RISPERIDONE tablet, orally disintegrating

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Dr. Reddy's Laboratories Limited

INN (International Name):

risperidone

Composition:

risperidone 0.5 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Risperidone orally disintegrating tablets are indicated for the treatment o 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 orally disintegrating tablets 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 orally disintegrating tablets 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 orally disintegrating tablets are indicated for the treatment of irritability associated with autistic d

Product summary:

Risperidone orally disintegrating tablets USP, 0.5 mg are white to off white capsule shaped tablets, flat on one side with ‘R-207’ embossing and, concave and plain on other side and are supplied in cartons of 3 packs and 10 packs containing 10 tablets each. Carton of 3 packs (NDC 55111-207-81), each pack containing 10 tablets (NDC 55111-207-79) Carton of 10 packs (NDC 55111-207-78), each pack containing 10 tablets (NDC 55111-207-79) Risperidone orally disintegrating tablets USP, 1 mg are white to off white capsule shaped tablets, flat on one side with ‘R-208’ embossing and, concave and plain on other side and are supplied in cartons of 3 packs and 10 packs containing 10 tablets each. Carton of 3 packs (NDC 55111-208-81), each pack containing 10 tablets (NDC 55111-208-79) Carton of 10 packs (NDC 55111-208-78), each pack containing 10 tablets (NDC 55111-208-79) Risperidone orally disintegrating tablets USP, 2 mg are white to off white capsule shaped biconcave beveled edged tablets with ‘R209’ embossing on one side and plain on other side and are supplied in cartons of 3 packs and 10 packs containing 10 tablets each. Carton of 3 packs (NDC 55111-209-81), each pack containing 10 tablets (NDC 55111-209-79) Carton of 10 packs (NDC 55111-209-78), each pack containing 10 tablets (NDC 55111-209-79) Risperidone orally disintegrating tablets USP, 3 mg are white to off white, round, biconcave, beveled edged tablets with ‘R470’ embossing on one side and plain on other side and are supplied in cartons of 3 packs and 10 packs containing 10 tablets each. Carton of 3 packs (NDC 55111-470-81), each pack containing 10 tablets (NDC 55111-470-79) Carton of 10 packs (NDC 55111-470-78), each pack containing 10 tablets (NDC 55111-470-79) Risperidone orally disintegrating tablets USP, 4 mg are white to off white, square, biconcave, beveled edged tablets with ‘R471’ embossing on one side and plain on other side and are supplied in cartons of 3 packs and 10 packs containing 10 tablets each. Carton of 3 packs (NDC 55111-471-81), each pack containing 10 tablets (NDC 55111-471-79) Carton of 10 packs (NDC 55111-471-78), each pack containing 10 tablets (NDC 55111-471-79) Store at 20°-25°C (68°-77°F); [See USP Controlled Room Temperature].  Keep out of reach of children.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

RISPERIDONE- RISPERIDONE TABLET, ORALLY DISINTEGRATING
DR. REDDY'S LABORATORIES LIMITED
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO
USERISPERIDONE ORALLY DISINTEGRATING
TABLETS SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR
RISPERIDONE ORALLY
DISINTEGRATING TABLETS.
RISPERIDONE ORALLY DISINTEGRATING TABLETS, 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 (5.8) 02/2017
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)
Risperidone Orally Disintegrating Tablets: Open the blister only when
ready to administer, and immediately place
tablet under tongue. Can be swallowed with or without liquid. (2.7)
DOSAGE FORMS AND STRE