Chemical formula: C₈H₁₇NO₅ Molecular mass: 207.224 g/mol PubChem compound: 441314
No data concerning the use of miglitol during pregnancy in humans is available. Animal studies do not indicate harmful effects with respect to pregnancy, embryonal or fœtal development, parturition or postnatal development.
When the patient plans to become pregnant and during pregnancy, diabetes should not be treated with miglitol but insulin should be used to maintain blood glucose levels as close to normal as possible in order to lower risk of fœtal malformations associated with abnormal blood glucose levels.
Miglitol must not be used during lactation. Miglitol is excreted in milk in very low concentrations.
No studies on the effects on the ability to drive and use machines have been performed. Patients should be alerted to the possible risk of hypoglycaemia when miglitol is used in combination with a sulfonylurea.
The frequencies listed below are defined as: very common (≥1/10), common (≥1/100 to <1/10) and uncommon (≥1/1,000 to <1/100).
When used in combination with other antidiabetic treatments (sulfonylureas and insulin), hypoglycaemia has been commonly reported.
Owing to its mode of action, miglitol may result in a greater proportion of undigested carbohydrate being digested in the large bowel. These carbohydrates may also be utilised by the intestinal flora, resulting in the increased formation of intestinal gas. The majority of patients are therefore likely to experience one or more gastro-intestinal symptoms:
Very common: flatulence, diarrhoea and abdominal pain.
Common: nausea, constipation and dyspepsia.
The symptoms are related to both dose and dietary substrate and may subside with continued treatment. Symptoms can be reduced by adherence to the prescribed diabetic diet and the avoidance of sucrose, or foodstuffs containing sugar. If symptoms are poorly tolerated, a reduction in dosage is recommended.
Should diarrhoea persist, patients should be closely monitored and the dosage reduced or therapy withdrawn, if necessary.
Common: transaminases increased.
Uncommon: hepatic function abnormal.
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