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Glucovance

Glucovance

glibenclamide + metformin

Manufacturer:

Merck

Distributor:

Zuellig Pharma
Concise Prescribing Info
Contents
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
Indications/Uses
2nd-line therapy in patients w/ type 2 diabetes when diet, exercise & initial treatment w/ sulphonylurea or metformin results in inadequate glycaemic control.
Dosage/Direction for Use
Individualized dose. Previously-treated patient (2nd-line therapy) Recommended starting dose: 500 mg/2.5 mg or 500 mg/5 mg bd. Max: 2,000 mg/20 mg daily. Geriatric population Dosage should be adjusted depending on renal function parameters (start w/ 1 tab of Glucovance 500 mg/2.5 mg), ≥65 yr Start w/ lowest available dose.
Administration
Should be taken with food: Take w/ meals.
Contraindications
Hypersensitivity to metformin HCl or glibenclamide or any other sulphonylureas or sulphonamides. Type 1 diabetes, diabetic pre-coma; any type of acute metabolic acidosis eg, lactic acidosis, diabetic ketoacidosis; acute conditions w/ potential to alter renal function eg, dehydration, severe infection, shock; disease causing tissue hypoxia eg, cardiac or resp failure, recent MI. Acute alcohol intoxication, alcoholism; porphyria. Concomitant use w/ miconazole. Severe renal failure (GFR <30 mL/min), hepatic insufficiency. Lactation.
Special Precautions
Temporarily discontinue use if dehydration occurs; in presence of conditions altering renal function. Lactic acidosis. Hypoglycaemia in case of energy-restricted diet, intensive or prolonged exercise, alcohol intake; malnutrition, irregular & missed meals, fasting, poor balance between physical exercise & carbohydrate intake, thyroid, pituitary & adrenal gland insufficiency. Blood-sugar imbalance; stable chronic heart failure. May reduce vit B12 levels. Assess renal function prior to initiation & regularly thereafter. Regularly perform usual lab tests for diabetes monitoring. Overwt patients should continue energy-restricted diet. Discontinue use prior to, during or 48 hr after use of intravascular iodinated contrast agents & surgery under general, spinal or peridural anaesth. Not to be used in congenital galactosemia, glucose-galactose malabsorption syndrome or lactase deficiency. G6PD deficiency. Not recommended in concomitant use w/ alcohol, phenylbutazone or danazol. Concomitant use w/ antihypertensives, diuretics, NSAIDs. May affect ability to drive & use machines. Hepatic failure or severe renal failure. Pregnancy. Not recommended in childn. Elderly ≥65 yr.
Adverse Reactions
GI disorders eg, nausea, vomiting, diarrhoea, abdominal pain & loss of appetite. Vit B12 decrease/deficiency; taste disturbance; transient visual disturbances.
Drug Interactions
Increased hypoglycaemic effect w/ miconazole. Antabuse effect & increased risk of lactic acidosis w/ alcohol. Increased hypoglycaemic effects w/ phenylbutazone; danazol. Elevated blood glucose w/ chlorpromazine, corticosteroids (glucocorticoids), systemic & local tetracosactides, β2-agonists. Decreased blood glucose levels w/ ACE inhibitors. Triggered lactic acidosis w/ diuretics. Renal failure w/ iodinated contrast agents. Reduced efficacy w/ organic cation transporters (OCT) 1 substrates/inhibitors eg, verapamil. Increased GI absorption & efficacy w/ OCT1 inducers eg, rifampicin. Increased plasma conc w/ OCT2 substrates/inhibitors eg, cimetidine, dolutegravir, crizotinib, olaparib, daclatasvir, vandetanib. Masked some hypoglycaemic symptoms by β-blockers. Increased sulphonylurea t½ w/ fluconazole. Reduced plasma conc w/ bosentan. Reduced antidiuretic activity w/ desmopressin. Reduced hypoglycaemic effect w/ bile acid sequestrants, colesevelam.
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.
Presentation/Packing
Form
Glucovance 500 mg/2.5 mg FC tab
Packing/Price
120's
Form
Glucovance 500 mg/5 mg FC tab
Packing/Price
120's
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