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Glyburide

GLYBURIDE

Manufacturer: RPK Pharmaceuticals, Inc.

Score: 141.0

Quick Summary

Glyburide is an oral blood-glucose-lowering drug of the sulfonylurea class, used as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. The usual starting dose is 2.5 to 5 mg daily, and the maximum daily dose is 20 mg. Glyburide is contraindicated in patients with known hypersensitivity, diabetic ketoacidosis, and type 1 diabetes mellitus. Important safety information includes the risk of hypoglycemia, cardiovascular mortality, and liver enzyme elevations. Special population considerations include use during pregnancy, nursing mothers, pediatric use, and geriatric use.

Key Clinical Findings and Indications

  • Glyburide is used to improve glycemic control in adults with type 2 diabetes mellitus
  • The drug stimulates the release of insulin from the pancreas
  • Glyburide produces a mild diuresis by enhancement of renal free water clearance

Important Safety Information

Warning

The administration of oral hypoglycemic drugs has been reported to be associated with increased cardiovascular mortality as compared to treatment with diet alone or diet plus insulin

Contraindications

  • Known hypersensitivity or allergy to the drug
  • Diabetic ketoacidosis, with or without coma
  • Type 1 diabetes mellitus
  • Concomitant administration of bosentan

Adverse Reactions

  • Hypoglycemia
  • Gastrointestinal reactions
  • Dermatologic reactions
  • Hematologic reactions
  • Metabolic reactions

Dosing Recommendations

General Guidance

Dosage increases should be made in increments of no more than 2.5 mg at weekly intervals based upon the patient's blood glucose response

Type 2 diabetes mellitus

Adult Dose

2.5 to 5 mg daily, administered with breakfast or the first main meal

Pediatric Dose

Not recommended for use in pediatric patients

Special Population Considerations

Pregnancy

  • Glyburide should be used during pregnancy only if clearly needed
  • The drug should be discontinued at least two weeks before the expected delivery date

Nursing Mothers

  • A decision should be made whether to discontinue nursing or to discontinue the drug
  • If the drug is discontinued, and if diet alone is inadequate for controlling blood glucose, insulin therapy should be considered

Pediatric Use

  • Safety and effectiveness in pediatric patients have not been established
  • Not recommended for use in pediatric patients

Geriatric Use

  • Elderly patients are particularly susceptible to the hypoglycemic action of glucose lowering drugs
  • The initial and maintenance dosing should be conservative to avoid hypoglycemic reactions