Resdal

Company: Niche Generics Ltd.
Legal category: Prescription. GMS. Sport permitted.
Active ingredient: Risperidone 0.5mg, 1mg, 2mg.
Description: Round, slightly convex, pink marbled orodispersible tablets.
Presentation: 0.5mg-28, €8.80; 1mg-28, €18.93; 2mg-28, €37.92.
Indications: Treatment of schizophrenia. Maintenance treatment in order to prevent relapse in chronic schizophrenia in patients having shown a response to initial treatment.

Pharmacology: Risperidone is a mono-aminergic antagonist. It shows a high affinity for the serotnine 5-HT2 and dopamine-D2 receptors. Risperdone binds to the α1-adrenergic receptor and, with a lower affinity to the histamine-H1 and α2-adrenergic receptor. Risperidone does not have any affinity for the cholinergic receptors. Risperidone is effective on positive symptoms of schizophrenia. Its therapeutic activity may also be extended to the negative and affective symptoms of schizophrenia.
Dosage: Adult: Do not divide the tablets. Tablets disintegrate within a few seconds when placed on the tongue. Initially 2mg daily; may increase dose to 4mg on day 2. Usual optimal dose: 4-6mg daily. Doses >10mg daily did not increase therapeutic effect. Over 16mg, not recommended. If further sedation required benzodiazepine can be administered concomitantly. Renal disorders: Initially 1 mg daily with slow titration to the optimal dose (half adult doses). Moderate to severe hepatic impairment: Caution. Elderly: Initially 0.5mg twice daily. Maintain or adjust individually with 0.5mg twice daily increments up to 1-2mg twice daily. Children: Over 15 years, as per adults. Under 15 years, not recommended.
Contraindications: Hypersensitivity to the active substance or to any of the excipients. Pregnancy (unless benefits outweigh risk), lactation.
Special precautions: Elderly patients with dementia: Avoid dehydration, increased risk of cerebrovascular events; assess risks against benefits of treatment. May cause orthostatic hypotension; consider dose reduction. Possible induction of tardive dyskinesia. Neuroleptic malignant syndrome may occur. Caution: Lewy body dementia, Parkinson’s disease, epilepsy, family history of QT prolongation, known cardiovascular disease (e.g. congenital long QTc syndrome, coronary heart disease, disturbances in conduction, arrhythmia), non drug-related hyperprolactinaemia, prolactin-dependent tumours (e.g. breast cancer), diabetes (or at risk patients).Driving/using machines. Contains: Phenylalanine (aspartame), sorbitol.
Drug interactions: Avoid alcohol. Caution: Drugs acting on CNS including other antipsychotics, lithium, antidepressants, antiparkinson agents and active substances with a central anticholinergic effect, levodopa and other dopaminergic agonists, carbamazepine or other hepatic enzyme inducing drugs, phenothiazines, TCAs and certain beta-blockers, strong inhibitors of CYP2D6 (e.g. quinidine, fluoxetine, paroxetine, terbinafine), cimetidine, ranitidine, drugs prolonging QT-interval or causing electrolyte disturbances.
Adverse drug reactions: Agitation, anxiety, insomnia, headache and sedation (more common in adolescents), weight gain.
Full prescribing information and references available from Niche Generics Ltd. Telephone: (052) 26960 Fax: (052) 26961. E-mail: ann.ryan@nichegenerics.com