Download Risperidone - Barnsley CCG

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.
Risperidone
Introduction
Indication/Licensing information
Risperidone is indicated for the treatment of schizophrenia.
Risperidone is indicated for the treatment of moderate to severe manic episodes associated with bipolar
disorders.
Risperidone is indicated for the short-term treatment (up to 6 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.
Risperidone is indicated for the short-term symptomatic treatment (up to 6 weeks) of persistent aggression in
conduct disorder in children from the age of 5 years and adolescents with subaverage intellectual functioning or
mental retardation diagnosed according to DSM-IV criteria, in whom the severity of aggressive or other
disruptive behaviours require pharmacologic treatment.
Dosage and administration
Adults
Risperidone may be given once daily or twice daily.
Patients should start with 2 mg/day risperidone. The dosage may be increased on the second day to 4 mg.
Subsequently, the dosage can be maintained unchanged, or further individualised, if needed. Most patients will
benefit from daily doses between 4 and 6 mg. In some patients, a slower titration phase and a lower starting
and maintenance dose may be appropriate.
Doses above 10 mg/day have not demonstrated superior efficacy to lower doses and may cause increased
incidence of extrapyramidal symptoms. Safety of doses above 16 mg/day has not been evaluated, and are
therefore not recommended.
Elderly
A starting dose of 0.5 mg twice daily is recommended. This dosage can be individually adjusted with 0.5 mg
twice daily increments to 1 to 2 mg twice daily.
Paediatric population
Risperidone is not recommended for use in children below age 18 with schizophrenia due to a lack of data on
efficacy.
Manic episodes in bipolar disorder
Adults
Risperidone should be administered on a once daily schedule, starting with 2 mg risperidone. Dosage
adjustments, if indicated, should occur at intervals of not less than 24 hours and in dosage increments of 1 mg
per day. Risperidone can be administered in flexible doses over a range of 1 to 6 mg per day to optimize each
patient's level of efficacy and tolerability. Daily doses over 6 mg risperidone have not been investigated in
patients with manic episodes.
As with all symptomatic treatments, the continued use of Risperidone must be evaluated and justified on an
ongoing basis.
Risperidone Shared care Guideline
Date Prepared: November 2015
Page 1 of 7
Review Date: November 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.
Elderly
A starting dose of 0.5 mg twice daily is recommended. This dosage can be individually adjusted with 0.5 mg
twice daily increments to 1 to 2 mg twice daily. Since clinical experience in elderly is limited, caution should be
exercised.
Paediatric population
Risperidone is not recommended for use in children below age 18 with bipolar mania due to a lack of data on
efficacy.
Persistent aggression in patients with moderate to severe Alzheimer's dementia
A starting dose of 0.25 mg twice daily is recommended. This dosage can be individually adjusted by increments
of 0.25 mg twice daily, not more frequently than every other day, if needed. The optimum dose is 0.5 mg twice
daily for most patients. Some patients, however, may benefit from doses up to 1 mg twice daily.
Risperidone should not be used more than 6 weeks in patients with persistent aggression in Alzheimer's
dementia. During treatment, patients must be evaluated frequently and regularly, and the need for continuing
treatment reassessed.
Conduct disorder
Children and adolescents from 5 to 18 years of age
For subjects 50 kg, a starting dose of 0.5 mg once daily is recommended. This dosage can be individually
adjusted by increments of 0.5 mg once daily not more frequently than every other day, if needed. The optimum
dose is 1 mg once daily for most patients. Some patients, however, may benefit from 0.5 mg once daily while
others may require 1.5 mg once daily. For subjects <50 kg, a starting dose of 0.25 mg once daily is
recommended. This dosage can be individually adjusted by increments of 0.25 mg once daily not more
frequently than every other day, if needed. The optimum dose is 0.5 mg once daily for most patients. Some
patients, however, may benefit from 0.25 mg once daily while others may require 0.75 mg once daily.
Responsibilities of the specialist initiating treatment
 Initiate and stabilise treatment with risperidone (this phase is expected to last at least three months). To
initiate therapy, arrange prescription and evaluate over the first 3 months. To establish baseline and
after 3 months of treatment weight, blood pressure, fasting blood glucose or HbA1c and full lipid
screen (where possible). FBC and LFT should be measured where appropriate. Baseline renal function
 Discuss the benefits and side effects of treatment with the patient and DOCUMENT it in their
communications
 Ask the GP whether he or she is willing to participate in shared care and agree with the GP as to who
will discuss the shared care arrangement with the patient.
