RISPERIDONE tablet film coated

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

McKesson Packaging Services a business unit of McKesson Corporation

INN (International Name):

RISPERIDONE

Composition:

RISPERIDONE 1 mg

Prescription type:

PRESCRIPTION DRUG

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

RISPERIDONE- RISPERIDONE TABLET, FILM COATED
MCKESSON PACKAGING SERVICES A BUSINESS UNIT OF MCKESSON CORPORATION
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
RISPERIDONE TABLETS USP SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR RISPERIDONE TABLETS
USP.
RISPERIDONE TABLETS 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)
INDICATIONS AND USAGE
Risperidone is an atypical antipsychotic agent indicated for:
•
•
DOSAGE AND ADMINISTRATION
Initial Dose
Titration
Target Dose
Effe ctive
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 mg
at ≥2 weeks
0.5 mg/day
(<20 kg)
1 mg/day
(≥20 kg)
0.5-3
mg/day
DOSAGE FORMS AND STRENGTHS
•
CONTRAINDICATIONS
•
WARNINGS AND PRECAUTIONS
•
•
•
Treatment of schizophrenia in adults and adolescents aged 13 to 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 to 17 years (1.2)
Treatment of irritability associated with autistic disorder in
children and adolescents aged 5 to 16 years (1.3)
Tablets: 0.25 mg, 0.5 mg, 1 mg, 2 mg, 3 mg, and 4 mg (3)
Known hypersensitivity to the product (4)
Cerebrovascul