RISPERIDONE tablet, film coated

Држава: Сједињене Америчке Државе

Језик: Енглески

Извор: NLM (National Library of Medicine)

Активни састојак:

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

Доступно од:

TYA Pharmaceuticals

INN (Међународно име):

RISPERIDONE

Састав:

RISPERIDONE 0.5 mg

Пут администрације:

ORAL

Тип рецептора:

PRESCRIPTION DRUG

Терапеутске индикације:

RISPERIDONE (risperidone) is 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 is 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 ( )

Резиме производа:

NDC:64725-0113-1 in a BOTTLE of 60 TABLET, FILM COATEDS Risperidone Tablets USP, 0.25 mg are dark yellow, round, biconvex film-coated tablets debossed with "Z" on one side and "4" on the other side and are supplied as follows: NDC 68382-112-06in bottle of 30 tablets NDC 68382-112-14 in bottle of 60 tablets NDC 68382-112-16 in bottle of 90 tablets NDC 68382-112-01 in bottle of 100 tablets NDC 68382-112-05 in bottle of 500 tablets NDC 68382-112-10 in bottle of 1000 tablets Risperidone Tablets USP, 0.5 mg are red-brown colored, round, biconvex film-coated tablets debossed with "Z" on one side and "6" on other side and are supplied as follows: NDC 68382-113-06 in bottle of 30 tablets NDC 68382-113-14 in bottle of 60 tablets NDC 68382-113-16 in bottle of 90 tablets NDC 68382-113-01 in bottle of 100 tablets NDC 68382-113-05 in bottle of 500 tablets NDC 68382-113-10 in bottle of 1000 tablets Risperidone Tablets USP, 1 mg are white to off-white, round, biconvex film-coated tablets debossed with "ZC 75" on one side and plain on other side and are supplied as follows: NDC 68382-114-06 in bottle of 30 tablets NDC 68382-114-14 in bottle of 60 tablets NDC 68382-114-16 in bottle of 90 tablets NDC 68382-114-01 in bottle of 100 tablets NDC 68382-114-05 in bottle of 500 tablets NDC 68382-114-10 in bottle of 1000 tablets Risperidone Tablets USP, 2 mg are orange, round, biconvex film-coated tablets debossed with "ZC 76" on one side and plain on other side and are supplied as follows: NDC 68382-115-06 in bottle of 30 tablets NDC 68382-115-14 in bottle of 60 tablets NDC 68382-115-16 in bottle of 90 tablets NDC 68382-115-01 in bottle of 100 tablets NDC 68382-115-05 in bottle of 500 tablets NDC 68382-115-10 in bottle of 1000 tablets Risperidone Tablets USP, 3 mg are yellow, round, biconvex film-coated tablets debossed with "ZC 77"on one side and plain on other side and are supplied as follows: NDC 68382-116-06 in bottle of 30 tablets NDC 68382-116-14 in bottle of 60 tablets NDC 68382-116-16 in bottle of 90 tablets NDC 68382-116-01 in bottle of 100 tablets NDC 68382-116-05 in bottle of 500 tablets NDC 68382-116-10 in bottle of 1000 tablets Risperidone Tablets USP, 4 mg are green, round, biconvex film-coated tablets debossed with "ZC 78" on one side and plain on other side and are supplied as follows: NDC 68382-117-06 in bottle of 30 tablets NDC 68382-117-14 in bottle of 60 tablets NDC 68382-117-16 in bottle of 90 tablets NDC 68382-117-01 in bottle of 100 tablets NDC 68382-117-05 in bottle of 500 tablets NDC 68382-117-10 in bottle of 1000 tablets 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. Keep out of reach of children. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Статус ауторизације:

Abbreviated New Drug Application

Карактеристике производа

RISPERIDONE- RISPERIDONE TABLET, FILM COATED
TYA PHARMACEUTICALS
----------
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,
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 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:
SUMMARY OF HEART PROTECTION STUDY RESULTS
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
0.25 mg (Weight < 20 kg)
0.5 mg (<20 kg)
0.5 to 3 mg
(2.3)
1 mg
0.5 mg (Weight ≥ 20 kg)
(≥ 20 kg)
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
dementiarelated psychosis: RISPERIDONE is not
approved for use in pati