PALIPERIDONE tablet, extended release

Země: Spojené státy

Jazyk: angličtina

Zdroj: NLM (National Library of Medicine)

Aktivní složka:

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

Dostupné s:

Patriot Pharmaceuticals, LLC

INN (Mezinárodní Name):

paliperidone

Složení:

paliperidone 3 mg

Podání:

ORAL

Druh předpisu:

PRESCRIPTION DRUG

Terapeutické indikace:

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

Přehled produktů:

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.

Stav Autorizace:

New Drug Application Authorized Generic

Charakteristika produktu

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