GLUCOPHAGE XR

Страна: Индонезия

Език: индонезийски

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

Активна съставка:

METFORMIN HYDROCHLORIDE

Предлага се от:

MERCK TBK - Indonesia

INN (Международно Name):

METFORMIN HYDROCHLORIDE

дозиране:

1000 MG

Лекарствена форма:

TABLET PELEPASAN LAMBAT

Броя в опаковка:

BOX, 6 BLISTER @ 10 TABLET (BULK PACK)

Произведено от:

MERCK SANTE SAS, France

Дата Оторизация:

2016-08-09

Данни за продукта

_Page 1 of 8 _
_IP/dw/17Dec2019 _
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
▪
Reduction in the risk or delay of the onset of type 2 diabetes
mellitus in adult, overweight patients with IGT*
(Prediabetes) and/or IFG*, and/or increased HbA1C who are:
- at high risk for developing overt type 2 diabetes mellitus and
- still progressing towards type 2 diabetes mellitus despite
implementation of intensive lifestyle change for
3 to 6 months
Treatment with Glucophage XR must be based on a risk score
incorporating appropriate measures of
glycaemic control and including evidence of high cardiovascular risk.
Lifestyle modifications should be continued when Metformin is
initiated, unless the patient is unable to do so
because of medical reasons.
*IGT: Impaired Glucose Tolerance; IFG: Impaired Fasting Glucose
▪
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
ADULTS WITH NORMAL RENAL FUNCTION (GFR ≥90 ML/MIN)
_REDUCTION IN THE RISK OR DELAY OF THE ONSET OF TYPE 2 DIABETES _
▪
Metformin should only be considered where intensive lifestyle
modifications for 3 to 6 months have not
resulted in adequate glycaemic control.
▪
The therapy should be initiated with one