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Amaryl

[Glimepiride]

A multiple-dose titration study was also conducted in 16 NIDDM patients with renal impairment using doses ranging from 1-8 mg daily for 3 months. The results were consistent with those observed after single doses. All patients with a CLcr less than 22 mL/min had adequate control of their glucose levels with a dosage regimen of only 1 mg daily. The results from this study suggested that a starting dose of 1 mg AMARYL may be given to NIDDM patients with kidney disease, and the dose may be titrated based on fasting blood glucose levels.

Hepatic Insufficiency.

No studies were performed in patients with hepatic insufficiency.

Text Continues Below



Other Populations.

There were no important differences in glimepiride metabolism in subjects identified as phenotypically different drug-metabolizers by their metabolism of sparteine.

The pharmacokinetics of glimepiride in morbidly obese patients were similar to those in the normal weight group, except for a lower Cmax and AUC. However, since neither Cmax nor AUC values were normalized for body surface area, the lower values of Cmax and AUC for the obese patients were likely the result of their excess weight and not due to a difference in the kinetics of glimepiride.

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