Miglitol, used as monotherapy, is indicated as an adjunct to diet and exercise to improve glycemic control in patients with Type II Diabetes whose hyperglycemia cannot be adequately controlled by diet alone. It may also be used in combination with a sulfonylurea when diet plus either Miglitol or a sulfonylurea alone fails to achieve satisfactory glycemic control.

Miglitol is a desoxynojirimycin derivative and does not stimulate insulin secretion. Its antihyperglycemic effect results from the reversible inhibition of membrane-bound intestinal α-glucosidase enzymes. These enzymes in the brush border of the small intestine break down oligosaccharides and disaccharides into glucose and other monosaccharides. In diabetic patients, inhibition of these enzymes delays glucose absorption and reduces postprandial hyperglycemia. Consequently, Miglitol lowers plasma glucose levels and reduces glycosylated hemoglobin levels.

There is no fixed dosage regimen for the management of diabetes mellitus with Miglitol or any other pharmacologic agent. The dosage of Miglitol must be individualized on the basis of both effectiveness and tolerance.

Initial Dosage: The recommended starting dosage of Miglitol is 25 mg, given orally three times daily at the start of each main meal. However, some patients may benefit by starting at 25 mg once daily to minimize gastrointestinal adverse effects, and gradually increasing the frequency of administration to 3 times daily.

Maintenance Dosage: The usual maintenance dose of Miglitol is 50 mg 3 times daily, although some patients may benefit from increasing the dose to 100 mg 3 times daily. In order to allow adaptation to potential gastrointestinal adverse effects, it is recommended that Miglitol therapy be initiated at a dosage of 25 mg 3 times daily, the lowest effective dosage, and then gradually titrated upward to allow adaptation. After 4 - 8 weeks of the 25 mg 3 times daily regimen, the dosage should be increased to 50 mg 3 times daily for approximately three months, following which a glycosylated hemoglobin level should be measured to assess therapeutic response. If, at that time, the glycosylated hemoglobin level is not satisfactory, the dosage may be further increased to 100 mg 3 times daily, the maximum recommended dosage. If no further reduction in postprandial glucose or glycosylated hemoglobin levels is observed with titration to 100 mg 3 times daily, consideration should be given to lowering the dose. Once an effective and tolerated dosage is established, it should be maintained.

Maximum Dosage: The maximum recommended dosage of Miglitol is 100 mg 3 times daily.

Children: The safety and effectiveness of Miglitol in pediatric patients have not been established.

Co-administration of Miglitol with glyburide or metformin reduces the mean Cmax and AUC of these agents. Miglitol may also decrease the bioavailability of ranitidine and propranolol. Intestinal adsorbents (e.g., charcoal) and digestive enzyme preparations containing carbohydrate-splitting enzymes (e.g., amylase, pancreatin) can diminish the therapeutic effect of Miglitol and should not be used concomitantly.

Miglitol is contraindicated in patients with known hypersensitivity to the drug or any of its components. It is also contraindicated in patients with diabetic ketoacidosis; inflammatory bowel disease, colonic ulceration, or partial intestinal obstruction; and in those predisposed to intestinal obstruction. Additionally, it should not be used in chronic intestinal diseases associated with significant disorders of digestion or absorption, or in conditions that may worsen due to increased intestinal gas formation.

Gastrointestinal effects such as abdominal pain, diarrhea, and flatulence may occur in patients taking Miglitol. Dermatological reactions including skin rash have also been reported. Laboratory abnormalities, such as reduced serum iron levels, have been observed more frequently, though these were generally transient and not associated with significant reductions in hemoglobin or other hematologic changes.

Miglitol is classified as pregnancy category B. Adequate and well-controlled studies in pregnant women are lacking; therefore, it should be used during pregnancy only if clearly necessary. Miglitol is excreted in human milk in very small amounts. Despite the low levels, its use is not recommended in breastfeeding women.

When used in combination with a sulfonylurea, Miglitol may further lower blood glucose and increase the risk of hypoglycemia. In conditions of stress such as fever, trauma, infection, or surgery, temporary loss of glycemic control may occur, and insulin therapy may be required. Plasma levels of Miglitol are increased in patients with renal impairment in proportion to the severity of dysfunction. Due to the lack of adequate studies, use in patients with significant renal impairment is not recommended.

An overdose of Miglitol does not typically cause hypoglycemia. However, it may lead to transient gastrointestinal symptoms such as flatulence, diarrhea, and abdominal discomfort. Since Miglitol has minimal systemic absorption, serious systemic toxicity is unlikely in overdose.

Alpha-Glucosidase inhibitor

Store in a cool and dry place, protected from light.