Country: মার্কিন যুক্তরাষ্ট্র
ভাষা: ইংরেজি
সূত্র: NLM (National Library of Medicine)
risperidone (UNII: L6UH7ZF8HC) (risperidone - UNII:L6UH7ZF8HC)
Cardinal Health
risperidone
risperidone 0.25 mg
ORAL
PRESCRIPTION DRUG
Risperidone is indicated for the treatment of schizophrenia. Efficacy was established in 4 short-term trials in adults, 2 short-term trials in adolescents (ages 13 to 17 years), and one long-term maintenance trial in adults [see Clinical Studies (14.1)] . Monotherapy Risperidone is indicated for the treatment of acute manic or mixed episodes associated with Bipolar I Disorder. Efficacy was established in 2 short-term trials in adults and one short-term trial in children and adolescents (ages 10 to 17 years) [see Clinical Studies (14.2)] . Adjunctive Therapy Risperidone 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 is indicated for the treatment of irritability associated with autistic disorder, including symptoms of aggression towards others, deliberate self-injuriousness, temper tantrums, and quickly changing
Risperidone Tablets Risperidone Tablets are imprinted " PATR" on one side and either "Ris 0.25", "Ris 0.5", "R1", "R2", "R3", or "R4" according to their respective strengths. 1 mg white, capsule-shaped tablets: Overbagged with 10 tablets per bag, NDC 55154-1413-0 Risperidone Tablets should be stored at controlled room temperature 15°–25°C (59°–77°F). Protect from light and moisture. Keep out of reach of children.
New Drug Application
RISPERIDONE- RISPERIDONE TABLET CARDINAL HEALTH ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE RISPERIDONE TABLETS, ORAL SOLUTION, AND ORALLY DISINTEGRATING TABLETS SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR RISPERIDONE TABLETS, ORAL SOLUTION, AND ORALLY DISINTEGRATING TABLETS. RISPERIDONE TABLETS, RISPERIDONE ORAL SOLUTION, RISPERIDONE ORALLY DISINTEGRATING TABLETS INITIAL U.S. APPROVAL: 1993 _SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._ • • INDICATIONS AND USAGE Risperidone is an atypical antipsychotic indicated for: • • • DOSAGE AND ADMINISTRATION • INITIAL DOSE TARGET DOSE EFFECTIVE DOSE RANGE Schizophrenia: adults (2.1) 2 mg 4 to 8 mg 4 to 16 mg Schizophrenia: adolescents (2.1) 0.5 mg 3 mg 1 to 6 mg Bipolar mania: Adults (2.2) 2 to 3 mg 1 to 6 mg 1 to 6 mg Bipolar mania: in children and adolescents (2.2) 0.5 mg 1 to 2.5 mg 1 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 to 3 mg • • • DOSAGE FORMS AND STRENGTHS • • • WARNING: INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS 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) 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) Recommended daily dosage: 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) Oral Solution: Can be administered directly from calibrated pipette or mixed with beverage (water, coffee, orange juice, or low-fat m সম্পূর্ণ নথি পড়ুন