No

Antidiabetic Agent (Miscellaneous)

Noninsulin-dependent diabetes mellitus (NIDDM)

Monotherapy adjunct to diet to improve glycemic control in patients with NIDDM whose hyperglycemia cannot be managed with diet alone

Combination therapy with a sulfonylurea when diet plus either miglitol or a sulfonylurea alone do not result in adequate glycemic control. The effect of miglitol to enhance glycemic control is additive to that of sulfonylureas when used in combination.

B

Diabetic ketoacidosis, inflammatory bowel disease, colonic ulceration, partial intestinal obstruction, patients predisposed to intestinal obstruction, chronic intestinal diseases associated with marked disorders of digestion or absorption or with conditions that may deteriorate as a result of increased gas formation in the intestine; hypersensitivity to drug or any of its components

GI symptoms are the most common reactions. The incidence of abdominal pain and diarrhea tend to diminish considerably with continued treatment. Long-term clinical trials in diabetic patients with significant renal dysfunction (serum creatinine >2 mg/dL) have not been conducted. Treatment of these patients is not recommended. Because of its mechanism of action, miglitol administered alone should not cause hypoglycemia in the fasting of postprandial state. In combination with a sulfonylurea will cause a further lowering of blood glucose and may increase the hypoglycemic potential of the sulfonylurea.

>10%: Gastrointestinal: Flatulence (41.5%), diarrhea (28.7%), abdominal pain (11.7%)

1% to 10%: Dermatologic: Rash

An overdose of miglitol will not result in hypoglycemia. An overdose may result in transient increases in flatulence, diarrhea, and abdominal discomfort. No serious systemic reactions are expected in the event of an overdose.

Decreased effect:

Digestive enzymes (amylase, pancreatin, charcoal) may reduce the effect of miglitol and should not be taken concomitantly

In contrast to sulfonylureas, miglitol does not enhance insulin secretion; the antihyperglycemic action of miglitol results from a reversible inhibition of membrane-bound intestinal alpha-glucosidases which hydrolyze oligosaccharides and disaccharides to glucose and other monosaccharides in the brush border of the small intestine; in diabetic patients, this enzyme inhibition results in delayed glucose absorption and lowering of postprandial hyperglycemia

Absorption: Saturable at high doses: 25% mg dose: Completely absorbed; 100 mg dose: 50% to 70% absorbed; Peak concentrations within 2-3 hours

Distribution: V_d: 0.18 L/kg

Protein binding: Negligible (<4%)

Metabolism: Not metabolized

Half-life, elimination: ~2 hours

Elimination: Renal as unchanged drug

Adults: Oral: 25 mg 3 times/day with the first bite of food at each meal; the dose may be increased to 50 mg 3 times/day after 4-8 weeks; maximum recommended dose: 100 mg 3 times/day

Dosing adjustment in hepatic impairment: No adjustment necessary

Monitor therapeutic response by periodic blood glucose tests; measurement of glycosylated hemoglobin is recommended for the monitoring of long-term glycemic control

Target range: Adults:

Glycosylated hemoglobin: <7%

None reported

None reported

No information available to require special precautions

No effects or complications reported

Take this medication exactly as directed, with the first bite of each main meal. Do not change dosage or discontinue without first consulting prescriber. Do not take other medications with or within 2 hours of this medication unless so advised by prescriber. It is important to follow dietary and lifestyle recommendations of prescriber. You will be instructed in signs of hypo-/hyperglycemia by prescriber or diabetic educator. If combining miglitol with other diabetic medication (eg, sulfonylureas, insulin), keep source of glucose (sugar) on hand in case hypoglycemia occurs. You may experience mild side effects during first weeks of therapy (eg, bloating, flatulence, diarrhea, abdominal discomfort); these should diminish over time. Report severe or persistent side effects, fever, extended vomiting or flu, or change in color of urine or stool. Breast-feeding precautions: Consult prescriber if breast-feeding.

Tablet: 25 mg, 50 mg, 100 mg