RISPERDAL- risperidone tablet

Land: USA

Språk: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv ingrediens:

risperidone (UNII: L6UH7ZF8HC) (risperidone - UNII:L6UH7ZF8HC)

Tilgjengelig fra:

Rebel Distributors Corp

INN (International Name):

risperidone

Sammensetning:

risperidone 1 mg

Administreringsrute:

ORAL

Resept typen:

PRESCRIPTION DRUG

Indikasjoner:

Adults RISPERDAL® (risperidone) is indicated for the acute and maintenance treatment of schizophrenia [see Clinical Studies (14.1)] . Adolescents RISPERDAL® is indicated for the treatment of schizophrenia in adolescents aged 13–17 years [see Clinical Studies (14.1)] . Monotherapy - Adults and Pediatrics RISPERDAL® is indicated for the short-term treatment of acute manic or mixed episodes associated with Bipolar I Disorder in adults and in children and adolescents aged 10–17 years [see Clinical Studies (14.2)] . Combination Therapy – Adults The combination of RISPERDAL® with lithium or valproate is indicated for the short-term treatment of acute manic or mixed episodes associated with Bipolar I Disorder [ see Clinical Studies (14.3)] . Pediatrics RISPERDAL® is indicated for the treatment of irritability associated with autistic disorder in children and adolescents aged 5–16 years, including symptoms of aggression towards others, deliberate self-injuriousness, temper tantrums, and quickly changing moods [s

Produkt oppsummering:

RISPERDAL® (risperidone) Tablets RISPERDAL® (risperidone) Tablets are imprinted " JANSSEN" on one side and either "R1", or "R3" according to their respective strengths. 1 mg white, capsule-shaped tablets: bottles of 15 NDC 21695-113-15 3 mg yellow, capsule-shaped tablets: bottles of 30 NDC 21695-115-30 and bottles of 60 NDC 21695-113-60. Storage and Handling RISPERDAL® Tablets should be stored at controlled room temperature 15°–25°C (59°–77°F). Protect from light and moisture. Keep out of reach of children.

Autorisasjon status:

New Drug Application

Informasjon til brukeren

Rebel Distributors Corp
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DOSAGE: For information about the use of RISPERDAL® (risperidone),
please see accompanying
Package Insert.
STORAGE: Store bottle at controlled room temperature
(59°-77°F/15°–25°C) away from children; avoid
freezing and protect from light.
Manufactured by:
Janssen Pharmaceutica N.V.
Beerse, Belgium
Manufactured for:
Janssen, Division of Ortho-McNeil-Janssen
Pharmaceuticals, Inc.
Titusville, NJ, United States 08560
Posologia: Para información acerca del uso de RISPERDAL®
(risperidona), sirvase leer el prospecto
adjunto en el paquete.
Almacenamiento: Almacene el frasco a temperatura ambiente controlada
(59°-77°F/15° -25°C) lejos de
los niños; evite que se congele y protéjalo de la luz.
Manufacturado por:
Janssen Pharmaceutica N.V.
Beerse, Bélgica
Manufacturado para:
Janssen, Division of Ortho-McNeil-Janssen
Pharmaceuticals, Inc.
Titusville, NJ, Estados Unidos 08560
Repackaged by:
Rebel Distributors Corp
Thousand Oaks, CA 91320
Revised: 12/2010
Document Id: fca1c3cd-45f3-45cc-bb1d-656c65e91c8a
Set id: 01859e07-1262-4cc6-b7ed-5a273cbf0c36
Version: 2
Effective Time: 20101227
Rebel Distributors Corp

Preparatomtale

RISPERDAL- RISPERIDONE TABLET
REBEL DISTRIBUTORS CORP
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
RISPERDAL SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING INFORMATION FOR RISPERDAL .
RISPERDAL (RISPERIDONE) TABLETS, RISPERDAL® (RISPERIDONE) ORAL
SOLUTION, RISPERDAL M-TAB
(RISPERIDONE) ORALLY DISINTEGRATING 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. RISPERDAL
IS NOT APPROVED FOR USE IN PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS.
(5.1)
RECENT MAJOR CHANGES
Warnings and Precautions, Leukopenia, Neutropenia, and Agranulocytosis
(5.8) 07/2009
INDICATIONS AND USAGE
RISPERDAL® 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)
Treatment of irritability associated with autistic disorder in
children and adolescents aged 5–16 years (1.3)
DOSAGE AND ADMINISTRATION
Initial Dose
T itration
Target Dose
Effective Dose Range
Schizophrenia- adults
(2.1)
2 mg/day
1–2 mg daily
4–8 mg daily
4–16 mg/day
Schizophrenia –
adolescents (2.1)
0.5mg/day
0.5– 1 mg daily
3mg/day
1–6 mg/day
Bipolar mania – adults
(2.2)
2–3 mg/day
1mg daily
1–6mg/day
1–6 mg/day
Bipolar mania in
childre n/adole sce nts
(2.2)
0.5 mg/day
0.5–1mg daily
2.5mg/day
0.5–6 mg/day
Irritability associated
with autistic disorder
(2.3)
0.25 mg/day (<20 kg)
0.5 mg/day (≥20 kg)
0.25–0.5 mg at ≥ 2
weeks
0.5 mg/day (<20 kg)
1 mg/day (≥20 kg)
0.5–3 mg/day
DOSAGE FORMS AND STRENGTHS
Tablets: 0.25 mg, 0.5 mg, 1 mg, 2 mg, 3 mg, and 4 m