RISPERIDONE- risperidone tablet

Country: Ամերիկայի Միացյալ Նահանգներ

language: անգլերեն

source: NLM (National Library of Medicine)

active_ingredient:

RISPERIDONE (UNII: L6UH7ZF8HC) (RISPERIDONE - UNII:L6UH7ZF8HC)

MAH:

Nucare Pharmaceuticals,Inc.

INN:

RISPERIDONE

composition:

RISPERIDONE 2 mg

administration_route:

ORAL

prescription_type:

PRESCRIPTION DRUG

therapeutic_indication:

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 irritability associated with autistic disorder, including symptoms of aggression towards others, deliberate self-injuriousness,

leaflet_short:

Risperidone Tablets Risperidone Tablets USP 2 mg are yellow, circular, biconvex film-coated tablets, engraved with 'RI4' on one side and plain on other and are supplied as follows: NDC 68071-3356-3 Bottles of 30 Risperidone tablets should be stored at 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86°F) [see USP controlled room temperature]. Protect from light and moisture. Keep out of reach of children.

authorization_status:

Abbreviated New Drug Application

SPC

RISPERIDONE- RISPERIDONE TABLET
NUCARE PHARMACEUTICALS,INC.
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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 TABLETS ARE NOT APPROVED FOR USE IN PATIENTS WITH
DEMENTIA-RELATED PSYCHOSIS. (5.1)
RECENT MAJOR CHANGES
Warnings and Precautions ( 5.8) 02/2017
INDICATIONS AND USAGE
Risperidone tablets are 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 I 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 tablets. ( 4)
WARNINGS AND PRECAUTIONS
Cerebrovascular events, including str