Risperidone 3 MG Disintegrating Oral Tablet
1 INDICATIONS AND USAGE Risperidone orally disintegrating tablets are 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 ) 1.1 schizophrenia Risperidone orally disintegrating tablets 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) ] . 1.2 Bipolar Mania 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) ] . 1.3 Irritability Associated with Autistic Disorder Risperidone orally disintegrating tablets are indicated for the treatment of irritability associated with autistic disorder, including symptoms of aggression towards others, deliberate self-injuriousness, temper tantrums, and quickly changing moods. Efficacy was established in 3 short-term trials in children and adolescents (ages 5 to 17 years) [see Clinical Studies (14.4) ] .
Jubilant Cadista Pharmaceuticals Inc.
ROUND ORANGE C 04
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16 HOW SUPPLIED/STORAGE AND HANDLING 16.1 How Supplied
RISPERIDONE Orally Disintegrating Tablets, USP 0.5 mg are yellow colored, mottled, round, flat faced beveled edged tablets, debossed with ‘C’ on one side and ‘01’ on the other side with characteristic flavor. 7 Blister cards each containing 4 tablets NDC 59746-010-22 3 Blister cards each containing 10 tablets NDC 59746-010-32
RISPERIDONE Orally Disintegrating Tablets, USP 1 mg are white, round, flat faced beveled edged tablets, debossed with ‘C’ on one side and ‘02’ on the other side with characteristic flavor. 7 Blister cards each containing 4 tablets NDC 59746-020-22 3 Blister cards each containing 10 tablets NDC 59746-020-32
RISPERIDONE Orally Disintegrating Tablets, USP 2 mg are blue colored, mottled, round, flat faced beveled edged tablets, debossed with ‘C’ on one side and ‘03’ on the other side with characteristic flavor. 7 Blister cards each containing 4 tablets NDC 59746-030-22
RISPERIDONE Orally Disintegrating Tablets, USP 3 mg are orange colored, mottled, round, flat faced beveled edged tablets, debossed with ‘C’ on one side and ‘04’ on the other side with characteristic flavor. 7 Blister cards each containing 4 tablets NDC 59746-040-22
RISPERIDONE Orally Disintegrating Tablets, USP 4 mg are pink colored, mottled, round, flat faced beveled edged tablets, debossed with ‘C’ on one side and ‘05’ on the other side with characteristic flavor. 7 Blister cards each containing 4 tablets NDC 59746-050-22 16.2 Storage and Handling
RISPERIDONE Orally Disintegrating Tablets, USP: Store at room temperature between 20°C to 25°C (68°C to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [See USP Controlled Room Temperature]. Keep out of reach of children.
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