Glyset (miglitol)

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Last reviewed · Source: First Databank (FDB) drug data

Overview

Miglitol is an alpha-glucosidase inhibitor antidiabetic agent.

Miglitol inhibits alpha-glucosidase enzymes (e.g., sucrase, glucoamylase, maltase, isomaltase) that hydrolyze oligosaccharides, trisaccharides, and disaccharides to glucose and other monosaccharides in the small intestinal brush border. The drug has little or no inhibitory effect on trehalase, lactase, or pancreatic alpha-amylase; it is not expected to produce lactose intolerance. Miglitol delays ingested carbohydrate breakdown and glucose absorption and reduces postprandial hyperglycemia in diabetic patients; fasting blood glucose concentrations are mildly decreased.

In contrast to sulfonylurea antidiabetic agents, miglitol does not enhance insulin secretion. The drug does not produce hypoglycemia when given as monotherapy in the fasted or postprandial state. When used in combination with sulfonylurea antidiabetic agents, miglitol reduces the insulinotropic and weight-increasing effects of sulfonylureas.

Miglitol does not produce clinically important weight loss.

Miglitol is absorbed via an active transport system that is saturable at high dosages. The bioavailability of miglitol is 100% or 50-70% following administration of a 25- or 100-mg dose, respectively. Peak plasma concentrations of miglitol are attained within 2-3 hours.

The therapeutic effects of miglitol principally result from local actions on the small intestine; there is no evidence that systemic absorption contributes to therapeutic response. The reduction in postprandial blood glucose concentrations persists for 3-4 hours following a single dose of miglitol in healthy individuals. Miglitol is distributed principally into extracellular fluid and concentrated in enterocytes of the small intestine.

Binding of miglitol to plasma proteins is negligible (<4%). Miglitol is not metabolized. No metabolites have been detected in the plasma, urine, or feces.

Following oral administration of a 25-mg dose, miglitol is excreted principally in urine (95%) as unchanged drug. The half-life of miglitol is approximately 2-3 hours in healthy individuals over the therapeutic dosage range. Since miglitol is excreted principally by the kidneys, accumulation is expected in patients with renal impairment.

The pharmacokinetics of miglitol are not altered in patients with cirrhosis; as miglitol is not metabolized, hepatic function is not expected to have an effect on pharmacokinetics. No difference in the pharmacokinetics of miglitol were noted between genders in geriatric patients when body weight was considered or based on race.

USES: Miglitol is used with a proper diet and exercise program to control high blood sugar in people with type 2 diabetes. Controlling high blood sugar helps prevent kidney damage, blindness, nerve problems, loss of limbs, and sexual function problems. Proper control of diabetes may also lessen your risk of a heart attack or stroke.

Miglitol works in your intestines to slow the breakdown and absorption of carbohydrates from foods that you eat. This effect helps lessen your blood sugar rise after a meal.

Generic name: miglitol
Pronunciation: (MIG-li-tol)

Reference product & biosimilars

No reference, biosimilar or interchangeable associated with this drug.

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Indications

The following indications are listed for Glyset:

  • Type 2 Diabetes Mellitus

Also known as: Adult Onset Diabetes, Adult Onset Diabetes Mellitus, Adult Onset Dm, Diabetes Mellitus Type 2, Diabetes Mellitus Type Ii, Ketosis-Resistant Diabetes Mellitus, Ketosis-Resistant Dm, Maturity Onset Diabetes, Maturity Onset Diabetes Mellitus, Non-Insulin Dependent Diabetes Mellitus, Non-Insulin-Dependent Diabetes Mellitus, Type Ii Diabetes Mellitus.

Dosing

No dosing information is available for this tab.

Drug interactions

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Contraindications

*Known hypersensitivity to the drug or any excipients in the formulation

*Diabetic ketoacidosis.

*Inflammatory bowel disease, colonic ulceration, or partial intestinal obstruction or predisposition to this condition.

*Chronic intestinal diseases associated with marked disorders of digestion or absorption.

*Coexisting conditions that may deteriorate as a result of increased intestinal gas formation.

Adverse reactions

The most common adverse effects of miglitol are GI symptoms, including abdominal pain, diarrhea, and flatulence.

Precautions

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ICD codes

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Formulary status

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Last reviewed · Source: First Databank (FDB) drug data