PALIPERIDONE- paliperidone tablet, extended release

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

REMEDYREPACK INC.

INN (International Name):

PALIPERIDONE

Composition:

PALIPERIDONE 9 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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 treated with risperidone and

Product summary:

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.

Authorization status:

New Drug Application

Summary of Product characteristics

PALIPERIDONE- PALIPERIDONE TABLET, EXTENDED RELEASE
REMEDYREPACK INC.
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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
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)
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-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 Paliper