Ország: Indonézia
Nyelv: indonéz
Forrás: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency
METFORMIN HYDROCHLORIDE
MERCK TBK - Indonesia
METFORMIN HYDROCHLORIDE
1000 MG
TABLET PELEPASAN LAMBAT
BOX, 6 BLISTER @ 10 TABLET (BULK PACK)
MERCK SANTE SAS, France
2016-08-09
_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 Olvassa el a teljes dokumentumot