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|Glucovance

GLYBURIDE AND METFORMIN (Systemic)†

Some commonly used brand names are:

In the U.S.—

• Glucovance

† Not commercially available in Canada.

Category

• Antidiabetic agent

Description

Glyburide and Metformin (GLYE-byoor-ide and met-FOR-min)

combination is used to treat high blood sugar levels that are caused by type 2 diabetes. Normally, after you eat, your pancreas releases insulin to help your body store excess sugar for later use. This process occurs during normal digestion of food. In type 2 diabetes, your body does not work properly to store the excess sugar and the sugar remains in your bloodstream. Chronic high blood sugar can lead to serious health problems in the future. Proper diet is the first step in managing type 2 diabetes but often medicines are needed to help your body. With two actions, the combination of glyburide and metformin helps your body cope with high blood sugar. Glyburide stimulates the release of insulin from the pancreas, directing your body to store blood sugar. Metformin has three different actions: it slows the absorption of sugar in your small intestine; it also stops your liver from converting stored sugar into blood sugar; and it helps your body use your natural insulin more efficiently.

This medicine is available only with your doctor"s prescription, in the following dosage form:

• Oral
• Tablets (U.S.)

Before Using This Medicine

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For glyburide and metformin, the following should be considered:

Allergies—Tell your doctor if you have ever had any unusual or allergic reaction to glyburide or metformin. Also, tell your health care professional if you are allergic to any other substances, such as foods, preservatives, or dyes.

Pregnancy—Glyburide and metformin combination has not been studied in pregnant women or animals. However, independent studies with glyburide and also with metformin have not shown that either medicine causes birth defects or other problems in animal studies. It is easier during pregnancy to control your blood sugar by using injections of insulin rather than by taking oral diabetes medicines. Close control of your blood sugar can reduce the chance of your baby gaining too much weight, having birth defects, or having high blood sugar before birth. Before taking this medicine, make sure your doctor knows if you are pregnant or if you may become pregnant.

Breast-feeding— It is not known whether glyburide or metformin passes into human breast milk. Although most medicines pass into breast milk in small amounts, many of them may be used safely while breast-feeding. Mothers who are taking this medicine and who wish to breast-feed should discuss this with their doctor.

Children—Studies on this medicine have been done only in adult patients, and there is no specific information comparing use of glyburide and metformin in children with use in other age groups.

Older adults—This medicine has been tested and has not been shown to cause different side effects or problems in older people than it does in younger adults.

Other medicines—Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking glyburide and metformin, it is especially important that your health care professional know if you are taking any of the following:

• Alcohol— Drinking alcohol may increase the risk of developing lactic acidosis and/or very low blood sugar.

• Beta-adrenergic blocking agents (acebutolol [e.g., Sectral], atenolol [e.g., Tenormin], betaxolol [e.g., Kerlone], bisoprolol [e.g., Zebeta], carteolol [e.g., Cartrol], labetalol [e.g., Normodyne], metoprolol [e.g., Lopressor], nadolol [e.g., Corgard], oxprenolol [e.g., Trasicor], penbutolol [e.g., Levatol], pindolol [e.g., Visken], propranolol [e.g., Inderal], sotalol [e.g., Betapace], timolol [e.g., Blocadren])—Beta-adrenergic blocking agents can hide the symptoms of low blood sugar. Because of this, a person with diabetes might not recognize that he or she has low blood sugar and might not take immediate steps to treat it.

• Cimetidine (e.g., Tagamet) or
• Furosemide (e.g., Lasix)— Use with a medicine that contains metformin may cause high blood levels of metformin, which may increase the chance of low blood sugar or other side effects.

Other medical problems—The presence of other medical problems may affect the use of glyburide and metformin. Make sure you tell your doctor if you have any other medical problems, especially:

• Acid in the blood (acidosis or ketoacidosis) or
• Surgery (major)—Use of insulin is best to help control diabetes in patients with these conditions.

• Blood poisoning or
• Dehydration (severe) or
• Heart or blood vessel disorders or
• Kidney disease or
• Liver disease—Lactic acidosis can occur in these conditions and chances of it occurring are even greater with a medicine that contains metformin.

• Kidney, heart, or other problems that require medical tests or examinations that use certain medicines called contrast agents, with x-ray exams—Because this medicine contains metformin, your doctor should advise you to stop taking it before you have any medical exams or diagnostic tests that might cause less urine output than usual; you may be advised to start taking the medicine again 48 hours after the exams or tests if your kidney function is tested and found to be normal.

Proper Use of This Medicine

Follow carefully the special meal plan your doctor gave you. This is the most important part of controlling your condition, and is necessary if the medicine is to work properly. Also, exercise regularly and test for sugar in your blood or urine as directed.

Glyburide and metformin combination should be taken with meals to help reduce the gastrointestinal side effects that may occur during the first few weeks of treatment.

Dosing—The dose of the glyburide and metformin combination will be different for different patients. Follow your doctor"s orders or the directions on the label . The following information includes only the average doses of glyburide and metformin. If your dose is different, do not change it unless your doctor tells you to do so.

