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miglitol (Glyset)

 

Classes: Antidiabetics, Alpha-Glucosidase Inhibitors

Dosing and uses of Glyset (miglitol)

 

Adult dosage forms and strengths

tablet

  • 25mg
  • 50mg
  • 100mg

 

Type 2 DM (Monotherapy or with Sulfonylurea)

Initial: 25 mg PO q8hr at meals (with first bite)

Maintanance: Usually 50 mg PO q8hr, increase after 4-8 weeks

Not more than 100 mg PO q8hr

 

Hepatic Impairment

No admustment necessary

 

Renal Impairment

Mild-moderate impairment: No dosage adjustment

Severe impairment: Not recommended

 

Pediatric dosage forms and strengths

Safety & efficacy not established

 

Geriatric dosage forms and strengths

Initial: 25 mg PO q8hr at meals (with first bite)

Maintanance: Usually 50 mg PO q8hr, increase after 4-8 weeks

Not more than 100 mg PO q8hr

 

Glyset (miglitol) adverse (side) effects

>10%

Flatulence (42%)

Diarrhea (29%)

Abdominal pain (12%)

 

1-10%

Rash (4.3%)

 

Frequency not defined

Low serum iron

 

Warnings

Contraindications

Hypersensitivity to miglitoL

Diabetic ketoacidosis, inflammatory bowel disease, colonic ulceration, partial intestinal obstruction

Disorders of GI digestion or absorption

Conditions that may deteriorate due to increased GI gas

Severe renal impairment

 

Cautions

Concurrent use with sulfonylureas may result in hypoglycemia; treat hypoglycemia with oral glucose, not sucrose

 

Pregnancy and lactation

Pregnancy category: B

Lactation: Enters slightly into breast milk; nor recommended

 

Pregnancy categories

A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

NA: Information not available.

 

Pharmacology of Glyset (miglitol)

Mechanism of action

Delays glucose absorption by delaying digestion of ingested carbohydrates. Inhibits hydrolysis of disacharides and oligosaccharides to gucose. Lowers postprandial hyperglycemia

 

Pharmacokinetics

Half-Life: 2 hr

Absorption: saturable; 100% at 25 mg; 50-70% for 100 mg

Bioavailability: 100%

Protein Bound: <4%

Vd: 0.18 L/kg

Metabolism: noneExcretion: urine >95%