Glyset

Take the missed dose as soon as you remember it. Remember that miglitol should only be taken with a meal. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.

In case of overdose, call your local poison control center at 1-800-222-1222. If the victim has collapsed or is not breathing, call local emergency services at 911.

Keep all appointments with your doctor and the laboratory. Your blood sugar should be checked regularly to determine your response to miglitol. Your doctor will order certain lab tests to check your response to miglitol. Your doctor will also tell you how to check your response to this medication by measuring your blood or urine sugar levels at home. Follow these instructions carefully.

You should always wear a diabetic identification bracelet to be sure you get proper treatment in an emergency.

Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.

• The initial miglitol dose may start at 25 mg three times daily and then increase after four to eight weeks to 50-100 mg three times daily.
• The maximum dose is 100 mg three times daily.
• Some patients may benefit from starting at 25 mg once daily to reduce the occurrence of upset stomach.
• Miglitol should be taken at the first bite of each meal.
• Smaller doses may be adequate for patients with severe kidney dysfunction.
• Miglitol therapy is not advised in the presence of certain medical conditions such as inflammatory bowel disease (Crohn's disease or ulcerative colitis) or intestinal obstruction and chronic intestinal diseases involving difficulty with digestion or absorption such as Crohn's disease.
• Miglitol doses should be adjusted based upon blood glucose levels taken one hour after a meal and blood HbA1c levels taken about three months after starting or changing the dose. (HbA1c is a chemical in the blood that is a good indicator of blood glucose control over a prolonged period of time.)

Miglitol may interfere with digoxin (Lanoxin) absorption thereby decreasing digoxin blood levels and its effect. Therefore, the digoxin dose may need to be increased if miglitol is begun.

Miglitol also may reduce the effectiveness of ranitidine (Zantac) and propranolol (Inderal). An adjustment in dose based on monitoring of the patient may be necessary if miglitol is used with either of these drugs.

Intestinal adsorbents (for example, charcoal) and digestive enzymes (for example, amylase, pancreatin) may reduce the effect of miglitol and should not be taken concomitantly.

Adding a sulfonylurea during therapy with miglitol may lower blood glucose further, and the risk for developing hypoglycemia is greater. Caution should be used when combining these drugs.

If mild to moderate hypoglycemia occurs while taking miglitol in combination with a sulfonylurea, oral glucose (dextrose) should be used for treatment instead of sucrose (table sugar). Since miglitol blocks the digestion of sucrose to glucose, hypoglycemia will not be rapidly corrected if sucrose is given. Miglitol alone does not produce hypoglycemia.

Diarrhea, gas, upset stomach, or stomach pain may occur in the first few weeks of treatment as your body adjusts to this medication but usually improve with time. If any of these effects persist or worsen, notify your doctor or pharmacist promptly.Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.Miglitol does not cause low blood sugar (hypoglycemia). However, this effect can occur if you also take other anti-diabetic drugs (e.g., sulfonylureas, insulin) and if you do not consume enough calories (from food, juices, fruit, etc.). The symptoms include chills, cold sweat, blurred vision, dizziness, drowsiness, shaking, rapid heart rate, weakness, headache, fainting, tingling of the hands or feet, or hunger. Do not use table sugar or drink non-diet soda to relieve these symptoms because miglitol delays the breakdown of table sugar. Carry glucose tablets or gel with you to treat low blood sugar. If you are in a situation where you don't have these reliable forms of glucose, eat some honey or drink a glass of orange juice to quickly raise your blood sugar level. Tell your doctor immediately about the reaction. To help prevent hypoglycemia, eat meals on a regular schedule and do not skip meals.Check with your doctor or pharmacist about what you should do if you miss a meal.Symptoms of high blood sugar (hyperglycemia) include thirst, increased urination, confusion, drowsiness, flushing, rapid breathing, or fruity breath odor. If these symptoms occur, tell your doctor immediately. Your medication dosage may need to be increased or you may need other drugs.This medication may rarely cause a serious intestinal condition (pneumatosis cystoides intestinalis). Tell your doctor right away if you develop: persistent diarrhea, constipation, blood/mucus in stool.A very serious allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction may include: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.In the US -Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Common Side Effects of Miglitol

Tell your doctor if any of the following side effects become severe or don't go away:

• Gas
• Bloating
• Diarrhea
• Stomach pain

Serious Side Effects of Miglitol

Tell your doctor if you experience any of the symptoms listed in the Miglitol Warnings section above, or any of the following serious side effects:

• Bloody stools
• Severe or persistent diarrhea, constipation, or nausea
• Severe stomach pain or bloating
• Signs of a severe allergic reaction (may include rash, hives, itching, difficulty breathing, tightness in the chest, or swelling of the face, mouth, lips, or tongue)

No information provided..

