RISPERIDONE tablet
البلد: الولايات المتحدة
اللغة: الإنجليزية
المصدر: NLM (National Library of Medicine)
خصائص المنتج
(SPC)
06-10-2011
ارسل طلب
العنصر النشط:
RISPERIDONE (UNII: L6UH7ZF8HC) (RISPERIDONE - UNII:L6UH7ZF8HC)
متاح من:
STAT Rx USA LLC
INN (الاسم الدولي):
RISPERIDONE
تركيب:
RISPERIDONE 2 mg
طريقة التعاطي:
ORAL
نوع الوصفة الطبية :
PRESCRIPTION DRUG
الخصائص العلاجية:
Adults Risperidone tablets are indicated for the acute and maintenance treatment of schizophrenia [see Clinical Studies (14.1)]. Adolescents Risperidone tablets are indicated for the treatment of schizophrenia in adolescents aged 13-17 years [see Clinical Studies (14.1)]. 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 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 tablets are 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
ملخص المنتج:
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 9990 NDC-13668-035-09 100 Unit Dose Tablets NDC-13668-035-74 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 8500 NDC-13668-036-54 100 Unit Dose Tablets NDC-13668-036-74 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 4200 NDC-13668-037-55 100 Unit Dose Tablets NDC-13668-037-74 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 4200 NDC-13668-038-55 100 Unit Dose Tablets NDC-13668-038-74 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 2750 NDC-13668-039-56 100 Unit Dose Tablets NDC-13668-039-74 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 2100 NDC-13668-040-57 90 Unit Dose Tablets NDC-13668-040-64 Store at 20º to 25º C (68º to 77º F); excursions permitted to 15º to 30º C (59º to 86º F). [See USP Controlled Room Temperature]. PROTECT FROM MOISTURE. Keep out of reach of children. Dispense in a tight, light-resistant container.
الوضع إذن:
Abbreviated New Drug Application
خصائص المنتج
RISPERIDONE - RISPERIDONE TABLET
STAT RX USA LLC
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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 and adolescents aged 13-17 years
(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, and alone in children
and adolescents aged 10-17 years (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
Schizophrenia-adolescents (2.1)
0.5 mg/day
0.5-1 mg daily
3 mg daily
1-6 mg/day
Bipolar mania-adults (2.2)
2-3 mg/day
1mg daily
1-6 mg/day
1-6 mg /day
Bipolar mania in
children/adolescents (2.2)
0.5 mg/day
0.5-1 mg 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
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
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