Country: Indonesia
Bahasa: Indonesia
Sumber: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency
METFORMIN HYDROCHLORIDE
MERCK TBK - Indonesia
METFORMIN HYDROCHLORIDE
750 MG
TABLET PELEPASAN LAMBAT
DUS, 8 BLISTER @ 15 TABLET PELEPASAN LAMBAT
MERCK - Indonesia
2021-05-26
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 WI Baca dokumen lengkap