displayName: DESCRIPTION SECTION
FDA Article Code: 34089-3
Glyburide tablets USP contain glyburide, which is an oral blood-glucose-lowering drug of the sulfonylurea class. Glyburide is a white, crystalline compound. The chemical name for glyburide is 1-[[p-[2-(5-chloro-o-anisamido)ethyl]phenyl]-sulfonyl]-3-cyclohexylurea and the molecular weight is 493.99. It has the following structural formula:
Molecular formula: C23H28ClN3O5S
Each tablet, for oral administration, contains 1.25 mg, 2.5 mg or 5 mg of glyburide. In addition, each tablet contains the following inactive ingredients: microcrystalline cellulose, pregelatinized starch, sodium starch glycolate, colloidal silicon dioxide, and magnesium stearate. In addition, the 2.5
mg contains FD&C yellow No. 6 and the 5 mg contains D&C yellow No. 10, and FD&C blue No. 1.
INDICATIONS AND USAGE
displayName: INDICATIONS & USAGE SECTION
FDA Article Code: 34067-9
Glyburide tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
displayName: CONTRAINDICATIONS SECTION
FDA Article Code: 34070-3
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.
SPECIAL WARNING ON INCREASED RISK OF CARDIOVASCULAR MORTALITY
displayName: WARNINGS SECTION
FDA Article Code: 34071-1
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 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.
displayName: PRECAUTIONS SECTION
FDA Article Code: 42232-9
Bioavailability studies have demonstrated that micronized glyburide tablets 3 mg provide serum glyburide concentrations that are not bioequivalent to those from nonmicronized glyburide tablets 5 mg. Therefore, patients should be retitrated when transferred from micronized glyburide tablets or other oral hypoglycemic agents.
displayName: ADVERSE REACTIONS SECTION
FDA Article Code: 34084-4
Hypoglycemia: See PRECAUTIONS and OVERDOSAGE sections.
Gastrointestinal Reactions: Cholestatic jaundice and hepatitis may occur rarely which may progress to liver failure; Glyburide Tablets USP should be discontinued if this occurs.
Liver function abnormalities, including isolated transaminase elevations, have been reported.
Gastrointestinal disturbances, e.g
., 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, e.g
., pruritus, erythema, urticaria, and morbilliform or maculopapular eruptions occurred in 1.5% of treated patients during clinical trials. These may be transient and may disappear despite continued use of glyburide; if skin reactions persist, the drug should be discontinued.
Porphyria cutanea tarda and photosensitivity reactions have been reported with sulfonylureas.
Hematologic Reactions: Leukopenia, agranulocytosis, thrombocytopenia, hemolytic anemia (see PRECAUTIONS), aplastic anemia, and pancytopenia have been reported with sulfonylureas.
Metabolic Reactions: Hepatic porphyria and disulfiram-like reactions have been reported with sulfonylureas; however, hepatic porphyria has not been reported with glyburide and disulfiram-like reactions have been reported very rarely.
Cases of hyponatremia have been reported with glyburide and all other sulfonylureas, most often in patients who are on other medications or have medical conditions known to cause hyponatremia or increase release of antidiuretic hormone. The syndrome of inappropriate antidiuretic hormone (SIADH) secretion has been reported with certain other sulfonylureas, and it has been suggested that these sulfonylureas may augment the peripheral (antidiuretic) action of ADH and/or increase release of ADH.
Other Reactions: Changes in accommodation and/or blurred vision have been reported with glyburide and other sulfonylureas. These are thought to be related to fluctuation in glucose levels.
In addition to dermatologic reactions, allergic reactions such as angioedema, arthralgia, myalgia and vasculitis have been reported.
displayName: OVERDOSAGE SECTION
FDA Article Code: 34088-5
Overdosage of sulfonylureas, including glyburide tablets, can produce hypoglycemia. Mild hypoglycemic symptoms, without loss of consciousness or neurological findings, should be treated aggressively with oral glucose and adjustments in drug dosage and/or meal patterns. Close monitoring should continue until the physician is assured that the patient is out of danger. Severe hypoglycemic reactions with coma, seizure, or other neurological impairment occur infrequently, but constitute medical emergencies requiring immediate hospitalization. If hypoglycemic coma is diagnosed or suspected, the patient should be given a rapid intravenous injection of concentrated (50%) glucose solution. This should be followed by a continuous infusion of a more dilute (10%) glucose solution at a rate which will maintain the blood glucose at a level above 100 mg/dL. Patients should be closely monitored for a minimum of 24 to 48 hours, since hypoglycemia may recur after apparent clinical recovery.
DOSAGE AND ADMINISTRATION
displayName: DOSAGE & ADMINISTRATION SECTION
FDA Article Code: 34068-7
Patients should be retitrated when transferred from glyburide (micronized) tablets or other oral hypoglycemic agents (see PRECAUTIONS).
There is no fixed dosage regimen for the management of diabetes mellitus with glyburide tablets or any other hypoglycemic agent. In addition to the usual monitoring of urinary glucose, the patient’s blood glucose must also be monitored periodically to determine the minimum effective dose for the patient; to detect primary failure, i.e., inadequate lowering of blood glucose at the maximum recommended dose of medication; and to detect secondary failure, i.e., loss of adequate blood glucose lowering response after an initial period of effectiveness. Glycosylated hemoglobin levels may also be of value in monitoring the patient’s response to therapy.
Short-term administration of glyburide tablets may be sufficient during periods of transient loss of control in patients usually controlled well on diet.
displayName: HOW SUPPLIED SECTION
FDA Article Code: 34069-5
Glyburide tablets USP, 1.25 mg are white, round, bi-convex, compressed tablets engraved with N horizontal bisect 342 on one side and 1.25 on the other side. They are supplied as follows:
NDC 0093-8342-01 bottles of 100
Glyburide tablets USP, 2.5 mg are peach-colored, round, bi-convex, compressed tablets engraved with N horizontal bisect 343 on one side and 2.5 on the other side. They are supplied as follows:
NDC 0093-8343-98 bottles of 90
NDC 0093-8343-01 bottles of 100
NDC 0093-8343-05 bottles of 500
NDC 0093-8343-10 bottles of 1000
NDC 0093-8343-50 bottles of 5000
Glyburide tablets USP, 5 mg are light-green colored, round, bi-convex, compressed tablets engraved with N horizontal bisect 344 on one side and 5 on the other side. They are supplied as follows:
NDC 0093-8344-98 bottles of 90
NDC 0093-8344-01 bottles of 100
NDC 0093-8344-05 bottles of 500
NDC 0093-8344-10 bottles of 1000
NDC 0093-8344-50 bottles of 5000
NDC 0093-8344-93 unit-dose boxes of 100 (10 x 10)
Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].
Dispense in tight, light-resistant container. Keep container tightly closed.
Manufactured In Canada By:
Toronto, Canada M1B 2K9
TEVA PHARMACEUTICALS USA
Sellersville, PA 18960
Rev. O 6/2010