What is the most important information I should know about glyburide and metformin?

You should not use this medication if you are allergic to glyburide or metformin, or if you have kidney disease or are in a state of diabetic ketoacidosis (call your doctor for treatment with insulin).

If you need to have any type of x-ray or CT scan using a dye that is injected into your veins, you will need to temporarily stop taking glyburide and metformin.

Before you take this medication, tell your doctor if you have liver or heart disease, a history of heart attack or stroke, or an enzyme deficiency called glucose-6-phosphate dehydrogenase deficiency (G6PD).

Some people develop lactic acidosis while taking glyburide and metformin. Get emergency medical help if you have even mild symptoms such as: muscle pain or weakness, numb or cold feeling in your arms and legs, trouble breathing, stomach pain, nausea with vomiting, slow or uneven heart rate, dizziness, or feeling very weak or tired.

What is glyburide and metformin?

Glyburide and metformin is a combination of two oral diabetes medicines that help control blood sugar levels.

Glyburide and metformin is used to treat type 2 diabetes. This medication is not for treating type 1 diabetes.

Glyburide and metformin may also be used for purposes not listed in this medication guide.

What should I discuss with my healthcare provider before taking glyburide and metformin?

You should not use this medication if you are allergic to glyburide or metformin, if you have kidney disease, or if you are in a state of diabetic ketoacidosis (call your doctor for treatment with insulin).

• kidney disease; or
• if you are in a state of diabetic ketoacidosis (call your doctor for treatment with insulin).

If you need to have any type of x-ray or CT scan using a dye that is injected into your veins, you will need to temporarily stop taking glyburide and metformin.

Some people develop a life-threatening condition called lactic acidosis while taking metformin. You may be more likely to develop lactic acidosis if you have liver or kidney disease, congestive heart failure, a severe infection, if you are dehydrated, or if you drink large amounts of alcohol. Older adults may also have a higher risk of developing lactic acidosis. Talk with your doctor about your individual risk.

To make sure you can safely take this medication, tell your doctor if you have any of these other conditions:

• an enzyme deficiency called glucose-6-phosphate dehydrogenase deficiency (G6PD);
• liver disease; or
• heart disease or a history of heart attack or stroke.
• a history of heart attack or stroke.

FDA pregnancy category B. This medicine is not expected to harm an unborn baby. Similar diabetes medications have caused severe hypoglycemia in newborn babies whose mothers had used the medication near the time of delivery. Tell your doctor if you are pregnant or plan to become pregnant during treatment.

It is not known whether this medicine passes into breast milk or if it could harm a nursing baby. You should not breast-feed while taking glyburide and metformin.

Certain oral diabetes medications may increase your risk of serious heart problems. However, not treating your diabetes can damage your heart and other organs. Talk to your doctor about the risks and benefits of treating your diabetes with glyburide and metformin.

How should I take glyburide and metformin?

Take exactly as prescribed by your doctor. Do not take in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label. Your doctor may occasionally change your dose to make sure you get the best results.

Take glyburide and metformin with meals. Your blood sugar will need to be checked often, and you may need other blood tests at your doctor's office. Visit your doctor regularly.

Know the signs of low blood sugar (hypoglycemia) and how to recognize them: headache, hunger, weakness, sweating, tremor, irritability, or trouble concentrating.

Keep a source of sugar available in case you have symptoms of low blood sugar. Sugar sources include orange juice, glucose gel, candy, or milk. If you have severe hypoglycemia and cannot eat or drink, use an injection of glucagon. Your doctor can give you a prescription for a glucagon emergency injection kit and tell you how to give the injection.

Check your blood sugar carefully during a time of stress or illness, if you travel, exercise more than usual, drink alcohol, or skip meals. These things can affect your glucose levels and your dose needs may also change.

Ask your doctor how to adjust your dose if needed. Do not change your medication dose or schedule without your doctor's advice.

If you need surgery, tell the surgeon ahead of time that you are using glyburide and metformin. You may need to stop using the medicine for a short time.

This medicine is only part of a complete program of treatment that also includes diet, exercise, and weight control.

Store at room temperature away from moisture, heat, and light.

