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GLYSET (MIGLITOL): PRECAUTIONS

Macrovascular Outcomes

There have been no clinical studies establishing conclusive evidence of macrovascular risk reduction with Glyset (Miglitol) or any other anti-diabetic drug.

General

Hypoglycemia

Because of its mechanism of action, Miglitol (Glyset) when administered alone should not cause hypoglycemia in the fasted or postprandial state. Sulfonylurea agents may cause hypoglycemia. Because Glyset tablets given in combination with a sulfonylurea will cause a further lowering of blood glucose, it may increase the hypoglycemic potential of the sulfonylurea, although this was not observed in clinical trials. Oral glucose (dextrose), whose absorption is not delayed by Glyset (Miglitol), should be used instead of sucrose (cane sugar) in the treatment of mild-to-moderate hypoglycemia.

Sucrose, whose hydrolysis to glucose and fructose is inhibited by Miglitol (Glyset), is unsuitable for the rapid correction of hypoglycemia. Severe hypoglycemia may require the use of either intravenous glucose infusion or glucagon injection.

Loss of Control of Blood Glucose

When diabetic patients are exposed to stress such as trauma, fever, infection, or surgery, a temporary loss of control of blood glucose may occur. At such times, temporary insulin therapy may be necessary.

Renal Impairment

Plasma concentrations of Glyset (Miglitol) in renally impaired volunteers were proportionally increased relative to the degree of renal dysfunction. Long-term clinical trials in diabetic patients with significant renal dysfunction (serum creatinine > 2.0 mg/dL) have not been conducted. Therefore, treatment of these patients with Miglitol (Glyset) is not recommended.

Laboratory Tests

Therapeutic response to Glyset (Miglitol) may be monitored by periodic blood glucose tests. Measurement of glycosylated hemoglobin levels is recommended for the monitoring of long-term glycemic control.

Carcinogenesis, Mutagenesis, and Impairment of Fertility

Miglitol (Glyset) was administered to mice by the dietary route at doses as high as approximately 500 mg/kg body weight (corresponding to greater than 5 times the exposure in humans based on AUC) for 21 months. In a two-year rat study, miglitol was administered in the diet at exposures comparable to the maximum human exposures based on AUC. There was no evidence of carcinogenicity resulting from dietary treatment with miglitol.

In vitro, miglitol was found to be nonmutagenic in the bacterial mutagenesis (Ames) assay and the eukaryotic forward mutation assay (CHO/HGPRT). Miglitol did not have any clastogenic effects in vivo in the mouse micronucleus test. There were no heritable mutations detected in dominant lethal assay.

A combined male and female fertility study conducted in Wistar rats treated orally with miglitol at dose levels of 300 mg/kg body weight (approximately 8 times the maximum human exposure based on body surface area) produced no untoward effect on reproductive performance or capability to reproduce. In addition, survival, growth, development, and fertility of the offspring were not compromised.



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