Glimepiride

DEA Class; Rx

Common Brand Names; Amaryl

Indicated for the treatment of type 2 diabetes mellitus as an adjunct to diet and exercise.

Hypersensitivity; sulfa allergy

Type 1 diabetes

Diabetic ketoacidosis (with or without coma)

Complicated gestational diabetes mellitus

• Hypoglycemia (4-20%)
• Dizziness (1.7%)
• Asthenia (1.6%)
• Headache (1.5%)
• Nausea (1.1%)
• Allergic skin reactions
• Erythema
• Morbilliform or maculopapular eruptions
• Pruritus
• Urticaria
• Diarrhea
• Gastrointestinal pain
• Vomiting
• Agranulocytosis
• Anemia
• Aplastic anemia
• Leukopenia
• Pancytopenia
• Thrombocytopenia, hemolytic
• Cholestasis
• Elevation of liver enzyme levels
• Hepatic porphyria reactions
• Jaundice (rare)
• Disulfiram-like reactions
• Hyponatremia
• Serious hypersensitivity reactions, including anaphylaxis, angioedema, and Stevens- Johnson Syndrome
• Hemolytic anemia in patients with and without G6PD deficiency
• Hepatic impairment (eg, cholestasis, jaundice), as well as hepatitis, which may progress to liver failure
• Porphyria cutanea tarda, photosensitivity reactions and allergic vasculitis
• Leukopenia, agranulocytosis, aplastic anemia, and pancytopenia
• Thrombocytopenia (including severe cases with platelet count <10,000/mcL) and thrombocytopenic purpura
• Hepatic porphyria reactions and disulfiram-like reactions
• Hyponatremia and SIADH, most often in patients on other medications or have medical conditions known to cause hyponatremia or increase release of antidiuretic hormone
• Dysgeusia
• Alopecia

Patients with risk of severe hypoglycemia: Elderly, debilitated, or malnourished; adrenal or pituitary insufficiency; patients with stress due to infection, fever, trauma, or surgery

If patient is exposed to stress, it may be necessary to discontinue glimepiride and initiate insulin

Use caution in hepatic/renal impairment

Pregnancy, lactation

Increased risk of cardiovascular mortality

Persons allergic to other sulfonamide derivatives may develop allergic reaction to glimepiride

Hypoglycemia may be difficult to recognize in patients with autonomic neuropathy

Hemolytic anemia may occur with glucose 6-phosphate dehydrogenase (G6PD) deficiency when treated with sulfonylurea agents

Fluid retention, which may exacerbate or lead to heart failure, may occur

Combination use with insulin and use in congestive heart failure NYHA Class I and II may increase risk of other cardiovascular effects

Potential risk of ischemic cardiovascular (CV) events relative to placebo reported in meta-analysis studies, but not confirmed in long-term CV outcome trial versus metformin or sulfonylurea

Dose-related edema, weight gain, and anemia may occur

Macular edema reported

Increased incidence of bone fracture reported

Postmarketing reports for glimepiride 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

Available data from a small number of published studies and postmarketing experience in pregnancy over decades have not identified any drug associated risks for major birth defects, miscarriage, or adverse maternal outcomes. However, sulfonylureas (including glimepiride) cross the placenta and have been associated with neonatal adverse reactions such as hypoglycemia; therefore, therapy should be discontinued at least two weeks before expected delivery; poorly controlled diabetes in pregnancy is also associated with risks to mother and fetus

Breastfed infants of lactating women in therapy should be monitored for symptoms of hypoglycemia; not known whether drug is excreted in human milk and there are no data on effects of drug on milk production

Glimepiride

tablet

• 1mg
• 2mg
• 3mg
• 4mg