Glyset

DRUG DESCRIPTION

GLYSET Tablets contain miglitol, an oral alpha-glucosidase inhibitor for use in the management of non-insulin-dependent diabetes mellitus (NIDDM). Miglitol is a desoxynojirimycin derivative, and is chemically known as 3,4,5-piperidinetriol, 1-(2-hydroxyethyl)-2-(hydroxymethyl)-, [2R-(2?,3?,4?, 5?)]-. It is a white to pale-yellow powder with a molecular weight of 207.2. Miglitol is soluble in water and has a pKa of 5.9. Its empirical formula is C8H17NO5 and its chemical structure is as follows:

Glyset® (miglitol) Structural Formula Illustration

GLYSET (miglitol) is available as 25 mg, 50 mg and 100 mg tablets for oral use. The inactive ingredients are starch, microcrystalline cellulose, magnesium stearate, hypromellose, polyethylene glycol, titanium dioxide, and polysorbate 80.

What are the possible side effects of miglitol (Glyset)?

Stop taking miglitol and seek emergency medical attention if you experience an allergic reaction (difficulty breathing; closing of your throat; swelling of your lips, tongue, or face; or hives).

Other, less serious side effects, are more likely to occur. Continue to take miglitol and talk to your doctor if you experience

  • abdominal pain,
  • diarrhea,
  • flatulence, or
  • a rash.

Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems...

Read All Potential Side Effects and See Pictures of Glyset »

What are the precautions when taking miglitol (Glyset)?

Before taking miglitol, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: a certain metabolic condition (diabetic ketoacidosis), intestine/bowel problems (e.g., inflammatory bowel disease, intestinal blockage, digestion/absorption disorders).

Before using this medication, tell your doctor or pharmacist your medical history, especially of: kidney disease.

You may experience blurred vision, dizziness, or drowsiness due to extremely low...

Read All Potential Precautions of Glyset »


Glyset Consumer (continued)

SIDE EFFECTS: 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.

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.

PRECAUTIONS: Before taking miglitol, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: a certain metabolic condition (diabetic ketoacidosis), intestine/bowel problems (e.g., inflammatory bowel disease, intestinal blockage, digestion/absorption disorders).

Before using this medication, tell your doctor or pharmacist your medical history, especially of: kidney disease.

You may experience blurred vision, dizziness, or drowsiness due to extremely low or high blood sugar levels. Do not drive, use machinery, or do any activity that requires alertness or clear vision until you are sure you can perform such activities safely. Limit alcoholic beverages because it can increase the risk of developing hypoglycemia.

During times of stress, such as fever, infection, injury or surgery, it may be more difficult to control your blood sugar. Consult your doctor, as a change in your medication or how often you test your blood sugar may be required.

This medication should be used only when clearly needed during pregnancy. Your doctor may substitute insulin for this drug during your pregnancy. Follow all instructions carefully. Discuss the risks and benefits with your doctor.

This drug passes into breast milk. Consult your doctor before breast-feeding.


Glyset Patient Information Including Side Effects

Brand Names: Glyset

Generic Name: miglitol (Pronunciation: MIG lih tall)

  • What is miglitol (Glyset)?
  • What are the possible side effects of miglitol (Glyset)?
  • What is the most important information I should know about miglitol (Glyset)?
  • Who should not take miglitol (Glyset)?
  • How should I take miglitol (Glyset)?
  • What happens if I miss a dose (Glyset)?
  • What happens if I overdose (Glyset)?
  • What should I avoid while taking miglitol (Glyset)?
  • What other drugs will affect miglitol (Glyset)?
  • Where can I get more information?

What is miglitol (Glyset)?

Miglitol delays the digestion of carbohydrates (forms of sugar) in your body. This decreases the amount of sugar that passes into your blood after a meal and prevents periods of hyperglycemia (high blood sugar).

Miglitol is used to treat non-insulin-dependent (Type II) diabetes mellitus.

Miglitol may also be used for purposes other than those listed in this medication guide.

What are the possible side effects of miglitol (Glyset)?

Stop taking miglitol and seek emergency medical attention if you experience an allergic reaction (difficulty breathing; closing of your throat; swelling of your lips, tongue, or face; or hives).

Other, less serious side effects, are more likely to occur. Continue to take miglitol and talk to your doctor if you experience

  • abdominal pain,
  • diarrhea,
  • flatulence, or
  • a rash.

Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome. You may report side effects to FDA at 1-800-FDA-1088.

What is the most important information I should know about miglitol (Glyset)?

Take each dose of miglitol with the first bite of a main meal.

Know the signs and symptoms of low blood sugar, which include headache, drowsiness, weakness, dizziness, fast heartbeat, sweating, tremor, and, nausea. Carry glucose tablets, paste, or another glucose or dextrose substance to treat episodes of low blood sugar.

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