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Glynase
Generic Name: Glyburide (PresTab)
Drug Category: Sulfonylurea
Litigation Alert Level: High
This drug has been approved for use by males and females over the age of 18 years old for a maximum duration of 3 years.
| Approved Uses |
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Indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Daily doses more than 12 mg are not recommended. GLYNASE PresTab Tablets are contraindicated in patients with:
Bioavailability studies have demonstrated that GLYNASE PresTab Tablets 3 mg provide serum glyburide concentrations that are not bioequivalent to those from MICRONASE Tablets 5 mg. Therefore, patients should be retitrated when transferred from MICRONASE or Diabeta or other oral hypoglycemic agents. There have been no clinical studies establishing conclusive evidence of macrovascular risk reduction with GLYNASE PresTab or any other anti-diabetic drug. 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. Cholestatic jaundice and hepatitis may occur rarely which may progress to liver failure. Porphyria cutanea tarda and photosensitivity reactions have been reported with sulfonylureas. 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. All sulfonylureas including GLYNASE PresTab are capable of producing severe hypoglycemia. Proper patient selection and dosage and instructions are important to avoid hypoglycemic episodes. Renal or hepatic insufficiency may cause elevated drug levels of glyburide and the latter may also diminish gluconeogenic capacity, both of which increase the risk of serious hypoglycemic reactions. Elderly, debilitated or malnourished patients, and those with adrenal or pituitary insufficiency, are particularly susceptible to the hypoglycemic action of glucose-lowering drugs. Hypoglycemia may be difficult to recognize in the elderly and in people who are taking beta-adrenergic blocking drugs. Hypoglycemia is more likely to occur when caloric intake is deficient, after severe or prolonged exercise, when alcohol is ingested, or when more than one glucose lowering drug is used. The risk of hypoglycemia may be increased with combination therapy. When a patient stabilized on any diabetic regimen is exposed to stress such as fever, trauma, infection or surgery, a loss of control may occur. At such times it may be necessary to discontinue GLYNASE PresTab and administer insulin. Treatment of patients with glucose 6-phosphate dehydrogenase (G6PD) deficiency with sulfonylurea agents can lead to hemolytic anemia. 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, the patient should be observed closely for hypoglycemia. When such drugs are withdrawn from a patient receiving glyburide, the patient should be observed closely for loss of control. Certain drugs tend to produce hyperglycemia and may lead to loss of control. These drugs include the thiazides and other diuretics, corticosteroids, phenothiazines, thyroid products, estrogens, oral contraceptives, phenytoin, nicotinic acid, sympathomimetics, calcium channel blocking drugs, and isoniazid. When such drugs are administered to a patient receiving glyburide, the patient should be closely observed for loss of control. When such drugs are withdrawn from a patient receiving glyburide, the patient should be observed closely for hypoglycemia. A possible interaction between glyburide and ciprofloxacin, a fluoroquinolone antibiotic, has been reported, resulting in a potentiation of the hypoglycemic action of glyburide. The mechanism of action for this interaction is not known. A potential interaction between oral miconazole and oral hypoglycemic agents leading to severe hypoglycemia has been reported. Whether this interaction also occurs with the intravenous, topical or vaginal preparations of miconazole is not known. Concomitant administration of colesevelam and glyburide resulted in reductions in glyburide. Prolonged severe hypoglycemia (4 to 10 days) has been reported in neonates born to mothers who were receiving a sulfonylurea drug at the time of delivery. Although it is not known whether glyburide is excreted in human milk, some sulfonylurea drugs are known to be excreted in human milk. |
| Off-label Uses |
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• Use in patients under the age of 18. GoToSource • Dosage greater than 12 mg daily. GoToSource • Malignant edema and stroke. GoToSource • Traumatic brain injury. GoToSource |
| Adverse Events |
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Hypoglycemia (low blood sugar). GoToSource Increased risk of cancer. GoToSource Increased risk of cardiovascular mortality. GoToSource Cholestatic hepatitis with liver failure. GoToSource Hemolytic anemia (red blood cells are destroyed faster than they can be made). GoToSource Leukocytoclastic vasculitis. GoToSource Fournier gangrene. GoToSource Weight gain, skin reactions and abnormal liver function tests. GoToSource |
| Litigation |
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Lawsuits filed for ketoacidosis, kidney injury and necrotizing fasciitis. |
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