Země: Indonésie
Jazyk: indonéština
Zdroj: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency
BREXPIPRAZOLE
OTSUKA INDONESIA - Indonesia
BREXPIPRAZOLE
3.0 MG
TABLET SALUT SELAPUT
DUS, 2000 BLISTER @ 10 TABLET SALUT SELAPUT (BULK)
KOREA OTSUKA PHARMACEUTICAL - Republic Of Korea
2020-02-09
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 Přečtěte si celý dokument