Glyset is part of the drug class:

• Alpha glucosidase inhibitors

Serious side effects have been reported with acarbose including the following:

• Hypoglycemia. When used in combination with other medications to treat type 2 diabetes, acarbose can cause hypoglycemia (low blood sugar). Tell your healthcare provider right away if you have some or all of the following symptoms of hypoglycemia:
  • shakiness
  • dizziness or lightheadedness
  • sweating
  • nervousness or irritability
  • sudden changes in behavior or mood
  • headache
  • numbness or tingling around the mouth
  • weakness
  • pale skin
  • hunger or thirst
  • clumsy or jerky movements
  • confusion
  • weakness
  • blurred vision

Do not take Glyset if you:

• are allergic to Glyset or to any of its ingredients
• have diabetic ketoacidosis
• have cirrhosis
• have inflammatory bowel disease, colonic ulceration, or partial intestinal obstruction
• have chronic intestinal diseases or disorders of digestion or absorption
• have conditions that may deteriorate as a result of increased gas formation in the intestine

Before taking this medication, tell your doctor if you have

• an inflammatory bowel disease, such as ulcerative colitis or Chron's disease; or any other disease of the stomach or intestines;
• ulcers of the colon;
• a blockage or obstruction in your intestines; or
• kidney disease.

You may not be able to take miglitol, or you may require a dosage adjustment or special monitoring during treatment if you have any of the conditions listed above.

Call your doctor if you develop a fever or an infection, or if you experience a serious injury. You may require insulin for a period of time to control your blood sugar levels.

Miglitol is in the FDA pregnancy category B. This means that it is not expected to harm an unborn baby. Do not take miglitol without first talking to your doctor if you are pregnant.

Miglitol passes into breast milk and may affect a nursing infant. Do not take miglitol without first talking to your doctor if you are breast-feeding a baby.

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 this medicine.

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.

Storage

Oral

Tablets

25°C (may be exposed to 15–30°C).1

In the U.S.

• Glyset

Available Dosage Forms:

• Tablet

Therapeutic Class: Antidiabetic

Pharmacologic Class: Alpha-Glucosidase Inhibitor

• If you have an allergy to miglitol or any other part of Glyset (miglitol).
• If you are allergic to any drugs like this one, any other drugs, foods, or other substances. Tell your doctor about the allergy and what signs you had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.
• If you have any of these health problems: Bowel block or at risk for bowel block, bowel problems like inflammatory bowel disease, diabetic acid problems, malabsorption syndrome, problems with food break down, or ulcers in the colon.
• If you have kidney disease.
• If you are breast-feeding. Do not breast-feed while you take this medicine.

This is not a list of all drugs or health problems that interact with Glyset.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take this medicine with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Low blood sugar can happen. The chance of low blood sugar may be raised when this medicine is used with other drugs for high blood sugar (diabetes). Signs may be dizziness, headache, feeling sleepy, feeling weak, shaking, a fast heartbeat, confusion, hunger, or sweating. Call your doctor right away if you have any of these signs. Follow what you have been told to do if you get low blood sugar. This may include taking glucose tablets, liquid glucose, or some fruit juices.

• Store at room temperature.
• Store in a dry place. Do not store in a bathroom.
• Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
• Check with your pharmacist about how to throw out unused drugs.

Glyset Tablets are contraindicated in patients with:

• Diabetic ketoacidosis
• Inflammatory bowel disease, colonic ulceration, or partial intestinal obstruction, and in patients predisposed to intestinal obstruction
• Chronic intestinal diseases associated with marked disorders of digestion or absorption, or with conditions that may deteriorate as a result of increased gas formation in the intestine
• Hypersensitivity to the drug or any of its components.

Macrovascular Outcomes

There have been no clinical studies establishing conclusive evidence of macrovascular risk reduction with Glyset or any other anti-diabetic drug.

General

Hypoglycemia

Because of its mechanism of action, Glyset, when administered alone, should not cause hypoglycemia in the fasted or postprandial state. Sulfonylureas and insulin can cause hypoglycemia. Because Glyset Tablets given in combination with a sulfonylurea or insulin will cause a further lowering of blood glucose, it may increase the hypoglycemic potential of the sulfonylurea or insulin. Consider reducing the dose of sulfonylureas or insulin when Glyset is used in combination with these medications.

