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 Institutional Inc.
ROUND BROWN M PD6
Related Pills
paliperidone tablet film coated extended release
mylan institutional inc.
24 HR paliperidone 3 MG Extended Release Oral Tablet
Mylan Institutional Inc.
24 HR paliperidone 6 MG Extended Release Oral Tablet
Mylan Pharmaceuticals Inc.
DISCLAIMER:
"This tool does not provide medical advice, and is for informational and educational purposes only, and is not a substitute for professional medical advice, treatment or diagnosis. Call your doctor to receive medical advice. If you think you may have a medical emergency, please dial 911."
"Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service."
"This product uses publicly available data from the U.S. National Library of Medicine (NLM), National Institutes of Health, Department of Health and Human Services; NLM is not responsible for the product and does not endorse or recommend this or any other product."
PillSync may earn a commission via links on our site
16 HOW SUPPLIED/STORAGE AND HANDLING Paliperidone Extended-Release Tablets are available containing 3 mg, 6 mg or 9 mg of paliperidone, USP. 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 42292-026-20 – Unit dose blister packages of 100 (10 cards of 10 tablets each). 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 42292-027-20 – Unit dose blister packages of 100 (10 cards of 10 tablets each). 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 42292-055-05 – Unit dose blister packages of 20 (2 cards of 10 tablets each). Storage and Handling: Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Protect from moisture. Keep out of reach of children.
More pills like ROUND M PD6