ABILIFY TABLET 15 MG

Negara: Indonesia

Bahasa: Bahasa Indonesia

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

Bahan aktif:

ARIPIPRAZOLE

Tersedia dari:

OTSUKA INDONESIA - Indonesia

INN (Nama Internasional):

ARIPIPRAZOLE

Dosis:

15 MG

Bentuk farmasi:

TABLET

Unit dalam paket:

DUS, 1 BLISTER @ 10 TABLET

Diproduksi oleh:

KOREA OTSUKA PHARMACEUTICAL Co. Ltd - Korea

Tanggal Otorisasi:

2015-05-12

Karakteristik produk

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