Valsts: Amerikas Savienotās Valstis
Valoda: angļu
Klimata pārmaiņas: NLM (National Library of Medicine)
RISPERIDONE (UNII: L6UH7ZF8HC) (RISPERIDONE - UNII:L6UH7ZF8HC)
Proficient Rx LP
RISPERIDONE
RISPERIDONE 0.25 mg
ORAL
PRESCRIPTION DRUG
RISPERIDONE (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) ]. Pediatrics RISPERIDONE is indicated for the treatment of irritability associated with autistic disorder, including symptoms of aggression towards others, deliberate self-injuriousness, temper tantru
Risperidone Tablets USP, 0.25 mg are dark yellow, round, biconvex film-coated tablets debossed with "Z" on one side and "4" on the other side and are supplied as follows: NDC 63187-418-60 in bottle of 60 tablets Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Protect from light and moisture. Dispense in a tight, light-resistant container. Keep out of reach of children. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Abbreviated New Drug Application
RISPERIDONE- RISPERIDONE TABLET, FILM COATED PROFICIENT RX LP ---------- 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 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. • • INDICATIONS AND USAGE RISPERIDONE is an atypical antipsychotic indicated for: • • • DOSAGE AND ADMINISTRATION • SUMMARY OF HEART PROTECTION STUDY RESULTS Initial Dose (2) Target Dose (2) Effective Dose (2) Range (2) Schizophrenia: adults (2.1) (2) 2 mg (2) 4 to 8 mg (2) 4 to 16 mg (2) Schizophrenia: adolescents (2.1) (2) 0.5 mg (2) 3 mg (2) 1 to 6 mg (2) Bipolar mania: Adults (2.2) (2) 2 to 3 mg (2) 1 to 6 mg (2) 1 to 6 mg (2) Bipolar mania: in children and adolescents (2.2) (2) 0.5 mg (2) 1 to 2.5 mg (2) 1 to 6 mg (2) Irritability associated with autistic disorder (2) 0.25 mg (Weight < 20 kg) (2) 0.5 mg (<20 kg) (2) 0.5 to 3 mg (2) (2.3) (2) 1 mg (2) 0.5 mg (Weight ≥ 20 kg) (2) (≥ 20 kg) (2) • DOSAGE FORMS AND STRENGTHS • CONTRAINDICATIONS • WARNINGS AND PRECAUTIONS • • • • • • • • • • 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) Tablets: 0.25 mg, 0.5 mg, 1 mg, 2 mg, 3 mg, and 4 mg (3) Known Izlasiet visu dokumentu