RISPERIDONE tablet, film coated

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

AvPAK

INN (International Name):

RISPERIDONE

Composition:

RISPERIDONE 0.5 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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

Product summary:

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: 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 50268-695-15   10 Tablets per card, 5 cards per carton 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 50268-696-15   10 Tablets per card, 5 cards per carton 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 50268-697-15   10 Tablets per card, 5 cards per carton 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 50268-698-15   10 Tablets per card, 5 cards per carton 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 50268-699-15   10 Tablets per card, 5 cards per carton Dispensed in Blister Punch Material.  For Institutional Use Only. 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.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

RISPERIDONE- RISPERIDONE TABLET, FILM COATED
AVPAK
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HIGHLIGHTS OF PRESCRIBING INFORMATION
RISPERIDONE TABLETS, USP
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)
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:
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