XIGDUO XR

Pays: Indonésie

Langue: indonésien

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

Ingrédients actifs:

DAPAGLIFLOZIN PROPENADIOL; METFORMIN HYDROCHLORIDE

Disponible depuis:

ASTRAZENECA INDONESIA - Indonesia

DCI (Dénomination commune internationale):

DAPAGLIFLOZIN PROPENADIOL; METFORMIN HYDROCHLORIDE

Dosage:

5/500 MG

forme pharmaceutique:

TABLET SALUT SELAPUT

Unités en paquet:

BOX, 4 BLISTERS @ 7 TABLET SALUT SELAPUT

Fabriqué par:

ASTRAZENECA INDONESIA - Indonesia

Date de l'autorisation:

2018-09-24

Résumé des caractéristiques du produit

1
XIGDUO XR
TM
XR
5/500 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 5/500 mg: Each film-coated tablet contains 5 mg
dapagliflozin as dapagliflozin
propanediol and 500 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/500 mg tablets are orange, capsule shaped, film-coated tablets
debossed with “1070”
and “5/500” 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.
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 may resemble the original tablet.
•
Dosing may be adjusted based on effectiveness and tolerability while
not exceeding
the maximum recommen