PREGNANCY AND BREASTFEEDING SAFETY:
- Glucovance has not been adequately evaluated in pregnant women. Due to the lack of conclusive safety data, Glucovance should be used in pregnancy only if the potential benefit justifies the potential risk to the fetus. Glucovance is classified as FDA pregnancy risk category B.
- It is not known if Glucovance is excreted in breast milk. Due to the lack of safety data and the potential risk for hypoglycemia (low blood glucose) in nursing infants, use of Glucovance in nursing mothers is not recommended.
PREPARATIONS: Oral tablets: 1.25/250, 2.5/500, and 5/500 mg
- Tablets should be stored at room temperature, between 15 C and 30 C (59 F to 86 F).
- Tablets should be dispensed and stored in an air- tight, light resistance container.
DRUG CLASS AND MECHANISM:
- Glucovance (glyburide/metformin) is a combination antidiabetic medication containing glyburide and metformin. Glucovance is used to improve blood glucose (sugar) control in adults with type 2 diabetes mellitus.
- Glyburide is a second generation oral sulfonylurea. It helps to lower blood glucose by stimulating the release of insulin, the hormone responsible for regulating blood glucose.
- Metformin is an oral biguanide antidiabetic agent. It decreases the production of glucose in the liver, decreases the absorption of glucose by the intestines, and increases the uptake and use of blood glucose by cells throughout the body.
- In clinical studies, glyburide/metformin therapy was observed to be superior in improving fasting plasma glucose, post-meal blood glucose, and HbA1c levels versus treatment with glyburide or metformin alone.
- Glucovance was approved by the FDA in July, 2000.
REFERENCE: FDA Prescribing Information.
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