Glyburide: uses, appearance and warnings

Glyburide tablets is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.

Glyburide tablets, USP are supplied as follows: Glyburide tablets, USP 1.25 mg (White to off white colored, capsule shaped, biconvex tablets de-bossed with 'I35' on one side and scored on the other side) Bottles of 30 NDC 62135-583-30 Glyburide tablets, USP 2.5 mg (Pink colored, slightly mottled, capsule shaped, biconvex tablets de-bossed with 'I36' on one side and scored on the other side) Bottles of 30 NDC 62135-584-30 Glyburide tablets, USP 5 mg (Blue colored, slightly mottled, capsule shaped, biconvex tablets de-bossed with 'I37' on one side and scored on the other side) Bottles of 90 NDC 62135-585-90 Rx only Store at 20° to 25°C (68° to 77°F) [see USP controlled room temperature]. Dispensed in well closed containers with safety closures. Keep container tightly closed. Manufactured by: USV Private Limited Daman - 396210, India Manufactured for: Chartwell RX, LLC. Congers, NY 10920 Revised : 04/2023 L71445

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 insulin. Type I diabetes mellitus. Concomitant administration of bosentan. 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 warning is based on the study conducted by the University Group Diabetes Program (UGDP), a long-term prospective clinical trial designed to evaluate the effectiveness of glucose-lowering drugs in preventing or delaying vascular complications in patients with non-insulin-dependent diabetes. The study involved 823 patients who were randomly assigned to one of four treatment groups. UGDP reported that patients treated for 5 to 8 years with diet plus a fixed dose of tolbutamide (1.5 grams per day) had a rate of cardiovascular mortality approximately 2½ times that of patients treated with diet alone. A significant increase in total mortality was not observed, but the use of tolbutamide was discontinued based on the increase in cardiovascular mortality, thus limiting the opportunity for the study to show an increase in overall mortality. Despite controversy regarding the interpretation of these results, the findings of the UGDP study provide an adequate basis for this warning. The patient should be informed of the potential risks and advantages of glyburide tablets and of alternative modes of therapy. Although only one drug in the sulfonylurea class (tolbutamide) was included in this study, it is prudent from a safety standpoint to consider that this warning may also apply to other oral hypoglycemic drugs in this class, in view of their close similarities in mode of action and chemical structure.

Hypoglycemia : See Precautions and Overdosage Sections. Gastrointestinal Reactions: Cholestatic jaundice and hepatitis may occur rarely which may progress to liver failure; glyburide tablets should be discontinued if this occurs. Liver function abnormalities, including isolated transaminase elevations, have been reported. Gastrointestinal disturbances, eg, nausea, epigastric fullness, and heartburn are the most common reactions, having occurred in 1.8% of treated patients during clinical trials. They tend to be dose related and may disappear when dosage is reduced. Dermatologic Reactions: Allergic skin reactions, eg, pruritus, erythema, urticaria, and morbilliform or maculopapular eruptions occurred in 1.5% of treated patients during clinical trials. …

The hypoglycemic action of sulfonylureas may be potentiated by certain drugs including nonsteroidal anti-inflammatory agents and other drugs that are highly protein bound, salicylates, sulfonamides, chloramphenicol, probenecid, coumarins, monoamine oxidase inhibitors, and beta adrenergic blocking agents. When such drugs are administered to a patient receiving glyburide tablets, the patient should be observed closely for hypoglycemia. When such drugs are withdrawn from a patient receiving glyburide tablets, the patient should be observed closely for loss of control. An increased risk of liver enzyme elevations was observed in patients receiving glyburide concomitantly with bosentan. Therefore, concomitant administration of glyburide tablets and bosentan is contraindicated. Certain drugs tend to produce hyperglycemia and may lead to loss of control. …