESR & U&E
•
Echo within 3-6 months of starting treatment, then every 6-12 months
•
Future monitoring guided by symptomatology
Parkinson’s Disease Shared care Guideline
Date Prepared: January 2015
Page 11 of 21
Review Date:January 2017
Shared Care Protocol –remains open to review in light of any new evidence
Amber = To be initiated and titrated to a stable dose in secondary care with follow up prescribing and monitoring by primary
care.
Cabergoline
SPC available at: http://www.medicines.org.uk/emc/medicine/27147
See BNF at: https://www.medicinescomplete.com/mc/bnf/current/PHP3068cabergoline.htm?q=cabergoline&t=search&ss=text&p=1#_hit
Licensed Indications: Parkinson’s Disease
Dose: Initially 1mg daily, increased by increments of 0.5-1mg at 7 or 14 day intervals.
Maximum dose 3mg daily.
Preparations available:
Tablets – 1mg tablets, 2mg tablets
Capsules (Cabaser®) – 1mg tablets, 2mg tablets
Side Effects: Hypotensive reactions in some patients may be disturbing in the first few days of
treatment. Particular care should be exercised when driving or operating machinery. Tolerance
may be reduced by alcohol. Drowsiness (including sudden onset of sleep) may affect
performance of skilled tasks. Patients who are affected should not drive or undertake
potentially dangerous activities. May cause retroperitoneal and pleural fibrosis. See Drug
Safety Update July 2008. Available at: http://www.mhra.gov.uk/home/groups/plp/documents/publication/con020567.pdf
Cautions and contraindications: History of peptic ulcer, Raynaud’s syndrome, cardiovascular
disease, history of serious mental health disease, acute porphyria. Exclude pregnancy before
starting and discontinue one month before intended conception.
Drug Interactions: Antipsychotics may antagonise the effects of dopamine agonists however
atypical antipsychotics are used to treat medication induced psychosis.
Monitoring:
GP: Unexplained malaise, breathlessness
Specialist:
•
May cause retro peritoneal and pleural fibrosis
•
Baseline chest x-ray, ECG, ESR & U&E
•
Echo within 3-6 months of starting treatment, then every 6-12 months
•
Future monitoring guided by symptomatology
Parkinson’s Disease Shared care Guideline
Date Prepared: January 2015
Page 12 of 21
Review Date:January 2017
Shared Care Protocol –remains open to review in light of any new evidence
Amber = To be initiated and titrated to a stable dose in secondary care with follow up prescribing and monitoring by primary
care.
Pergolide
See BNF at: https://www.medicinescomplete.com/mc/bnf/current/PHP3073-pergolide-nonproprietary.htm?q=pergolide&t=search&ss=text&p=1#PHP3073-pergolide-non-proprietary
Licensed Indications: Alone or as adjunct to co-beneldopa or co-careldopa in Parkinson’s
disease where dopamine receptor agonists, other than ergot derivative, not appropriate
Dose: 50micrograms at night on day 1, then 50micrograms twice daily on days 2 to 4, then
increased by 100 to 250microgram daily every three to four days up to 1.5mg daily in 3 divided
doses at day 28. After day 30 further increases every 3-4 days of up to 250micrograms daily.
Usual maintenance dose is 2.1-2.5mg daily. Maximum dose is 3mg daily.
Preparations available:
Tablets – 50microgram tablets, 250microgram tablets, 1mg tablets
Capsules (Parlodel®) – 5mg capsules, 10mg capsules
Side Effects: Hypotensive reactions in some patients may be disturbing in the first few days of
treatment. Particular care should be exercised when driving or operating machinery. Tolerance
may be reduced by alcohol. Drowsiness (including sudden onset of sleep) may affect
performance of skilled tasks. Patients who are affected should not drive or undertake
potentially dangerous activities. May cause retroperitoneal and pleural fibrosis. See Drug
Safety Update July 2008. Available at: http://www.mhra.gov.uk/home/groups/plp/documents/publication/con020567.pdf
Cautions: History of peptic ulcer, Raynaud’s syndrome, arrhythmias, cardiovascular disease,
history of serious mental health disease, acute porphyria. History of confusion, psychosis or
hallucinations.
