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 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 ) ] .
Apotex Corp
OVAL ORANGE APO RI 2
APO RI 2 OVAL ORANGE
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16 HOW SUPPLIED / STORAGE AND HANDLING 16.1 How Supplied Risperidone tablets, USP 0.25 mg are available for oral administration as yellow ochre, capsule shaped, biconvex, film-coated tablets, engraved "APO" on one side, "RI .25" on the other side. They are supplied as follows: Bottles of 30 (NDC 60505-2584-3) Bottles of 60 (NDC 60505-2584-6) Bottles of 500 (NDC 60505-2584-5) Bottles of 1,000 (NDC 60505-2584-8) Bottles of 42,000 (NDC 60505-2584-7) Blisters of 100 (NDC 60505-2584-0) Risperidone tablets, USP 0.5 mg are available for oral administration as brownish-red, capsule shaped, biconvex, film-coated tablets, engraved "APO" on one side, "RI .5" on the other side. They are supplied as follows: Bottles of 30 (NDC 60505-2585-3) Bottles of 60 (NDC 60505-2585-6) Bottles of 500 (NDC 60505-2585-5) Bottles of 1,000 (NDC 60505-2585-8) Bottles of 20,000 (NDC 60505-2585-7) Blisters of 100 (NDC 60505-2585-0) Risperidone tablets, USP 1 mg are available for oral administration as white, capsule shaped, biconvex, film-coated tablets, engraved "APO" on one side, "RI 1" on the other side. They are supplied as follows: Bottles of 30 (NDC 60505-2586-3) Bottles of 60 (NDC 60505-2586-6) Bottles of 500 (NDC 60505-2586-5) Bottles of 1,000 (NDC 60505-2586-8) Bottles of 20,000 (NDC 60505-2586-7) Blisters of 100 (NDC 60505-2586-0) Risperidone tablets, USP 2 mg are available for oral administration as light orange, capsule shaped, biconvex, film-coated tablets, engraved "APO" on one side, "RI 2" on the other side. They are supplied as follows: Bottles of 30 (NDC 60505-2587-3) Bottles of 60 (NDC 60505-2587-6) Bottles of 500 (NDC 60505-2587-5) Bottles of 1,000 (NDC 60505-2587-8) Bottles of 10,000 (NDC 60505-2587-7) Blisters of 100 (NDC 60505-2587-0) Risperidone tablets, USP 3 mg are available for oral administration as beige, capsule shaped, biconvex, film-coated tablets, engraved "APO" on one side, "RI 3" on the other side. They are supplied as follows: Bottles of 30 (NDC 60505-2588-3) Bottles of 60 (NDC 60505-2588-6) Bottles of 500 (NDC 60505-2588-5) Bottles of 1,000 (NDC 60505-2588-8) Bottles of 10,000 (NDC 60505-2588-7) Blisters of 100 (NDC 60505-2588-0) Risperidone tablets, USP 4 mg are available for oral administration as light green, capsule shaped, biconvex, film-coated tablets, engraved "APO" on one side, "RI 4" on the other side. They are supplied as follows: Bottles of 30 (NDC 60505-2589-3) Bottles of 60 (NDC 60505-2589-6) Bottles of 1,000 (NDC 60505-2589-8) Bottles of 7,300 (NDC 60505-2589-7) Blisters of 100 (NDC 60505-2589-0) 16.2 Storage and Handling Store at 20ºC to 25ºC (68ºF to 77ºF); excursions permitted from 15ºC to 30ºC (59ºF to 86ºF) [see USP Controlled Room Temperature]. Dispense in a tight, light-resistant container [see USP]. Protect from moisture. Keep out of reach of children.
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