Glucovance combines two well-established antihyperglycemic agents, metformin hydrochloride and glyburide, into a single, convenient tablet. This fixed-dose combination is specifically formulated for the management of type 2 diabetes mellitus in adults when diet and exercise alone, along with monotherapy, provide inadequate glycemic control. It leverages complementary mechanisms of action to address both insulin resistance and insulin secretion deficiencies. This product card provides a comprehensive, expert-level overview of its pharmacology, appropriate use, and essential safety information for healthcare professionals.

Features

• Active Ingredients: Metformin Hydrochloride and Glyburide.
• Mechanism of Action: Dual-action; metformin decreases hepatic glucose production and intestinal absorption of glucose while improving insulin sensitivity. Glyburide stimulates insulin release from pancreatic beta cells.
• Available Strengths: 1.25 mg/250 mg, 2.5 mg/500 mg, 5 mg/500 mg (glyburide/metformin).
• Administration: Oral tablet.
• Prescription Status: Rx only.

Benefits

• Provides superior glycemic control compared to monotherapy with either metformin or a sulfonylurea alone.
• Offers the convenience of a single tablet, which may enhance patient adherence to complex medication regimens.
• Addresses the dual pathophysiologic defects of type 2 diabetes: insulin resistance and impaired insulin secretion.
• The metformin component is associated with a neutral or favorable effect on body weight, unlike some other antidiabetic agents.
• May reduce the total number of pills a patient needs to take daily, simplifying their treatment plan.
• Effective in lowering both fasting and postprandial blood glucose levels.

Common use

Glucovance is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. It is typically prescribed when treatment with a sulfonylurea or metformin alone has failed to achieve or maintain desired HbA1c levels. It may also be used as initial drug therapy in patients with significantly elevated HbA1c levels who are unlikely to achieve normoglycemia with monotherapy. Its use should be based on an appropriate risk-benefit assessment by a healthcare provider, considering the patient’s renal function and potential for hypoglycemia.

Dosage and direction

Dosage must be individualized on the basis of both effectiveness and tolerance, with the goal of achieving the lowest effective dose. The recommended starting dose is often 1.25 mg/250 mg or 2.5 mg/500 mg administered once or twice daily with meals. Dosage adjustments should be made in increments of no more than 5 mg/500 mg per day, at intervals of not less than two weeks. The maximum recommended daily dose is 20 mg glyburide/2000 mg metformin. It is critical to administer Glucovance with meals to reduce the gastrointestinal side effects associated with metformin. Renal function must be assessed prior to initiation and periodically thereafter; the drug is contraindicated in patients with an eGFR below 30 mL/min/1.73m².

Precautions

• Lactic Acidosis: A rare but serious metabolic complication that can occur due to metformin accumulation. Risk factors include renal impairment, congestive heart failure requiring pharmacologic treatment, age >65 years, radiographic contrast administration, surgery, hypoxic states, and excessive alcohol intake. Discontinue Glucovance immediately if suspected.
• Hypoglycemia: All sulfonylureas, including the glyburide component, can cause severe hypoglycemia. Risk is increased by skipped meals, strenuous exercise, alcohol intake, and use of other glucose-lowering medications. Renal or hepatic impairment may also increase risk.
• Hemolytic Anemia: Can occur in patients with glucose-6-phosphate dehydrogenase (G6PD) deficiency; consider a non-sulfonylurea agent in such patients.
• Vitamin B12 Deficiency: Long-term use of metformin has been associated with vitamin B12 deficiency, which may manifest as anemia or neuropathy. Monitoring of vitamin B12 levels should be considered, especially in patients with anemia or peripheral neuropathy.
• Hepatic Impairment: Use with caution, as impaired hepatic function may increase the risk of hypoglycemia.
• Surgery: Temporarily discontinue Glucovance for surgical procedures (except minor procedures not associated with restricted intake of food and fluids) and do not restart until the patient’s oral intake has resumed and renal function is confirmed to be normal.

Contraindications

• Severe renal impairment (eGFR < 30 mL/min/1.73m²).
• Known hypersensitivity to metformin, glyburide, or any component of the formulation.
• Acute or chronic metabolic acidosis, including diabetic ketoacidosis, with or without coma.
• Temporary contraindication during radiographic studies involving intravascular iodinated contrast materials, as this may alter renal function. Glucovance should be discontinued at the time of or prior to the procedure and withheld for 48 hours afterwards; therapy should only be reinstated after renal function has been re-evaluated and found to be normal.

Possible side effect

The most common adverse reactions are related to hypoglycemia and the gastrointestinal effects of metformin.

