Gliclazide
Regulatory sources consulted
- AEMPS-CIMA-FT-63644
- AEMPS CIMA · nº registro 63644 ↗
- RxNorm rxcui 4816 ↗
Approved indications
- Type 2 diabetes mellitus in adults, when dietary measures, physical exercise and weight loss are not sufficient to control blood glucose.
Contraindications
Absolute
- Hypersensitivity to the active substance, other sulfonylureas or sulfonamides; Type 1 diabetes; Diabetic ketoacidosis; Severe renal or hepatic impairment; Treatment with miconazole; Lactation.
Clinical warnings
- Major warning · Risk of hypoglycemia, especially in elderly, malnourished patients, with irregular meal schedules, or with renal/hepatic impairment. Requires regular blood glucose monitoring. — EMA SPC
Drug interactions
- HighMiconazole (systemic route, oromucosal gel)J02AB01
Mechanism: Inhibition of gliclazide metabolism (CYP2C9), increasing its concentration and the risk of severe hypoglycemia, potentially leading to coma.
Recommendation: Contraindicated. Avoid combination.
EMA SPC
Adverse events
Common (≥1%)
hypoglycemia · abdominal pain · nausea · diarrhea · constipation
Rare but serious
severe cutaneous reactions (Stevens-Johnson Syndrome) · blood dyscrasias · hepatitis
Pregnancy and lactation
Pregnancy: Not recommended. Switch to insulin is required. Lactation: Contraindicated.