Action and Spectrum

Drug Interaction

Adverse Reaction

Frequency defined 

>10% 

Flatulence  

Diarrhea  

Abdominal pain 

1-10% 

Rash 

Frequency not defined 

Low serum iron 

Black Box Warning

Contraindication / Caution

Contraindication/Caution: 

miglitol is an oral medication used to treat type 2 diabetes by decreasing the absorption of carbohydrates from the diet. Like all medications, miglitol has some contraindications and cautions that should be considered before prescribing or taking it. Here are some important contraindications and cautions for miglitol: 

• Hypersensitivity: miglitol is contraindicated in patients with a known hypersensitivity to the drug. 
• Bowel or intestinal disorders: miglitol may exacerbate certain bowel or intestinal disorders, such as inflammatory bowel disease, colonic ulceration, and intestinal obstruction. Therefore, caution should be exercised when prescribing miglitol to patients with these conditions. 
• Gastrointestinal disorders: miglitol may cause gastrointestinal side effects such as diarrhea, abdominal pain, and flatulence. Therefore, caution should be exercised when prescribing miglitol to patients with gastrointestinal disorders. 
• Renal impairment: miglitol is primarily excreted by the kidneys, so caution should be exercised when prescribing miglitol to patients with renal impairment. 
• Pregnancy and breastfeeding: The safety of miglitol during pregnancy and breastfeeding has not been established. Therefore, caution should be exercised when prescribing miglitol to pregnant or breastfeeding women. 
• Hypoglycemia: miglitol should be used with caution in patients who are at risk of hypoglycemia, such as those who take other antidiabetic medications, have liver or kidney disease, or have malnutrition or adrenal or pituitary gland disorders. 
• Surgery: miglitol should be temporarily discontinued before and after surgery, as it may interfere with carbohydrate metabolism and increase the risk of hypoglycemia. 

Pregnancy / Lactation

Pregnancy consideration:  

Category B 

Breastfeeding warnings:  

Slightly excreted in breastmilk; hence miglitol is not recommended during lactation 

Pregnancy category: 

• Category A: Satisfactory and well-controlled studies show no risk to the fetus in the first or later trimester. 
• Category B: No evidence of risk to the fetus is found in animal reproduction studies, and there are not enough studies on pregnant women. 
• Category C: Adverse effects on the fetus found with evidence in animal reproduction studies and no adequate evidence for a human product; Pregnant women must take care of the potential risks. 
• Category D: There is adequate data with sufficient evidence of human fetal risk from various platforms. However, despite potential dangers may be used only in emergencies for potential benefits. 
• Category X: Drugs listed in this category outweigh the risks over benefits. The drug is not for pregnant women. 
• Category N: No data is available for the drug under this category. 

Pharmacology

Pharmacology: 

miglitol is an oral medication used to treat type 2 diabetes mellitus. It is classified as an alpha-glucosidase inhibitor and works by slowing down the digestion and absorption of carbohydrates in the small intestine, thereby reducing the rise in blood glucose levels after meals. 

Pharmacodynamics: 

miglitol’s pharmacodynamics can be summarized as follows: 

Mechanism of action: miglitol works by inhibiting alpha-glucosidase enzyme, which reduces the absorption of carbohydrates and slows down the rise of blood glucose levels. 

Effect on blood glucose levels: miglitol reduces the postprandial increase in blood glucose levels after meals. 

Effect on insulin secretion: miglitol does not directly affect insulin secretion from the pancreas. However, by reducing the postprandial increase in blood glucose levels, miglitol may indirectly reduce the demand for insulin. 

Duration of action: miglitol’s effect is relatively short-acting, with a peak effect observed 1-2 hours after administration and a duration of action of 4-6 hours. 

Overall, miglitol’s pharmacodynamics make it a useful option for the management of type 2 diabetes, particularly in individuals who experience postprandial hyperglycemia. 

Pharmacokinetics: 

Absorption 

The half-life of the drug is 2 hours 

The drug is saturable and absorbed completely at 25 mg. It gets 50-70% absorbed at 100 mg 

The bioavailability is 100% 

The bound protein is less than 4% 

Distribution 

The volume of distribution is 0.18L/kg 

Metabolism 

No contents are metabolised  

Elimination and Excretion 

The drug is excreted more than 95% in the urine 

Adminstartion

Administration: 

• Dosage: The recommended starting dose for miglitol is usually 25 mg taken orally three times a day. The dose can be increased to a maximum of 100 mg three times a day, if necessary, but this should be done gradually and under the supervision of a healthcare provider. 
• Timing: miglitol should be taken with the first bite of each main meal. If a meal is skipped, the dose of miglitol should also be skipped. 
• Swallowing: miglitol tablets should be swallowed whole with a glass of water. Do not crush, chew, or break the tablets. 
• Adjustments for renal impairment: Patients with moderate to severe renal impairment (creatinine clearance < 60 ml/min) should be started at a lower dose of miglitol and have their dose titrated slowly. Miglitol is not recommended for patients with severe renal impairment (creatinine clearance < 25 ml/min) or end-stage renal disease. 
• Food and drink interactions: miglitol should be taken with the first bite of a meal and may cause digestive side effects such as gas, bloating, and diarrhea. It is recommended to avoid consuming foods or drinks with high sugar content when taking miglitol. 

Patient Information Leaflet

Patient information leaflet 

Generic Name: miglitol 

Pronounced: mig-li-tol 

Why do we use miglitol? 

It is used to: 

• Control of postprandial hyperglycemia: miglitol is particularly effective at reducing the rise in blood sugar levels that occur after meals. This helps to control postprandial hyperglycemia, which is a common problem in patients with type 2 diabetes. 
• Reducing hemoglobin A1c levels: miglitol has been shown to reduce hemoglobin A1c (HbA1c) levels, which is a measure of average blood sugar levels over the previous 2-3 months. Lowering HbA1c levels is an important goal of diabetes treatment, as it can reduce the risk of long-term complications such as neuropathy, retinopathy, and nephropathy. 
• Combination therapy: miglitol is often used in combination with other anti-diabetic medications, such as metformin or insulin, to achieve better glycemic control. 
• Safety profile: miglitol has a good safety profile and is generally well-tolerated by patients. It does not cause weight gain or hypoglycemia, which are common side effects of other diabetes medications.