risperidone 3 mg 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) ] .

amneal pharmaceuticals ny llc

FDA Reported Adverse Reactions
`[1] gynaecomastia` `[2] drug ineffective` `[3] off label use` `[4] toxicity to various agents` `[5] completed suicide` `[6] drug abuse` `[7] drug interaction` `[8] weight increased` `[9] nausea` `[10] fatigue`

3 years ago

ROUND YELLOW r3

16 HOW SUPPLIED/STORAGE AND HANDLING 16.1 How Supplied

RISPERIDONE Tablets USP, 0.25 mg, are supplied as yellow, round, biconvex, film coated tablet debossed with ‘r’ on one side and plain on other side. They are available as follows: Bottles of 60: NDC 69238-2108-6 Bottles of 500: NDC 69238-2108-5

RISPERIDONE Tablets USP, 0.5 mg, are supplied as brown, round, biconvex, film coated tablet debossed with ‘r 5’ on one side and plain on other side. They are available as follows: Bottles of 60: NDC 69238-2109-6 Bottles of 500: NDC 69238-2109-5

RISPERIDONE Tablets USP, 1 mg, are supplied as white, round, biconvex, film coated tablet debossed with ‘r 1’ on one side and plain on other side. They are available as follows: Bottles of 60: NDC 69238-2110-6 Bottles of 500: NDC 69238-2110-5

RISPERIDONE Tablets USP, 2 mg, are supplied as orange, round, biconvex, film coated tablet debossed with ‘r 2’ on one side and plain on other side. They are available as follows: Bottles of 60: NDC 69238-2111-6 Bottles of 500: NDC 69238-2111-5

RISPERIDONE Tablets USP, 3 mg, are supplied as yellow, round, biconvex, film coated tablet debossed with ‘r 3’ on one side and plain on other side. They are available as follows: Bottles of 60: NDC 69238-2112-6 Bottles of 500: NDC 69238-2112-5

RISPERIDONE Tablets USP, 4 mg, are supplied as green, round, biconvex, film coated tablet debossed with ‘r 4’ on one side and plain on other side. They are available as follows: Bottles of 60: NDC 69238-2113-6 Bottles of 500: NDC 69238-2113-5 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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