displayName: DESCRIPTION SECTION
FDA Article Code: 34089-3
Glyburide tablets (micronized), USP contain smaller particle size. Glyburide is an oral blood-glucose-lowering drug of the sulfonylurea class. Glyburide is a white, crystalline compound. Each tablet, for oral administration, contains 1.5 mg, 3 mg, or 6 mg of glyburide. Inactive ingredients: microcrystalline cellulose, pregelatinized starch, sodium starch glycolate, colloidal silicon dioxide, magnesium stearate. In addition, the 3 mg, and 6 mg strengths contain FD&C Blue No. 1 Aluminum Lake and FD&C Blue No. 2 Aluminum Lake. The chemical name for glyburide is 1-[[p-[2-(5-Chloro-o-anisamido)ethyl]phenyl]sulfonyl]-3-cyclohexylurea. The molecular formula is C23H28ClN3O5S, and the molecular weight is 494.01. The structural formula is represented below:
Glyburide tablets (micronized), USP meets USP Dissolution Test 2.
INDICATIONS AND USAGE
displayName: INDICATIONS & USAGE SECTION
FDA Article Code: 34067-9
Glyburide tablets (micronized) 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 (micronized) 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 (Diabetes, 19 (Suppl. 2):747-830, 1970).
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 2 1/2 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 (micronized) 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: OVERDOSAGE SECTION
FDA Article Code: 34088-5
Overdosage of sulfonylureas, including glyburide, 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 nonmicronized glyburide tablets or other oral hypoglycemic agents.
There is no fixed dosage regimen for the management of diabetes mellitus with glyburide tablets (micronized), USP 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 (micronized), USP 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 (micronized), USP are supplied as follows:
Glyburide tablets (micronized), USP 1.5 mg are white, oval-shaped, flat face, beveled-edge, compressed tablets, debossed with 1.5 | 034 on one side and stylized N on the reverse. They are supplied as follows:
NDC 0093-8034-01 bottles of 100
Glyburide tablets (micronized), USP 3 mg are pale-blue colored, oval-shaped, flat face, beveled-edge, compressed tablets, debossed with 3 | 035 on one side and stylized N on the reverse. They are supplied as follows:
NDC 0093-8035-01 bottles of 100
NDC 0093-8035-05 bottles of 500
NDC 0093-8035-50 bottles of 5000
Glyburide tablets (micronized), USP 6 mg are dark-blue colored, oval-shaped, flat face, beveled-edge, compressed tablets, debossed with 6 | 036 on one side and stylized N on the reverse. They are supplied as follows:
NDC 0093-8036-01 bottles of 100
The glyburide tablet (micronized), USP can be easily divided in half for a more flexible dosing regimen. Press gently on the score and the tablet will split in even halves.
Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container with safety closure. Keep container tightly closed.
Manufactured In Canada By:
TEVA CANADA LIMITED
Toronto, Canada M1B 2K9
TEVA PHARMACEUTICALS USA
Sellersville, PA 18960
Rev. J 7/2012
PRINCIPAL DISPLAY PANEL
displayName: PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
FDA Article Code: 51945-4