Oral glucose (dextrose), whose absorption is not delayed by Glyset, should be used instead of sucrose (cane sugar) in the treatment of mild-to-moderate hypoglycemia. Sucrose, whose hydrolysis to glucose and fructose is inhibited by Glyset, is unsuitable for the rapid correction of hypoglycemia. Severe hypoglycemia may require the use of either intravenous glucose infusion or glucagon injection.

Loss of Control of Blood Glucose

When diabetic patients are exposed to stress such as fever, trauma, infection, or surgery, a temporary loss of control of blood glucose may occur. At such times, temporary insulin therapy may be necessary.

Renal Impairment

Plasma concentrations of Glyset in renally impaired volunteers were proportionally increased relative to the degree of renal dysfunction. Long-term clinical trials in diabetic patients with significant renal dysfunction (serum creatinine >2.0 mg/dL) have not been conducted. Therefore, treatment of these patients with Glyset is not recommended.

Information for Patients

The following information should be provided to patients:

• Glyset should be taken orally three times a day at the start of each main meal. It is important to continue to adhere to dietary instructions, a regular exercise program, and regular testing of urine and/or blood glucose.
• Glyset itself does not cause hypoglycemia when administered to patients in the fasted state. Sulfonylurea drugs and insulin, however, can lower blood sugar levels and cause symptoms or life-threatening hypoglycemia. Because Glyset given in combination with a sulfonylurea or insulin will cause a further lowering of blood sugar, it may increase the hypoglycemic potential of these agents. The risk of hypoglycemia, its symptoms and treatment, and conditions that predispose to its development should be well understood by patients and responsible family members. Because Glyset prevents the breakdown of table sugar, a source of glucose (dextrose, D-glucose) should be readily available to treat symptoms of low blood sugar when taking Glyset in combination with a sulfonylurea or insulin.
• If side effects occur with Glyset, they usually develop during the first few weeks of therapy. They are most commonly mild-to-moderate dose-related gastrointestinal effects, such as flatulence, soft stools, diarrhea, or abdominal discomfort, and generally diminish in frequency and intensity with time. Discontinuation of drug usually results in rapid resolution of these gastrointestinal symptoms.

Physician Counseling Information for Patients

In initiating treatment for type 2 diabetes, diet should be emphasized as the primary form of treatment. Caloric restriction and weight loss are essential in the obese diabetic patient. Proper dietary management alone may be effective in controlling the blood glucose and symptoms of hyperglycemia. The importance of regular physical activity should also be stressed, and cardiovascular risk factors should be identified and corrective measures taken where possible. Use of Glyset or other antidiabetic medications must be viewed by both the physician and patient as a treatment in addition to diet and not as a substitution or as a convenient mechanism for avoiding dietary restraint. Furthermore, loss of blood glucose control on diet alone may be transient, thus requiring only short-term administration of Glyset or other antidiabetic medications. Maintenance or discontinuation of Glyset or other antidiabetic medications should be based on clinical judgment using regular clinical and laboratory evaluations.

Laboratory Tests

Therapeutic response to Glyset may be monitored by periodic blood glucose tests. Measurement of glycosylated hemoglobin levels is recommended for the monitoring of long-term glycemic control.

Drug Interactions

Several studies investigated the possible interaction between miglitol and glyburide. In six healthy volunteers given a single dose of 5 mg glyburide on a background of 6 days treatment with miglitol (50 mg 3 times daily for 4 days followed by 100 mg 3 times daily for 2 days) or placebo, the mean Cmax and AUC values for glyburide were 17% and 25% lower, respectively, when glyburide was given with miglitol. In a study in diabetic patients in which the effects of adding miglitol 100 mg 3 times daily for 7 days or placebo to a background regimen of 3.5 mg glyburide daily were investigated, the mean AUC value for glyburide was 18% lower in the group treated with miglitol, although this difference was not statistically significant. Information on a potential interaction with glyburide was obtained from one of the large U.S. clinical trials (Study 7) in which patients were dosed with either miglitol or placebo on a background of glyburide 10 mg twice daily. At the 6-month and 1-year clinic visits, patients taking concomitant miglitol 100 mg 3 times daily exhibited mean Cmax values for glyburide that were 16% and 8% lower, respectively, compared to patients taking glyburide alone. However, these differences were not statistically significant. Thus, although there was a trend toward lower AUC and Cmax values for glyburide when co-administered with Glyset, no definitive statement regarding a potential interaction can be made based on the foregoing three studies.

The effect of miglitol (100 mg 3 times daily for 7 days) on the pharmacokinetics of a single 1000 mg dose of metformin was investigated in healthy volunteers. Mean AUC and Cmax values for metformin were 12% to 13% lower when the volunteers were given miglitol as compared with placebo, but this difference was not statistically significant.

