24 HR paliperidone 6 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 12-17): 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 extended-release tablets in schizoaffective disorder was established in two 6-week trials in adults.
Mylan Pharmaceuticals Inc.
ROUND BROWN M PD6
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16 HOW SUPPLIED/STORAGE AND HANDLING
PALIPERIDONE Extended-Release Tablets are available containing 1.5 mg, 3 mg, 6 mg or 9 mg of
PALIPERIDONE, USP. The 1.5 mg tablets are brown, film-coated, round, unscored tablets imprinted with M over PD1 in black ink on one side of the tablet and blank on the other side. They are available as follows: NDC 0378-3978-93 bottles of 30 tablets The 3 mg tablets are white, film-coated, round, unscored tablets imprinted with M over PD3 in black ink on one side of the tablet and blank on the other side. They are available as follows: NDC 0378-3979-93 bottles of 30 tablets The 6 mg tablets are light beige, film-coated, round, unscored tablets imprinted with M over PD6 in black ink on one side of the tablet and blank on the other side. They are available as follows: NDC 0378-3980-93 bottles of 30 tablets The 9 mg tablets are pink, film-coated, round, unscored tablets imprinted with M over PD9 in black ink on one side of the tablet and blank on the other side. They are available as follows: NDC 0378-3981-93 bottles of 30 tablets 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, light-resistant container as defined in the USP using a child-resistant closure. Keep out of reach of children.
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