Company: Rowex Ltd.
Legal category: Prescription. GMS. Sport Permitted.
Active ingredient: Risperidone 1mg/ml oral solution and 0.5mg tablet.
Description: Clear, colourless solution and red oval film-coated tablet with breaking notch.
Presentation: 1mg/ml-100ml, €59.46; 0.5mg-20, €11.26.
Indications: Solution: The treatment of schizophrenia. Maintenance of schizophrenia in responsive patients. Treatment of moderate to severe manic episodes. Solution and 0.5mg tablet: Treatment of severe behavioural disturbances associated with aggressiveness and self-inflicted injury diagnosed according to DSM-IV criteria in children, adolescents and adults with mental retardation.
Dosage: Adult: Schizophrenia: Take once or twice daily. 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. Administer as single or divided dose. If sedation required benzodiazepine can be administered concomitantly. Elderly: Initially 0.5mg twice daily. Can be increased with 0.5mg twice daily increments up to 1-2mg twice daily. Manic episodes: Initially 2mg once daily. Adjust dose if indicated at intervals of 24 hours. Recommended dose: 2-6mg daily. Behavioural disturbances: Patients weighing <50kg: Initially 0.25mg once daily; can be increased by an additional 0.25mg once daily no sooner than every second day. Usual maintenance dose, 0.5mg once daily (range 0.25-0.75mg once daily). Patients weighing ≥50kg: Initially 0.5mg once daily; can be increased by an additional 0.5mg once daily no sooner than every second day. Usual maintenance dose, 1mg once daily (range 0. 5-1.5mg once daily). Hepatic/renal impairment: Half starting and maintenance dose as well as slower titration recommended. Children: Schizophrenia: Under 15 years, not recommended. Manic episodes: Under 18 years, not recommended. Behavioural disturbances: Under 5 years, not recommended.
Contraindications: Hypersensitivity to risperidone or to any of the excipients. Pregnancy (unless benefit outweighs risk), lactation. Solution: Preexisting, not drug induced hyperprolactinemia.
Special precautions: Elderly patients with dementia; avoid dehydration in these patients. Dementia patients with history of CVA, TIA, hypertension or diabetes. Can cause orthostatic hypotension. If hypotension occurs consider dose reduction. Long term treatment: Tardive dyskinesia can occur. Neuroleptic malignant syndrome may occur. Caution: Hepatic/renal impairment, elderly, lewy body dementia or Parkinson’s disease, epilepsy , diabetes (or at risk patients), cardiovascular disease (increase gradually due to hypotension risk) or family history of QT prolongation, prolactin-dependent tumours or possible prolactin-dependent tumours,patients exposed to extremes of temperature. Psycho-organicdisturbances, increased risk of undesirable effects. Contains lactose.Driving or using machine.
Drug interactions: Avoid alcohol, other antipsychotics. Caution:Centrally acting drugs, lithium, antidepressants, anti parkinsonian drugs, drugs with a central anticholinergic effect, levodopa and other dopaminergic agonists, carbamazepine or other hepaticenzyme inducing drugs, strong inhibitors of CYP2D6 (e.g. quinidine,fluoxetine, paroxetine, terbinafine), diuretics, antacids, cimetidine, ranitidine, products prolonging QTc interval.
Adverse drug reactions: Insomnia, agitation, anxiety, headache, sedation, weight increase.
Full prescribing information and references available from RowexLtd. Freephone: 1800 304 400. Fax: (027) 50417.E-mail: rowex@rowa-pharma.ie
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