Pajjiż: Stati Uniti
Lingwa: Ingliż
Sors: NLM (National Library of Medicine)
RISPERIDONE (UNII: L6UH7ZF8HC) (RISPERIDONE - UNII:L6UH7ZF8HC)
McKesson Contract Packaging
RISPERIDONE
RISPERIDONE 0.25 mg
PRESCRIPTION DRUG
Abbreviated New Drug Application
RISPERIDONE- RISPERIDONE TABLET, FILM COATED MCKESSON CONTRACT PACKAGING ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE RISPERIDONE TABLETS SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR RISPERIDONE TABLETS. RISPERIDONE TABLETS, USP INITIAL U.S. APPROVAL: 1993 WARNING: INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS _SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING_ ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS TREATED WITH ANTIPSYCHOTIC DRUGS ARE AT AN INCREASED RISK OF DEATH. RISPERIDONE IS NOT APPROVED FOR USE IN PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS. (5.1) INDICATIONS AND USAGE Risperidone is an atypical antipsychotic agent indicated for: Treatment of schizophrenia in adults and adolescents aged 13 to 17 years. (1.1) Alone, or in combination with lithium or valproate, for the short-term treatment of acute manic or mixed episodes associated with Bipolar I Disorder in adults, and alone in children and adolescents aged 10 to 17 years. (1.2) Treatment of irritability associated with autistic disorder in children and adolescents aged 5 to 16 years. (1.3) DOSAGE AND ADMINISTRATION Initial Dose T itration T arge t Dose Effe ctive Dose Range Schizophre nia - adults (2.1) 2 mg/day 1 mg to 2 mg daily 4 mg to 8 mg daily 4 to 16 mg/day Schizophre nia - adolescents (2.1) 0.5 mg/day 0.5 mg to 1 mg daily 3 mg/day 1 to 6 mg/day Bipolar mania - adults (2.2) 2 to 3 mg/day 1 mg daily 1 to 6 mg/day 1 to 6 mg/day Bipolar mania in childre n/adole sce nts (2.2) 0.5 mg/day 0.5 mg to 1 mg daily 2.5 mg/day 0.5 to 6 mg/day Irritability associated with autistic disorder (2.3) 0.25 mg/day (< 20 kg) 0.5 mg/day (≥ 20 kg) 0.25 mg to 0.5 mg at ≥ 2 weeks 0.5 mg/day (< 20 kg) 1 mg/day (≥ 20 kg) 0.5 to 3 mg/day DOSAGE FORMS AND STRENGTHS CONTRAINDICATIONS Known hypersensitivity to the product (4) WARNINGS AND PRECAUTIONS Cerebrovascular events, including stroke, in elderly patients with dementia-related psychosis. Ris Aqra d-dokument sħiħ