البلد: الولايات المتحدة
اللغة: الإنجليزية
المصدر: NLM (National Library of Medicine)
PALIPERIDONE (UNII: 838F01T721) (PALIPERIDONE - UNII:838F01T721)
Patriot Pharmaceuticals, LLC
paliperidone
paliperidone 3 mg
ORAL
PRESCRIPTION DRUG
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. 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. Paliperidone Extended-Release Tablets are contraindicated in patients with a known hypersensitivity to either paliperidone or risperidone, or to any of the excipients in the Paliperidone Extended-Release Tablets formulation. Hypersensitivity reactions, including anaphylactic reactions and angioedema, have been reported in patients t
Paliperidone Extended-Release Tablets are available in the following strengths and packages. All tablets are capsule-shaped. 1.5 mg tablets are orange-brown and imprinted with "PAL 1.5", and are available in bottles of 30 (NDC 10147-0951-3). 3 mg tablets are white and imprinted with "PAL 3", and are available in bottles of 30 (NDC 10147-0952-3) and hospital unit dose packs of 100 (NDC 10147-0952-1). 6 mg tablets are beige and imprinted with "PAL 6", and are available in bottles of 30 (NDC 10147-0953-3) and hospital unit dose packs of 100 (NDC 10147-0953-1). 9 mg tablets are pink and imprinted with "PAL 9", and are available in bottles of 30 (NDC 10147-0954-3) and hospital unit dose packs of 100 (NDC 10147-0954-1). Storage and Handling Store up to 25ºC (77ºF); excursions permitted to 15 – 30ºC (59 – 86ºF) [see USP Controlled Room Temperature]. Protect from moisture. Keep out of reach of children.
New Drug Application Authorized Generic
PALIPERIDONE- PALIPERIDONE TABLET, EXTENDED RELEASE PATRIOT PHARMACEUTICALS, LLC ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE PALIPERIDONE EXTENDED- RELEASE TABLETS SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR PALIPERIDONE EXTENDED-RELEASE TABLETS. PALIPERIDONE EXTENDED-RELEASE TABLETS INITIAL U.S. APPROVAL: 2006 WARNING: INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS _SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._ ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS TREATED WITH ANTIPSYCHOTIC DRUGS ARE AT AN INCREASED RISK OF DEATH. PALIPERIDONE EXTENDED-RELEASE TABLETS ARE NOT APPROVED FOR USE IN PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS. ( 5.1) 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) DOSAGE AND ADMINISTRATION INITIAL DOSE RECOMMENDED DOSE MAXIMUM DOSE Schizophrenia - adults ( 2.1) 6 mg/day 3 – 12 mg/day 12 mg/day Schizophrenia-adolescents ( 2.1) Weight < 51kg 3 mg/day 3 – 6 mg/day 6 mg/day Weight ≥ 51kg 3 mg/day 3 – 12 mg/day 12 mg/day Schizoaffective disorder - adults ( 2.2) 6 mg/day 3 – 12 mg/day 12 mg/day Tablet should be swallowed whole and should not be chewed, divided, or crushed. ( 2.3) DOSAGE FORMS AND STRENGTHS Tablets: 1.5 mg, 3 mg, 6 mg, and 9 mg ( 3) CONTRAINDICATIONS Known hypersensitivity to paliperidone, risperidone, or to any excipients in Paliperidone Extended-Release Tablets. ( 4) WARNINGS AND PRECAUTIONS _Cerebrovascular Adverse Reactions:_An increased incidence of cerebrovascular adverse reactions (e.g. stroke, transient isc اقرأ الوثيقة كاملة