RISPERIDONE- risperidone solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Heritage Pharmaceuticals Inc.

INN (International Name):

RISPERIDONE

Composition:

RISPERIDONE 1 mg in 1 mL

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Risperidone is 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 is 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 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 is indicated for the treatment of irritability associated with autistic disorder, including symptoms of aggression towards others, deliberate self-injuriousness, temper tantrums, and quickly changing

Product summary:

Risperidone oral solution USP, 1 mg/mL is a colorless to clear solution supplied in bottles of 30 mL. Risperidone oral solution should be stored at controlled room temperature 15°- 25°C (59°-77°F). Protect from light and freezing. Keep out of reach of children.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

RISPERIDONE- RISPERIDONE SOLUTION
HERITAGE PHARMACEUTICALS 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.
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 ( 5.8)
02/2017
INDICATIONS AND USAGE
Risperidone is an atypical antipsychotic agent 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/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
(<20 kg)
0.5 to 3 mg
0.5 mg
(Weight≥20 kg)
1 mg
(≥20 kg)
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)
Oral Solution: Can be administered directly from calibrated pipette or
mixed with beverage (water, coffee, orange juice,
or low-fat milk). ( 2.6)
DOSAGE FORMS AND STRENGTHS
Oral Solution: 1 mg/mL ( 3)
CONTRAINDICATIONS
Known hypersensitivity to risperidone, paliperidone, or to any
excipients in