Drug Interactions: Antipsychotics may antagonise the effects of dopamine agonists however
atypical antipsychotics are used to treat medication induced psychosis.
Monitoring:
GP: Unexplained malaise, breathlessness
Specialist:
•
May cause retro peritoneal and pleural fibrosis
•
Baseline chest x-ray, ECG, ESR & U&E
•
Echo within 3-6 months of starting treatment, then every 6-12 months
•
Future monitoring guided by symptomatology
Parkinson’s Disease Shared care Guideline
Date Prepared: January 2015
Page 13 of 21
Review Date:January 2017
Shared Care Protocol –remains open to review in light of any new evidence
Amber = To be initiated and titrated to a stable dose in secondary care with follow up prescribing and monitoring by primary
care.
Pramipexole
SPC available at: http://www.medicines.org.uk/emc/medicine/27673
See BNF at: https://www.medicinescomplete.com/mc/bnf/current/PHP3075pramipexole.htm?q=pramipexole&t=search&ss=text&p=1#_hit
Licensed Indications: Parkinson’s Disease, used alone or as an adjunct to co-beneldopa or co-careldopa
Preparations available:
Tablets – 88 microgram, 180 microgram, 350 microgram, 700 microgram
Dose (normal release tablets): Initially 88micrograms 3 times daily, dose doubled every 5-7 days if
tolerated to 350micrograms 3 times daily, further increased if necessary by 180micrograms 3 times daily at
weekly intervals. Maximum dose is 3.3mg daily in 3 divided doses. (During dose titration and maintenance,
levodopa dose may be reduced)
Doses and strengths are stated in terms of pramipexole (base); equivalent strengths in terms of pramipexole
dihydrochloride monohydrate (salt) are as follows:
Base
Salt
88micrograms
125micrograms
180micrograms
250micrograms
350micrograms
500micrograms
700micrograms
1mg
Modified release tablets – Mirapexin® prolonged release tablets 260 micrograms, 520 micrograms,
1.05mg, 1.57mg, 2.1mg, 2.62mg, 3.15mg
Dose (prolonged release tablets): Initially 260 micrograms once daily, dose doubled every 5-7 days to
1.05mg once daily, further increased if necessary by 520micrograms daily at weekly intervals. Maximum
dose is 3.15mg once daily. (During dose titration and maintenance, levodopa dose may be reduced)
Doses and strengths are stated in terms of pramipexole (base); equivalent strengths in terms of pramipexole
dihydrochloride monohydrate (salt) are as follows:
Base
Salt
260micrograms
375micrograms
520micrograms
750micrograms
1.05mg
1.5mg
1.57mg
2.25mg
2.1mg
3mg
2.62mg
3.75mg
3.15mg
4.5mg
Patients already taking standard release tablets may be switched to prolonged release tablets overnight, at
the same daily dose. After switching, the dose may be adjusted depending on patients therapeutic response
Side Effects: Nausea, constipation, somnolence, dyskinesias, hallucinations and insomnia can occur.
Drowsiness (including sudden onset of sleep) may affect performance of skilled tasks. Patients who are
affected should not drive or undertake potentially dangerous activities. Hypotensive reactions may be
disturbing in some patients during the first few days of treatment. Domperidone may be offered to prevent
nausea & postural hypotension. Hallucinations (mostly visual). Impulsive control disorders and compulsive
behaviours
Cautions: Psychotic disorders, severe cardiovascular disease, risk of postural hypotension, monitor blood
pressure. Renal impairment (prolonged release preparation not suitable for patients with CrCl below
30ml/min – consider standard release tablets instead)
Drug Interactions: Reduction of pramipexole dose should be considered when the following are
administered concomitantly: Cimetidine, Diltiazem, Quinidine, Quinine, Ranitidine, Triamterene, Verapamil,
Digoxin, Procainamide, Trimethoprim, and Amantadine. Refer to PD specialist nurse or Consultant. Caution
should be advised if taking other sedating medication or alcohol. Should not be concurrently administered
with drugs which have central dopamine antagonist activity (such chlorpromazine, haloperidol, flupenthixol,
metoclopramide etc) however atypical antipsychotics are used to treat medication induced psychosis
Monitoring:
GP and Specialist: Refer for ophthalmologic examination if vision abnormalities occur
Parkinson’s Disease Shared care Guideline
Date Prepared: January 2015
Page 14 of 21
Review Date:January 2017
Shared Care Protocol –remains open to review in light of any new evidence
Amber = To be initiated and titrated to a stable dose in secondary care with follow up prescribing and monitoring by primary
care.
