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Risperdal advertisement, 1999 This advertisement is intended for health professionals You've been called to see an elderly woman. The man next door says she throws objects out of the window. She lives on the 10th floor. Every night at 11:45 she screams. Until 2:30 AM. She has only one close relative. He lives in Tasmania. Do you knock her out or just hit her symptoms hard? RISPERDAL risperidone From psychotic to cool, calm and collected. RISPERDAL TM UK ABBREVIATED PRESCRIBING INFORMATION Please refer to Summary of Product Characteristics (SmPC) before prescribing Risperdal (risperidone). USES Acute and chronic schizophrenia, and other psychotic conditions, in which positive and/or negative symptoms are prominent. Also alleviates affective symptoms associated with schizophrenia. DOSAGE Where medically appropriate, gradual discontinuation of previous antipsychotic treatment while Risperdal is initiated is recommended and, when switching from depot antipsychotics, consider initiating Risperdal in place of the next scheduled injection. Need for continuing existing antiparkinson medication should be re-evaluated periodically. Elderly: Starting dose: 0.5mg bd. Individually adjust with 0.5mg bd increments to 1 to 2mg bd. Well tolerated by the elderly. Use with caution if renal and liver disease. Adults: Refer to SmPC. Not recommended in children aged less than 15 years. Contra-indications: Known hypersensitivity. Precautions: Orthostatic hypotension. Caution with known cardiovascular disease. Consider dose reduction if hypotension occurs. For further sedation, give additional drug (such as a benzodiazepine) rather than increase dose of Risperdal. Dopamine antagonists have been associated with tardive dyskinesia; if signs and symptoms appear, consider discontinuation of all antipsychotic drugs. Exercise caution with Parkinson's disease or epilepsy. Advise of the potential for weight gain. May interfere with activities requiring mental alertness. Advise patients not to drive or operate machinery until susceptibility known. Pregnancy and lactation: Use in pregnancy only if benefits outweigh risks. Women receiving Risperdal should not breast feed. Interactions: Use with caution in combination with other centrally acting drugs. May antagonise the effect of levodopa and other dopamine agonists. On initiation of carbamazepine or other hepatic enzyme-inducing drugs, re-evaluate the dosage of Risperdal. On discontinuation of such drugs, decrease the dosage of Risperdal if necessary.Side effects: Generally well tolerated and in many instances it has been difficult to differentiate adverse events from symptoms of the underlying disease. Common adverse events include: insomnia, agitation, anxiety, headache. Less common adverse events include: somnolence, fatigue, dizziness, impaired concentration, constipation, dyspepsia, nausea/vomiting, abdominal pain, blurred vision, priapism, erectile dysfunction, ejaculatory dysfunction, orgasmic dysfunction, urinary incontinence, rhinitis, rash and other allergic reactions. The incidence and severity of extrapyramidal symptoms are significantly less than with haloperidol. However, the following may occur: tremor, rigidity, hypersalivation, bradykinesia, akathisia, acute dystonia. If acute, these symptoms are usually mild and reversible upon dose reduction and/or administration of antiparkinson medication. Rare cases of Neuroleptic Malignant Syndrome have been reported. In such an event, all antipsychotic drugs should be discontinued. Occasionally, orthostatic dizziness, hypotension, tachycardia and hypertension have been observed. Plasma prolactin concentration can increase which may be associated with galactorrhoea, gynaecomastia and disturbances of the menstrual cycle. Oedema and increased hepatic enzyme levels have been observed. A mild fall in neutrophil and/or thrombocyte count has been reported. Rarely: water intoxication with hyponatraemia, tardive dyskinesia, body temperature dysregulation and seizures. Overdosage: Reported signs and symptoms include drowsiness and sedation, tachycardia and hypotension, and extrapyramidal symptoms. Prolonged QT interval reported with 360mg. Consider gastric lavage, activated charcoal and a laxative. Cardiovascular monitoring. No specific antidote. Teat hypotension and circulatory collapse with appropriate measures. In case of severe extrapyramidal symptoms, give anticholinergic medication. Continue medical supervisio and monitoring until recovery. PHARMACEUTICAL PRECAUTIONS Tablets and liquid: Store below 30 ° C. Do not refrigerate. LEGAL CATEGORY POM. PRESENTATIONS, PACK SIZES, PRODUCT LICENCE NUMBERS & BASIC NHS COSTS White, oblong tablets containing 1mg risperidone in packs of 20. PL 0242/0186 £13.45. Pale orange, oblong tablets containing 2mg risperidone in packs of 60. PL 0242/0187 £79.56. Clear, colourless solution containing 1mg risperidone per ml in bottles containing 100ml. PL 0242/0199 £65.00. FURTHER INFORMATION IS AVAILABLE FROM THE PRODUCT LICENCE HOLDER: Janssen-Cilag Ltd, Saunderton, High Wycombe, Buckinghamshire HP14 4HJ. APIVERELD111298 © Janssen-Cilag Ltd TM trademark Date of Preparation Jan 1999 |