Label Changes for:

Glucovance (Glyburide and Metformin HCl) tablets

October 2013

Changes have been made to the CONTRAINDICATIONS and PRECAUTIONS sections of the safety label.

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)

 

October 2013

CONTRAINDICATIONS

  • Concomitant administration of bosentan.

PRECAUTIONS

Drug Interactions

Glyburide

  • An increased risk of liver enzyme elevations was observed in patients receiving glyburide concomitantly with bosentan. Therefore concomitant administration of Glucovance and bosentan is contraindicated.
  • Colesevelam: Concomitant administration of colesevelam and glyburide resulted in reductions in glyburide AUC and Cmax of 32% and 47%, respectively. The reductions in glyburide AUC and Cmax were 20% and 15%, respectively when administered 1 hour before, and not significantly changed (-7% and 4%, respectively) when administered 4 hours before colesevelam.

Patient Information

Can I take Glucovance with other medications?

  • Do not take Glucovance if you are taking bosentan used for pulmonary arterial hypertension (PAH), which is high blood pressure in the vessels of the lungs.

 

November 2010

ADVERSE REACTIONS

Gastrointestinal
  • In postmarketing reports cholestatic jaundice and hepatitis may occur rarely which may progress to liver failure; Glucovance should be discontinued if this occurs.

 

Summary View November 2009

 

*sulfonylurea agent class change

PRECAUTIONS

Glyburide
Hemolytic anemia
  • Treatment of patients with glucose-6-phosphate dehydrogenase (G6PD) deficiency with sulfonylurea agents can lead to hemolytic anemia. Because Glucovance belongs to the class of sulfonylurea agents, caution should be used in patients with G6PD deficiency and a non-sulfonylurea alternative should be considered. In postmarketing reports, hemolytic anemia has also been reported in patients who did not have known G6PD deficiency.

 

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