Land: Indonesien
Språk: indonesiska
Källa: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency
ARIPIPRAZOLE
OTSUKA INDONESIA - Indonesia
ARIPIPRAZOLE
10 MG
TABLET
DUS, 1 BLISTER @ 10 TABLET
KOREA OTSUKA PHARMACEUTICAL Co. Ltd - Korea
2015-05-12
ABILIFY ® TABLETS ABILIFY ® ORAL SOLUTION ABILIFY DISCMELT ® ORALLY DISINTEGRATING TABLETS (ARIPIPRAZOLE) WARNINGS: INCREASED MORTALITY ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS AND SUICIDALITY AND ANTIDEPRESSANT DRUGS ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS TREATED WITH ANTIPSYCHOTIC DRUGS ARE AT AN INCREASED RISK OF DEATH. ABILIFY (ARIPIPRAZOLE) IS NOT APPROVED FOR THE TREATMENT OF PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS _[SEE WARNINGS AND PRECAUTIONS _ _(5.1)]_. ANTIDEPRESSANTS INCREASED THE RISK OF SUICIDAL THOUGHTS AND BEHAVIOR IN CHILDREN, ADOLESCENTS, AND YOUNG ADULTS IN SHORT-TERM STUDIES. THESE STUDIES DID NOT SHOW AN INCREASE IN THE RISK OF SUICIDAL THOUGHTS AND BEHAVIOUR WITH ANTIDEPRESSANTS USE IN PATIENTS OVER AGE 24; THERE WAS A REDUCTION IN RISK WITH ANTIDEPRESSANTS USE IN PATIENTS AGED 65 AND OLDER. [SEE _WARNINGS AND PRECAUTIONS (5.3)_]. IN PATIENTS OF ALL AGES WHO ARE STARTED ON ANTIDEPRESSANT THERAPY, MONITOR CLOSELY FOR WORSENING, AND FOR EMERGENCE OF SUICIDAL THOUGHTS AND BEHAVIOR. ADVISE FAMILIES AND CAREGIVERS OF THE NEED FOR CLOSE OBSERVATION AND COMMUNICATION WITH THE PRESCRIBER. _[SEE WARNINGS AND PRECAUTIONS (5.3)]_. 1 INDICATIONS AND USAGE 1.1 SCHIZOPHRENIA ABILIFY is indicated for the treatment of schizophrenia. The efficacy of ABILIFY was established in four 4-6 week trials in adults and one 6-week trial in adolescents (13 to 17 years). Maintenance efficacy was demonstrated in one trial in adults and can be extrapolated to adolescents _[see Clinical Studies (14.1)]. _ 1.2 BIPOLAR I DISORDER ACUTE TREATMENT OF MANIC AND MIXED EPISODES ABILIFY is indicated for the acute treatment of manic and mixed episodes associated with bipolar I disorder, both as monotherapy and as an adjunct to lithium or valproate. DISETUJUI OLEH BPOM : 27/09/2021 ID : EREG10021412100088 EREG10021412100089 EREG10021412100090 EREG10021412100091 EREG10021412100092 EREG10021412100095 Efficacy as monotherapy was established in four 3-week monotherapy trials in adults and one 4-week monotherapy tri Läs hela dokumentet