Glucovance

Per 250 mg/1.25 mg FC tab Metformin HCl 250 mg, glibenclamide 1.25 mg. Per 500 mg/2.5 mg FC tab Metformin HCl 500 mg, glibenclamide 2.5 mg. Per 500 mg/5 mg FC tab Metformin HCl 500 mg, glibenclamide 5 mg

250 mg/1.25 mg 1st line therapy in type 2 DM, when diet & exercise alone is inadequate. 500 mg/2.5 mg & 500 mg/5 mg) Treatment of type 2 DM in adults as 2nd line therapy, when diet, exercise & initial treatment w/ metformin or glibenclamide (or another sulfonylureas) do not result in adequate glycemic control, & as replacement for previous treatment w/ metformin & glibenclamide in patients whose glycemia is stable & well controlled.

Adult Initial treatment: 1st-line therapy Initially 1 tab of 250 mg/1.25 mg once daily (bid may be used if HbA1c >9% or FPG >2 g/L). May increase dose in increments of 1 tab of 250 mg/1.25 mg/day every 2 wk or longer according to glycemia results. 2nd-line therapy Initially 1 tab of 500 mg/2.5 mg or 500 mg/5 mg once daily. Initial dose must not exceed the daily doses of glibenclamide (or equiv dose of another sulfonylurea) or metformin already being taken. May increase dose in increments of no more than 500 mg/5 mg/day every 2 wk or longer according to the glycemia results. Replacement for previous combination therapy w/ metformin & sulfonylurea For patients already treated w/ a combination of metformin & glibenclamide, 2 tab of metformin + glibenclamide 500 mg/2.5 mg can be replaced by 1 tab of metformin + glibenclamide 1 g/5 mg. May increase dose in increments of no more than 500 mg/5 mg/day every 2 wk or longer according to the glycemia results. Max: Metformin HCl 2,000 mg/glibenclamide 20 mg daily. Elderly Start w/ lowest available & increased gradually if necessary. Renal impairment CrCl 30-59 mL/min or eGFR 45-59 mL/min/1.73 m² Max: Metformin 1,000 mg daily. Renal function should be closely monitored every 3-6 mth, CrCl 30-59 mL/min or eGFR 30-44 mL/min/1.73 m² Max: Metformin 1,000 mg daily. Renal function should be closely monitored every 3 mth.

Should be taken with food.

Hypersensitivity to metformin HCl, glibenclamide or other sulfonylureas & sulfonamides. Any type of metabolic acidosis (eg, lactic acidosis, diabetic ketoacidosis), diabetic pre-coma; severe renal failure (CrCl <30 mL/min or eGFR <30 mL/min/1.73 m²); acute conditions w/ potential to alter renal function eg, severe dehydration, severe infection, CV collapse (shock). Disease (especially acute disease or worsening of chronic diseases) which may cause tissue hypoxia eg, unstable CHF, resp failure, recent MI, CV collapse or shock; hepatic insufficiency, acute alcohol intoxication, alcoholism; porphyria. Concomitant use w/ miconazole even for local use. Discontinue 48 hr before or from the time of intravascular administration of iodinated contrast media & not reinstituted until 48 hr afterwards & only after renal function has been re-evaluated & found to be normal. Discontinue 48 hr before an elective major surgery & may not be reinstituted until 48 hr afterwards & only after kidney function has been re-evaluated & found to be normal. Lactation.

Risk of lactic acidosis, hypoglycemia, blood sugar imbalance. Patients suffering from any infectious illnesses eg, flu, infection of the air passages or UTI. Determine renal function before initiating treatment & regularly thereafter. Risk of hypoxia & renal insufficiency in patients w/ heart failure. Regular monitoring of cardiac & renal function in patients w/ CHF. Patients w/ congenital galactosemia, glucose & galactose malabsorption syndrome or lactase deficiency; G6PD deficiency. Renal & hepatic impairment. May affect ability to drive & use machines. Pregnancy. Elderly ≥65 yr.

GI disorders eg, nausea, vomiting, diarrhea, abdominal pain & loss of appetite. Taste disturbance; vit B₁₂ decrease/deficiency.

Glibenclamide: Increased hypoglycemic effect w/ miconazole. Increased risk of hepatotoxicity & reduced hypoglycemic effect w/ bosentan. Masked hypoglycemic symptoms w/ β-blockers, clonidine, reserpine, guanethidine or sympathomimetics. Increase t_½ w/ possible onset of hypoglycemic manifestations w/ fluconazole. Reduction in antidiuretic effect of desmopressin. Reduced plasma conc & hypoglycemic effect w/ colesevelam. Decreased blood glucose levels w/ ACE inhibitors. Metformin: May lead to renal failure w/ iodinated contrast agents. Increased risk of lactic acidosis during alcohol intoxication. Lactic acidosis w/ diuretics particularly loop diuretics. May reduce efficacy w/ OCT1 substrate/inhibitor (eg, verapamil). May increase GI absorption & efficacy w/ OCT1 inducers (eg, rifampicin). May decrease renal elimination w/ OCT2 substrate/inhibitor (eg, cimetidine, dolutegravir, crizotinib, olaparib, daclatasvir, vandetanib). Sulfonylureas: May increase hypoglycemic action w/ alcohol, phenylbutazone (systemic route). All antidiabetic agents: Medicinal products w/ intrinsic hyperglycemic activity eg, glucocorticoids & tetracosactides (systemic & local routes), β₂ agonists, danazol & chlorpromazine (high dosages of 100 mg/day), diuretics.

Antidiabetic Agents

A10BD02 - metformin and sulfonylureas ; Belongs to the class of combinations of oral blood glucose lowering drugs. Used in the treatment of diabetes.

Rx