risperidone tablet film coated
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 are 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) ].
mylan pharmaceuticals inc.
ROUND WHITE R13
R13 ROUND WHITE
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16 HOW SUPPLIED/STORAGE AND HANDLING 16.1 How Supplied Risperidone Tablets, USP are available containing 0.25 mg, 0.5 mg, 1 mg, 2 mg, 3 mg or 4 mg of risperidone, USP. The 0.25 mg tablets are white, film-coated, round, unscored tablets debossed with M on one side of the tablet and R on the other side. They are available as follows: NDC 0378-3502-91 bottles of 60 tablets NDC 0378-3502-05 bottles of 500 tablets The 0.5 mg tablets are beige, film-coated, round, unscored tablets debossed with M on one side of the tablet and R5 on the other side. They are available as follows: NDC 0378-3505-91 bottles of 60 tablets NDC 0378-3505-05 bottles of 500 tablets The 1 mg tablets are white, film-coated, round, unscored tablets debossed with M on one side of the tablet and R11 on the other side. They are available as follows: NDC 0378-3511-91 bottles of 60 tablets NDC 0378-3511-05 bottles of 500 tablets The 2 mg tablets are beige, film-coated, round, unscored tablets debossed with M on one side of the tablet and R12 on the other side. They are available as follows: NDC 0378-3512-91 bottles of 60 tablets NDC 0378-3512-05 bottles of 500 tablets The 3 mg tablets are white, film-coated, round, unscored tablets debossed with M on one side of the tablet and R13 on the other side. They are available as follows: NDC 0378-3513-91 bottles of 60 tablets NDC 0378-3513-05 bottles of 500 tablets The 4 mg tablets are beige, film-coated, round, unscored tablets debossed with M on one side of the tablet and R14 on the other side. They are available as follows: NDC 0378-3514-91 bottles of 60 tablets 16.2 Storage and Handling 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 as defined in the USP using a child-resistant closure. Keep out of reach of children.
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