Glyburide Tablets

Overdosage of sulfonylureas, including Diaβeta, can produce hypoglycemia. Mild hypoglycemic symptoms without loss of consciousness or neurologic 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 that 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.

You should not use this medication if you are allergic to glyburide, if you are being treated with bosentan (Tracleer), if you have type 1 diabetes, or if you are in a state of diabetic ketoacidosis (call your doctor for treatment with insulin).

Before taking glyburide, tell your doctor if you are allergic to sulfa drugs, if you have been using insulin or chlorpropamide (Diabinese), or if you have hemolytic anemia (a lack of red blood cells), an enzyme deficiency (G6PD), a nerve disorder, liver disease, or kidney disease.

Take care not to let your blood sugar get too low. Low blood sugar (hypoglycemia) can occur if you skip a meal, exercise too long, drink alcohol, or are under stress. Symptoms include headache, hunger, weakness, sweating, tremor, irritability, or trouble concentrating. Carry hard candy or glucose tablets with you in case you have low blood sugar. Other sugar sources include orange juice and milk. Be sure your family and close friends know how to help you in an emergency.

You should not use this medication if you are allergic to glyburide, or:

• if you are being treated with bosentan (Tracleer);
• if you have type 1 diabetes; or
• if you are in a state of diabetic ketoacidosis (call your doctor for treatment with insulin).

To make sure you can safely take glyburide, tell your doctor if you have any of these other conditions:

• hemolytic anemia (a lack of red blood cells);
• an enzyme deficiency called glucose-6-phosphate dehydrogenase deficiency (G6PD);
• a nerve disorder affecting bodily functions;
• liver or kidney disease;
• if you are allergic to sulfa drugs; or
• if you have been using insulin or taking chlorpropamide (Diabinese).

Certain oral diabetes medications may increase your risk of serious heart problems. However, not treating your diabetes can damage your heart and other organs. Talk to your doctor about the risks and benefits of treating your diabetes with glyburide.

FDA pregnancy category C. It is not known whether glyburide will harm an unborn baby. Similar diabetes medications have caused severe hypoglycemia in newborn babies whose mothers had used the medication near the time of delivery. Tell your doctor if you are pregnant or plan to become pregnant while using this medication.

It is not known whether glyburide passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

Older adults may be more likely to have low blood sugar while taking glyburide.

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: C 23H 28ClN 3O 5S

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: lactose monohydrate, magnesium stearate, sodium starch glycolate, and talc. In addition, the 2.5 mg contains red iron oxide and yellow iron oxide; the 5 mg contains D&C yellow No. 10 aluminum lake and FD&C blue No. 1/brilliant blue FCF aluminum lake.

Glyburide Tablets are contraindicated in patients with:

1. Known hypersensitivity or allergy to the drug.
2. Diabetic ketoacidosis, with or without coma. This condition should be treated with insulin.
3. Type I diabetes mellitus.
4. Concomitant administration of bosentan.

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.

Rx only

Glyburide Tablets, USP 5 mg

100 Tablets

NDC 52817-122-10