 Periodically review the patient’s condition and communicate promptly with the GP when treatment is
changed. To review the patient and treatment at least once a year until the patient is discharged
from the mental health service where this is possible.
 Advise the GP on when to adjust the dose, stop treatment, or consult with the specialist
 Report adverse events to the MHRA and GP
 Ensure that clear backup arrangements exist for GPs to obtain advice and support
 Specialists should be clear in their communication (letters) to GPs if they want GP to take over
prescribing or if the letter is just a treatment progress information / feedback to GPs.
 Specialist needs to enclose a completed SC Agreement form with the letter when requesting GP to
take over prescribing.
Responsibilities
of other
 Specialist should
indicateprescribers
specific diagnosis clearly in their letter. They should also make sure the
diagnosis is covered by the SCG before requesting GPs to take over prescribing.
.
Risperidone Shared care Guideline
Date Prepared: November 2015
Page 2 of 7
Review Date: November 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.
Baseline Tests
Prolactin, Urea & electrolytes (U&Es), Weight, blood pressure Fasting Plasma Glucose (FPG)/HbA1c or Oral
Glucose Tolerance Test (OGTT) and Blood Lipids
Routine Tests
Prolactin if symptoms occur, U&Es – 6 monthly, Weight and other tests if required
Disease monitoring
If the service user deteriorates please refer back to secondary care. Intervals of review should be agreed
between primary and secondary care.
General Practitioner Responsibilities
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.
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To reply to the request for shared care as soon as possible.
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 (guideline should include details of monitoring
requirements and what to do when each of the defined parameters alters).
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).
Clinical Particulars
The information given below is not exhaustive and merely is a guide with salient information about
risperidone preparations. When in doubt, please refer to an up to date copy of the Specific Product
Characteristics, the British National Formulary or The Maudsley Prescribing Guidelines.
BNF therapeutic
class
4.2.1 Antipsychotic drugs; Atypical antipsychotic drugs
Cautions and
Contraindications
Hypersensitivity to the active substance or to any of the excipients.
Cautions
dementia with Lewy bodies; prolactin-dependent tumours, dehydration; cataract
surgery (risk of intra-operative floppy iris syndrome); avoid in acute porphyria #
Hepatic impairment
initial and subsequent oral doses should be halved
Renal impairment
initial and subsequent oral doses should be halved
Adverse Drug
Reactions
hypertension, respiratory disorders (including infection), epistaxis, appetite changes,
sleep disorders, anxiety, depression, malaise, urinary disorders, arthralgia, myalgia,
toothache, oedema; less commonly hypoaesthesia, paraesthesia, taste disturbances,
elevated plasma-triglyceride and -cholesterol concentrations, visual disorders, tinnitus,
alopecia; rarely intestinal obstruction, pancreatitis, pulmonary embolism, inappropriate
Risperidone Shared care Guideline
Date Prepared: November 2015
Page 3 of 7
Review Date: November 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.
antidiuretic hormone secretion, rhabdomyolysis, intra-operative floppy iris syndrome
 .
Refer to manufacturer’s SPC and to BNF for a full list of side-effects.
Special precautions:
Monitoring

Neuroleptic malignant syndrome This is a potentially fatal disorder associated
with anti-psychotic use and rare cases have been reported during treatment with
risperidone. The disorder is characterised by hyper-pyrexia, muscle rigidity,
altered mental status and autonomic instability (irregular pulse or blood pressure,
tachycardia, diaphoresis and cardiac dysrhythmia ). Typically, creatinine kinase
levels are elevated and may develop acute renal failure. All anti-psychotic drugs,
including risperidone, should be immediately stopped and urgent medical opinion /
treatment sought.

Tardive Dyskinesia – these have been uncommonly reported with risperidone, in
simple terms this is characterised by abnormal movements, particularly orofacial
movements. Approximately 50% of cases are irreversible once tardive dyskinesia
is established.
