RISPERIDONE tablet, film coated

Šalis: Jungtinės Valstijos

kalba: anglų

Šaltinis: NLM (National Library of Medicine)

Veiklioji medžiaga:

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

Prieinama:

Aurolife Pharma LLC

INN (Tarptautinis Pavadinimas):

RISPERIDONE

Sudėtis:

RISPERIDONE 0.25 mg

Vartojimo būdas:

ORAL

Recepto tipas:

PRESCRIPTION DRUG

Terapinės indikacijos:

Risperidone tablets, USP are indicated for the treatment of irritability associated with autistic disorder in children and adolescents aged 5 to 16 years, including symptoms of aggression towards others, deliberate self-injuriousness, temper tantrums, and quickly changing moods [see Clinical Studies (14.4)] . 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

Autorizacija statusas:

Abbreviated New Drug Application

Prekės savybės

RISPERIDONE - RISPERIDONE TABLET, FILM COATED
AUROLIFE PHARMA LLC
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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 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)
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
T arge t
Dose
Effe ctive
Dose Range
Schizophre nia
- adults (2.1)
2 mg/day
1 to 2 mg daily
4 to 8 mg
daily
4 to 16
mg/day
Schizophre nia
- adolescents
(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
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 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)
WARNIN