Miglitol

Miglitol slows down the breakdown of carbohydrates (types of sugar) in your body. This reduces the amount of sugar that enters your blood after eating and helps prevent episodes of hyperglycemia (high blood sugar).

Miglitol is used along with diet and exercise to help control blood sugar in adults with type 2 diabetes.

Miglitol may also be used for reasons not mentioned in this medication guide.

Miglitol is usually taken 3 times a day at the beginning of a meal. Follow all instructions on your prescription label. Your doctor may sometimes change your dose to ensure you get the best results. Do not take this medicine in larger or smaller amounts or for longer than recommended.

Take each dose with the first bite of your main meal.

Low blood sugar (hypoglycemia) can happen to anyone with diabetes. Symptoms include headache, hunger, sweating, irritability, dizziness, nausea, fast heart rate, and feeling anxious or shaky.

To quickly treat low blood sugar while taking miglitol, use a dextrose-based source of sugar (such as honey, dates, raisins, plums, or apricots). A sucrose-based source of sugar may not work because miglitol can inhibit the action of sucrose in the body. Sucrose-based sugar sources include cane sugar, candy, table sugar, chocolate, syrup, and non-diet soda or other sweetened foods.

Your doctor can prescribe a glucagon emergency injection kit to use in case of severe hypoglycemia when you cannot eat or drink. Make sure your family and close friends know how to give you this injection in an emergency.

Blood sugar levels can be affected by stress, illness, surgery, exercise, alcohol use, or skipping meals. Ask your doctor before changing your dose or medication schedule.

Miglitol is only part of a complete treatment program that may also include diet, exercise, weight control, regular blood sugar testing, and special medical care. Follow your doctor's instructions very closely.

Store at room temperature away from moisture and heat.

You should not use miglitol if you have inflammatory bowel disease (ulcerative colitis, Crohn's), a blockage in your intestines, a chronic intestinal disorder that affects digestion, or a stomach disorder that causes excess gas. Do not take miglitol if you are in a state of diabetic ketoacidosis.

You should not use miglitol if you are allergic to it, or if you have:

• an inflammatory bowel disease, ulcerative colitis, Crohn's disease;
• a chronic intestinal disorder that affects your digestion;
• blockage in your intestines;
• a stomach disorder that causes excess gas; or
• diabetic ketoacidosis (call your doctor for treatment with insulin).

To make sure miglitol is safe for you, tell your doctor if you have kidney disease.

Miglitol is not expected to harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using miglitol.

Miglitol can pass into breast milk and may harm a nursing baby. You should not breast-feed while using this medicine.

Do not give this medication to anyone under 18 years old without medical advice.

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Miglitol may cause serious side effects. Call your doctor right away if you have:

• severe diarrhea or constipation;
• bloody or tarry stools;
• rectal bleeding; or
• diarrhea that contains blood or mucus.

Common side effects of miglitol may include:

• stomach discomfort;
• diarrhea;
• gas; or
• mild rash.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Usual Adult Dose for Diabetes Type 2:

Individualize dose based on efficacy and tolerability:Initial dose: 25 mg orally 3 times a day -After 4 to 8 weeks, may increase to 50 mg orally 3 times a day if needed; after 3 more months, may increase to 100 mg orally 3 times a day if needed based on glycosylated hemoglobin Maintenance dose: 50 mg to 100 mg orally 3 times a dayMaximum dose: 100 mg orally 3 times a dayComments:-Take orally at the start (with first bite) of each main meal; patients should be adhering to a diabetic diet to minimize GI side effects. -Some patients benefit from starting at 25 mg orally once a day with subsequent titration to 3 times a day to minimize GI side effects. -If no further reduction in postprandial glucose or HbA1c is observed with titration to 100 mg three times a day, consider lowering the dose. Use: As an adjunct to diet and exercise to improve glycemic control in patients with type 2 diabetes mellitus.

Take your dose as soon as you remember. If it is almost time for your next scheduled dose, skip the missed dose. Do not take extra medicine to make up for the missed dose.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

• Follow your doctor's instructions about any restrictions on food, beverages, or activity.

Certain digestive-enzyme supplements may reduce the effectiveness of miglitol and should not be taken at the same time, including:

• pancreatin (amylase, protease, lipase); or
• products such as Arco-Lase, Cotazym, Donnazyme, Pancrease, Creon, Ku-Zyme, and others.

You may be more likely to have low blood sugar if you take miglitol with other medications that can lower blood sugar, including insulin or other oral diabetes medications.

Tell your doctor about all your current medications and any you start or stop using, especially:

• propranolol; or
• ranitidine.

These lists are not complete, and many other medications can increase or decrease the effects of miglitol on lowering your blood sugar. This includes prescription and over-the-counter medications, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.