Glimepiride

What it is and how it works

Mechanism of Action Glimepiride primarily lowers blood glucose by stimulating the release of insulin from pancreatic beta cells. Sulfonylureas bind to the sulfonylurea receptor in the pancreatic beta-cell plasma membrane, leading to closure of the ATP-sensitive potassium channel, thereby stimulating the release of insulin.

Indications

Glimepiride Tablet, USP is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus ]. Glimepiride Tablet USP is a sulfonylurea indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus . Important Limitations of Use: Not for treating type 1 diabetes mellitus or diabetic ketoacidosis . Important Limitations of Use Glimepiride should not be used for the treatment of type 1 diabetes mellitus or diabetic ketoacidosis, as it would not be effective in these settings.

Dosage and administration (summary)

Recommended starting dose is 1 or 2 mg once daily. Increase in 1 or 2 mg increments no more frequently than every 1-2 weeks based on glycemic response. Maximum recommended dose is 8 mg once daily . Administer with breakfast or first meal of the day . Use 1 mg starting dose and titrate slowly in patients at increased risk for hypoglycemia (e.g., elderly, patients with renal impairment) . Recommended Dosing Glimepiride should be administered with breakfast or the first main meal of the day. The recommended starting dose of glimepiride is 1 mg or 2 mg once daily.

Contraindications

Glimepiride is contraindicated in patients with a history of a hypersensitivity reaction to: Glimepiride or any of the product's ingredients [ see Warnings and Precautions ]. Sulfonamide derivatives: Patients who have developed an allergic reaction to sulfonamide derivatives may develop an allergic reaction to Glimepiride. Do not use glimepiride in patients who have a history of an allergic reaction to sulfonamide derivatives.

Warnings and precautions

Hypoglycemia: May be severe. Ensure proper patient selection, dosing, and instructions, particularly in at-risk populations (e.g., elderly, renally impaired) and when used with other anti-diabetic medications . Hypersensitivity Reactions: Post-marketing reports include anaphylaxis, angioedema and Stevens-Johnson Syndrome. Promptly discontinue glimepiride, assess for other causes, institute appropriate monitoring and treatment, and initiate alternative treatment for diabetes . Hemolytic Anemia: Can occur if glucose 6-phosphate dehydrogenase (G6PD) deficient.

Pregnancy

Pregnancy Pregnancy Category C There are no adequate and well-controlled studies of glimepiride in pregnant women. In animal studies there was no increase in congenital anomalies, but an increase in fetal deaths occurred in rats and rabbits at glimepiride doses 50 times (rats) and 0.1 times (rabbits) the maximum recommended human dose (based on bod…

Storage and supply

Storage and Handling Store at 20º to 25ºC (68º to 77ºF) (See USP Controlled Room Temperature) Dispense in well-closed containers with safety closures.

Source: Glimepiride (Glimepiride) — US FDA prescribing information, 2019-02-13, DailyMed. Summarised and shortened; the full label governs. Iranian registration, indications and labelling may differ.