PALIPERIDONE tablet, film coated, extended release

Negara: Amerika Serikat

Bahasa: Inggris

Sumber: NLM (National Library of Medicine)

Bahan aktif:

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

Tersedia dari:

Mylan Institutional Inc.

INN (Nama Internasional):

PALIPERIDONE

Komposisi:

PALIPERIDONE 3 mg

Rute administrasi :

ORAL

Jenis Resep:

PRESCRIPTION DRUG

Indikasi Terapi:

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

Ringkasan produk:

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.

Status otorisasi:

Abbreviated New Drug Application

Karakteristik produk

PALIPERIDONE- PALIPERIDONE TABLET, FILM COATED, EXTENDED RELEASE
MYLAN INSTITUTIONAL INC.
----------
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 EXTENDED-RELEASE TABLETS
ARE NOT APPROVED
FOR USE IN PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS. ( 5.1)
RECENT MAJOR CHANGES
Warnings and Precautions ( 5.5) Removed 07/2018
Warnings and Precautions ( ERROR! HYPERLINK REFERENCE NOT VALID.)
Removed 07/2018
Warnings and Precautions, Monitoring: Laboratory Removed
Tests ( ERROR! HYPERLINK REFERENCE NOT VALID.) 07/2018
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)
DOSAGE AND ADMINISTRATION
INITIAL
DOSE
RECOMMENDED
DOSE
MAXIMUM
DOSE
DOSE
DOSE
DOSE
Schizophrenia – adults ( 2.1)
6 mg/day
3 - 12 mg/day
12 mg/day
Schizophrenia –
adolescents (
2.1)
Weight
< 51 kg
3 mg/day
3 - 6 mg/day
6 mg/day
Weight
≥ 51 kg
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
Tabl