Label: GLYBURIDE tablet

  • NDC Code(s): 0093-8034-01, 0093-8035-01, 0093-8035-05, 0093-8036-01
  • Packager: Teva Pharmaceuticals USA, Inc.
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated February 2, 2023

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  • DESCRIPTION
    Glyburide tablets, USP contain micronized (smaller particle size) glyburide, USP which is an oral blood-glucose-lowering drug of the sulfonylurea class. Glyburide, USP is a white, crystalline ...
  • CLINICAL PHARMACOLOGY
    Actions - Glyburide appears to lower the blood glucose acutely by stimulating the release of insulin from the pancreas, an effect dependent upon functioning beta cells in the pancreatic islets ...
  • INDICATIONS AND USAGE
    Glyburide Tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
  • CONTRAINDICATIONS
    Glyburide tablets are contraindicated in patients with: Known hypersensitivity or allergy to the drug. Diabetic ketoacidosis, with or without coma. This condition should be treated with ...
  • SPECIAL WARNING ON INCREASED RISK OF CARDIOVASCULAR MORTALITY
    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. This ...
  • PRECAUTIONS
    Macrovascular Outcomes - There have been no clinical studies establishing conclusive evidence of macrovascular risk reduction with glyburide or any other anti-diabetic drug. Bioavailability ...
  • ADVERSE REACTIONS
    Hypoglycemia - See PRECAUTIONS and OVERDOSAGE sections. Gastrointestinal Reactions - Cholestatic jaundice and hepatitis may occur rarely which may progress to liver failure; glyburide tablets ...
  • OVERDOSAGE
    Overdosage of sulfonylureas, including glyburide, can produce hypoglycemia. Mild hypoglycemic symptoms, without loss of consciousness or neurological findings, should be treated aggressively with ...
  • DOSAGE AND ADMINISTRATION
    Patients should be retitrated when transferred from nonmicronized glyburide tablets or other oral hypoglycemic agents. There is no fixed dosage regimen for the management of diabetes mellitus ...
  • HOW SUPPLIED
    Glyburide tablets, USP are supplied as follows: Glyburide Tablets USP 1.5 mg are white, oval-shaped, flat faced, bevel-edged, compressed tablets, debossed with 1.5 | 034 on one side and stylized ...
  • Package/Label Display Panel
    NDC 0093-8034-01 - GlyBURIDE Tablets, USP - 1.5 mg - Rx only - 100 Tablets
  • Package/Label Display Panel
    NDC 0093-8035-01 - GlyBURIDE Tablets, USP - 3 mg - Rx only - 100 Tablets
  • Package/Label Display Panel
    NDC 0093-8036-01 - GlyBURIDE Tablets, USP - 6 mg - Rx only - 100 Tablets
  • INGREDIENTS AND APPEARANCE
    Product Information