Țară: Statele Unite ale Americii
Limbă: engleză
Sursă: NLM (National Library of Medicine)
RISPERIDONE (UNII: L6UH7ZF8HC) (RISPERIDONE - UNII:L6UH7ZF8HC)
Lake Erie Medical DBA Quality Care Products LLC
RISPERIDONE
RISPERIDONE 2 mg
ORAL
PRESCRIPTION DRUG
Adults RISPERIDONE (risperidone) is indicated for the acute and maintenance treatment of schizophrenia [see Clinical Studies (14.1)]. Adolescents RISPERIDONE is indicated for the treatment of schizophrenia in adolescents aged 13–17 years [see Clinical Studies (14.1)]. Monotherapy Adults and Pediatrics RISPERIDONE is indicated for the short-term treatment of acute manic or mixed episodes associated with Bipolar I Disorder in adults and in children and adolescents aged 10-17 years [see Clinical Studies (14.2)]. Combination Therapy Adults The combination of RISPERIDONE with lithium or valproate is indicated for the short-term treatment of acute manic or mixed episodes associated with Bipolar I Disorder [see Clinical Studies (14.3)]. Pediatrics RISPERIDONE is indicated for the treatment of irritability associated with autistic disorder in children and adolescents aged 5–16 years, including symptoms of aggression towards others, deliberate self-injuriousness, temper tantrums, and quickly changing moods [see CLINIC
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: Risperidone Tablets USP, 0.5 mg are red-brown colored, round, biconvex film-coated tablets debossed with "Z" on one side and "6" on other side and are supplied as follows: Risperidone Tablets USP, 1 mg are white to off-white, round, biconvex film-coated tablets debossed with "ZC 75" on one side and plain on other side and are supplied as follows: Risperidone Tablets USP, 2 mg are orange, round, biconvex film-coated tablets debossed with "ZC 76" on one side and plain on other side and are supplied as follows: NDC: 55700-017-30 Bottles of 30 NDC: 55700-017-60 Bottles of 60 NDC: 55700-017-90 Bottles of 90 Risperidone Tablets USP, 3 mg are yellow, round, biconvex film-coated tablets debossed with "ZC 77"on one side and plain on other side and are supplied as follows: Risperidone Tablets USP, 4 mg are green, round, biconvex film-coated tablets debossed with "ZC 78" on one side and plain on other side and are supplied as follows: Storage and Handling Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Protect from light and moisture. 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 LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC ---------- 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. 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) RECENT MAJOR CHANGES Warnings and Precautions, Metabolic Changes (5.5) September 2011 INDICATIONS AND USAGE RISPERIDONE is an atypical antipsychotic agent indicated for: • • • DOSAGE AND ADMINISTRATION INITIAL DOSE TITRATION TARGET DOSE EFFECTIVE DOSE RANGE Schizophrenia – adults (2.1) 2 mg/day 1-2 mg daily 4-8 mg daily 4-16 mg/day Schizophrenia – adolescents (2.1) 0.5 mg /day 0.5-1 mg daily 3 mg /day 1-6 mg /day Bipolar mania –adults (2.2) 2-3 mg/day 1 mg daily 1-6 mg/day 1-6 mg/day Bipolar mania in children/adolescents (2.2) 0.5 mg /day 0.5-1mg daily 2.5 mg/day 0.5-6 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 • CONTRAINDICATIONS • WARNINGS AND PRECAUTIONS • • • • • _Hyperglycemia and Diabetes Mellitus: _Monitor patients for symptoms of hyperglycemia including polydipsia, polyuria, polyphagia, and weakness. Monitor glucose regularly in patients with diabetes or at risk for diabetes. (5.5) • _Dyslipidemia: _Undesirable alterations have been observed in patients treated with atypical antipsychotics. (5.5) • _Weight Gain: _Significant weight gain has been reported. Monitor weight gain. (5.5) • • • • • • • • • • • • • ADVERSE REACTIONS Citiți documentul complet