RISPERIDONE- risperidone solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Par Pharmaceutical

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 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 oral solution 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 oral solution is indicated for the treatment of irritability associated with autistic disorder, including symptoms of aggression towards others, deliberate self-injur

Product summary:

Risperidone 1 mg/mL oral solution USP (NDC 0603-9424-45) is a clear and colorless to light yellow oral solution and is available in 30 mL (1 fl oz) bottles with a calibrated (in milligrams and milliliters) pipette. The minimum calibrated volume is 0.25 mL, while the maximum calibrated volume is 3 mL. Risperidone oral solution USP 1 mg/mL should be stored at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Protect from light and freezing. Keep out of reach of children.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

RISPERIDONE- RISPERIDONE SOLUTION
PAR PHARMACEUTICAL
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
RISPERIDONE ORAL SOLUTION SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR RISPERIDONE ORAL
SOLUTION.
RISPERIDONE ORAL SOLUTION
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 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)
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 per mL (3)
CONTRAINDICATIONS
Known hypersensitivity to risperidone, paliperidone, or to any
excipient