দেশ: মার্কিন যুক্তরাষ্ট্র
ভাষা: ইংরেজি
সূত্র: NLM (National Library of Medicine)
RISPERIDONE (UNII: L6UH7ZF8HC) (RISPERIDONE - UNII:L6UH7ZF8HC)
Torrent Pharmaceuticals Limited
RISPERIDONE
RISPERIDONE 0.25 mg
ORAL
PRESCRIPTION DRUG
Risperidone tablets are 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 tablets are 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 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 tablets are indicated for the treatment of i
Risperidone tablets, USP 0.25 mg are yellow, oblong shaped, biconvex film coated tablets debossed with '0.25' on one side and '1035' on other side. Bottle of 30 NDC-13668-035-30 Bottle of 60 NDC-13668-035-60 Bottle of 100 NDC-13668-035-01 Bottle of 500 NDC-13668-035-05 Bottle of 9,990 NDC-13668-035-09 Risperidone tablets, USP 0.5 mg are red, oblong shaped, biconvex film coated tablets debossed with 'R 0.50' on one side and '1036' on other side. Bottle of 30 NDC-13668-036-30 Bottle of 60 NDC-13668-036-60 Bottle of 100 NDC-13668-036-01 Bottle of 500 NDC-13668-036-05 Bottle of 8,500 NDC-13668-036-54 Risperidone tablets, USP 1 mg are white to off white, oblong shaped, biconvex film coated tablets debossed with 'R 1' on one side and '1037' on other side. Bottle of 60 NDC-13668-037-60 Bottle of 100 NDC-13668-037-01 Bottle of 500 NDC-13668-037-05 Bottle of 4,200 NDC-13668-037-55 Risperidone tablets, USP 2 mg are light orange, oblong shaped, biconvex film coated tablets debossed with 'R 2' on one side and '1038' on other side. Bottle of 60 NDC-13668-038-60 Bottle of 100 NDC-13668-038-01 Bottle of 500 NDC-13668-038-05 Bottle of 4,200 NDC-13668-038-55 Risperidone tablets, USP 3 mg are yellow, oblong shaped, biconvex film coated tablets debossed with 'R 3' on one side and '1039' on other side. Bottle of 60 NDC-13668-039-60 Bottle of 100 NDC-13668-039-01 Bottle of 500 NDC-13668-039-05 Bottle of 2,750 NDC-13668-039-56 Risperidone tablets, USP 4 mg are yellow, oblong shaped, biconvex film coated tablets debossed with 'R 4' on one side and '1040' on other side. Bottle of 60 NDC-13668-040-60 Bottle of 100 NDC-13668-040-01 Bottle of 500 NDC-13668-040-05 Bottle of 2,100 NDC-13668-040-57 Store at 20 o to 25 o C (68 o to 77 o F); excursions permitted to 15 o to 30 o C (59 o to 86 o F). [See USP Controlled Room Temperature]. PROTECT FROM MOISTURE. Keep out of reach of children. Dispense in a tight, light-resistant container.
Abbreviated New Drug Application
RISPERIDONE- RISPERIDONE TABLET TORRENT PHARMACEUTICALS LIMITED ---------- 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, 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 THE TREATMENT OF PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS. _[SEE WARNINGS AND PRECAUTIONS ( 5.1)]_ RECENT MAJOR CHANGES Warnings and Precautions ( 5.3, 5.4) 2/2021 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 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 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 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) DOSAGE FORMS AND STRENGTHS Tablets: 0.25 mg, 0.5 mg, 1 mg, 2 mg, 3 mg, and 4 mg ( 3) CONTRAINDICATIONS Known hypersensitivity to risperidone, paliperidone, or to any excipients in risperidone ( 4) WARNINGS AND PRECAUTIONS Cerebrovas সম্পূর্ণ নথি পড়ুন