RISPERIDONE tablet, film coated

Страна: США

мова: англійська

Джерело: NLM (National Library of Medicine)

Активний інгредієнт:

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

Доступна з:

Bryant Ranch Prepack

ІПН (Міжнародна Ім'я):

RISPERIDONE

Склад:

RISPERIDONE 0.5 mg

Адміністрація маршрут:

ORAL

Тип рецепту:

PRESCRIPTION DRUG

Терапевтичні свідчення:

Risperidone tablets USP are indicated for the treatment of schizophrenia. Efficacy was established in 4 short-term trials in adults, 2 short-term trials in adolescents (ages 13 to 17 years), and one long-term maintenance trial in adults [see Clinical Studies (14.1) ]. Monotherapy Risperidone tablets USP are indicated for the treatment of acute manic or mixed episodes associated with Bipolar I Disorder. Efficacy was established in 2 short-term trials in adults and one short-term trial in children and adolescents (ages 10 to 17 years) [see Clinical Studies (14.2) ]. Adjunctive Therapy Risperidone adjunctive therapy with lithium or valproate is indicated for the treatment of acute manic or mixed episodes associated with Bipolar I Disorder. Efficacy was established in one short-term trial in adults [see Clinical Studies (14.3) ]. Risperidone tablets USP are indicated for the treatment of irritability associated with autistic disorder, including symptoms of aggression towards others, deliberate self-injuriou

Огляд продуктів:

Risperidone tablets USP are available as: 0.25 mg dark yellow, film-coated, capsule-shaped, convex, debossed “5683” on one side and debossed “V” on the reverse side, supplied as follows: Bottles of 10:     NDC 0603-5683-10 Bottles of 60:     NDC 0603-5683-20 Bottles of 500:   NDC 0603-5683-28 Bottles of 1000: NDC 0603-5683-32 0.5 mg reddish-brown, film-coated, capsule-shaped, convex, debossed “5684” on one side and debossed “V” on the reverse side, supplied as follows: Bottles of 10:     NDC 0603-5684-10 Bottles of 60:     NDC 0603-5684-20 Bottles of 500:   NDC 0603-5684-28 Bottles of 1000: NDC 0603-5684-32 1 mg white, film-coated, capsule-shaped, convex, debossed “5685” on one side and debossed “V” on the reverse side, supplied as follows: Bottles of 10:     NDC 0603-5685-10 Bottles of 60:     NDC 0603-5685-20 Bottles of 500:   NDC 0603-5685-28 Bottles of 1000: NDC 0603-5685-32 2 mg pink, film-coated, capsule-shaped, convex, debossed “5686” on one side and debossed “V” on the reverse side, supplied as follows: Bottles of 10:     NDC 0603-5686-10 Bottles of 60:     NDC 0603-5686-20 Bottles of 500:   NDC 0603-5686-28 Bottles of 1000: NDC 0603-5686-32 3 mg yellow, film-coated, capsule-shaped, convex, debossed “5687” on one side and debossed “V” on the reverse side, supplied as follows: Bottles of 10:     NDC 0603-5689-10 Bottles of 60:     NDC 0603-5689-20 Bottles of 500:   NDC 0603-5689-28 Bottles of 1000: NDC 0603-5689-32 4 mg green, film-coated, capsule-shaped, convex, debossed “5688” on one side and debossed “V” on the reverse side, supplied as follows: Bottles of 10:     NDC 0603-5688-10 Bottles of 60:     NDC 0603-5688-20 Bottles of 500:   NDC 0603-5688-28 Bottles of 1000: NDC 0603-5688-32 Protect from light and moisture. Keep out of reach of children.

Статус Авторизація:

Abbreviated New Drug Application

Характеристики продукта

RISPERIDONE- RISPERIDONE TABLET, FILM COATED
BRYANT RANCH PREPACK
----------
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)
RECENT MAJOR CHANGES
Warnings and Precautions, Metabolic Changes (5.5) September 2011
INDICATIONS AND USAGE
Risperidone is an atypical antipsychotic indicated for:
Treatment of schizophrenia (1.1)
As monotherapy or adjunctive therapy with lithium or valproate, for
the treatment of acute manic or mixed episodes
associated with Bipolar I Disorder (1.2)
Treatment of irritability associated with autistic disorder (1.3)
DOSAGE AND ADMINISTRATION
Recommended daily dosage:
Initial Dose
Target Dose Effective Dose Range
Schizophrenia: Adults (2.1)
2 mg
4 to 8 mg
4 to 16 mg
Schizophrenia: Adolescents (2.1)
0.5 mg
3 mg
1 to 6 mg
Bipolar mania: Adults (2.2)
2 to 3 mg
1 to 6 mg
1 to 6 mg
Bipolar mania: In children and adolescents (2.2) 0.5 mg
1 to 2.5 mg
1 to 6 mg
Irritability associated with
autistic disorder (2.3)
0.25 mg
(Weight < 20 kg)
0.5 mg
(Weight ≥ 20 kg)
0.5 mg
(< 20 kg)
1 mg
(≥ 20 kg)
0.5 to 3 mg
Severe Renal or Hepatic Impairment in Adults: Use a lower starting
dose of 0.5 mg twice daily. May increase to dosages
above 1.5 mg twice daily at intervals of at least one week. (2.4)
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 risperidone (4)
WARNINGS AND PRECAUTIONS
Cerebrovascular events, including stroke, in elderly patients with
dementia-r