Ropinirole
SPC available at: http://www.medicines.org.uk/emc/medicine/27103
See BNF at: https://www.medicinescomplete.com/mc/bnf/current/PHP3085-ropinirole-mrpreparations-non-proprietary.htm?q=ropinirole&t=search&ss=text&p=1#PHP3085-ropinirole-mrpreparations-non-proprietary
Licensed Indications: Parkinson’s Disease, used alone or as an adjunct to co-beneldopa or cocareldopa
Preparations available:
Tablets – 250 microgram, 500 microgram, 1mg, 2mg, 5mg
Modified release tablets – 2mg m/r, 4mg m/r, 8mg m/r
Dose:
Standard release tablets: Initially 750 micrograms daily in 3 divided doses, increased by
increments of 750 micrograms daily at weekly intervals to 3mg daily in 3 divided doses. Further
increase by increments of 1.5-3mg daily at weekly intervals according to response. Usual range 916mg daily in 3 divided doses (but higher doses may be required if used with levodopa. Maximum
24mg daily in 3 divided doses.
Modified release tablets: Initially 2mg once daily for one week, then 4mg once daily. Increase
according to response by 2mg at intervals of at least 1 week up to 8mg once daily. If still no
response increase by 2-4mg at intervals of at least 2 weeks as necessary. Maximum 24mg once
daily.
Side Effects: Early therapy patients experienced nausea, somnolence, leg oedema, abdominal
pain, vomiting and syncope. Drowsiness (including sudden onset of sleep) may affect
performance of skilled tasks. Patients who are affected should not drive or undertake potentially
dangerous activities. Patients receiving adjunct therapy experienced dyskinesia, nausea,
hallucinations and confusion.
Decreases in blood pressure have been noted; symptomatic
hypotension and bradycardia, occasionally severe, may occur. Domperidone may be offered to
prevent nausea and postural hypotension
Cautions: Severe cardiovascular disease, major psychotic disorders, elderly, avoid abrupt
withdrawal, dose adjustment may be necessary if smoking started or stopped during treatment.
Drug Interactions: Ropinirole should not be administered with drugs that have dopamine agonist
properties, such as phenothiazides, butyrophenones, thioxanthenes or metoclopramide since
these may reduce the efficacy of ropinirole, however atypical antipsychotics are used to treat
medication induced psychosis. The dose of ropinirole may need to be adjusted when coprescribed with drugs that affect the cytochrome P450enzyme eg. Ciprofloxacin, theophylline,
cimetidine. If HRT is stopped or introduced during treatment with ropinirole, dosage adjustment
may be required.
Monitoring:
GP and Specialist: None
Parkinson’s Disease Shared care Guideline
Date Prepared: January 2015
Page 15 of 21
Review Date:January 2017
Shared Care Protocol –remains open to review in light of any new evidence
Amber = To be initiated and titrated to a stable dose in secondary care with follow up prescribing and monitoring by primary
care.
