Country: Singapore
Language: English
Source: HSA (Health Sciences Authority)
GLIBENCLAMIDE; METFORMIN HCl
MERCK PTE. LTD.
A10BD02
5 mg
TABLET, FILM COATED
GLIBENCLAMIDE 5 mg; METFORMIN HCl 500 mg
ORAL
Prescription Only
MERCK SANTE SAS
ACTIVE
2003-06-23
5 2 2 140 140 5 5 5 2 2 10 MC-1528-2014 M C- 152 8- 20 14 M C- 152 8- 20 14 _Other precautions_ _Because this medicinal product contains lactose, it is contraindicated in case of _ _congenital galactosemia, glucose and galactose malabsorption syndrome or in _ _case of lactase deficiency._ _Hypoxic states--_-Cardiovascular collapse (shock) from whatever cause, acute congestive heart failure, acute myocardial infarction, and other conditions characterized by hypoxemia have been associated with lactic acidosis and may also cause prerenal azotemia. When such events occur in patients on GLUCOVANCE therapy, the drug should be promptly discontinued. _Alcohol intake_---Alcohol is known to potentiate the effect of metformin on lactate metabolism. Patients, therefore, should be warned against excessive alcohol intake, acute or chronic, while receiving GLUCOVANCE. Due to its effect on the gluconeogenic capacity of the liver, alcohol may also increase the risk of hypoglycemia. _Impaired hepatic function_--Since impaired hepatic function has been associated with some cases of lactic acidosis, GLUCOVANCE should generally be avoided in patients with clinical or laboratory evidence of hepatic disease. _Vitamin B_ _12_ _ levels_---In controlled clinical trials with metformin of 29 weeks duration, a decrease to subnormal levels of previously normal serum Vitamin B 12 without clinical manifestations, was observed in approximately 7% of patients. Such decrease, possibly due to interference with B 12 absorption from the B 12 -intrinsic factor complex, is, however, very rarely associated with anemia (see ADVERSE REACTIONS) and appears to be rapidly reversible with discontinuation of metformin or Vitamin B 12 supplementation. Measurement of hematologic parameters on an annual basis is advised in patients on metformin and any apparent abnormalities should be appropriately investigated and managed (see PRECAUTIONS: Laboratory Tests) Read the complete document
MERCK GLUCOVANCE (METFORMIN HCL AND GLIBENCLAMIDE TABLETS) DESCRIPTION GLUCOVANCE (Metformin HCI and Glibenclamide Tablets) contains two oral antihyperglycemic drugs used in the management of type 2 diabetes, metformin hydrochloride and glibenclamide. GLUCOVANCE is available for oral administration in tablets containing 500 mg metformin hydrochloride with 5 mg glibenclamide In addition, each tablet contains the following inactive ingredients: microcrystalline cellulose, povidone, croscarmellose sodium, magnesium stearate, lactose monohydrate, hypromellose 15cP, titanium dioxide (E171) and macrogol 4000. The tablets are film coated, which provides color differentiation. PHARMACOLOGY PHARMACODYNAMIC GLUCOVANCE combines metformin hydrochloride and glibenclamide, two antihyperglycemic agents with complementary mechanisms of action, to improve glycemic control in patients with type 2 diabetes. Metformin hydrochloride is an antihyperglycemic agent that improves glucose tolerance in patients with type 2 diabetes, lowering both basal and postprandial plasma glucose. Metformin hydrochloride decreases hepatic glucose production, decreases intestinal absorption of glucose, and improves insulin sensitivity by increasing peripheral glucose uptake and utilization. Glibenclamide is a second generation sulphonylurea which appears to lower blood glucose acutely by stimulating the release of insulin from the pancreas, an effect dependent upon functioning beta cells in the pancreatic islets. Results from controlled, double blind clinical trials versus reference products in the treatment of type 2 diabetes inadequately controlled by monotherapy with metformin or glibenclamide combined with diet and exercise, have demonstrated that the combination had an additive effect on glucose regulation. PHARMACOKINETICS _ABSORPTION AND BIOAVAILABILITY _ _Related to GLUCOVANCE _ In bioavailability studies of GLUCOVANCE 500 mg/5 mg, the mean area under the plasma concentration versus time curve (AUC) for the glibenclamide component was 18 Read the complete document