国家: 美国
语言: 英文
来源: NLM (National Library of Medicine)
RISPERIDONE (UNII: L6UH7ZF8HC) (RISPERIDONE - UNII:L6UH7ZF8HC)
Mylan Institutional Inc.
RISPERIDONE
RISPERIDONE 1 mg
ORAL
PRESCRIPTION DRUG
Risperidone orally disintegrating tablets, USP are indicated for the treatment of schizophrenia. Efficacy was established in four short-term trials in adults, two short-term trials in adolescents (ages 13 to 17 years), and one long-term maintenance trial in adults [see Clinical Studies (14.1)] . Risperidone orally disintegrating tablets are indicated for the treatment of acute manic or mixed episodes associated with Bipolar I Disorder. Efficacy was established in two short-term trials in adults and one short-term trial in children and adolescents (ages 10 to 17 years) [see Clinical Studies (14.2)] . Risperidone orally disintegrating tablets adjunctive therapy with lithium or valproate is indicated for the treatment of acute manic or mixed episodes associated with Bipolar I Disorder. Efficacy was established in one short-term trial in adults [see Clinical Studies (14.3)] . Risperidone orally disintegrating tablets are indicated for the treatment of irritability associated with autistic disorder, including s
Risperidone Orally Disintegrating Tablets, USP are available containing 1 mg, 2 mg or 3 mg of risperidone, USP. The 1 mg tablets are white, round, unscored tablets debossed with M over RN1 on one side of the tablet and blank on the other side. They are available as follows: NDC 51079-345-05 – Unit dose blister packages of 20 (2 cards of 10 tablets each). The 2 mg tablets are peach, round, unscored tablets debossed with M over RN2 on one side of the tablet and blank on the other side. They are available as follows: NDC 51079-346-05 – Unit dose blister packages of 20 (2 cards of 10 tablets each). The 3 mg tablets are green, round, unscored tablets debossed with M over RN3 on one side of the tablet and blank on the other side. They are available as follows: NDC 51079-347-05 – Unit dose blister packages of 20 (2 cards of 10 tablets each). Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Protect from light and moisture.
Abbreviated New Drug Application
RISPERIDONE- RISPERIDONE TABLET, ORALLY DISINTEGRATING MYLAN INSTITUTIONAL INC. ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE RISPERIDONE SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR RISPERIDONE ORALLY DISINTEGRATING TABLETS. RISPERIDONE ORALLY DISINTEGRATING TABLETS USP, FOR ORAL USE 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 indicated for: Treatment of schizophrenia ( 1.1) As monotherapy or adjunctive therapy with lithium or valproate, for the treatment of acute manic or mixed episodes associated with Bipolar I Disorder ( 1.2) Treatment of irritability associated with autistic disorder ( 1.3) DOSAGE AND ADMINISTRATION Recommended daily dosage: Initial Dose Target Dose Effective Dose Range Schizophrenia-adults ( 2.1) 2 mg 4 mg to 8 mg 4 mg to 16 mg Schizophrenia- adolescents ( 2.1) 0.5 mg 3 mg 1 mg to 6 mg Bipolar mania- adults ( 2.2) 2 mg to 3 mg 1 mg to 6 mg 1 mg to 6 mg Bipolar mania in children and adolescents ( 2.2) 0.5 mg 1 mg to 2.5 mg 1 mg to 6 mg Irritability associated with autistic disorder ( 2.3) 0.25 mg (Weight < 20 kg) 0.5 mg (Weight ≥ 20 kg) 0.5 mg (< 20 kg) 1 mg (≥ 20 kg) 0.5 mg to 3 mg Severe Renal or Hepatic Impairment in Adults: Use a lower starting dose of 0.5 mg twice daily. May increase to dosages above 1.5 mg twice daily at intervals of at least one week. ( 2.4) Risperidone Orally Disintegrating Tablets: Open the bottle only when ready to administer, and immediately place tablet under tongue. Can be swallowed with or without liquid. ( 2.7) DOSAGE FORMS AND STRENGTHS Orally disintegrating tablets: 0.25 mg, 0.5 mg, 阅读完整的文件