A fixed-dose combination (FDC) oral anti-diabetic drug containing a sulfonylurea (Glimepiride) and a biguanide (Metformin). It is a second-line therapy for the management of type 2 diabetes mellitus (T2DM) in adults when diet, exercise, and monotherapy with either metformin or a sulfonylurea do not result in adequate glycemic control. It addresses both insulin resistance and insulin secretion deficiency.
Adult: One tablet of Glimepiride (2mg) + Metformin (500mg) once or twice daily with meals. The dose must be individualized based on efficacy and tolerability. Maximum recommended daily dose: Glimepiride 8mg + Metformin 2000mg.
Note: Should be taken with or immediately after the main meals (breakfast and/or dinner) to reduce gastrointestinal side effects of metformin and minimize risk of hypoglycemia. Tablet should be swallowed whole with a glass of water; do not crush or chew.
This combination provides a dual mechanism: Glimepiride stimulates insulin release from pancreatic beta cells and may increase peripheral tissue sensitivity to insulin. Metformin decreases hepatic glucose production (gluconeogenesis), decreases intestinal absorption of glucose, and improves insulin sensitivity by increasing peripheral glucose uptake and utilization.
Pregnancy: Category C (US FDA). Insulin is the drug of choice for glycemic control during pregnancy. This combination is not recommended. Glimepiride may cross the placenta; risks include neonatal hypoglycemia. Metformin is used in some cases of gestational diabetes but as monotherapy and under specialist care.
Driving: Caution advised. The drug can cause hypoglycemia, dizziness, and visual disturbances, which may impair the ability to drive or operate machinery. Patients should be aware of their own warning signs of hypoglycemia.
| Other Anti-diabetics (Insulin, DPP-4 inhibitors, SGLT2 inhibitors, etc.) | Increased risk of hypoglycemia. | Major |
| Beta-blockers (e.g., Propranolol) | May mask tachycardia (warning signs) of hypoglycemia and potentiate hypoglycemic effect. | Moderate |
| Alcohol | Acute: Potentiates hypoglycemic effect of glimepiride. Chronic: Increases risk of lactic acidosis with metformin. | Major |
| Warfarin | Glimepiride may potentiate anticoagulant effect; monitor INR. | Moderate |
| CYP2C9 Inhibitors (e.g., Fluconazole, Amiodarone) | Increase glimepiride plasma levels, risk of hypoglycemia. | Moderate |
| CYP2C9 Inducers (e.g., Rifampicin) | Decrease glimepiride plasma levels, reducing efficacy. | Moderate |
| Cationic Drugs (e.g., Cimetidine, Ranitidine, Digoxin, Morphine, Vancomycin) | Competitively inhibit renal tubular secretion of metformin, potentially increasing its plasma levels. | Moderate |
| Diuretics (especially Thiazides and Loop diuretics) | May cause hyperglycemia, reducing efficacy. Also risk of lactic acidosis with metformin in setting of dehydration. | Moderate |
| Corticosteroids (e.g., Prednisolone) | Cause hyperglycemia, reducing anti-diabetic efficacy. | Moderate |
| Iodinated Contrast Media | Risk of lactic acidosis and acute renal failure. Metformin must be withheld before and after the procedure as per guidelines. | Major |
Same composition (Glimepiride (2mg) + Metformin (500mg)), different brands: