Țară: Indonezia
Limbă: indoneziană
Sursă: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency
GLIBENCLAMIDE; METFORMIN HYDROCHLORIDE
MERCK TBK - Indonesia
GLIBENCLAMIDE; METFORMIN HYDROCHLORIDE
250/1.25 MG
TABLET SALUT SELAPUT
DUS, 10 BLISTER @ 10 TABLET SALUT SELAPUT
MERCK TBK - Indonesia
2019-02-28
GLUCOVANCE ® METFORMIN HYDROCHLORIDE - GLIBENCLAMIDE COMBINATIONS OF ORAL BLOOD GLUCOSE LOWERING DRUGS 1. QUALITATIVE AND QUANTITATIVE COMPOSITION GLUCOVANCE 250 MG/1.25 MG: each film-coated tablet contains Metformin hydrochloride 250 mg with Glibenclamide 1.25 mg. GLUCOVANCE 500 MG/2.5 MG: each film-coated tablet contains Metformin hydrochloride 500 mg with Glibenclamide 2.5 mg. GLUCOVANCE 500 MG/5 MG: each film-coated tablet contains Metformin hydrochloride 500 mg with Glibenclamide 5 mg. GLUCOVANCE 1000 MG/5 MG: each film-coated tablet contains Metformin hydrochloride 1000 mg with Glibenclamide 5 mg. 2. PHARMACEUTICAL FORM Film-coated tablet. 3. CLINICAL PARTICULARS 3.1 INDICATIONS GLUCOVANCE 250 MG/1.25 MG, GLUCOVANCE 500 MG/2.5 MG Glucovance is indicated as initial therapy, as an adjunct to diet and exercise, to improve glycemic control in patients with type 2 diabetes with HbA1c above 8% whose hyperglycemia cannot be satisfactorily managed with diet and exercise alone. GLUCOVANCE 250 MG/1.25 MG, GLUCOVANCE 500 MG/2.5 MG, GLUCOVANCE 500 MG/5 MG, GLUCOVANCE 1000 MG/5 MG Glucovance is indicated as second-line therapy when diet, exercise, and initial treatment with a Sulfonylurea or Metformin do not result in adequate glycemic control in patients with type 2 diabetes with HbA1c above 8%. 3.2 POSOLOGY AND METHOD OF ADMINISTRATION GENERAL CONSIDERATIONS Dosage of Glucovance must be individualized on the basis of both effectiveness and tolerance while not exceeding the maximum recommended daily dose of 2000 mg Metformin/20 mg Glibenclamide. Glucovance should be given with meals and should be initiated at a low dose, with gradual dose escalation as described below, in order to avoid hypoglycemia (largely due to Glibenclamide), to reduce GI side effects (largely due to Metformin), and to permit determination of the minimum effective dose for adequate control of blood glucose for the individual patient. With initial treatment and during dose titration, appropriate blood glucos Citiți documentul complet