GLUCOPHAGE XR

Krajina: Indonézia

Jazyk: indonézština

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

Aktívna zložka:

METFORMIN HYDROCHLORIDE

Dostupné z:

MERCK TBK - Indonesia

INN (Medzinárodný Name):

METFORMIN HYDROCHLORIDE

Dávkovanie:

500 MG

Forma lieku:

TABLET PELEPASAN LAMBAT

Počet v balení:

DUS, 8 BLISTER @ 15 TABLET PELEPASAN LAMBAT

Výrobca:

MERCK - Indonesia

Dátum Autorizácia:

2021-04-21

Súhrn charakteristických

1
GLUCOPHAGE XR®
METFORMIN HYDROCHLORIDE
ORAL BLOOD GLUCOSE LOWERING DRUGS
1.
NAME OF THE MEDICINAL PRODUCT
Glucophage XR
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Glucophage XR 500 mg prolonged release tablet contains 500 mg
Metformin hydrochloride corresponding to
390 mg Metformin base.
Glucophage XR 750 mg prolonged release tablet contains 750 mg
Metformin hydrochloride corresponding to
585 mg Metformin base.
Glucophage XR 1000 mg prolonged release tablet contains 1000 mg
Metformin hydrochloride corresponding
to 780 mg Metformin base.
3.
PHARMACEUTICAL FORM
Prolonged release tablet.
4.
CLINICAL PARTICULARS
4.1 INDICATIONS
Treatment of type 2 diabetes mellitus in adults, particularly in
overweight patients, when dietary management
and exercise alone does not result in adequate glycaemic control.
Glucophage XR may be used as
monotherapy or in combination with other oral antidiabetic agents, or
with Insulin.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
MONOTHERAPY OF GLUCOPHAGE XR 500 MG, 750 AND 1000 MG
The usual starting dose is one tablet of Glucophage XR 500 mg once
daily.
After 10 to 15 days the dose should be adjusted on the basis of blood
glucose measurements. A slow
increase of dose may improve gastro-intestinal tolerability. The
maximum recommended dose is 2000 mg
XR once daily with the evening meal.
If glycaemic control is not achieved on 2000 mg once daily, Glucophage
XR 1000 mg twice daily should be
considered, with both doses being given with food. If glycaemic
control is still not achieved, patients may
be switched to Metformin tablets IR tablets to a maximum dose of 3000
mg daily.
In patients already treated with Metformin tablets, the starting dose
of Glucophage XR should be equivalent
to the daily dose of Metformin IR tablets. In patients treated with
Metformin at a dose above 2000 mg daily,
switching to Glucophage XR is not recommended.
If transfer from another oral antidiabetic agent is intended:
discontinue the other agent and initiate
Glucophage XR at the dose indicated above.
COMBINATION WIT