RISPERIDONE solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Dr. Reddy's Laboratories Limited

INN (International Name):

RISPERIDONE

Composition:

RISPERIDONE 1 mg in 1 mL

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Risperidone oral solution is indicated for the acute and maintenance treatment of schizophrenia [see Clinical Studies(14.1) ]. Risperidone oral solution is indicated for the treatment of schizophrenia in adolescents aged 13 to 17 years [see Clinical Studies (14.1) ]. Risperidone oral solution 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 to 17 years[see Clinical Studies(14.2) ].   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) ]. Risperidone oral solution is indicated for the treatment of irritability associated with autistic disorder in children and adolescents aged 5 to16 years, including symptoms of aggression towards others, deliberate self-injuriousness, temper tantrums, and quickly changing moods [see Clinical Studies (14.4) ]. Hypersensitivity

Product summary:

Risperidone Oral Solution USP   Risperidone oral solution USP, 1 mg/ml is a colorless to clear solution supplied in bottles of 30 ml.  Bottles of 30 ml                                                                      NDC 55111-579-30 Store bottle at 20°-25°C (68°-77°F) [see USP Controlled Room Temperature] away from children; avoid freezing and protect from light.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

RISPERIDONE- RISPERIDONE SOLUTION
DR. REDDY'S LABORATORIES LIMITED
----------
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 ORAL SOLUTION USP
INITIAL U.S. APPROVAL: 1993
WARNING: INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED
PSYCHOSISSEE 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: (1)
Treatment of schizophrenia in adults and adolescents aged 13-17
years(1.1) (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)
(1)
(1)
(1)
DOSAGE AND ADMINISTRATION
(2)
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/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 mgat ≥
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 pa