What happens if I miss a dose?

Take the missed dose as soon as you remember (be sure to take the medicine with food). Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. A glyburide and metformin overdose can cause life-threatening hypoglycemia.

Symptoms of severe hypoglycemia include extreme weakness, blurred vision, sweating, trouble speaking, tremors, stomach pain, confusion, and seizure (convulsions).

Overdose may also cause lactic acidosis. Get emergency medical help if you have any of these symptoms of lactic acidosis: weakness, increasing sleepiness, slow heart rate, cold feeling, muscle pain, shortness of breath, stomach pain, feeling light-headed, and fainting.

What should I avoid while taking glyburide and metformin?

Avoid drinking alcohol. It can lower your blood sugar and may increase the risk of lactic acidosis while you are taking this medicine.

What are the possible side effects of glyburide and metformin?

This medication may cause lactic acidosis (a build-up of lactic acid in the body, which can be fatal). Lactic acidosis can start slowly and get worse over time. Get emergency medical help if you have even mild symptoms of lactic acidosis, such as: muscle pain or weakness, numb or cold feeling in your arms and legs, trouble breathing, stomach pain, nausea with vomiting, slow or uneven heart rate, dizziness, or feeling very weak or tired.

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

Stop using this medicine and call your doctor at once if you have a serious side effect such as:

• pale or yellowed skin, dark colored urine, fever, confusion or weakness; or
• nausea, upper stomach pain, itching, loss of appetite, clay-colored stools, jaundice (yellowing of the skin or eyes).

Less serious side effects may include:

• sneezing, runny nose, cough or other signs of a cold;
• headache, mild dizziness; or
• mild dizziness; or
• mild nausea or vomiting, diarrhea, upset stomach.

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.

What other drugs will affect glyburide and metformin?

Tell your doctor about all other medications you use, especially:

• cimetidine (Tagamet) or ranitidine (Zantac);
• morphine (MS Contin, Kadian, Oramorph);
• quinine (Qualaquin);
• an antibiotic such as ciprofloxacin (Cipro), trimethoprim (Proloprim, Primsol, Cotrim), or vancomycin (Vancocin, Lyphocin); or
• heart or blood pressure medicines such as amiloride (Midamor), digoxin (Lanoxin), furosemide (Lasix), nifedipine (Adalat, Procardia), procainamide (Pronestyl), quinidine (Quin-G), or triamterene (Dyrenium).

You may be more likely to have hyperglycemia (high blood sugar) if you take glyburide and metformin with other drugs that can raise blood sugar, such as:

• isoniazid;
• diuretics (water pills) or blood pressure medicine;
• steroids (prednisone and others);
• niacin (Advicor, Niaspan, Niacor, Simcor, Slo-Niacin, and others);
• phenothiazines (Compazine and others);
• thyroid medicine (Synthroid and others);
• birth control pills and other hormones;
• seizure medicines (Dilantin and others);
• diet pills, medicines to treat asthma, colds or allergies; or
• heart or blood pressure medication such as diltiazem (Cartia, Cardizem), nifedipine (Nifedical, Procardia), verapamil (Calan, Covera, Isoptin, Verelan), and others.

You may be more likely to have hypoglycemia (low blood sugar) if you take glyburide and metformin with:

• exenatide (Byetta);
• probenecid (Benemid).
• some nonsteroidal anti-inflammatory drugs (NSAIDs);
• aspirin or other salicylates (including Pepto-Bismol);
• a blood thinner (warfarin, Coumadin, and others);
• sulfa drugs Bactrim, Gantanol, Gantrisin, Septra, SMX-TMP, and others);
• a monoamine oxidase inhibitor (MAOI);
• beta-blockers (Toprol, Inderal, and others); or
• other oral diabetes medications, especially acarbose (Precose), metformin (Glucophage), miglitol (Glyset), pioglitazone (Actos), or rosiglitazone (Avandia).

These lists are not complete and there are many other medicines that can increase or decrease the effects of glyburide and metformin on lowering your blood sugar. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

Where can I get more information?

Your pharmacist can provide more information about glyburide and metformin.