The patient should be informed of the potential risks and advantages of glimepiride and of alternative modes of therapy.
Hypoglycemia: All sulfonylurea drugs are capable of producing severe hypoglycemia.
Patients with impaired renal function may be more sensitive to the glucose-lowering effect of glimepiride.
Debilitated or malnourished patients and those with hepatic, adrenal, or pituitary insufficiency are particularly susceptible to the hypoglycemic action. Hypoglycemia may be difficult to recognize in the elderly and in people who are taking beta-adrenergic blocking drugs or other sympatholytic agents.
Hypoglycemia is more likely to occur when caloric intake is deficient, after severe or prolonged exercise, when alcohol is ingested, or when more than one glucose-lowering drug is used.
Combined use of glimepiride with insulin or metformin may increase the potential for hypoglycemia.
Loss of control of blood glucose: When a patient stabilized on any diabetic regimen is exposed to stress such as fever, trauma, infection, or surgery, a loss of control may occur. At such times, it may be necessary to add insulin in combination with glimepiride or even use insulin monotherapy.
Fasting blood glucose should be monitored periodically to determine therapeutic response. Glycosylated hemoglobin should also be monitored, usually every 3 to 6 months, to more precisely assess long-term glycemic control.
Hypersensitivity reactions: 2 mg: There have been reports of hypersensitivity reactions in patients treated with glimepiride, including serious reactions such as anaphylaxis, angioedema, and Stevens-Johnson syndrome. If a hypersensitivity reaction is suspected, promptly discontinue glimepiride, assess for other potential causes for the reaction, and institute alternative treatment for diabetes.
Hemolytic anemia: 2 mg: Sulfonylureas can cause hemolytic anemia in patients with glucose 6-phosphate dehydrogenase (G6PD) deficiency. Because glimepiride is a sulfonylurea, use caution in patient with G6PD deficiency and consider the use of a non-sulfonylurea alternative. There are also reports of hemolytic anemia in patients receiving glimepiride who did not have known G6PD deficiency.
Increased risk of cardiovascular mortality with sulfonylureas: 2 mg: The administration of oral hypoglycemic drugs has been reported to be associated with increased cardiovascular mortality as compared to treatment with diet alone or diet plus insulin. The patients should be informed of the potential risks and advantages of glimepiride and of alternative modes of therapy.
Glimepiride STELLA 2 mg/Glimepiride STELLA 4 mg contains lactose. Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicine.
Effects on ability to drive and use machines: The patient's ability to concentrate and react may be impaired as a result of hypoglycaemia or hyperglycaemia or visual impairment. Patients should be advised to take precautions to drive or operate machinery.