glibenclamide + metformin




Apex Pharma Marketing
Concise Prescribing Info
Per FC tab Metformin HCl 500 mg, glibenclamide 5 mg
2nd-line therapy in type 2 diabetes when diet, exercise & initial treatment w/ a sulfonylurea or metformin do not result in adequate glycemic control.
Dosage/Direction for Use
Adult Individualized dosage. Max recommended daily dose: Metformin 2,000 mg/glibenclamide 20 mg. 2nd-line therapy Initially 500 mg/5 mg bd. Daily dose should be titrated in increments of not >500 mg/5 mg up to the min effective dose to achieve adequate control of blood glucose or to a max dose of 2,000 mg/20 mg daily.
Should be taken with food.
Hypersensitivity to metformin hydrochloride, glibenclamide or other sulphonylurea & sulphonamide. Type I diabetes, diabetic pre-coma. Any type of acute metabolic acidosis (eg, lactic acidosis or diabetic ketoacidosis). Renal disease or dysfunction. Acute conditions w/ the potential to alter renal function (eg, dehydration, severe infection, shock). Acute or chronic diseases which may cause tissue hypoxia (eg, cardiac or resp failure, recent MI, shock). Hepatic insufficiency, acute alcohol intoxication, alcoholism. Porphyria. In association w/ miconazole. Discontinue use 48 hr prior to elective major surgery & may not be reinstituted until 48 hr afterwards & only after kidney function has been re-evaluated & found to be normal. Lactation.
Special Precautions
Risk of lactic acidosis. Temporarily discontinue use in case of dehydration. Increased risk of CV mortality. Monitor for hypoglycemia; renal function. Concomitant use w/ medications affecting renal function or metformin disposition eg, cationic drugs. Intravascular administration of iodinated contrast agents may lead to contrast induced nephropathy; discontinue use prior to or at the time of imaging procedure & not restarted until 48 hr after, provided that renal function has been re-evaluated & found to be stable. Promptly discontinue use when hypoxic states occur. Blood sugar imbalance. Excessive alcohol intake. Monitor vit B12 serum levels annually; increased risk of low vit B12 levels w/ increasing metformin dose, treatment duration &/or in patients w/ risk factors known to cause vit B12 deficiency. Patients w/ G6PD deficiency. Contraindicated in case of congenital galactosemia, glucose & galactose malabsorption syndrome or lactase deficiency. Periodically perform fasting blood glucose & glycosylated hemoglobin measurements. Perform initial & periodic monitoring of hematologic parameters & renal function at least on an annual basis. Exclude vit B12 deficiency if megaloblastic anemia is suspected. Hepatic impairment. May affect the ability to drive or use machines. Do not use during pregnancy. Do not use in childn & elderly.
Adverse Reactions
Upper resp infection, headache, GI reactions (eg, diarrhea, nausea/vomiting, abdominal pain), dizziness. Hypoglycemia. Taste disturbance; vit B12 deficiency.
Drug Interactions
May lead to loss of blood glucose control w/ thiazides & other diuretics, corticosteroids, phenothiazines, thyroid products, estrogens, OCs, phenytoin, nicotinic acid, sympathomimetics, Ca channel blockers & INH. Alcohol & alcohol-containing medications. Danazol. Medicines w/ intrinsic hyperglycaemic activity. ACE inhibitors. Glibenclamide: May potentiate hypoglycemic action w/ NSAIDs & other drugs that are highly protein bound, salicylates, sulfonamides, chloramphenicol, probenecid, coumarins, MAOIs, β-adrenergic blockers; ciprofloxacin. Increased hypoglycaemic effect w/ possible onset of hypoglycaemic manifestations or even coma w/ miconazole. Phenylbutazone. May reduce hypoglycaemic effect & increased risk of hepatotoxicity w/ bosentan. May mask hypoglycaemia symptoms by β-blockers; clonidine, reserpine, guanethidine & sympathomimetics. Fluconazole. Reduction in antidiuretic activity of desmopressin. Hypoglycaemic effect may be reduced w/ colesevelam. Metformin HCl: Iodinated contrast materials, furosemide, nifedipine, cationic drugs. May increase risk of lactic acidosis w/ NSAIDs including cyclo-oxygenase II inhibitors, ACE inhibitos, AIIA, diuretics (especially loop diuretics). Organic cation transporters.
MIMS Class
Antidiabetic Agents
ATC Classification
A10BD02 - metformin and sulfonylureas ; Belongs to the class of combinations of oral blood glucose lowering drugs. Used in the treatment of diabetes.
Glucovance 500 mg/5 mg FC tab
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