RISPERIDONE tablet

البلد: الولايات المتحدة

اللغة: الإنجليزية

المصدر: NLM (National Library of Medicine)

العنصر النشط:

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

متاح من:

Hikma Pharmaceutical

INN (الاسم الدولي):

RISPERIDONE

تركيب:

RISPERIDONE .25 mg

طريقة التعاطي:

ORAL

نوع الوصفة الطبية :

PRESCRIPTION DRUG

الخصائص العلاجية:

Adults Risperidone tablets, USP 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 USP, 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 Pharmaceut

ملخص المنتج:

Risperidone Tablets, USP 0.25 mg dark yellow, oval-shape, film-coated tablets with beveled edges, engraved with W10 and supplied as:  Bottles of 60 Tablets  Bottles of 500 Tablets 0.5 mg red-brown, oval-shaped, film-coated tablets with beveled edges, engraved with W11 and supplied as:  Bottles of 60 Tablets  Bottles of 500 Tablets 1 mg white, oval-shaped, film-coated tablets with beveled edges, engraved with W12 and supplied as:  Bottles of 60 Tablets  Bottles of 500 Tablets 2 mg orange, oval-shaped, film-coated tablets, engraved with W13 and supplied as:  Bottles of 60 Tablets  Bottles of 500 Tablets 3 mg yellow, oval-shaped, film-coated tablets with beveled edges, engraved with W14 and supplied as:  Bottles of 60 Tablets  Bottles of 500 Tablets 4 mg green, modified capsule-shaped, film-coated tablets, engraved with W15 and supplied as:  Bottles of 60 Tablets  Bottles of 500 Tablets Storage and Handling Risperidone tablets, USP: Store at 20-25ºC (68-77ºF) [See USP Controlled Room Temperature]. Protect from light and moisture. Keep out of reach of children.

الوضع إذن:

Abbreviated New Drug Application

خصائص المنتج

RISPERIDONE- RISPERIDONE TABLET
HIKMA PHARMACEUTICAL
----------
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, 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
Boxed Warning 08/2008
Warnings and Precautions (5.1) 08/2008
Warnings and Precaustion, Leukopenia, Neutropenia, and Agranulocytosis
(5.8) 09/2009
INDICATIONS AND USAGE
Risperidone is an atypical antipsychotic agent indicated for:
Treatment of schizophrenia in adults and adolescents aged 13-17 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 10-17 years (1.2)
_Due to Janssen Pharmaceuticals Corporation's marketing exclusivity
rights, this drug product is not labeled for use in_
_pediatric patients with schizophrenia, bipolar mania or autistic
disorder._ (1.1, 1.2, 1.3)
DOSAGE AND ADMINISTRATION
INITIAL DOSE
T ITRATIO N
TARGET DOSE
EFFECTIVE DOSE RANGE
Schizophrenia – adults (2.1) 2 mg/day
1-2 mg daily 4-8 mg daily 4-16 mg/day
Bipolar mania –adults (2.2)
2-3 mg/day 1 mg daily
1-6 mg/day
1-6 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