RISPERIDONE tablet, film coated

দেশ: মার্কিন যুক্তরাষ্ট্র

ভাষা: ইংরেজি

সূত্র: NLM (National Library of Medicine)

সক্রিয় উপাদান:

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

থেকে পাওয়া:

WOCKHARDT LIMITED

INN (আন্তর্জাতিক নাম):

RISPERIDONE

রচনা:

RISPERIDONE 0.25 mg

প্রশাসন রুট:

ORAL

প্রেসক্রিপশন টাইপ:

PRESCRIPTION DRUG

থেরাপিউটিক ইঙ্গিত:

Pregnancy Category C. The teratogenic potential of risperidone was studied in three Segment II studies in Sprague- Dawley and Wistar rats (0.63 to 10 mg/kg or 0.4 to 6 times the maximum recommended human dose [MRHD] on a mg/m2 basis) and in one Segment II study in New Zealand rabbits (0.31 to 5 mg/kg or 0.4 to 6 times the MRHD on a mg/m2 basis). The incidence of malformations was not increased compared to control in offspring of rats or rabbits given 0.4 to 6 times the MRHD on a mg/m2 basis. In three reproductive studies in rats (two Segment III and a multigenerational study), there was an increase in pup deaths during the first 4 days of lactation at doses of 0.16 to 5 mg/kg or 0.1 to 3 times the MRHD on a mg/m2 basis. It is not known whether these deaths were due to a direct effect on the fetuses or pups or to effects on the dams. There was no no-effect dose for increased rat pup mortality. In one Segment III study, there was an increase in stillborn rat pups at a dose of 2.5 mg/kg or 1.5 times the

অনুমোদন অবস্থা:

Abbreviated New Drug Application

পণ্য বৈশিষ্ট্য

RISPERIDONE - RISPERIDONE TABLET, FILM COATED
WOCKHARDT LIMITED
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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 TABLETS
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, Metabolic Changes (5.5) September 2011
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
Target Dose
Effe ctive
Dose Range
Schizophrenia-adults (2.1)
2 mg /day
1 to 2 mg daily
4 to 8 mg daily
4 to 16 mg
/day
Schizophre nia-adole sce nts
(2.1)
0.5 mg/ day
0.5 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
children/adolescents (2.2)
0.5 mg/day
0.5 to 1 mg daily
1 to 6 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
Tablets: 0.25 mg, 0.5 mg, 1 mg, 2 mg, 3 mg and 4 mg (3)
CONTRAINDICATIONS
Known hypersensitivity to the product (4)
WARNINGS AND PRECAUTIO