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Europe — EMA

Glucovance

Glucovance is an oral tablet combining metformin and glibenclamide for type 2 diabetes; learn its uses, side effects, precautions, and drug interactions.

Metformin Hydrochloride, Glibenclamide

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What is Metformin Hydrochloride, Glibenclamide?

Glucovance is a prescription oral tablet that combines metformin hydrochloride and glibenclamide. It is classified as a biguanide/sulfonylurea combination and is marketed in the European Union. The product contains both agents in a fixed-dose formulation, though specific strength details are not disclosed here. Glucovance is intended for adult patients with type 2 diabetes mellitus to improve glycemic control. It is administered orally and requires a prescription from a healthcare professional.

What is Metformin Hydrochloride, Glibenclamide used for?

Glucovance is indicated for the management of type 2 diabetes mellitus in adults when diet, exercise, and monotherapy with either component are insufficient.

- When metformin alone does not achieve target fasting glucose levels, Glucovance provides additional insulin secretagogue activity. - When sulfonylurea monotherapy fails to maintain post‑prandial glucose control, the metformin component adds hepatic glucose reduction. - Patients requiring a single tablet to simplify regimens may benefit from the fixed‑dose combination. - Glucovance can be used as part of a comprehensive diabetes care plan that includes diet, exercise, and regular monitoring. - The combination is appropriate for adults with preserved pancreatic beta‑cell function who need both insulin sensitization and stimulation.

What are the side effects of Metformin Hydrochloride, Glibenclamide?

Glucovance may be associated with adverse effects typical of its individual components; patients should be aware of both common and less frequent serious reactions.

Common: - Nausea, vomiting, or abdominal discomfort. - Diarrhea or loose stools. - Mild hypoglycemia, especially when meals are missed. - Headache or dizziness. - Metallic taste in the mouth. - Weight gain or loss, variable among patients.

Serious: - Lactic acidosis, a rare but life‑threatening condition. - Severe hypoglycemia requiring assistance. - Allergic reactions such as rash, pruritus, or angioedema. - Hepatic dysfunction manifested by elevated liver enzymes. - Pancreatitis presenting with abdominal pain and elevated enzymes.

The frequency and severity of these events can vary based on individual health status and concomitant medications.

What precautions apply to Metformin Hydrochloride, Glibenclamide?

When prescribing Glucovance, clinicians should evaluate patient history and monitor for conditions that could increase risk of adverse outcomes.

- Avoid use in patients with severe renal impairment (eGFR <30 mL/min/1.73 m²) due to increased metformin accumulation. - Caution in moderate renal dysfunction; dose adjustment and monitoring are recommended. - Do not prescribe to individuals with known hypersensitivity to metformin, glibenclamide, or any sulfonylurea. - Use carefully in patients with hepatic disease, as reduced clearance may elevate drug levels. - Elderly patients may be more prone to hypoglycemia; begin with the lowest effective dose. - Pregnancy and lactation status should be reviewed; safety data are limited.

What does Metformin Hydrochloride, Glibenclamide interact with?

Glucovance can interact with several medications; recognizing these interactions helps to prevent reduced efficacy or increased toxicity.

Avoid: - Concurrent use with iodinated contrast media for radiographic studies; metformin should be discontinued before and after the procedure. - Other sulfonylureas or meglitinides, which may increase risk of severe hypoglycemia. - Strong CYP2C9 inhibitors (e.g., fluconazole, amiodarone) that can raise glibenclamide plasma levels.

Use with caution: - Renal‑impairing agents such as ACE inhibitors or NSAIDs; monitor kidney function. - Corticosteroids or thiazide diuretics that may raise blood glucose; adjust dose as needed. - Alcohol consumption, which can potentiate metformin‑related lactic acidosis.

Frequently asked questions

What is Glucovance and how does it work?+
Glucovance is an oral tablet that combines metformin hydrochloride, which reduces hepatic glucose production and improves insulin sensitivity, with glibenclamide, a sulfonylurea that stimulates insulin release from pancreatic beta cells.
Which patients are eligible for Glucovance therapy?+
Glucovance is prescribed for adult patients with type 2 diabetes mellitus when diet, exercise, and single‑agent therapy do not achieve adequate glycemic control.
How does Glucovance differ from taking metformin and glibenclamide separately?+
Glucovance provides a fixed‑dose combination in a single tablet, simplifying the regimen and potentially improving adherence compared with taking the two drugs as separate prescriptions.
What are the most common side effects of Glucovance?+
Common adverse effects include gastrointestinal symptoms such as nausea, vomiting, abdominal discomfort, diarrhea, a metallic taste, as well as mild hypoglycemia, headache, and dizziness.
Can Glucovance cause low blood sugar?+
Yes, because glibenclamide stimulates insulin release, Glucovance can cause hypoglycemia, especially if meals are missed, alcohol is consumed, or other glucose‑lowering agents are used.
What should I do if I miss a dose of Glucovance?+
If a dose is missed, take it as soon as you remember unless it is close to the time of the next scheduled dose. Do not double the dose. Consult your prescriber for personalized guidance.
Are there any dietary restrictions while taking Glucovance?+
Patients should follow a balanced diet consistent with diabetes management, monitor carbohydrate intake, and avoid excessive alcohol, which can increase the risk of lactic acidosis with metformin.
How does renal function affect the use of Glucovance?+
Reduced kidney function can lead to accumulation of metformin and increase the risk of lactic acidosis; severe renal impairment is a contraindication, and dose adjustments may be needed for moderate impairment.
Is it safe to consume alcohol while on Glucovance?+
Alcohol should be limited because it can potentiate metformin‑related lactic acidosis and increase the risk of hypoglycemia from glibenclamide.
What medications should be avoided when taking Glucovance?+
Avoid concurrent use of iodinated contrast agents, other sulfonylureas or meglitinides, and strong CYP2C9 inhibitors such as fluconazole or amiodarone, as these can increase the risk of severe hypoglycemia or toxicity.
How should Glucovance be stored?+
Store Glucovance at room temperature, away from moisture and heat. Keep the container tightly closed and out of reach of children.
Does Glucovance have any special considerations during pregnancy or breastfeeding?+
Safety data for Glucovance in pregnancy and lactation are limited; the medication should only be used if the potential benefit justifies the potential risk, and decisions should be made in consultation with a healthcare professional.
Information provided on this page is for educational use by procurement and clinical professionals. Always consult a licensed healthcare provider for medical advice and prescribing decisions. GNH USA supplies this product subject to applicable regulatory and licensing requirements.

Product details

Drug
Metformin Hydrochloride, Glibenclamide
Route
Oral Use
Manufacturer
Merck B.V.
Origin
EU

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