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Glyset
Generic Name: Miglitol
Drug Category: Alpha-Glucosidase Inhibitor
Litigation Alert Level: Low
This drug has been approved for use by males and females over the age of 18 years old for a maximum duration of 1 year.
| Approved Uses |
|
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 GLYSET or any other anti-diabetic drug. Little information is available on the safety of miglitol in patients with creatinine clearance <25 mL/min. Therefore, treatment of these patients with miglitol is not recommended. Low serum iron occurred more often in patients treated with GLYSET than in placebo-treated patients but did not persist in the majority of cases and was not associated with reductions in hemoglobin or changes in other hematologic indices. GLYSET Tablets are contraindicated in patients with:
Because of its mechanism of action, GLYSET, when administered alone, should not cause hypoglycemia in the fasted or postprandial state. Sulfonylureas and insulin can cause hypoglycemia. Because GLYSET Tablets given in combination with a sulfonylurea or insulin will cause a further lowering of blood glucose, it may increase the hypoglycemic potential of the sulfonylurea or insulin. Consider reducing the dose of sulfonylureas or insulin when GLYSET is used in combination with these medications. Intestinal adsorbents (e.g., charcoal) and digestive enzyme preparations containing carbohydrate-splitting enzymes (e.g., amylase, pancreatin) may reduce the effect of GLYSET and should not be taken concomitantly. The safety of GLYSET in pregnant women has not been established. Although the levels of miglitol reached in human milk are exceedingly low, it is recommended that GLYSET not be administered to a nursing woman. |
| Off-label Uses |
|
• Use in patients under the age of 18. GoToSource • Reactive hypoglycemia. GoToSource • Anti-atherogenic agent. GoToSource • Weight loss. GoToSource |
| Adverse Events |
|
Pneumatosis cystoides intestinalis (gas cysts in bowel wall). GoToSource Diarrhea and abdominal pain. GoToSource Hallucinations. GoToSource |
| Litigation |
|
No major injury lawsuits reported. |
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