Risperidone 0.5 MG Oral Tablet
1 INDICATIONS AND USAGE Risperidone tablets are 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 ) 1.1 schizophrenia Risperidone 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 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 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 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) ] .
Ajanta Pharma Limited
ROUND ORANGE R12
R12 ROUND ORANGE
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16 HOW SUPPLIED/STORAGE AND HANDLING 16.1 How Supplied
RISPERIDONE Tablets
RISPERIDONE Tablets, USP 0.25 mg are orange, circular, biconvex, film-coated tablets, engraved with 'RI1' on one side and plain on other and are supplied as follows: Bottles of 60’s with child-resistant closure NDC 27241-002-06 Bottles of 500's NDC 27241-002-50
RISPERIDONE Tablets, USP 0.5 mg are orange, circular, biconvex, film-coated tablets, engraved with 'RI2' on one side and plain on other and are supplied as follows: Bottles of 60’s with child-resistant closure NDC 27241-003-06 Bottles of 500's NDC 27241-003-50
RISPERIDONE Tablets, USP 1 mg are white to off white, circular, biconvex, film-coated tablets, engraved with 'RI3' on one side and plain on other and are supplied as follows: Bottles of 60’s with child-resistant closure NDC 27241-001-06 Bottles of 500's NDC 27241-001-50
RISPERIDONE Tablets, USP 2 mg are yellow, circular, biconvex film-coated tablets, engraved with 'RI4' on one side and plain on other and are supplied as follows: Bottles of 60’s with child-resistant closure NDC 27241-004-06 Bottles of 500's NDC 27241-004-50
RISPERIDONE Tablets, USP 3 mg are orange, capsule shaped, biconvex film-coated tablets, engraved with 'RI5' on one side and plain on other and are supplied as follows: Bottles of 60’s with child-resistant closure NDC 27241-005-06 Bottles of 500's NDC 27241-005-50
RISPERIDONE Tablets, USP 4 mg are brown, ovaloid, biconvex, film-coated tablets, engraved with 'RI6' on one side and plain on other and are supplied as follows: Bottles of 60’s with child-resistant closure NDC 27241-006-06 Bottles of 500's NDC 27241-006-50 16.2 Storage and Handling
RISPERIDONE tablets should be stored at 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86°F) [see USP controlled room temperature]. Protect from light and moisture. Keep out of reach of children.
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