24 HR paliperidone 1.5 MG Extended Release Oral Tablet
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 to 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.
Actavis Pharma, Inc.
ROUND BROWN WPI 1 5
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16 HOW SUPPLIED/STORAGE AND HANDLING Paliperidone extended-release tablets are available in the following strengths and packages. 1.5 mg tablets are beige, round, unscored, film-coated tablets, imprinted with “ WPI ” and “ 1.5 ”, and are available in bottles of 30 (NDC 0591-3692-30). 3 mg tablets are white to off-white, round, unscored, film-coated tablets, imprinted with “ WPI ” and “ 3 ”, and are available in bottles of 30 (NDC 0591-3693-30). 6 mg tablets are reddish-brown, round, unscored, film-coated tablets, imprinted with “ WPI ” and “ 6 ”, and are available in bottles of 30 (NDC 0591-3694-30). 9 mg tablets are blue, round, unscored, film-coated tablets, imprinted with “ WPI ” and “ 9 ”, and are available in bottles of 30 (NDC 0591-3695-30). Storage and Handling Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Protect from moisture. Dispense in a tight container. Keep out of reach of children.
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