Baseline Tests
Prolactin, Urea & electrolytes (U&Es), Weight, blood pressure Fasting Plasma
Glucose (FPG)/HbA1c or Oral Glucose Tolerance Test (OGTT) and Blood Lipids
Routine Tests
Prolactin if symptoms occur, U&Es – 6 monthly, Weight and other tests if required
Interactions
Antidepressants,
Tricyclic
possible increased risk of ventricular arrhythmias when
risperidone given with tricyclics
Antipsychotics
possible increased risk of ventricular arrhythmias when
risperidone given with antipsychotics that prolong the
QT interval
Clozapine
avoid concomitant use of depot formulation of risperidone
with clozapine as cannot be withdrawn quickly if
neutropenia occurs
increased risk of extrapyramidal side-effects and possibly
neurotoxicity when risperidone given with lithium
Lithium
Mefloquine
manufacturer of risperidone advises possible risk of ventricular
arrhythmias when risperidone given with mefloquine
Quinine
possible increased risk of ventricular arrhythmias when risperidone given
with quinine
Sotalol
possible increased risk of ventricular arrhythmias when risperidone given
with sotalol
Risperidone Shared care Guideline
Date Prepared: November 2015
Page 4 of 7
Review Date: November 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.
RISPERIDONE - Communication
Specialist to GP
The specialist will inform the GP when they have initiated drug risperidone. When the patient is near
completing the satisfactory initiation period, the specialist will write to the GP to request they take over
prescribing and where possible give an indication as to the expected length of treatment. The Specialist will
also send a Shared care request form to support the GP in undertaking shared care. (Appendix A)
GP to specialist
If the GP has concerns over the prescribing of drug risperidone, they will contact the specialist as soon as
possible.
Contact names and details
Contact Details
Telephone number
Email
Sarah Hudson Lead Pharmacist
01226 434649
[email protected]
Medicines Information
01924 327619
[email protected]
References
Dr S Chari (North Team)
01226 434171
[email protected]
BNF
61Kirk
http://bnf.org
Dr G
(Central Team)
01226 433523
[email protected]
NICE
www.NICE.org.uk
.
Dr A Guidance
Karan (South
Team)
01226 341374
[email protected]
01226 341374
[email protected]
Dr H Malik (Dearne Team)
References
1. BNF 70 www.medicinescomplete.org
2. SPC risperidone accessed EMC 15/10/15. Available at:
http://www.medicines.org.uk/emc/medicine/30434
Development Process
This guidance has been produced by Sarah Hudson Lead Pharmacist SWYPFT following an AMBER
classification status of Risperidone by the Barnsley Area Prescribing Committee. This guideline has been
subject to consultation and endorsement by the Area Prescribing Committee on 9th December 2015 and the
LMC on 8th March 2016.
Risperidone Shared care Guideline
Date Prepared: November 2015
Page 5 of 7
Review Date: November 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 – Shared Care request form (Amber)
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Specialist to complete when requesting GP to enter a shared care arrangement.
GP to return signed copy of form.
Both parties should retain a signed copy of the form in the patient’s record.
From (Specialist):
To (GP):
Patient details
Name:
ID Number:
Address:
DOB:
Diagnosed condition:
Amber Drug details
Drug name:
Dose:
Date of initiation:
Length of treatment:
The patient will be reviewed by the Consultant on:
Telephone number(s) for contact:
The patient should be reviewed by the GP by:
Consultant:
Date:
Monitoring
The following monitoring should be undertaken by the GP:
Parameter
Date next test due
Risperidone Shared care Guideline
Date Prepared: November 2015
Frequency
Page 6 of 7
Review Date: November 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.
Communication
Consultant
Telephone number:
Fax number:
Email address:
Specialist Nurse
Telephone number:
Fax number:
Email address:
Confirmation of acceptance of shared care
Specialist (Doctor/Nurse) name:
Specialist (Doctor/Nurse) signature:
Date:
I, Dr …………………………….., can confirm I :
□
accept the request to participate in shared care for the patient named above.
□
reject the request to participate in shared care for the patient named above. The reason for
this being ………………………………………………………………………………………..
GP signature:
Date:
Risperidone Shared care Guideline
Date Prepared: November 2015
Page 7 of 7
Review Date: November 2017