Glimepiride

GLIMEPIRIDE

Manufacturer: Florida Pharmaceutical Products, LLC

Score: 141.0

Quick Summary

Glimepiride is an oral sulfonylurea used to improve glycemic control in adults with type 2 diabetes mellitus. It works by stimulating the release of insulin from pancreatic beta cells. The recommended starting dose is 1 or 2 mg once daily, with a maximum dose of 8 mg once daily. Glimepiride is contraindicated in patients with a history of hypersensitivity to sulfonylureas or sulfonamide derivatives. It is not recommended for use in pediatric patients due to adverse effects on body weight and hypoglycemia. Special considerations are needed for use in pregnancy, nursing mothers, and geriatric patients.

Key Clinical Findings and Indications

Improves glycemic control in adults with type 2 diabetes mellitus
Stimulates the release of insulin from pancreatic beta cells
Indicated as an adjunct to diet and exercise

Important Safety Information

Warning

May cause hypoglycemia, especially in elderly patients or those with renal impairment

Contraindications

Hypersensitivity to glimepiride or any of the product's ingredients
Hypersensitivity to sulfonamide derivatives

Adverse Reactions

Hypoglycemia
Headache
Nausea
Dizziness

Dosing Recommendations

General Guidance

Dose adjustments should be made based on glycemic response, with a conservative titration scheme recommended for patients at increased risk for hypoglycemia

Type 2 diabetes mellitus

Adult Dose

1 or 2 mg once daily, with a maximum dose of 8 mg once daily

Pediatric Dose

Not recommended for use in pediatric patients

Special Population Considerations

Pregnancy

Glimepiride should be discontinued at least two weeks before expected delivery
May cause neonatal hypoglycemia

Nursing Mothers

Monitor breastfed infants for signs of hypoglycemia
Glimepiride is present in rat milk, but it is not known whether it is excreted in human milk

Pediatric Use

Not recommended for use in pediatric patients due to adverse effects on body weight and hypoglycemia
The pharmacokinetics of glimepiride have been evaluated in pediatric patients, but the results did not meet the primary objective of showing a similar reduction in HbA1c compared to metformin

Geriatric Use

Use caution when initiating glimepiride and increasing the dose in elderly patients
Elderly patients are more likely to have renal impairment, which may increase the risk of hypoglycemia