RISPERIDONE tablet film coated

País: Estats Units

Idioma: anglès

Font: NLM (National Library of Medicine)

ingredients actius:

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

Disponible des:

McKesson Contract Packaging

Designació comuna internacional (DCI):

RISPERIDONE

Composición:

RISPERIDONE 0.25 mg

tipo de receta:

PRESCRIPTION DRUG

Estat d'Autorització:

Abbreviated New Drug Application

Fitxa tècnica

RISPERIDONE- RISPERIDONE TABLET, FILM COATED
MCKESSON CONTRACT PACKAGING
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
RISPERIDONE TABLETS SAFELY AND EFFECTIVELY.
SEE FULL PRESCRIBING INFORMATION FOR RISPERIDONE TABLETS.
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:
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)
DOSAGE AND ADMINISTRATION
Initial
Dose
T itration
T arge t
Dose
Effe ctive
Dose
Range
Schizophre nia
- adults (2.1)
2 mg/day
1 mg to 2 mg daily
4 mg to 8 mg daily
4 to 16 mg/day
Schizophre nia
- adolescents (2.1)
0.5 mg/day
0.5 mg to 1 mg daily
3 mg/day
1 to 6 mg/day
Bipolar mania
- adults (2.2)
2 to 3 mg/day
1 mg daily
1 to 6 mg/day
1 to 6 mg/day
Bipolar mania in
childre n/adole sce nts
(2.2)
0.5 mg/day
0.5 mg to 1 mg daily
2.5 mg/day
0.5 to 6 mg/day
Irritability associated with
autistic disorder (2.3)
0.25 mg/day (< 20 kg)
0.5 mg/day (≥ 20 kg)
0.25 mg to 0.5 mg
at ≥ 2 weeks
0.5 mg/day (< 20 kg)
1 mg/day (≥ 20 kg)
0.5 to 3 mg/day
DOSAGE FORMS AND STRENGTHS
CONTRAINDICATIONS
Known hypersensitivity to the product (4)
WARNINGS AND PRECAUTIONS
Cerebrovascular events, including stroke, in elderly patients with
dementia-related psychosis. Ris