Land: Verenigde Staten
Taal: Engels
Bron: NLM (National Library of Medicine)
RISPERIDONE (UNII: L6UH7ZF8HC) (RISPERIDONE - UNII:L6UH7ZF8HC)
Physicians Total Care, Inc
RISPERIDONE
RISPERIDONE 0.5 mg
ORAL
PRESCRIPTION DRUG
Enter section text here Adults Risperidone tablets are indicated for the acute and maintenance treatment of schizophrenia [see Clinical Studies (14.1)]. Adolescents Due to Janssen Pharmaceuticals Corporation’s marketing exclusivity rights, this drug product is not labeled for use in pediatric patients with schizophrenia .Pediatric use information for the treatment of pediatric patients with schizophrenia, 13 to 17 years of age, is approved for Janssen Pharmaceuticals Corporation’s risperidone drug products. Monotherapy - Adults and Pediatrics Risperidone tablets are indicated for the short-term treatment of acute manic or mixed episodes associated with Bipolar I Disorder in adults [see Clinical Studies (14.2)]. Due to Janssen Pharmaceuticals Corporation’s marketing exclusivity rights, this drug product is not labeled for use in pediatric patients with bipolar mania. Pediatric use information for the treatment of pediatric patients with bipolar mania, 10 to 17 years of age, is approved for Janssen Ph
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. 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. Store at 20°- 25°C (68° - 77°F); excursions permitted to 15° - 30°C (59° - 86°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 PHYSICIANS TOTAL CARE, 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. RISPERIDONE TABLET FOR ORAL USE 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 (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 (1.2) Due to Janssen Pharmaceuticals Corporation’s marketing exclusivity rights; this drug product is not labeled for use in pediatric patients with schizophrenia or bipolar mania. (1.1, 1.2) Treatment of irritability associated with autistic disorder in children and adolescents aged 5-16 years (1.3) DOSAGE AND ADMINISTRATION Initial Dose T itration Target Dose Effective Dose Range Schizophrenia-adults (2.1) 2 mg/day 1- 2 mg daily 4-8 mg daily 4-16 mg/day Bipolar mania-adults (2.2) 2-3 mg/day 1mg daily 1-6 mg/day 1-6 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 Tablets: 0.25 mg, 0.5 mg, 1 mg, 2 mg, 3 mg, and 4 mg (3) CONTRAINDICATIONS Known hypersensitivity to the product (4) WARNINGS AND PRECAUTIONS Cerebrovascular events, including stroke, in elderly patients with dementia-related psychosis. Risperidone is not approved for use in patients with dementia-related psychosis (5.2) Neuroleptic Malig Lees het volledige document