In a study with healthy volunteers, co-administration of either 50 mg or 100 mg miglitol 3 times daily together with digoxin reduced the average plasma concentrations of digoxin by 19% and 28%, respectively. However, in diabetic patients under treatment with digoxin, plasma digoxin concentrations were not altered by co-administration of miglitol 100 mg 3 times daily for 14 days.

Other healthy volunteer studies have demonstrated that miglitol may significantly reduce the bioavailability of ranitidine and propranolol by 60% and 40%, respectively. No effect of miglitol was observed on the pharmacokinetics or pharmacodynamics of either warfarin or nifedipine.

Intestinal adsorbents (e.g., charcoal) and digestive enzyme preparations containing carbohydrate-splitting enzymes (e.g., amylase, pancreatin) may reduce the effect of Glyset and should not be taken concomitantly.

In 12 healthy males, concomitantly administered antacid did not influence the pharmacokinetics of miglitol.

Carcinogenesis, Mutagenesis, and Impairment of Fertility

Miglitol was administered to mice by the dietary route at doses as high as approximately 500 mg/kg body weight (corresponding to greater than 5 times the exposure in humans based on AUC) for 21 months. In a two-year rat study, miglitol was administered in the diet at exposures comparable to the maximum human exposures based on AUC. There was no evidence of carcinogenicity resulting from dietary treatment with miglitol.

In vitro, miglitol was found to be nonmutagenic in the bacterial mutagenesis (Ames) assay and the eukaryotic forward mutation assay (CHO/HGPRT). Miglitol did not have any clastogenic effects in vivo in the mouse micronucleus test. There were no heritable mutations detected in dominant lethal assay.

A combined male and female fertility study conducted in Wistar rats treated orally with miglitol at dose levels of 300 mg/kg body weight (approximately 8 times the maximum human exposure based on body surface area) produced no untoward effect on reproductive performance or capability to reproduce. Survival, growth, development, and fertility of the offspring were not compromised.

Pregnancy

Teratogenic Effects

The safety of Glyset in pregnant women has not been established. Developmental toxicology studies have been performed in rats at doses of 50, 150 and 450 mg/kg, corresponding to levels of approximately 1.5, 4, and 12 times the maximum recommended human exposure based on body surface area. In rabbits, doses of 10, 45, and 200 mg/kg corresponding to levels of approximately 0.5, 3, and 10 times the human exposure were examined. These studies revealed no evidence of fetal malformations attributable to miglitol. Doses of miglitol up to 4 and 3 times the human dose (based on body surface area), for rats and rabbits respectively, did not reveal evidence of impaired fertility or harm to the fetus. The highest doses tested in these studies, 450 mg/kg in the rat and 200 mg/kg in the rabbit promoted maternal and/or fetal toxicity. Fetotoxicity was indicated by a slight but significant reduction in fetal weight in the rat study and slight reduction in fetal weight, delayed ossification of the fetal skeleton and increase in the percentage of non-viable fetuses in the rabbit study. In the peri-postnatal study in rats, the NOAEL (No Observed Adverse Effect Level) was 100 mg/kg (corresponding to approximately four times the exposure to humans, based on body surface area). An increase in stillborn progeny was noted at the high dose (300 mg/kg) in the rat peri-postnatal study, but not at the high dose (450 mg/kg) in the delivery segment of the rat developmental toxicity study. Otherwise, there was no adverse effect on survival, growth, development, behavior, or fertility in either the rat developmental toxicity or peri-postnatal studies. There are however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, miglitol should be used during pregnancy only if clearly needed.

Nursing Mothers

Miglitol has been shown to be excreted in human milk to a very small degree. Total excretion into milk accounted for 0.02% of a 100 mg maternal dose. The estimated exposure to a nursing infant is approximately 0.4% of the maternal dose. Although the levels of miglitol reached in human milk are exceedingly low, it is recommended that Glyset not be administered to a nursing woman.

Pediatric Use

Safety and effectiveness of Glyset in pediatric patients have not been established.

Geriatric Use

Of the total number of subjects in clinical studies of Glyset in the United States, patients valid for safety analyses included 24% over 65, and 3% over 75. No overall differences in safety and effectiveness were observed between these subjects and younger subjects. The pharmacokinetics of miglitol were studied in elderly and young males (n=8 per group). At the dosage of 100 mg 3 times daily for 3 days, no differences between the two groups were found.

Applies to miglitol: oral tablet

Some side effects of miglitol (the active ingredient contained in Glyset) may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

• Bloated full feeling
• excess air or gas in stomach or intestines
• increase in bowel movements
• loose stools
• passing gas
• soft stools
• stomach or abdomen pain

Less common

• Skin rash