glyburide/metformin (Glucovance) (cont.)

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PREPARATIONS: Oral tablets: 1.25/250, 2.5/500, and 5/500 mg

STORAGE: 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.


For patients inadequately controlled on diet and exercise

  • Generally, the recommended starting dose ofGlucovance is 1.25/250 mg administered once daily with a meal.
  • A starting dose of 1.25/ 250 mg twice daily may be considered for patients with HbA1c >9% or fasting plasma glucose (FPG) >200 mg/dL.
  • If necessary, dosage may be increased in increments of 1.25/250 mg at two week intervals.
  • The maximum daily dose of Glucovance is 20/2000 mg.

For patients inadequately controlled on a sulfonylurea and/or metformin

  • Generally, the recommended starting dose of Glucovance is 2.5 mg/500 mg or 5 mg/500 mg orally twice a day with meals.

The safety and efficacy of Glucovance has not been established in pediatric patients. Therefore, use of Glucovance in this patient population is not recommended.


Drugs that cause blood glucose levels to increase may diminish the effectiveness of Glucovance therapy. These drugs include

When these drugs are stopped, patients should be closely observed for signs of low blood glucose.

Cimetidine (Tagamet), by decreasing the elimination of metformin from the body, can increase the amount of metformin in the blood by 40%. This may increase the frequency of side effects from metformin.

Contrast media used for radiological procedures may reduce kidney function which reduces elimination of metformin, leading to increased concentrations of metformin in the blood. Metformin should be stopped 48 hours before and after use of contrast media.

Alcohol consumption increases the effect of metformin on lactate production, increasing the risk of lactic acidosis.

Certain drugs may increase the blood glucose lowering actions of glyburide. It is possible that hypoglycemia (low blood glucose) and symptoms from hypoglycemia may result. Such drugs include

Coadministration of glyburide with bosentan (Tracleer) may cause an abnormal increase in liver enzymes. Therefore, concomitant use of these agents is not recommended.

Colesevelam (Welchol) may reduce blood levels of glyburide. Patients are advised to take glyburide 1 hour before or 4 hours after colesevelam administration to minimize the risk of their interaction.

PREGNANCY: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.

NURSING MOTHERS: 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.

REFERENCE: FDA Prescribing Information.

Medically Reviewed by a Doctor on 8/20/2015

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