GLUCOVANCE 500/5/MG FC TAB 30/TAB

Indications

Approved Uses

Adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus, particularly when treatment with metformin or a sulfonylurea alone does not provide adequate control (or when already on both).

Dosage & Administration

Dosing by Condition

Type 2 diabetes (adults): individualize and take with meals; typical starting dose is 1 tablet daily with a meal or 1 tablet twice daily with meals depending on prior therapy and glycemia; titrate no more frequently than every 2 weeks; maximum total daily dose: 20 mg glibenclamide / 2000 mg metformin (i.e., up to 4 tablets of 5/500 per day in divided doses).

Initial Dose

For patients inadequately controlled on sulfonylurea or metformin alone: 2.5 mg/500 mg or 5 mg/500 mg twice daily with meals (5 mg/500 mg not for initial therapy in treatment-naive due to hypoglycemia risk).

Maintenance Dose

1-3 tablets daily in divided doses with meals, titrated based on blood glucose response

Maximum Dose

Glibenclamide 20mg / Metformin 2000mg per day (4 tablets of 5mg/500mg)

Children's Dosage

Safety and efficacy evaluated in pediatric patients aged 9-16 years in a 26-week trial; not shown statistically superior to metformin or glyburide monotherapy.

Dose Adjustment Notes

Titrate gradually at intervals of at least 2 weeks based on glycemic response; use lower starting doses and cautious titration in older adults; assess renal function before initiation and periodically (contraindicated if eGFR <30 mL/min/1.73 m²; do not initiate if eGFR 30-45); temporarily withhold around iodinated contrast in at‑risk patients and restart after ~48 hours once renal function is stable; avoid in significant hepatic impairment.

How to Take

Oral: take with meals (e.g., breakfast and dinner if twice daily); swallow the film‑coated tablet whole with water; do not crush or chew.

Side Effects

Common Side Effects

Common: diarrhea, nausea, vomiting, abdominal pain/indigestion, loss of appetite, metallic taste; hypoglycemia; headache and dizziness.

Side Effect Frequency

Very common (≥10%): gastrointestinal effects (e.g., diarrhea, nausea/abdominal discomfort) and hypoglycemia (driven by glibenclamide). Common (1-10%): vomiting, dyspepsia/abdominal pain, taste disturbance; other events vary by source. Rare/very rare: lactic acidosis (metformin), hematologic dyscrasias and hepatic/skin reactions (sulfonylurea class).

Safety & Warnings

Contraindications

Contraindicated in: severe renal impairment (eGFR <30 mL/min/1.73 m²), acute or chronic metabolic acidosis (including DKA), hypersensitivity to metformin or sulfonylureas (including glibenclamide), and concomitant use with bosentan; also avoid/contraindicated in severe hepatic impairment per metformin risk of lactic acidosis.

Warnings & Precautions

Precautions: monitor renal function and withhold around iodinated contrast/surgery or acute illness causing dehydration/hypoxia; counsel on hypoglycemia risk (higher in elderly/irregular meals) and masking by beta-blockers; consider B12 monitoring with long-term use; caution in G6PD deficiency; be alert for possible increased CV mortality signal historically reported with sulfonylureas.

Age Restriction

Safety and effectiveness have not been established in pediatric patients; use with caution in elderly patients with caution regarding renal function

Driving Warning

May impair ability to drive or operate machinery due to hypoglycemia

Drug Interactions

Drug Interactions

Key interactions: alcohol (↑ lactic acidosis/hypoglycemia), iodinated contrast media (temporarily withhold metformin around procedures), bosentan (contraindicated with glibenclamide), miconazole (↑ severe hypoglycemia), carbonic anhydrase inhibitors (↑ metabolic acidosis risk), diuretics and corticosteroids (may worsen glycemic control), fluoroquinolones (dysglycemia), beta-blockers (mask hypoglycemia), and cimetidine (↑ metformin exposure).

