XIGDUO XR

País: Indonésia

Língua: indonésio

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

Ingredientes ativos:

DAPAGLIFLOZIN PROPENADIOL; METFORMIN HYDROCHLORIDE

Disponível em:

ASTRAZENECA INDONESIA - Indonesia

DCI (Denominação Comum Internacional):

DAPAGLIFLOZIN PROPENADIOL; METFORMIN HYDROCHLORIDE

Dosagem:

5/1000 MG

Forma farmacêutica:

TABLET SALUT SELAPUT

Unidades em pacote:

BOX, 4 BLISTERS @ 7 TABLET SALUT SELAPUT

Fabricado por:

ASTRAZENECA INDONESIA - Indonesia

Data de autorização:

2018-09-24

Características técnicas

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