JARDIANCE

Negara: Indonesia

Bahasa: Bahasa Indonesia

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

Bahan aktif:

EMPAGLIFLOZIN

Tersedia dari:

BOEHRINGER INGELHEIM INDONESIA - Indonesia

INN (Nama Internasional):

EMPAGLIFLOZIN

Dosis:

25 MG

Bentuk farmasi:

TABLET SALUT SELAPUT

Unit dalam paket:

DUS, 3 BLISTER @ 10 TABLET SALUT SELAPUT

Diproduksi oleh:

BOEHRINGER INGELHEIM - West Germany

Tanggal Otorisasi:

2017-11-27

Karakteristik produk

BLACK : BPOM APPROVAL CCDS 0278 VER 13 ON 4DEC18, GREEN : BPOM LATEST
APPROVAL CCDS 0278 VER14 ON 19APR2020
BLUE : BI PROPOSED CCDS 0278 VER 06 – CV INDICATION & POSOLOGY EGFR
> 30; BLUE WITH YELLOW HIGHLIGHT : INDICATION REVISED BY BPOM
BLACK WITH YELLOW HIGHLIGHT : BPOM LABELING REQUEST 16APR2020 –BACK
TO PREVIOUS APPROVAL
BOEHRINGER INGELHEIM INDONESIA
MEDICAL AND REGULATORY AFFAIRS
Page 1 of 30
JARDIANCE®
EMPAGLIFLOZIN
COMPOSITION
JARDIANCE film-coated tablets contain
10 or 25 mg
D-Glucitol,1,5-anhydro-1-C-[4-chloro-3-[[4-[[(3S)-tetrahydro-3-
furanyl]oxy]phenyl]methyl]phenyl]-, (1S) (= empagliflozin)
Excipients:
Lactose
monohydrate,
microcrystalline
cellulose,
hydroxypropylcellulose,
croscarmellose
sodium, colloidal anhydrous silica, magnesium stearate, hypromellose,
titanium dioxide, talc,
macrogol 400, iron oxide yellow.
INDICATIONS
ADD ON COMBINATION :
JARDIANCE is indicated in adult patients with type 2 diabetes mellitus
to improve glycemic
control,
when
metformin
used
alone
does
not
provide
adequate
glycemic
control,
in
combination with :
-
metformin
-
metformin and a sulfonylurea,
-
metformin and pioglitazone,
When the existing therapy, along with diet and exercise, does not
provide adequate glycemic
control
FOR
STUDY
RESULTS
WITH
RESPECT
TO
COMBINATION,
EFFECTS
ON
GLYCAEMIC
CONTROL
AND
CARDIOVASCULAR EVENTS, AND THE POPULATIONS STUDIED, SEE SECTIONS
SPECIAL WARNINGS AND
PRECAUTIONS
FOR
USE,
INTERACTION
WITH
OTHER
MEDICINAL
PRODUCTS
AND
OTHER
FORMS
OF
INTERACTIONS, AND PHARMACODYNAMIC PROPERTIES
DOSAGE AND ADMINISTRATION
RECOMMENDED DOSE AND DOSAGE ADJUSTMENT:
The recommended starting dose of JARDIANCE is 10 mg once daily. In
patients tolerating
empagliflozin
10
mg
once
daily
who
have
an
eGFR
≥60
ml/min/1.73m
2
and
requiring
additional glycemic control, the dose can be increased to 25 mg once
daily. JARDIANCE can
be taken with or without food. The maximum daily dose is 25 mg.
PATIENTS WITH RENAL IMPAIRMENT
The efficacy of JARDIANCE is dependent on renal function. Renal
function must be assessed
p