XIGDUO XR

Nazione: Indonesia

Lingua: indonesiano

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

Principio attivo:

DAPAGLIFLOZIN PROPENADIOL; METFORMIN HYDROCHLORIDE

Commercializzato da:

ASTRAZENECA INDONESIA - Indonesia

INN (Nome Internazionale):

DAPAGLIFLOZIN PROPENADIOL; METFORMIN HYDROCHLORIDE

Dosaggio:

10/1000 MG

Forma farmaceutica:

TABLET SALUT SELAPUT

Confezione:

BOX, 4 BLISTERS @ 7 TABLET SALUT SELAPUT

Prodotto da:

ASTRAZENECA INDONESIA - Indonesia

Data dell'autorizzazione:

2018-09-24

Scheda tecnica

1
XIGDUO XR
TM
XR
10/500 MG; 10/1000 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 10/500 mg: Each film-coated tablet contains 10 mg
dapagliflozin as
dapagliflozin propanediol and 500 mg metformin HCl extended-release
•
XIGDUO XR 10/1000 mg: Each film-coated tablet contains 10 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:
•
10 mg/500 mg tablets are pink, biconvex, capsule shaped, film-coated
tablets
debossed with “1072” and “10/500” on one side and plain on the
other side.
•
10 mg/1000 mg tablets are yellow to dark yellow, biconvex,
oval-shaped, and film-
coated tablets with "1073" and "10/1000" debossed on one side and
plain on the
reverse 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 curr