Страна: Соединенные Штаты
Язык: английский
Источник: NLM (National Library of Medicine)
RISPERIDONE (UNII: L6UH7ZF8HC) (RISPERIDONE - UNII:L6UH7ZF8HC)
McKesson Packaging Services a business unit of McKesson Corporation
RISPERIDONE
RISPERIDONE 1 mg
PRESCRIPTION DRUG
Abbreviated New Drug Application
RISPERIDONE- RISPERIDONE TABLET, FILM COATED MCKESSON PACKAGING SERVICES A BUSINESS UNIT OF MCKESSON CORPORATION ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE RISPERIDONE TABLETS USP SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR RISPERIDONE TABLETS USP. 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: • • DOSAGE AND ADMINISTRATION Initial Dose Titration Target Dose Effe ctive Dose Range Schizophrenia – adults (2.1) 2 mg/day 1–2 mg daily 4–8 mg daily 4–16 mg/day Schizophrenia – adolescents (2.1) 0.5 mg/day 0.5-1 mg daily 3 mg/day 1-6 mg/day Bipolar mania – adults (2.2) 2–3 mg/day 1 mg daily 1–6 mg/day 1–6 mg/day Bipolar mania in children/ adolescents (2.2) 0.5 mg/day 0.5-1 mg daily 2.5 mg/day 0.5-6 mg/day Irritability associated with autistic disorder (2.3) 0.25 mg/day (<20 kg) 0.5 mg/day (≥20 kg) 0.25-0.5 mg at ≥2 weeks 0.5 mg/day (<20 kg) 1 mg/day (≥20 kg) 0.5-3 mg/day DOSAGE FORMS AND STRENGTHS • CONTRAINDICATIONS • WARNINGS AND PRECAUTIONS • • • 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) Tablets: 0.25 mg, 0.5 mg, 1 mg, 2 mg, 3 mg, and 4 mg (3) Known hypersensitivity to the product (4) Cerebrovascul Прочитать полный документ