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Pronunciation:

(MIG li tol)

U.S. Brand Names:

Glyset®

Generic Available:

Canadian Brand Names:

Glyset®

Use:

Type 2 diabetes mellitus (noninsulin-dependent, NIDDM):

Monotherapy adjunct to diet to improve glycemic control in patients with type 2 diabetes mellitus (noninsulin-dependent, 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.

Pregnancy Risk Factor:

Pregnancy Implications:

Abnormal blood glucose levels are associated with a higher incidence of congenital abnormalities. Insulin is the drug of choice for the control of diabetes mellitus during pregnancy.

Lactation:

Enters breast milk (small amounts)/not recommended

Contraindications:

Hypersensitivity to miglitol or any of component of the formulation; diabetic ketoacidosis; inflammatory bowel disease; colonic ulceration; partial intestinal obstruction or predisposition 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

Warnings/Precautions:

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.

Adverse Reactions:

>10%: Gastrointestinal: Flatulence (42%), diarrhea (29%), abdominal pain (12%)

1% to 10%: Dermatologic: Rash

Overdosage/Toxicology:

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.

Drug Interactions:

Decreased effect:

Miglitol may decrease the absorption and bioavailability of digoxin, propranolol, ranitidine

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

Mechanism of Action:

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

Pharmacodynamics/Kinetics:

Absorption: Saturable at high doses: 25 mg dose: Completely absorbed; 100 mg dose: 50% to 70% absorbed

Distribution: Vd: 0.18 L/kg

Protein binding: <4%

Metabolism: None

Half-life elimination: ~2 hours

Time to peak: 2-3 hours

Excretion: Urine (as unchanged drug)

Dosage:

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 renal impairment: Miglitol is primarily excreted by the kidneys; there is little information of miglitol in patients with a Clcr<25 mL/minute

Dosing adjustment in hepatic impairment: No adjustment necessary

Administration:

Should be taken orally at the start (with the first bite) of each main meal

Monitoring Parameters:

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

Reference Range:

Target range: Adults:

Fasting blood glucose: <120 mg/dL

Glycosylated hemoglobin: <7%

Patient Education:

Inform prescriber of all prescriptions, OTC medications, or herbal products you are taking, and any allergies you have. Do not take any new medication during therapy unless approved by prescriber. Take 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 advised by prescriber. Avoid alcohol. It is important to follow dietary and lifestyle recommendations of prescriber. You will be instructed in signs of hypo- or hyperglycemia by prescriber or diabetic educator. If combining this medication with other diabetic medication (eg, sulfonylureas, insulin), keep source of glucose (sugar) on hand in case hypoglycemia occurs. May cause 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 precaution: Breast-feeding is not recommended.

Dental Health: Effects on Dental Treatment:

No significant effects or complications reported

Dental Health: Vasoconstrictor/Local Anesthetic Precautions:

No information available to require special precautions

Mental Health: Effects on Mental Status:

None reported

Mental Health: Effects on Psychiatric Treatment:

None reported

Dosage Forms:

Tablet: 25 mg, 50 mg, 100 mg

International Brand Names:

Diastabol® (AT, CH, DE, ES, FR, NL, NO, PL, RU, SI); Diastobol® (PL); Glyset® (CA); Miglitol Bayer® (AT); Plumarol® (ES)

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