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%