Glyset (miglitol)
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.
Today’s intelligence on Glyset
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.
Miglitol is administered orally at the beginning (with the first bite) of each main meal.
Store miglitol tablets at 25degreesC; excursions permitted to 15--30degreesC.
No dosing information is available for this tab.
No dosing information is available for this tab.
Drug interactions
There is no enhanced messaging for this drug.
There are no contraindication interactions for this drug.
There are no severe interactions for this drug.
There are no moderate interactions for this drug.
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.
There are no contraindication contraindications for this drug.
There are no severe contraindications for this drug.
There are no moderate contraindications for this drug.
Adverse reactions
The most common adverse effects of miglitol are GI symptoms, including abdominal pain, diarrhea, and flatulence.
There are no severe adverse reactions for this drug.
There are no less severe adverse reactions for this drug.
Precautions
No enhanced messaging available.
The safety and efficacy of miglitol have not been established in pediatric patients.
Safety of miglitol has not been established in pregnant women. There is no evidence of fetal malformations attributable to miglitol at dosages of up to 12 times the maximum recommended human exposure based on body surface area (BSA) in rats or up to 10 times that exposure in rabbits. Also, there is no evidence of impaired fertility or fetal harm in rats or rabbits at dosages of 4 or 3 times, respectively, the maximum recommended human exposure based on BSA. At the highest dosages tested, slight reductions in fetal weight were observed in rats and rabbits, and delayed ossification of the fetal skeleton and an increase in the percentage of nonviable fetuses were observed in rabbits. Miglitol should be used during pregnancy only when clearly needed.
Miglitol is distributed into human milk in low concentrations; use of the drug is not recommended in nursing women.
No dosage adjustment of miglitol is required based solely on age.
There are no substantial differences in safety and efficacy of miglitol in geriatric patients compared with younger adults. In clinical studies in adults, 24% of patients were >65 years of age and 3% were >75 years of age. In a pharmacokinetic study, there were no differences between geriatric and younger patients.
ICD codes
No ICD codes are available for this drug.
Formulary status
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Last reviewed · Source: First Databank (FDB) drug data
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