Negara: Malaysia
Bahasa: Inggris
Sumber: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
METFORMIN HYDROCHLORIDE
MERCK SDN. BHD.
METFORMIN HYDROCHLORIDE
120 Tablets
MERCK SANTE S.A.S.
N AME OF THE MEDICINAL PRODUCT GLUCOPHAGE 500 mg film -coated tablets Q UALITATIVE AND QUANTITATIVE COMPOSITION One film -coated tablet contains 500 mg metformin hydrochloride corresponding to 390 mg metformin ba se. F or a full list of excipients, see sect ion List of excipients. P HARMACEUTI CAL FORM Film -coated tablet. White, circular, convex film -coated tablets. C LI NI CAL PARTI CULARS Therapeutic indications Treatment of type 2 diabetes mellitus, when dietary manag ement and exercise alone does not result in adequate g lycaemic control. - In adults, GLUGOPHAGE® 500 mg film -coated tablet may be used as monotherapy or in combination with other oral anti -diabetic ag ents or with insulin. - I n children from 10 years of ag e and adolescents, GLUGOPHAGE® 500 mg film-coated tablet may be used a s monotherapy or in combination with insulin. A reduction of diabetic complications has been shown in overweig ht type 2 diabetic adult patients treated with metformin as first- line therapy after diet failure (see Pha rmacodynamic properties) . P osology and method of administration Adults with normal renal function (GFR ≥ 90 mL/min) : Monotherapy and combination with other oral antidiabetic agents: - The usual starting dose is one tablet 2 or 3 times daily g iven during or after meals. After 10 to 15 days the dose should be adjusted on the basis of blood g lucose measurements. A slow increase of dose may improve gastrointestinal tolerability. - The maximum recommended dose of metformin hydrochloride is 3 g daily, taken as 3 divided doses. - I f transfer from another oral antidiabetic ag ent is intended: discontinue the other ag ent and initiate metformin at the dose indicated above. Combination with insulin: Metformin and insulin may be used in combination therapy to achieve be tter blood g lucose control. Metformin hydrochloride is g iven at the usual starting dose of one tablet 2 or 3 times daily, while insulin dosag e is adjusted on the basis of blood g lucose measurements. Baca dokumen lengkapnya