Medication Guide App

Label Changes for:

Diabeta (glyburide) tablets

October 2013

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

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

 

October 2013

PRECAUTIONS

Drug Interactions
  • An increased incidence of elevated liver enzymes was observed in patients receiving glyburide concomitantly with bosentan. Therefore concomitant administration of Diaßeta and bosentan is Contraindicated.
  • Colesevelam: Concomitant administration of colesevelam and glyburide resulted in reductions in glyburide AUC and Cmax of 32% and 47%, respectively. When glyburide was administered 1 hour before colesevelam, the reductions in glyburide AUC and Cmax were 20% and 15%, respectively, and not significantly changed (-7% and 4%, respectively) when administered 4 hours before colesevelam. Therefore, glyburide should be administered at least 4 hours prior to colesevelam.
  • Glyburide is mainly metabolized by CYP 2C9 and to a lesser extent by CYP 3A4. There is a potential for drug-drug interaction when glyburide is coadministered with inducers or inhibitors of CYP 2C9, which should be taken into account when considering concomitant therapy.

 

 

July 2009 

The detailed view includes drug products with safety labeling changes to the BOXED WARNING, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, ADVERSE REACTIONS, or PATIENT PACKAGE INSERT/MEDICATION GUIDE sections. Deletions or editorial revisions made to these sections are not included in this summary.

 

CONTRAINDICATIONS

  • addition of patients with type 1 diabetes mellitus

WARNINGS

  •  “Persons allergic to other sulfonamide derivatives may develop an allergic reaction to glyburide as well.”

PRECAUTIONS

people in whom hypoglycemia may be difficult to recognize
  •  “patients with autonomic neuropathy” 
drugs that may potentiate the hypoglycemic action of sulfonylureas
  • addition of ACE inhibitors, disopyramide, and fluoxetine 
  • “Rifampin may worsen glucose control of glyburide because rifampin can significantly induce metabolic isozymes of glyburide such as CYP2C9 and 3A4.”

ADVERSE REACTIONS

  • addition of language that cholestatic jaundice and hepatitis may progress to liver failure.

 

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