RISPERIDONE- risperidone tablet, film coated

Land: USA

Sprog: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv bestanddel:

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

Tilgængelig fra:

NuCare Pharmaceuticals, Inc.

INN (International Name):

RISPERIDONE

Sammensætning:

RISPERIDONE 0.5 mg

Indgivelsesvej:

ORAL

Recept type:

PRESCRIPTION DRUG

Terapeutiske indikationer:

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 ( 14.3) ]. Pediatrics RISPERIDONE is indicated for the treatment of irritability associated with autistic disorder, including symptoms of aggression towards others, deliberate self-injuriousness, temper

Produkt oversigt:

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 68071-2138-3 Bottles of 30 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.

Autorisation status:

Abbreviated New Drug Application

Produktets egenskaber

RISPERIDONE- RISPERIDONE TABLET, FILM COATED
NUCARE PHARMACEUTICALS, INC.
----------
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, paliperidone, or to any
excipients in RISPERIDONE (4)
WARNINGS AND PRECAUTIONS
Cerebrovascular events, including stroke, in elderly patients with
dementiarelated p