REXULTI

Negara: Indonesia

Bahasa: Bahasa Indonesia

Sumber: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency

Bahan aktif:

BREXPIPRAZOLE

Tersedia dari:

OTSUKA INDONESIA - Indonesia

INN (Nama Internasional):

BREXPIPRAZOLE

Dosis:

1.0 MG

Bentuk farmasi:

TABLET SALUT SELAPUT

Unit dalam paket:

DUS, 1 BLISTER @ 10 TABLET SALUT SELAPUT

Diproduksi oleh:

KOREA OTSUKA PHARMACEUTICAL - Republic Of Korea

Tanggal Otorisasi:

2020-02-09

Karakteristik produk

REX-PI-1119-001.04
1
Rexulti
®
(Brexpiprazole) tablets 0.25mg, 0.5mg, 1mg, 2mg, 3mg and 4mg
FULL PRESCRIBING INFORMATION
WARNING: INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-
RELATED PSYCHOSIS
INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED
PSYCHOSIS
ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS TREATED WITH
ANTIPSYCHOTIC DRUGS ARE AT AN
INCREASED RISK OF DEATH. REXULTI IS NOT APPROVED FOR THE TREATMENT OF
PATIENTS WITH DEMENTIA-
RELATED PSYCHOSIS _[SEE WARNINGS AND PRECAUTIONS (5.1)]_.
1 INDICATIONS AND USAGE
ADULTS
Schizophrenia
Treatment of exacerbation and maintenance of schizophrenia for
adults_[see Clinical Studies (14.1)]_.
Adjunctive Treatment of Major Depressive Disorder (MDD)
REXULTI is indicated for use as an adjunct to antidepressants for the
treatment of major depressive disorder
(MDD) in adult patients with an inadequate response to prior
antidepressant treatments during the current
episode. REXULTI should be used for the shortest period of time that
is clinically indicated. The efficacy and
safety of REXULTI in the adjunctive treatment of MDD were demonstrated
in 6-week, double-blind, placebo
controlled trials in adult patients [_see Clinical Studies (14.2)_].
When considering the use of REXULTI as adjunctive treatment in MDD,
clinicians must take into account the
safety concerns associated with antipsychotic drugs, a class of drugs
to which REXULTI belongs. Safety
concerns of this class include: weight gain; hyperlipidemia;
hyperglycaemia; Tardive Dyskinesia; and
Neuroleptic Malignant Syndrome [_see Warnings and Precautions (5.6),
(5.7), (5.8)_]. REXULTI should only
be prescribed in patients with MDD by clinicians who are aware of the
importance and are experienced in the
early detection and management of the safety issues associated with
this class of drugs.
Clinical trials evaluating REXULTI in MDD did not include REXULTI
monotherapy treatment arms. It is,
therefore, not known whether efficacy in adjunct treatment is due to
REXULTI alone or from combined
treatment wit