Læknablaðið : fylgirit - 01.08.2003, Qupperneq 2

NEW
Risperdal
Consta
The first long-acting
atypical provides
constant coverage for
For patients who need long-term
antipsychotic treatment"3
kNEW
Protects against disruptions in therapy"5
Helps sustain everyday functioning5,6
RispetdalCOA/SM
RISPERIDONE [
At long last
ABBREVIATED PRESCRIBING INFORMATION
Risperdal ConstaTIVI Injection. See SmPC before prescribing.
USES: Schizophrenia and schizoaffective disorder DOSAGE(IM): Adults: 25mg every 2 weeks(alternate buttocks); consider 37-smg if stabilised on more than Zjmg/day oral. Consider i2.smg increase after 4 we^
Maximum; somg every 2 weeks. Ensure prior tolerability with oral risperidone. Supplement with oral risperidone for first 3 weeks as appropriate. Elderly: 25mg every 2 weeks, plus oral cover as above. Renal and hep2
impairment: Caution. 25mg every 2 weeks if minimum 2mg oral tolerated following titration. Children and adolescents under 18 years: Not studied. CONTRA-INDICATIONS: Hypersensitivity. PRECAUTIONS: Orthost*'
hypotension. Cardiovascular disease. Drugs prolonging QT. Reduce dose if hypotension. If tardive dyskinesia consider stopping all antipsychotic drugs. Parkinson’s disease. Epilepsy. If Neuroleptic Malignant Syndrof
stop all antipsychotics. Advise of potential for weight gain. Advise not to drive or operate machinery if alertness affected. Acute withdrawal symptoms, recurrence of psychoses. Recommend gradual withdra"
PREGNANCY: If benefits outweigh risks. LACTATION: Avoid. INTERACTIONS: Centrally acting drugs, dopamine agonists, hepatic enzyme-inducing drugs. SIDE EFFECTS: Generally well tolerated. Insomnia, agitation, anxi'
headache, somnolence, dizziness, impaired concentration, blurred vision, sexual dysfunctions, urinary incontinence, rash, other allergic reactions. Extrapyramidal symptoms, orthostatic dizziness, hypotension, tachyca'-
and hypertension. Increased plasma prolactin, hepatic enzymes, changes in white cell and platelet levels. Oedema, water intoxication with hyponatraemia, tardive dyskinesia, body temperature dysregulation and seizur[
Cerebrovascular accidents. Weight gain or loss, depression, fatigue, nervousness, sleep disorder, apathy, syncope, injection site reaction. LEGAL CATEGORY POM. PRESENTATIONS, PACK SIZES: 25mg prolonged-rele-
injection 1 dose; 37-5mg prolonged-release injection 1 dose; 5omg prolonged-release injection 1 dose. FURTHER INFORMATION AVAILABLE FROM PRODUCT LICENCE HOLDER: Janssen-Cilag Ltd, Saunderton, H'
Wycombe, Buckinghamshire HP14 4HJ UK. (c) 2002 Janssen-Cilag Ltd Date of preparation: August 2003
References: 1. Eérdekens M, Fleischhacker WW, Xie Y, et al. Long-term safety of long-acting risperidone microspheres. Poster presented at: nth Biennial Winter Workshop on Schizophrenia; February 24-March 1, 2^
Davos, Switzerland. 2. Kane J, Eérdekens M, Keith S, et al. Efficacy and safety of a novel long-acting risperidone microspheres formulation. Poster presented at: nth Biennial Winter Workshop on Schizophrenia; Febr^
24-March 1, 2002; Davos, Switzerland. 3. Chue P, Eérdekens M, Augustyns B, et al. Efficacy and safety of long-acting risperidone microspheres and risperidone oral tablets. Poster presented at: nth Biennial V0
Workshop on Schizophrenia; February 24-March 1, 2002; Davos, Switzerland. 4. Data on file, Janssen Pharmaceutica. 5. Data on file, Janssen Pharmaceutica. 6. Data on file, Janssen Pharmaceutica.