RISPERIDONE tablet, film coated

البلد: الولايات المتحدة

اللغة: الإنجليزية

المصدر: NLM (National Library of Medicine)

العنصر النشط:

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

متاح من:

Contract Pharmacy Services-PA

INN (الاسم الدولي):

RISPERIDONE

تركيب:

RISPERIDONE 0.25 mg

طريقة التعاطي:

ORAL

نوع الوصفة الطبية :

PRESCRIPTION DRUG

الخصائص العلاجية:

Adults  Risperidone tablets are indicated for the acute and maintenance treatment of schizophrenia [see Clinical Studies (14.1) ]. Adolescents Due to Janssen Pharmaceuticals Corporation’s marketing exclusivity rights, this drug product is not labeled for use in pediatric patients with schizophrenia. Pediatric use information for the treatment of pediatric patients with schizophrenia, 13 to 17 years of age, is approved for Janssen Pharmaceuticals Corporation’s risperidone drug products. Monotherapy - Adults and Pediatrics   Risperidone tablets are indicated for the short-term treatment of acute manic or mixed episodes associated with Bipolar I Disorder in adults [see Clinical Studies (14.2) ]. Due to Janssen Pharmaceuticals Corporation’s marketing exclusivity rights, this drug product is not labeled for use in pediatric patients with bipolar mania. Pediatric use information for the treatment of pediatric patients with bipolar mania, 10 to 17 years of age, is approved for Janssen Pharmaceuticals Corporation’s r

ملخص المنتج:

Risperidone tablets USP are available as follows: 0.25 mg – dark-yellow round, film-coated tablets, with one side of the tablet debossed with the number “93” and the other side debossed with the number “221”. 0.5 mg – red-brown round, film-coated tablets, with one side of the tablet debossed with the number “93” and the other side debossed with the number “225”. 1 mg – white to off-white round, film-coated tablets, with one side of the tablet debossed with the number “93” and the other side debossed with the number “7240”. 2 mg – orange round, film-coated tablets, with one side of the tablet debossed with the number “93” and the other side debossed with the number “7241”. 3 mg – yellow round, film-coated tablets, with one side of the tablet debossed with the number “93” and the other side debossed with the number “7242”. 4 mg – green round, film-coated tablets, with one side of the tablet debossed with the number “93” and the other side debossed with the number “7243”. Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Protect from light and moisture. Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required). Keep out of reach of children.

الوضع إذن:

Abbreviated New Drug Application

خصائص المنتج

RISPERIDONE- RISPERIDONE TABLET, FILM COATED
CONTRACT PHARMACY SERVICES-PA
----------
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 FOR ORAL USE
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 (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 (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
Effective Dose Range
Schizophrenia - adults (2.1)
2 mg/day
1 to 2 mg daily
4 to 8 mg daily
4 to 16 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
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)
WARNINGS AND PRECAUTIONS
Cerebrovascular events, including stroke, in elderly patients with
dementia-related psychosis. Risperidone is not
approved for use in patients with dementia-related psychosis (5.2)
Neuroleptic Malignant Syndrome (5.3)
Tardive dyskinesia (5.4)
Hyperglycemia and diabetes mellitus (5.5)
Hyperprolactinemia (5.6)
Orthostatic hypo