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.
Shared Care Guideline for Risperidone
This guidance has been produced by Sarah Hudson 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 13th February 2013
 The LMC on 12th March 2013
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
Risperidone Shared care Guideline
Date Prepared: 31/1/13
Page 1 of 6
Review Date: January 2015
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.
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.
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
Summary
1. 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. All baseline and
routine test results should be sent to the GP.
2. Discuss the benefits and side effects of treatment with the patient and DOCUMENT it in their
communications
3. 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.
4. 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.
5. Advise the GP on when to adjust the dose, stop treatment, or consult with the specialist
6. Report adverse events to the MHRA and GP
7. Ensure that clear backup arrangements exist for GPs to obtain advice and support
8. 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.
9 . Specialist needs to enclose a completed SC Agreement form with the letter when requesting GP to take
over prescribing.
Risperidone Shared care Guideline
Page 2 of 6
10. Specialist should indicate specific diagnosis clearly in their letter. They should also make sure the
diagnosis
is31/1/13
covered by the SCGReview
beforeDate:
requesting
Date
Prepared:
JanuaryGPs
2015to take over prescribing.
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.
General Practitioner responsibilities
1
2
3
4
Reply to the request for shared care as soon as practicable
Prescribe risperidone at the dose recommended
Adjust the dose as advised by the specialist
To monitor physical parameters such as weight, fasting blood sugar and full lipid screen where
necessary.
5. To request earlier specialist review or seek specialist advice when necessary
6 Report to and seek advice from the specialist on any aspect of patient care that is of concern to the GP
and may affect treatment.
7 Refer back to specialist if the patient’s condition deteriorates, as advised
8 Stop treatment on the advice of the specialist or immediately if an urgent need to stop treatment arises
9. Report adverse events to the specialist and MHRA
10. GPs should NOT routinely put the new medications on patient's record as issued unless specifically
indicated in the letter.
Clinical Particulars
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.
Adverse Drug
Reactions
Cautions

Children and adolescents (10 to 17 years of age). Quetiapine is not recommended
for use in children and adolescents below 18 years of age, due to a lack of data to
support use in this age group. Clinical trials have shown that in addition to the
known safety profile identified in adults, certain adverse events occurred at a
higher frequency in children and adolescents compared to adults (increased
appetite, elevations in serum prolactin, and extrapyramidal symptoms) and one
was identified that has not been previously seen in adult studies (increases in
blood pressure). Changes in thyroid function tests have also been observed in
children and adolescents.

Cardiovascular disease quetiapine should be used with caution in patients with
known cardiovascular disease, cerebrovascular disease, or other conditions
predisposing to hypotension

Hepatic impairment If jaundice develops, quetiapine should be discontinued.
Incidence, identification, importance and management (include details of when to refer
to specialist team).
Prolactin
Urea & Electrolytes (U&Es)
Weight
Fasting Plasma Glucose(FPG) /HbA1c or Oral Glucose Tolerance Test (OGTT)
Risperidone Shared care Guideline
Page 3 of 6
Monitoring
Date Prepared: 31/1/13
Review Date: January 2015
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.
Blood Lipids
Continuation
Prolactin – if symptoms occur
U&Es – 6 monthly
Weight – as needed
Creatine Phosphokinase (CPK) – if NMS suspected
Blood Lipids – after 3 months then yearly
Fasting Plasma Glucose FPG/HbA1c - annually
Interactions
Antifungals,
Imidazole
plasma concentration of quetiapine possibly increased
by imidazoles (reduce dose of quetiapine)
Antifungals,
Triazole
plasma concentration of quetiapine possibly increased
by triazoles (reduce dose of quetiapine)
Carbamazepine
metabolism of quetiapine accelerated by
carbamazepine (reduced plasma concentration)
Macrolides
plasma concentration of quetiapine possibly increased
by macrolides (reduce dose of quetiapine)
Phenytoin
metabolism of quetiapine accelerated by phenytoin
(reduced plasma concentration)
Valproate
plasma concentration of quetiapine possibly increased
by valproate
.
Communication
Specialist to GP
The specialist will inform the GP when they have initiated drug X. 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 X, they will contact the specialist as soon as possible.
Contact names and details
Contact Details
Telephone number
Email
PCT Pharmaceutical
01226 433798
chris.lawson@barsnleytpct.nhs.uk
SWYPFT Lead PHarmacist
01226 434649
sarah.hudson@swyt.nhs.uk
Medicines Information
01226 432857
gilliansmith2@nhs.net
Specialist: CMHT Sector Consultant
Hospital: Oakwell reception
01226 341374
01226 43666
References
SPC for Risperdal
http://www.medicines.org.uk/EMC/medicine/12818/SPC/Risperdal+Tablets%2c+Liquid+%26+Quicklet/
BNF www.bnf.org
Risperidone Shared care Guideline
Date Prepared: 31/1/13
Page 4 of 6
Review Date: January 2015
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)



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: 31/1/13
Frequency
Page 5 of 6
Review Date: January 2015
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: 31/1/13
Page 6 of 6
Review Date: January 2015