PALIPERIDONE tablet, extended release

国家: 美国

语言: 英文

来源: NLM (National Library of Medicine)

有效成分:

PALIPERIDONE (UNII: 838F01T721) (PALIPERIDONE - UNII:838F01T721)

可用日期:

Inventia Healthcare Limited

给药途径:

ORAL

处方类型:

PRESCRIPTION DRUG

疗效迹象:

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

產品總結:

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.

授权状态:

Abbreviated New Drug Application

产品特点

PALIPERIDONE- PALIPERIDONE TABLET, EXTENDED RELEASE
INVENTIA HEALTHCARE LIMITED
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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