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DiaBeta
Generic Name: Glyburide
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 4 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. There have been no clinical studies establishing conclusive evidence of macrovascular risk reduction with glyburide 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. All sulfonylureas including glyburide 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. Treatment of patients with glucose 6-phosphate dehydrogenase (G6PD) deficiency with sulfonylurea agents can lead to hemolytic anemia. Because Diaβeta belongs to the class of sulfonylurea agents, caution should be used in patients with G6PD deficiency and a non-sulfonylurea alternative should be considered. In postmarketing reports, hemolytic anemia has also been reported in patients who did not have known G6PD deficiency. DiaBeta is contraindicated in patients:
A possible interaction between glyburide and fluoroquinolone antibiotics has been reported resulting in a potentiation of the hypoglycemic action of glyburide. A potential interaction between oral miconazole and oral hypoglycemic agents leading to severe hypoglycemia has been reported. The hypoglycemic action of sulfonylureas may be potentiated by certain drugs including non-steroidal 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. 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. A possible interaction between glyburide and ciprofloxacin, a fluoroquinolone antibiotic, has been reported, resulting in a potentiation of the hypoglycemic action of glyburide. Concomitant administration of colesevelam and glyburide resulted in reductions in glyburide AUC and C max of 32% and 47%, respectively. There was a 22% decrease in C max and a 25% reduction in AUC 24 for glyburide during topiramate administration. There are no adequate and well controlled studies in pregnant women. 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. If Diaβeta is used during pregnancy, it should be discontinued at least two weeks before the expected delivery date. Although it is not known whether Diaβeta is excreted in human milk, some sulfonylureas are known to be excreted in human milk. |
| Off-label Uses |
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• Dosage greater than 20 mg per day. GoToSource • Traumatic brain injury. GoToSource • Management of gestational diabetes mellitus. GoToSource • Use in patients under the age of 18. GoToSource • Type 1 diabetes mellitus. GoToSource • Ischemic stroke. GoToSource |
| Adverse Events |
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Leukocytoclastic vasculitis (inflammation of small blood vessels). GoToSource Hypoglycemia (low blood sugar). GoToSource Increased risk of death. GoToSource Cholestatic jaundice (marked reduction in bile secretion and flow) and hepatitis (inflammation of liver). GoToSource Hemolytic anemia (red blood cells are destroyed faster than they can be made). GoToSource Acute coronary syndrome. GoToSource |
| Litigation |
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Lawsuits filed for heart attacks.
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