risperidone 2 mg
1 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 ) 1.1 schizophrenia Risperidone is 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 is 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 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 is 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) ] .
janssen pharmaceutical, inc.
OVAL ORANGE PATR R 2
PATR R 2 OVAL ORANGE
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16 HOW SUPPLIED/STORAGE AND HANDLING 16.1 How Supplied
RISPERIDONE Tablets
RISPERIDONE Tablets are imprinted "PATR" on one side and either "Ris 0.5", "R1", "R2", "R3", or "R4" according to their respective strengths. 0.5 mg red-brown, capsule-shaped tablets: bottles of 60 NDC 50458-591-60, bottles of 500 NDC 50458-591-50, and hospital unit dose blister packs of 100 NDC 50458-591-10. 1 mg white, capsule-shaped tablets: bottles of 60 NDC 50458-592-60, bottles of 500 NDC 50458-592-50, and hospital unit dose blister packs of 100 NDC 50458-592-10. 2 mg orange, capsule-shaped tablets: bottles of 60 NDC 50458-593-60, bottles of 500 NDC 50458-593-50, and hospital unit dose blister packs of 100 NDC 50458-593-10. 3 mg yellow, capsule-shaped tablets: bottles of 60 NDC 50458-594-60, bottles of 500 NDC 50458-594-50, and hospital unit dose blister packs of 100 NDC 50458-594-10. 4 mg green, capsule-shaped tablets: bottles of 60 NDC 50458-595-60 and hospital unit dose blister packs of 100 NDC 50458-595-10.
RISPERIDONE Oral Solution
RISPERIDONE 1 mg/mL Oral Solution (NDC 50458-596-01) is supplied in 30 mL bottles with a calibrated (in milliliters) oral dosing syringe. The minimum calibrated volume is 0.25 mL, while the maximum calibrated volume is 3 mL.
RISPERIDONE Orally Disintegrating Tablets
RISPERIDONE Orally Disintegrating Tablets are etched on one side with "P0.5", "P1", "P2", "P3", or "P4" according to their respective strengths.
RISPERIDONE Orally Disintegrating Tablets 0.5 mg, 1 mg, and 2 mg are packaged in blister packs of 4 (2 × 2) tablets.
RISPERIDONE Orally Disintegrating Tablets 3 mg and 4 mg are packaged in a child-resistant pouch containing a blister with 1 tablet. 0.5 mg light coral, round, biconvex tablets: 7 blister packages (4 tablets each) per box, NDC 50458-601-28. 1 mg light coral, square, biconvex tablets: 7 blister packages (4 tablets each) per box, NDC 50458-602-28. 2 mg coral, square, biconvex tablets: 7 blister packages (4 tablets each) per box, NDC 50458-603-28. 3 mg coral, round, biconvex tablets: 28 blisters per box, NDC 50458-604-28. 4 mg coral, round, biconvex tablets: 28 blisters per box, NDC 50458-605-28. 16.2 Storage and Handling
RISPERIDONE Tablets should be stored at controlled room temperature 15°–25°C (59°–77°F). Protect from light and moisture.
RISPERIDONE 1 mg/mL Oral Solution should be stored at controlled room temperature 15°–25°C (59°–77°F). Protect from light and freezing.
RISPERIDONE Orally Disintegrating Tablets should be stored at controlled room temperature 15°–25°C (59°–77°F). Keep out of reach of children.
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