24 HR paliperidone 3 MG Extended Release Oral Tablet
1 INDICATIONS AND USAGE Paliperidone extended-release tablets are 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 extended-release tablets 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.
Amneal Pharmaceuticals LLC
ROUND WHITE AN 81
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16 HOW SUPPLIED/STORAGE AND HANDLING
PALIPERIDONE extended-release tablets, 1.5 mg , are supplied as brown, round, biconvex tablets, debossed “AN” over “80” on one side and plain on the other side. They are available as follows: Bottles of 30: NDC 65162-280-03 Bottles of 90: NDC 65162-280-09
PALIPERIDONE extended-release tablets, 3 mg , are supplied as white, round, biconvex tablets, debossed “AN” over “81” on one side and plain on the other side. They are available as follows: Bottles of 30: NDC 65162-281-03 Bottles of 90: NDC 65162-281-09
PALIPERIDONE extended-release tablets, 6 mg , are supplied as light beige, round, biconvex tablets, debossed “AN” over “82” on one side and plain on the other side. They are available as follows: Bottles of 30: NDC 65162-282-03 Bottles of 90: NDC 65162-282-09
PALIPERIDONE extended-release tablets, 9 mg , are supplied as pink, round, biconvex tablets, debossed “AN” over “83” on one side and plain on the other side. They are available as follows: Bottles of 30: NDC 65162-283-03 Bottles of 90: NDC 65162-283-09 Storage and Handling Store at 20° to 25ºC (68° to 77ºF); excursions permitted between 15° to 30ºC (59° to 86ºF) [see USP Controlled Room Temperature]. Protect from moisture. Keep out of reach of children.
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