ABILIFY MAINTENA

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:

400 MG/ML

Bentuk farmasi:

CAIRAN INJEKSI

Unit dalam paket:

DUS, 1 PREFILLED DUAL CHAMBER SYRINGE

Diproduksi oleh:

OTSUKA PHARMACEUTICAL CO LTD - Japan

Tanggal Otorisasi:

2018-11-21

Karakteristik produk

ABI-PI-0819-001.01
1
ABILIFY MAINTENA
®
(ARIPIPRAZOLE)
FULL PRESCRIBING INFORMATION
_WARNING: 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. ABILIFY MAINTENA IS NOT APPROVED
FOR THE
TREATMENT
OF
PATIENTS
WITH
DEMENTIA-RELATED
PSYCHOSIS
_[SEE _
_WARNINGS _
_AND _
_PRECAUTIONS (5.1)]._
1 INDICATIONS AND USAGE
ABILIFY MAINTENA (aripiprazole) is indicated for :
•
Treatment of schizophrenia in adults _[see Clinical Studies (14.1)]_
•
Maintenance monotherapy treatment of bipolar I disorder in adults
_[see Clinical _
_Studies (14.2)]._
2 DOSAGE AND ADMINISTRATION
2.1
DOSAGE
OVERVIEW
FOR
THE
TREATMENT
OF
SCHIZOPHRENIA
AND
MAINTENANCE MONOTHERAPY OF BIPOLAR
I DISORDER
ABILIFY MAINTENA is only to be administered by intramuscular injection
by a
healthcare professional. The recommended starting and maintenance dose
of ABILIFY
MAINTENA is 400 mg monthly (no sooner than 26 days after the previous
injection).
For patients who have never taken aripiprazole, establish tolerability
with oral aripiprazo-
le prior to initiating treatment with ABILIFY MAINTENA. Due to the
half-life of oral
aripiprazole, it may take up to 2 weeks to fully assess tolerability.
After the first ABILIFY MAINTENA injection, administer oral
aripiprazole (10 mg to 20
mg) for 14 consecutive days to achieve therapeutic aripiprazole
concentrations during
initiation of therapy. For patients already stable on another oral
antipsychotic (and known
to
tolerate
aripiprazole),
after
the
first
ABILIFY
MAINTENA
injection,
continue
treatment
with
the
antipsychotic
for
14
consecutive
days
to
maintain
therapeutic
antipsychotic concentrations during initiation of therapy.
If there are adverse reactions with the 400 mg dosage, consider
reducing the dosage to
300 mg once monthly.
DISETUJUI OLEH BPOM: 07/09/2021
EREG10021412100093
EREG10021412100094
ABI-PI-0819-001.01
2
2.2 DOSAGE ADJUSTMENTS FOR MISSED DOSES
If the second or t