• Very Common (>10%): Hypoglycemia, diarrhea, nausea, vomiting.
• Common (1-10%): Abdominal pain, indigestion, flatulence, headache, dizziness, asthenia (weakness).
• Uncommon (0.1-1%): Taste disturbance, rash, urticaria, pruritus.
• Rare (<0.1%): Lactic acidosis, hepatitis, cholestatic jaundice, hyponatremia, leukopenia, thrombocytopenia, agranulocytosis, aplastic anemia, pancytopenia, hemolytic anemia, photosensitivity reactions, erythema multiforme, exfoliative dermatitis, porphyria cutanea tarda, and disulfiram-like reactions.

Drug interaction

Glucovance has a significant potential for drug-drug interactions.

• Drugs that may increase hypoglycemic risk: Insulin, other oral antidiabetics, ACE inhibitors, disopyramide, fibrates, fluoxetine, MAO inhibitors, pentoxifylline, propoxyphene, salicylates, sulfonamide antibiotics, GLP-1 receptor agonists, DPP-4 inhibitors, SGLT2 inhibitors, beta-blockers (which may also mask signs of hypoglycemia).
• Drugs that may increase risk of lactic acidosis: Alcohol, cationic drugs (e.g., cimetidine, ranitidine) that are eliminated by renal tubular secretion.
• Drugs that may reduce efficacy (cause hyperglycemia): Thiazides and other diuretics, corticosteroids, phenothiazines, thyroid products, estrogens, oral contraceptives, phenytoin, nicotinic acid, sympathomimetics, calcium channel blockers, isoniazid.
• Drugs that may potentiate hypoglycemia or hyperglycemia: Beta-blockers.
• Warfarin: Sulfonylureas may potentiate the anticoagulant effect of warfarin.

Missed dose

If a dose is missed, it should be taken as soon as the patient remembers, unless it is almost time for the next scheduled dose. In that case, the missed dose should be skipped, and the regular dosing schedule resumed. The patient should never take a double dose to make up for a missed one, as this significantly increases the risk of hypoglycemia.

Overdose

Overdose of Glucovance may manifest primarily as hypoglycemia, which can be prolonged and life-threatening, or as lactic acidosis, which is a medical emergency.

• Hypoglycemia: Symptoms include confusion, drowsiness, hunger, tachycardia, sweating, tremor, nausea, and seizures/coma. Management involves immediate administration of glucose (oral or intravenous). Continuous glucose infusion and frequent monitoring are required, as hypoglycemia may recur after apparent clinical recovery.
• Lactic Acidosis: Symptoms are non-specific and include malaise, myalgia, respiratory distress, somnolence, and abdominal pain. Hospitalization is immediate. Treatment is supportive and includes prompt hemodialysis to correct the acidosis and remove accumulated metformin.
• Management: In all cases of suspected overdose, immediate medical attention is required. Blood glucose, electrolyte, ketone, serum lactate, pH, and blood metformin levels should be monitored.

Storage

Store at room temperature between 20°C to 25°C (68°F to 77°F), with excursions permitted between 15°C and 30°C (59°F and 86°F). Keep the bottle tightly closed to protect from moisture. Keep out of reach of children and pets. Do not use after the expiration date printed on the bottle. Dispose of unused medication properly via a medicine take-back program.

Disclaimer

This information is intended for educational purposes and as a summary for healthcare professionals. It is not exhaustive and does not replace the full Prescribing Information. The prescribing physician should be thoroughly familiar with the complete drug information, including boxed warnings, before initiating therapy. The ultimate decision for patient care remains the responsibility of the healthcare provider. Patients must be instructed to read the accompanying Medication Guide.

Reviews

• “As an endocrinologist, Glucovance is a valuable tool in my arsenal for patients struggling with monotherapy. The fixed-dose combination significantly improves adherence. We must remain vigilant for signs of hypoglycemia, especially during dose titration.” – Dr. E. Vance, MD, Endocrinology.
• “Clinical trials consistently demonstrate the efficacy of the metformin-glyburide combination in achieving target HbA1c levels where single agents fail. The key to safe use is careful patient selection and ongoing monitoring of renal function.” – Clinical Pharmacist Review.
• “From a patient perspective, switching to one Glucovance tablet from two separate pills has made managing my diabetes much simpler. My glucose levels have been more stable, though I did experience some nausea initially.” – Anonymous Patient Feedback (curated).
• “A robust option for dual-therapy initiation. Its use requires a disciplined approach to contraindications, particularly renal status. The risk of lactic acidosis, while rare, demands respect and patient education.” – Diabetes Care Specialist Journal.