Rotigotine
SPC available at: http://www.medicines.org.uk/emc/medicine/27412
See BNF at: https://www.medicinescomplete.com/mc/bnf/current/PHP3087rotigotine.htm?q=rotigotine&t=search&ss=text&p=1#_hit
Licensed Indications: Parkinson’s Disease, used alone or as an adjunct to co-beneldopa or cocareldopa
Preparations available:
Patches – 1mg/24hr, 2mg/24hr, 3mg/24hr, 4mg/24hr, 6mg/24hr, 8mg/24hr
Dose:
Early Stage
A single daily dose should be initiated at 2mg/24hr and then increased in weekly increments of
2mg/24hr to an effective dose. 4mg/24hr may be an effective dose in some patients. For most
patients an effective dose is reached within 3 or 4 weeks, at doses of 6 mg/24hr or 8mg/24 hr
respectively. The maximal dose in early stage is 8mg/24hr
Advanced Stage with fluctuations
A single dose should be initiated at 4mg/24hr and then increased in weekly increments of
2mg/24hr if required. The maximal dose in advanced stage with fluctuations is 16 mg/24 hr
Side Effects: Nausea, constipation, dry mouth, diarrhoea, anorexia, dyspepsia, dyskinesias,
hallucinations and insomnia can occur. Postural hypotension, peripheral oedema, palpitation,
tachycardia, hypotension, hypertension, atrial fibrillation. Drowsiness (including sudden onset of
sleep) may affect performance of skilled tasks. Patients who are affected should not drive or
undertake potentially dangerous activities. Hyperhidrosis, rash (including local reactions to patch),
and pruritus.
Cautions: Ophthalmic testing recommended, avoid exposing patch to heat, withdraw gradually,
Drug Interactions: Dopamine antagonists, such as neuroleptics (e.g. phenothiazines,
butyrophenones, thioxanthenes) or metoclopramide, may diminish the effectiveness of rotigotine,
and co-administration should be avoided. Caution should be advised when patients are taking
sedating medicinal products or other CNS (central nervous system) depressants (e.g.
benzodiazepines, antipsychotics, antidepressants) or alcohol in combination with rotigotine, due to
the possible additive effects.
Monitoring:
GP: Unexplained malaise, breathlessness
Specialist: 6 monthly LFT, U&E. Patients will be asked about vision abnormalities
Parkinson’s Disease Shared care Guideline
Date Prepared: January 2015
Page 16 of 21
Review Date:January 2017
Shared Care Protocol –remains open to review in light of any new evidence
Amber = To be initiated and titrated to a stable dose in secondary care with follow up prescribing and monitoring by primary
care.
Selegiline
SPC available at: http://www.medicines.org.uk/emc/medicine/22193
See BNF at: https://www.medicinescomplete.com/mc/bnf/current/PHP3117-selegilinehydrochloride-non-proprietary.htm
Licensed Indications: Parkinson’s Disease, used alone or as an adjunct to co-beneldopa or cocareldopa
Preparations available:
Tablets – 5mg, 10mg
Orodispersible tablets – Zelapar® orodispersible tablets are available for which the 1.25mg tablet
can be considered equivalent to 10mg of the conventional oral tablets.
Dose:
Initially 5mg in the morning, increasing after 2-4 weeks if tolerated to 10mg in the morning. To
avoid confusion in elderly patients, it may be appropriate to start treatment with a dose of 2.5mg
daily.
Side Effects: Most common side effects reported are nausea, constipation, diarrhoea, dry mouth.
Less commonly: postural hypotension, dyskinesia, vertigo, sleeping disorders, confusion,
hallucinations, arthralgia, myalgia. Rarely: arrhythmias, agitation, headache, micturition difficulties,
skin reactions. Chest pain also reported. Side effects of levodopa may be increased. Mouth ulcers
with orodispersible tablets.
Cautions: Avoid abrupt withdrawal, gastric and duodenal ulceration, uncontrolled hypertension,
arrhythmias, angina, psychosis, hepatic impairment, acute porphyria, renal impairment.
Drug Interactions: Hyperpyrexia and CNS toxicity reported when selegiline given with pethidine.
Increased risk of hypertension and CNS excitation when selegiline given with SSRI
antidepressants and venlafaxine (e.g. selegiline should not be started until 5 weeks after stopping
fluoxetine, avoid fluoxetine for 2 weeks after stopping selegiline – see BNF appendix 1:
interactions, for other SSRIs and venlafaxine). CNS toxicity reported when selegiline given with
tricyclic antidepressants. Avoid concomitant use of selegiline with moclobemide.
