Glucovance Dosage & Drug Information

Concise Prescribing Info Full Prescribing Info Contents Description Action Indications/Uses Dosage/Direction for Use Overdosage Contraindications Special Precautions Use In Pregnancy & Lactation Adverse Reactions Drug Interactions Caution For Usage Storage MIMS Class ATC Classification Regulatory Classification Presentation/Packing

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 when diet, exercise & initial treatment w/ sulfonylureas or metformin results in inadequate glycaemic control in patients w/ type 2 diabetes.

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Dosage/Direction for Use

Previously-treated patient (2nd-line therapy) Individualized dose. Recommended starting dose: 500 mg/2.5 mg or 500 mg/5 mg bd. Max dose: 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.

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Overdosage

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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 precoma; any type of metabolic acidosis eg, lactic acidosis, diabetic ketoacidosis; dehydration, severe infection, cardiac or resp failure, recent MI, shock, acute alcohol intoxication, alcoholism, porphyria. Concomitant use w/ miconazole. Severe renal failure (GFR <30 mL/min) & hepatic insufficiency. Lactation.

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Special Precautions

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; cardiac function. May reduce vit B₁₂ levels during long-term use. Regularly perform usual lab tests for diabetes monitoring. Discontinue prior to, during or 48 hr after use of intravascular iodinated contrast media & elective surgery under general, spinal or peridural anaesth. Not recommended in concomitant use w/ alcohol, phenylbutazone, danazol. Concomitant use w/ antihypertensives, diuretics, NSAIDs. Overwt patients, G6PD deficiency; congenital galactosemia, glucose-galactose malabsorption syndrome or lactase deficiency. May affect ability to drive & use machines. Hepatic failure or severe renal failure. Pregnancy. Not recommended in childn. Elderly ≥65 yr.

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Use In Pregnancy & Lactation

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Adverse Reactions

GI disorders eg, nausea, vomiting, diarrhoea, abdominal pain & loss of appetite. Taste disturbances; transient visual disturbances; hypoglycaemia; vit B₁₂ deficiency.

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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 media. 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 t_½ w/ fluconazole. Reduced plasma conc w/ bosentan. Reduced antidiuretic activity w/ desmopressin. Reduced hypoglycaemic effect w/ bile acid sequestrants, colesevelam.

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Caution For Usage

For caution against possible variation of physical aspect of medicine... Click to view Glucovance detailed prescribing information

Storage

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Description

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Action

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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.

Regulatory Classification

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

Glucovance

glibenclamide + metformin

Manufacturer:

Merck

Distributor:

Zuellig Pharma