GLUCOVANCE 500/2.5/MG FC TAB 30/TAB

Indications

Approved Uses

Adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus when treatment with both metformin and a sulfonylurea is appropriate (e.g., inadequate control on either agent alone or already on the combination).

Dosage & Administration

Dosing by Condition

Type 2 diabetes (adults): start 1 tablet of 2.5/500 mg once daily with a meal or 1 tablet twice daily with meals depending on prior therapy and glycemic level; titrate every 1-2 weeks; usual max for this strength is 4 tablets/day in divided doses (total 10 mg glibenclamide/2000 mg metformin).

Initial Dose

For patients inadequately controlled on a sulfonylurea or metformin alone: 2.5mg/500mg or 5mg/500mg twice daily with meals.

Maintenance Dose

1-2 tablets twice daily with meals, adjusted based on glycemic response

Maximum Dose

Maximum daily dose: metformin 2000 mg/day and glibenclamide (glyburide) 20 mg/day (product-specific tablet count depends on strength).

Children's Dosage

Safety and efficacy have been studied in pediatric patients aged 11-16 years with type 2 diabetes; not recommended for children under 10 years.

Dose Adjustment Notes

Individualize and titrate gradually based on SMBG/HbA1c and tolerability; increase no more frequently than every 1-2 weeks; reduce dose if hypoglycemia occurs; temporarily withhold around iodinated contrast and major surgery/acute illness with dehydration or hypoxia risk.

How to Take

Take orally with meals (e.g., with breakfast and/or dinner); swallow the film‑coated tablet whole with water; do not crush or chew.

Side Effects

Common Side Effects

Common: diarrhea, nausea/vomiting, abdominal pain/dyspepsia, taste disturbance (metallic taste), and hypoglycemia; headache and dizziness can occur.

Safety & Warnings

Contraindications

Contraindicated in: eGFR <30 mL/min/1.73 m²/renal failure; acute or chronic metabolic acidosis (including DKA); hypersensitivity to metformin, glibenclamide (glyburide) or sulfonylureas; and use with iodinated contrast in patients with reduced renal function/other risk factors (temporarily discontinue per guidance). Also contraindicated with bosentan (due to glyburide interaction).

Warnings & Precautions

Key warnings/precautions: lactic acidosis risk (renal function monitoring; hold for hypoxia, dehydration, sepsis, surgery, and iodinated contrast as appropriate); hypoglycemia risk (higher in elderly, renal impairment, poor intake, adrenal/pituitary insufficiency; beta-blockers may mask symptoms); vitamin B12 deficiency with long-term metformin; avoid in hepatic disease; caution in G6PD deficiency; not for type 1 diabetes/DKA.

Age Restriction

Not recommended/approved in pediatric patients (<18 years); in older adults use cautiously with renal function assessment (avoid initiating in very elderly unless renal function is normal).

Drug Interactions

Drug Interactions

Key clinically significant interactions include: iodinated contrast (temporary stop), alcohol (↑ lactic acidosis/hypoglycemia), miconazole (↑ severe hypoglycemia with sulfonylureas), bosentan (contraindicated with glyburide), cimetidine and other cationic drugs (↑ metformin exposure), diuretics (e.g., furosemide) and steroids (↑ glucose), beta-blockers (mask hypoglycemia), NSAIDs/salicylates/sulfonamides/fluoroquinolones (may ↑ hypoglycemia or dysglycemia), and colesevelam (may reduce glyburide absorption-separate dosing).

Food Interaction

Take with food.

Alcohol Interaction

Dangerous

Special Populations

Children

Safety and efficacy have been studied in pediatric patients aged 11-16 years with type 2 diabetes; not recommended for children under 10 years.

Elderly

Use with caution; start at lowest available dose; monitor renal function closely; increased risk of hypoglycemia and lactic acidosis; avoid in patients with eGFR <45 mL/min/1.73m²

Kidney Impairment

Contraindicated in renal disease or renal dysfunction (e.g., serum creatinine ≥1.5 mg/dL [males], ≥1.4 mg/dL [females], or abnormal creatinine clearance).

Storage & Patient Advice

Stopping the Medicine

Do not stop without prescriber advice; temporarily discontinue for iodinated contrast procedures and around major surgery/acute illness per metformin guidance, and restart when renal function and oral intake are stable.

Patient Counseling

Take with meals and do not skip meals; recognize/treat hypoglycemia (carry fast-acting glucose); limit/avoid alcohol; report symptoms of lactic acidosis (e.g., unexplained fatigue, myalgias, abdominal discomfort, rapid breathing) urgently; inform providers before contrast imaging or surgery and during acute illness/dehydration; monitor glucose as instructed and review all concomitant medicines.

Pharmacology

Mechanism of Action

Glibenclamide stimulates insulin secretion by closing ATP-sensitive K+ channels in pancreatic beta cells; metformin decreases hepatic gluconeogenesis, decreases intestinal glucose absorption, and improves peripheral insulin sensitivity/increases glucose uptake.

Onset of Action

Glibenclamide: onset within ~1-2 hours; metformin: measurable glucose-lowering within days, with maximal effect typically over 1-2 (up to 4) weeks after titration/steady dosing.

Duration of Effect

Glibenclamide: glucose-lowering effect can persist up to ~24 hours; metformin: effect is maintained over the dosing interval with regular dosing (typically 12-24 hours depending on regimen).

Bioavailability

Metformin oral bioavailability ~50-60% (fasting); glibenclamide oral bioavailability is high but variable (commonly cited ~80-100%) and is not reliably “~100%” across references.

Metabolism

Glibenclamide: extensively hepatically metabolized (primarily CYP2C9, also CYP3A4) to weakly active/inactive metabolites. Metformin: not metabolized (excreted unchanged).

Product Information

Available Dosage Forms

Film-coated tablet.

Composition per Dose

Each film-coated tablet: 500mg metformin hydrochloride + 2.5mg glibenclamide.

Generic Availability

Yes

OTC Alternatives

No OTC alternative

Diabetes Type

Type 2

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