Interaction Severity

MAJOR/clinically significant: iodinated contrast media (metformin-temporary discontinuation in at-risk patients), alcohol/excessive alcohol intake (lactic acidosis risk and hypoglycemia), azole antifungals such as miconazole/fluconazole (increased sulfonylurea effect → severe hypoglycemia). MODERATE: beta-blockers (mask hypoglycemia), ACE inhibitors and NSAIDs (may potentiate hypoglycemia), corticosteroids/thiazide diuretics (hyperglycemia), cimetidine (↑ metformin exposure), carbonic anhydrase inhibitors (↑ metabolic acidosis risk), rifampin (may reduce sulfonylurea effect).

Food Interaction

Take with food.

Alcohol Interaction

Dangerous

Special Populations

Pregnancy

Category C

Breastfeeding

Contraindicated

Children

Safety and efficacy evaluated in pediatric patients aged 9-16 years in a 26-week trial; not shown statistically superior to metformin or glyburide monotherapy.

Elderly

Use with caution; start at lower doses; monitor renal function regularly as metformin is contraindicated if eGFR declines; increased risk of hypoglycemia with glibenclamide; avoid in patients with eGFR <45 mL/min/1.73m²

Kidney Impairment

Contraindicated if eGFR <30 mL/min/1.73 m²; do not initiate if eGFR 30-45; if already on therapy and eGFR falls <45, reassess risk/benefit and monitor closely; discontinue if eGFR <30.

Liver Impairment

Avoid use in hepatic impairment (no dose adjustment recommended because therapy should generally not be used in clinical/laboratory evidence of hepatic disease).

Storage & Patient Advice

Stopping the Medicine

Do not stop abruptly without prescriber advice; stopping can worsen glycemic control-contact the treating clinician to adjust therapy safely.

Overdose

Overdose may cause severe/prolonged hypoglycemia (glibenclamide) and/or lactic acidosis (metformin); treat hypoglycemia with rapid glucose (IV dextrose/glucagon as appropriate) and manage suspected lactic acidosis with immediate hospitalization and consider hemodialysis to remove metformin.

Patient Counseling

Take with meals and do not skip meals; recognize and treat hypoglycemia (carry fast-acting glucose); limit/avoid alcohol; inform providers before surgery or iodinated-contrast imaging (may need temporary interruption); monitor glucose as directed; seek urgent care for symptoms suggestive of lactic acidosis (e.g., severe weakness, muscle pain, abdominal discomfort, rapid breathing) or severe hypoglycemia.

Monitoring Requirements

Monitor blood glucose (self-monitoring as directed) and HbA1c about every 3 months until stable then at least twice yearly; renal function (eGFR) before start and at least annually (more often if elderly/at risk); vitamin B12 periodically with long-term metformin; monitor for hypoglycemia and weight; consider liver function assessment if clinically indicated.

Pharmacology

Mechanism of Action

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

Onset of Action

Glibenclamide: onset within ~1-2 hours; metformin: glucose-lowering begins within 1-3 days with full effect typically in ~1-2 weeks (sometimes longer for maximal HbA1c impact).

Duration of Effect

Approximately up to 24 hours for glucose-lowering with regular dosing (sulfonylurea effect can persist most of the day; metformin requires continued dosing for sustained effect).

Half-Life

Glibenclamide: ~10 hours (range commonly ~7-10 h); Metformin: plasma t1/2 ~6 hours (commonly cited ~6.2 h), with a longer apparent half-life in whole blood/RBC compartment (~17 hours).

Bioavailability

Metformin oral bioavailability ~50-60% (fasting). Glibenclamide oral bioavailability is high but variable (commonly cited ~80-100% depending on formulation/source).

Metabolism

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

Excretion

Glibenclamide (glyburide): eliminated mainly as metabolites via bile/feces with a smaller renal component; Metformin: eliminated by the kidneys largely unchanged (majority of dose, via tubular secretion).

Protein Binding

Glibenclamide: highly protein bound (>99%, mainly albumin); Metformin: negligible protein binding.

Product Information

Available Dosage Forms

Film-coated tablet.

Composition per Dose

Each film-coated tablet: Glibenclamide 5mg + Metformin hydrochloride 500mg

Generic Availability

Yes

OTC Alternatives

No OTC alternative

Diabetes Type

Type 2

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