INVEGA paliperidone tablet extended release

Страна: САЩ

Език: английски

Източник: NLM (National Library of Medicine)

Активна съставка:

paliperidone (UNII: 838F01T721) (paliperidone - UNII:838F01T721)

Предлага се от:

Avera McKennan Hospital

INN (Международно Name):

paliperidone

Композиция:

paliperidone 6 mg

Вид предписание :

PRESCRIPTION DRUG

Статус Оторизация:

New Drug Application

Данни за продукта

INVEGA- PALIPERIDONE TABLET, EXTENDED RELEASE
AVERA MCKENNAN HOSPITAL
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
INVEGA SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING INFORMATION FOR INVEGA .
INVEGA (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. INVEGA IS NOT APPROVED FOR USE IN PATIENTS WITH
DEMENTIA-RELATED PSYCHOSIS. (5.1)
INDICATIONS AND USAGE
INVEGA 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
RECO MMENDED
DO SE
MAXIMUM
DO SE
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
components in the formulation. (4)
WARNINGS AND PRECAUTIONS
_Cerebrovascular Adverse Reactions: _An increased incidence of
cerebrovascular adverse reactions (e.g. stroke, transient
ischemic attack, including fatalities) has been seen in elderly
patients with dementia- related psychoses treated with
atypical antipsy