AMARYL is indicated as an adjunct to diet and exercise to improve glycemic control in adults
with type 2 diabetes mellitus.

Adult Patients
The incidence of hypoglycemia with AMARYL, as documented by blood glucose values <60 mg/dL, ranged from 0.9-1.7% in two large, well-controlled, 1-year studies.

The hypoglycemic action of sulfonylureas may be potentiated by certain drugs, including nonsteroidal anti-inflammatory drugs, clarithromycin, disopyramide, fluoxetine, and quinolones and other drugs that are highly protein bound, such as salicylates, sulfonamides, chloramphenicol, coumarins, probenecid, monoamine oxidase inhibitors, and beta adrenergic blocking agents. When these drugs are administered to a patient receiving AMARYL, the patient should be observed closely for hypoglycemia. When these drugs are withdrawn from a patient receiving AMARYL, the patient should be observed closely for loss of glycemic control.

SPECIAL WARNING ON INCREASED RISK OF CARDIOVASCULAR MORTALITY
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