XIGDUO XR

Country: Индонезија

Језик: Индонежански

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

Активни састојак:

DAPAGLIFLOZIN PROPENADIOL; METFORMIN HYDROCHLORIDE

Доступно од:

ASTRAZENECA INDONESIA - Indonesia

INN (Међународно име):

DAPAGLIFLOZIN PROPENADIOL; METFORMIN HYDROCHLORIDE

Дозирање:

5/1000 MG

Фармацеутски облик:

TABLET SALUT SELAPUT

Јединице у пакету:

BOX, 4 BLISTERS @ 7 TABLET SALUT SELAPUT

Произведен од:

ASTRAZENECA INDONESIA - Indonesia

Датум одобрења:

2018-09-24

Карактеристике производа

1
XIGDUO XR
TM
XR
5/1000 MG
_(dapagliflozin/metformin HCl extended release) _
EXTENDED RELEASE FILM-COATED TABLET
QUALITATIVE AND QUANTITATIVE COMPOSITION
XIGDUO XR is available for oral administration as extended release
film- coated tablets
containing dapagliflozin and metformin hydrochloride as following
quantitative composition:
•
XIGDUO XR 5/1000 mg: Each film-coated tablet contains 5 mg
dapagliflozin as
dapagliflozin propanediol and 1000 mg metformin HCl extended-release
PHARMACEUTICAL FORM
XIGDUO XR is a combination of dapagliflozin and metformin HCl
extended-release.
XIGDUO XR tablets are available in the following dosage forms and
strengths:
•
5 mg/1000 mg tablets are pink to dark pink, biconvex, oval shaped,
film coated tablets
debossed with “1071” and “5/1000” on one side and plain on the
other side.
THERAPEUTIC INDICATION
XIGDUO XR (dapagliflozin and metformin HCl extended-release) is
indicated as
substitution therapy for treatment of type 2 diabetes mellitus in
adjunct to diet and exercise to
improve glycemic control in adults patients already controlled with
dapagliflozin and
metformin XR given concurrently at the same dose level (see section
Clinical trials and
Special warning and precautions for use for available data on
combination therapy).
For study results with respect to combination of therapies, effects on
glycaemic control and
cardiovascular events, and the populations studied, see sections
Special warnings and special
precautions for use, Undesirable effects, and Pharmacodynamic
properties.
POSOLOGY AND METHOD OF ADMINISTRATION
RECOMMENDED DOSING
•
Healthcare providers should individualize the starting dose of XIGDUO
XR based on
the patient’s current treatment. [See _Dosage Forms and Strengths
(3)_.]
•
XIGDUO XR should generally be taken orally, once daily with the
evening meal
•
XIGDUO XR tablets must be swallowed whole and never crushed, cut, or
chewed.
Occasionally, the inactive ingredients of XIGDUO XR will be eliminated
in the feces as a
soft, hydrated mass that ma