Quốc gia: Hoa Kỳ
Ngôn ngữ: Tiếng Anh
Nguồn: NLM (National Library of Medicine)
PALIPERIDONE (UNII: 838F01T721) (PALIPERIDONE - UNII:838F01T721)
Inventia Healthcare Limited
ORAL
PRESCRIPTION DRUG
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. 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. Paliperidoneis contraindicated in patients with a known hypersensitivity to either paliperidone or risperidone, or to any of the excipients in the Paliperidone formulation. Hypersensitivity reactions, including anaphylactic reactions and angioedema, have been reported in patients treated with risperidone and in patients treated with paliperidone. Paliperidone is a metabolite of risperidone. Pregnancy Exposure Reg
Paliperidone extended-release tablets are available in the following strengths and packages. All tablets are circular shaped. 1.5 mg tablets are orange-brown colored, circular shaped, biconvex, beveled edged, coated tablet plain on one side and "032" printed in black ink on other side, and are available in bottles of 30 (NDC 49252-032-10). 3 mg tablets are white to off-white colored, circular shaped, biconvex, beveled edged, coated tablet plain on one side and "033" printed in black ink on other side, and are available in bottles of 30 (NDC 49252-033-10). 6 mg tablets are beige colored, circular shaped, biconvex, beveled edged, coated tablet plain on one side and "034" printed in black ink on other side, and are available in bottles of 30 (NDC 49252-034-10). 9 mg tablets are pink colored, circular shaped, biconvex, beveled edged, coated tablet plain on one side and "035" printed in black ink on other side, and are available in bottles of 30 (NDC 49252-035-10). Storage and Handling Store at 20º to 25ºC (68º to 77ºF)[see USP Controlled Room Temperature] . Protect from moisture. Dispense in a tight container. Keep out of reach of children.
Abbreviated New Drug Application
PALIPERIDONE- PALIPERIDONE TABLET, EXTENDED RELEASE INVENTIA HEALTHCARE LIMITED ---------- 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, FOR ORAL USE 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 IS NOT APPROVED FOR USE IN PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS. (5.1) RECENT MAJOR CHANGES Warnings and Precautions (5.5) 07/2018 Warnings and Precautions, Suicide (5.15) Removed 07/2018 Warnings and Precautions, Monitoring: Laboratory Tests(5.21) Removed 07/2018 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- Weight < 51kg 3 mg/day 3 - 6 mg/day 6 mg/day adolescents (2.1) 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. (4) WARN Đọc toàn bộ tài liệu