RISPERIDONE- risperidone solution

Country: Ամերիկայի Միացյալ Նահանգներ

language: անգլերեն

source: NLM (National Library of Medicine)

active_ingredient:

Risperidone (UNII: L6UH7ZF8HC) (Risperidone - UNII:L6UH7ZF8HC)

MAH:

Taro Pharmaceuticals U.S.A., Inc.

INN:

Risperidone

composition:

Risperidone 1 mg in 1 mL

administration_route:

ORAL

prescription_type:

PRESCRIPTION DRUG

therapeutic_indication:

Adults 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 Clinical

leaflet_short:

Risperidone Oral Solution USP Risperidone Oral Solution USP 1 mg/mL (NDC 51672-1349-3) is supplied in 30 mL bottles with a calibrated (in milliliters) pipette. The minimum calibrated volume is 0.25 mL, while the maximum calibrated volume is 3 mL. DIRECTIONS FOR OPENING THE BOTTLE AND USING THE DISPENSING PIPETTE (SYRINGE) Using Your Risperidone Dispensing-Pipette and Bottle Use this product as indicated below, unless directed otherwise by your Physician. IMPORTANT: Please read these instructions before using Risperidone Oral Solution USP. Risperidone Oral Solution USP 1 mg/mL should be stored at 20°-25°C (68°-77°F) [see USP Controlled Room Temperature]. Protect from light and freezing. Keep out of reach of children.

authorization_status:

Abbreviated New Drug Application

SPC

RISPERIDONE- RISPERIDONE SOLUTION
TARO PHARMACEUTICALS U.S.A., 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 ORAL SOLUTION 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)
RECENT MAJOR CHANGES
Warnings and Precautions, Metabolic Changes (5.5)
September 2011
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 ITRATIO N
TARGET DOSE
EFFECTIVE DOSE
RANG E
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
0.5-1 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
Oral solution: 1 mg/mL (3)
CONTRAINDICATIONS
Known hypersensitivity to the product (4)
WARNINGS AND PRECAUTIONS
Cerebrovascular events, including stroke, in elderly patients with
dementia-relate