• For oral dosage form (tablets):
  • For type 2 diabetes:
    • For first-time treatment:
      • Adults: At first, 1.25 milligrams (mg) of glyburide and 250 mg of metformin one or two times a day with meals. Then, your doctor may increase your dose a little at a time every two weeks until your blood sugar is controlled.
      • Children: Use and dose must be determined by your doctor.
    • For patients previously treated with a sulfonylurea antidiabetic agent and/or metformin:
      • Adults: At first, 2.5 mg of glyburide and 500 mg of metformin or 5 mg of glyburide and 500 mg of metformin two times a day, with the morning and evening meals. Then, your doctor may increase your dose a little at a time until your blood sugar is controlled.
      • Children: Use and dose must be determined by your doctor.

Storage—To store this medicine:

• Keep out of the reach of children.
• Do not store in the bathroom, near the kitchen sink, or in other damp places. Heat or moisture may cause the medicine to break down.
• Keep the medicine from freezing. Do not refrigerate.
• Do not keep outdated medicine or medicine no longer needed. Ask your health care professional how you should dispose of any medicine you do not use. Be sure that any discarded medicine is out of the reach of children.

Precautions While Using This Medicine

Your doctor will want to check your progress at regular visits , especially during the first few weeks that you take this medicine.

Under certain conditions, too much metformin can cause lactic acidosis. Symptoms of lactic acidosis are severe and quick to appear and usually occur when other health problems not related to the medicine are present and are very severe, such as a heart attack or kidney failure. Symptoms of lactic acidosis include abdominal or stomach discomfort; decreased appetite; diarrhea; fast, shallow breathing; general feeling of discomfort; muscle pain or cramping; and unusual sleepiness, tiredness, or weakness.

If symptoms of lactic acidosis occur, you should get immediate emergency medical help.

It is very important to follow carefully any instructions from your health care team about:

• Alcohol—Drinking alcohol may cause severe low blood sugar. Discuss this with your health care team.
• Other medicines—Do not take other medicines unless they have been discussed with your doctor. This especially includes nonprescription medicines such as aspirin, and medicines for appetite control, asthma, colds, cough, hay fever, or sinus problems.
• Counseling—Other family members need to learn how to prevent side effects or help with side effects if they occur. Also, patients with diabetes may need special counseling about diabetes medicine dosing changes that might occur because of lifestyle changes, such as changes in exercise and diet. Furthermore, counseling on contraception and pregnancy may be needed because of the problems that can occur in patients with diabetes during pregnancy.
• Travel—Keep a recent prescription and your medical history with you. Be prepared for an emergency as you would normally. Make allowances for changing time zones and keep your meal times as close as possible to your usual meal times.

In case of emergency —There may be a time when you need emergency help for a problem caused by your diabetes. You need to be prepared for these emergencies. It is a good idea to wear a medical identification (ID) bracelet or neck chain at all times. Also, carry an ID card in your wallet or purse that says that you have diabetes and a list of all your medicines.

Symptoms of hypoglycemia (low blood sugar) include anxiety; behavior change similar to being drunk; blurred vision; cold sweats; confusion; cool, pale skin; difficulty in thinking; drowsiness; excessive hunger; fast heartbeat; headache (continuing); nausea; nervousness; nightmares; restless sleep; shakiness; slurred speech; or unusual tiredness or weakness.

Glyburide and metformin combination can cause low blood sugar. However, it also can occur if you delay or miss a meal or snack, drink alcohol, exercise more than usual, cannot eat because of nausea or vomiting, take certain medicines, or take glyburide and metformin with another type of diabetes medicine. Symptoms of low blood sugar must be treated before they lead to unconsciousness (passing out). Different people feel different symptoms of low blood sugar. It is important that you learn which symptoms of low blood sugar you usually have so that you can treat it quickly.

If symptoms of low blood sugar occur, eat glucose tablets or gel, corn syrup, honey, or sugar cubes; or drink fruit juice, nondiet soft drink, or sugar dissolved in water . Also, check your blood for low blood sugar. Glucagon is used in emergency situations when severe symptoms such as seizures (convulsions) or unconsciousness occur. Have a glucagon kit available, along with a syringe or needle, and know how to use it. Members of your household also should know how to use it.

Symptoms of hyperglycemia (high blood sugar) include blurred vision; drowsiness; dry mouth; flushed, dry skin; fruit-like breath odor; increased urination (frequency and volume); ketones in urine; loss of appetite; sleepiness; stomachache, nausea, or vomiting; tiredness; troubled breathing (rapid and deep); unconsciousness; or unusual thirst.

High blood sugar may occur if you do not exercise as much as usual, have a fever or infection, do not take enough or skip a dose of your diabetes medicine, or overeat or do not follow your meal plan.

If symptoms of high blood sugar occur, check your blood sugar level and then call your health care professional for instructions .

Side Effects of This Medicine

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Other side effects not listed above may also occur in some patients. If you notice any other effects, check with your doctor.

Developed: 12/07/2000

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