Glimepiride

ATC code

A10BB12

Therapeutic class

Sulfonylurea · Sulfonylurea derivative

Forms

oral tablet

Brand names

Glimepiride (US) · Amaryl (US) · Glimepirida Cinfa (ES) · Glimepiride Viatris (FR)

Overall confidence

high

Regulatory sources consulted

openfda-label-26cca05b-82f8-e191-e063-6394a90a56bd
aemps-cima-ft-67512
ansm-bdpm-rcp-69977393
OpenFDA · A10BB12
RxNorm rxcui 25789 ↗

Approved indications

As an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
Limitations of Use: Should not be used for the treatment of type 1 diabetes mellitus or diabetic ketoacidosis.

Contraindications

Absolute

Hypersensitivity to glimepiride, other sulfonylureas, sulfonamide derivatives, or any of the excipients.
Type 1 diabetes, diabetic coma, diabetic ketoacidosis.
Severe renal or hepatic impairment.

Clinical warnings

Major warning · Hypoglycemia: Increased risk with sulfonylureas. Can be severe. Educate patient on symptoms and management. Risk is increased in elderly, debilitated, malnourished patients, and those with adrenal, pituitary, or renal insufficiency. — FDA
Hemolytic anemia in patients with G6PD deficiency. Consider a non-sulfonylurea alternative in these patients. — ANSM

Drug interactions

HighFluconazoleJ02AC01
Mechanism: Potent inhibition of CYP2C9, which can double the AUC of glimepiride.
Recommendation: Closely monitor blood glucose due to high risk of hypoglycemia. Consider reducing glimepiride dose or avoiding concomitant use.
ANSM RCP
ModerateColesevelamC10AC04
Mechanism: Binds to glimepiride in the gastrointestinal tract, reducing its absorption.
Recommendation: Administer glimepiride at least 4 hours before colesevelam.
OpenFDA label
HighMiconazole (oral)A01AB09
Mechanism: Inhibition of CYP2C9, significantly increasing glimepiride exposure.
Recommendation: Severe hypoglycemia can occur. Concomitant use should be avoided or undertaken with extremely close glucose monitoring.
OpenFDA label

Adverse events

Common (≥1%)

hypoglycemia · dizziness · asthenia · headache · nausea

Rare but serious

hemolytic anemia · agranulocytosis · pancytopenia · hepatitis · leukocytoclastic vasculitis · hyponatremia

Pregnancy and lactation

Sulfonylureas, including glimepiride, cross the placenta and have been associated with neonatal adverse reactions such as hypoglycemia. Should be discontinued at least two weeks before the expected delivery date.