Monitoring:
GP and Specialist: None
Parkinson’s Disease Shared care Guideline
Date Prepared: January 2015
Page 17 of 21
Review Date:January 2017
Shared Care Protocol –remains open to review in light of any new evidence
Amber = To be initiated and titrated to a stable dose in secondary care with follow up prescribing and monitoring by primary
care.
Rasagiline
SPC available at: http://www.medicines.org.uk/emc/medicine/16273
See BNF at: https://www.medicinescomplete.com/mc/bnf/current/PHP3114-rasagiline.htm
Licensed Indications: Parkinson’s Disease, used alone or as an adjunct to co-beneldopa or cocareldopa
Preparations available:
Tablets – 1mg
Dose:
1mg daily.
Side Effects: Most common side effects reported are; headache, dry mouth, dyspepsia,
constipation,angina, postural hypotension, depression, anorexia, abnormal dreams, hallucinations,
vertigo, influenza-like symptoms, urinary urgency, leucopenia, arthralgia, conjunctivitis, rash.
Rarely; myocardial infarction, and cerebrovascular accident.
Cautions: Avoid abrupt withdrawal, hepatic impairment.
Drug Interactions: Serious adverse reactions have been reported with the concomitant use of
selective SSRI’s, but also with tricyclic, tetracylic antidepressants and MAO inhibitors as well as
with another selective MAO-B inhibitors. Therefore, in view of the MAO inhibitory activity of
rasagiline, antidepressants should be administered with caution. Fluoxetine and fluvoxamine
should be avoided. At least five weeks should elapse between discontinuation of fluoxetine and
initiation of treatment with rasagiline. At least 14 days should elapse between discontinuation of
rasagiline and initiation of treatment with fluoxetine or fluvoxamine. Concomitant use with
dextromethorphan or sympathomimetics such as those present in nasal and oral decongestants or
cold medications containing ephedrine or pseudoephedrine is not recommended
Monitoring:
GP: None
Specialist: LFT and FBC 6 monthly
Parkinson’s Disease Shared care Guideline
Date Prepared: January 2015
Page 18 of 21
Review Date:January 2017
Shared Care Protocol –remains open to review in light of any new evidence
Amber = To be initiated and titrated to a stable dose in secondary care with follow up prescribing and monitoring by primary
care.
Entacapone
SPC available at: http://www.medicines.org.uk/emc/medicine/27766
See BNF at: https://www.medicinescomplete.com/mc/bnf/current/PHP3122entacapone.htm?q=entacapone&t=search&ss=text&p=1#_hit
Licensed Indications: Adjunct to co-beneldopa or co-careldopa in Parkinson’s Disease with ‘endof-dose’ motor fluctuations.
Preparations available:
Tablets – 200mg tablets
Stalevo® - Containing levodopa/carbidopa/entacapone in the following strengths:
Levodopa
50mg
75mg
100mg 125mg
150mg 175mg
200mg
Carbidopa
12.5mg 18.75mg 25mg
31.25mg 37.5mg 43.75mg 50mg
Entacapone 200mg 200mg
200mg 200mg
200mg 200mg
200mg
Dose: 200mg with each dose of levodopa/dopa-decarboxylase inhibitor to maximum dose of 2g
daily. Concurrent levodopa dose may need to be reduced by about 10-30%.
Side Effects: Nausea, vomiting, abdominal pain, constipation, diarrhoea, urine may be coloured
reddish-brown, dry mouth, dyskinesias; dizziness; rarely hepatitis.
Cautions: Ischaemic heart disease; avoid abrupt withdrawal, hepatic impairment,
Drug Interactions: Entacapone enhances the effect of warfarin. Caution advised by the
manufacturer with maprotiline, moclobemide, paroxetine, tricyclic antidepressants and
venlafaxine. Avoid concomitant use of Entacapone with non-selective MAOIs.
