paliperidone 9 mg
1. INDICATIONS AND USAGE Paliperidone is an atypical antipsychotic agent indicated for Treatment of schizophrenia ( 1.1 ) • Adults: Efficacy was established in three 6-week trials and one maintenance trial. ( 14.1 ) • Adolescents (ages 12-17): Efficacy was established in one 6-week trial. ( 14.1 ) Treatment of schizoaffective disorder as monotherapy and as an adjunct to mood stabilizers and/or antidepressants ( 1.2 ) • Efficacy was established in two 6-week trials in adult patients ( 14.2 ) 1.1 Schizophrenia Paliperidone extended-release tablets are indicated for the treatment of schizophrenia [see Clinical Studies (14.1) ]. The efficacy of paliperidone in schizophrenia was established in three 6-week trials in adults and one 6-week trial in adolescents, as well as one maintenance trial in adults. 1.2 Schizoaffective Disorder Paliperidone extended-release tablets are indicated for the treatment of schizoaffective disorder as monotherapy and an adjunct to mood stabilizers and/or antidepressant therapy [see Clinical Studies (14.2) ]. The efficacy of paliperidone in schizoaffective disorder was established in two 6-week trials in adults.
ani pharmaceuticals, inc.
ROUND PINK 035
035 ROUND PINK
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16. HOW SUPPLIED/STORAGE AND HANDLING
PALIPERIDONE extended-release tablets are available in the following strengths and packages. All tablets are circular shaped. 1.5 mg tablets are orange-brown colored, circular shaped, biconvex, beveled edged, coated tablet plain on one side and "032" printed in black ink on other side, and are available in bottles of 30 (NDC 43975-349-03). 3 mg tablets are white to off-white colored, circular shaped, biconvex, beveled edged, coated tablet plain on one side and "033" printed in black ink on other side, and are available in bottles of 30 (NDC 43975-350-03). 6 mg tablets are beige colored, circular shaped, biconvex, beveled edged, coated tablet plain on one side and "034" printed in black ink on other side, and are available in bottles of 30 (NDC 43975-351-03). 9 mg tablets are pink colored, circular shaped, biconvex, beveled edged, coated tablet plain on one side and "035" printed in black ink on other side, and are available in bottles of 30 (NDC 43975-352-03). Storage and Handling Store at 20º to 25ºC (68º to 77ºF) [see USP Controlled Room Temperature] . Protect from moisture. Dispense in a tight container. Keep out of reach of children.
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