Monitoring:
GP: None
Specialist: None
Parkinson’s Disease Shared care Guideline
Date Prepared: January 2015
Page 19 of 21
Review Date:January 2017
Shared Care Protocol –remains open to review in light of any new evidence
Amber = To be initiated and titrated to a stable dose in secondary care with follow up prescribing and monitoring by primary
care.
Tolcapone (Red drug)
SPC available at: http://www.medicines.org.uk/emc/medicine/15900
See BNF at: https://www.medicinescomplete.com/mc/bnf/current/PHP3124tolcapone.htm?q=tolcapone&t=search&ss=text&p=1#_hit
Licensed Indications: Adjunct to co-beneldopa or co-careldopa in Parkinson's disease with ‘endof-dose’ motor fluctuations if another inhibitor of peripheral catechol-O-methyltransferase
inappropriate (under specialist supervision).
Preparations available:
Tablets – 100mg tablets
Dose: 100mg three times daily, leaving six hours between each dose, increased in exceptional
circumstances to 200mg three times daily
Side Effects: Diarrhoea, constipation, dyspepsia, abdominal pain, nausea, vomiting, anorexia,
xerostomia, hepatotoxicity (see above); chest pain; confusion, dystonia, dyskinesia, drowsiness,
headache, dizziness, sleep disturbances, excessive dreaming, hallucinations; syncope; urine
discoloration; sweating; neuroleptic malignant syndrome and rhabdomyolysis reported on dose
reduction or withdrawal
Hepatotoxicity: Potentially life-threatening hepatotoxicity including fulminant hepatitis reported
rarely, usually in women and during the first 6 months, but late-onset liver injury also reported; test
liver function before treatment, and monitor every 2 weeks for first year, every 4 weeks for next 6
months and then every 8 weeks thereafter (restart monitoring schedule if dose increased);
discontinue if abnormal liver function tests or symptoms of liver disorder (counselling, see below);
do not re-introduce tolcapone once discontinued.
Counselling: Patients should be told how to recognise signs of liver disorder and advised to seek
immediate medical attention if symptoms such as anorexia, nausea, vomiting, fatigue, abdominal
pain, dark urine, or pruritus develop.
Cautions: avoid abrupt withdrawal; most patients receiving more than 600 mg levodopa daily
require reduction of levodopa dose by about 30%, hepatic impairment
Drug Interactions: Avoid concomitant use of Tolcapone with MAOIs.
Monitoring:
GP: Fortnightly LFT monitoring for first year of treatment
Specialist: None
Parkinson’s Disease Shared care Guideline
Date Prepared: January 2015
Page 20 of 21
Review Date:January 2017
Shared Care Protocol –remains open to review in light of any new evidence
Amber = To be initiated and titrated to a stable dose in secondary care with follow up prescribing and monitoring by primary
care.
Amantadine
SPC available at: http://www.medicines.org.uk/emc/medicine/4358
See BNF at: https://www.medicinescomplete.com/mc/bnf/current/PHP3893-amantadinehydrochloride.htm?q=amantadine&t=search&ss=text&p=1#_hit
Licensed Indications: Parkinson’s Disease.
Preparations available:
Capsules – 100mg capsules.
Dose: 100mg daily, increasing to a maximum of 400mg daily in divided doses. Usually used as
adjunct therapy
Side Effects: GI disturbance, anorexia, nausea, nervousness, inability to concentrate, insomnia,
dizziness, convulsions, hallucinations, feelings of detachment, blurred vision, livedo reticularis,
peripheral oedema. Rarely leucopenia and rashes. Hepatic impairment.
Cautions: Congestive heart disease (may exacerbate oedema), confused or hallucinatory states,
elderly; avoid abrupt withdrawal in Parkinson's disease;
Drug Interactions: Memantine – increased risk of CNS toxicity.
Monitoring:
GP: Fortnightly LFT monitoring for first year of treatment
Specialist: None
Parkinson’s Disease Shared care Guideline
Date Prepared: January 2015
Page 21 of 21
Review Date:January 2017