Glyburide and Metformin (patient information)

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• Glyburide and Metformin#Patient Counseling Information

IMPORTANT WARNING

Metformin may cause a serious condition called lactic acidosis. Tell your doctor if you are over 80 years old and if you have ever had kidney or liver disease. Do not drink large amounts of alcohol while taking glyburide and metformin. If you are having a radiologic test with injectable contrast agents (for example, a CT scan, angiogram, urogram, or MRI), talk to your doctor about stopping glyburide and metformin a few days before the test. If you are having surgery, including dental surgery, tell the doctor or dentist that you are taking glyburide and metformin. If you experience any of the following symptoms, stop taking glyburide and metformin and call your doctor immediately: severe shortness of breath, excessive tiredness, muscle aches, stomach pain after the first few weeks of treatment, feeling cold, dizziness, or a slow or irregular heartbeat.

Why this medication is prescribed

The combination of glyburide and metformin is used to treat type 2 diabetes (condition in which the body does not use insulin normally and therefore cannot control the amount of sugar in the blood) in people whose diabetes cannot be controlled by diet and exercise alone. Glyburide belongs to a class of drugs called sulfonylureas, and metformin is in a class of drugs called biguanides. Glyburide lowers blood sugar by stimulating the pancreas, the organ that makes insulin. Insulin helps control blood sugar levels. The pancreas must produce insulin for this medication to work. Metformin helps your body regulate the amount of glucose (sugar) in your blood. It decreases the amount of glucose you get from your diet and the amount made by your liver. It also helps your body use its own insulin more effectively. Glyburide and metformin are not used to treat type 1 diabetes (condition in which the body does not produce insulin and therefore cannot control the amount of sugar in the blood).

How this medication should be used

Glyburide and metformin combination comes as a tablet to take by mouth. It is usually taken one to two times daily with meals. Your doctor may gradually increase your dose, depending on your response to glyburide and metformin. Monitor your blood glucose closely. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take glyburide and metformin exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

Glyburide and metformin combination controls diabetes but does not cure it. Continue to take glyburide and metformin even if you feel well. Do not stop taking glyburide and metformin without talking to your doctor.

Other uses for this medicine

This medication is sometimes prescribed for other uses; ask your doctor or pharmacist for more information.

Special precautions

Before taking glyburide and metformin:

• tell your doctor and pharmacist if you are allergic to glyburide, metformin, or any other drugs.
• tell your doctor and pharmacist what prescription and nonprescription medications you are taking, especially albuterol (Proventil, Ventolin); allergy or cold medications; anticoagulants ('blood thinners') such as warfarin (Coumadin); antipsychotics such as mesoridazine (Serentil) or thioridazine (Mellaril); aspirin or other nonsteroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen (Advil, Motrin) or naproxen (Aleve, Naprosyn); beta-blockers such as propranolol (Inderal); calcium channel blockers such as diltiazem (Cardizem, Tiazac), nifedipine (Adalat, Procardia), or verapamil (Calan, Verelan); chloramphenicol (Chloromycetin); chlorpromazine (Thorazine); cimetidine (Tagamet); ciprofloxacin (Cipro); corticosteroids such as dexamethasone (Decadron), methylprednisolone (Medrol), or prednisone (Deltasone, Orasone); digoxin (Lanoxin); diuretics ('water pills'); epinephrine; estrogens; isoniazid (INH); medications that contain alcohol or sugar; miconazole (Lotrimin, others); morphine (MS Contin, others); niacin; oral contraceptives (birth control pills); phenelzine (Nardil); phenytoin (Dilantin); probenecid (Benemid); procainamide (Procanbid, Pronestyl); prochlorperazine (Compazine); promethazine (Phenergan); quinidine (Quinalan, Quinidex); quinine (Quinamm); ranitidine (Zantac); salicylates such as diflunisal (Dolobid) or salsalate (Disalcid); terbutaline (Brethine, Bricanyl); thyroid medications; tranylcypromine (Parnate); trimethoprim (Proloprim, Trimpex); vancomycin (Vancocin, others); and vitamins or herbal products.
• in addition to the conditions listed in the IMPORTANT WARNING section, tell your doctor if you have or have ever had heart, pituitary, or thyroid disease; adrenal insufficiency; acute or chronic metabolic acidosis; diabetic ketoacidosis; hormone problems; or gastrointestinal absorption problems.
• tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while taking glyburide and metformin, call your doctor immediately.
• you should know that this drug may make you drowsy. Do not drive a car or operate machinery until you know how this drug affects you.
• remember that alcohol can add to the drowsiness caused by this drug.
• tell your doctor if you use tobacco products. Cigarette smoking may decrease the effectiveness of glyburide and metformin.
• plan to avoid unnecessary or prolonged exposure to sunlight and to wear protective clothing, sunglasses, and sunscreen. Glyburide and metformin may make your skin sensitive to sunlight.
• tell your doctor if you have fever, infection, injury, or illness with vomiting or diarrhea. These may affect your blood sugar level.

Special dietary instructions

Be sure to follow all exercise and dietary recommendations made by your doctor or dietitian. Calorie reduction, weight loss, and exercise will help control your diabetes and will also make glyburide and metformin work better. It is important to eat a healthy diet.

Alcohol may decrease blood sugar and can affect the amount of lactic acid made. Ask your doctor about the safe use of alcoholic beverages while you are taking glyburide and metformin.

What to do if you forget a dose

Before you start taking glyburide and metformin, ask your doctor what to do if you forget to take a dose or accidentally take an extra dose. Write these directions down so you can refer to them later.

As a general rule, take the missed dose as soon as you remember it. 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.

Side effects

Minor side effects

This medication may cause changes in your blood sugar. You should know the symptoms of low and high blood sugar and what to do if you have these symptoms.

You may experience hypoglycemia (low blood sugar) while you are taking this medication. Your doctor will tell you what you should do if you develop hypoglycemia. He or she may tell you to check your blood sugar, eat or drink a food or beverage that contains sugar, such as hard candy or fruit juice, or get medical care. Follow these directions carefully if you have any 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
• clumsy or jerky movements

If hypoglycemia is not treated, severe symptoms may develop. Be sure that your family, friends, and other people who spend time with you know that if you have any of the following symptoms, they should get medical treatment for you immediately.

• confusion
• seizures
• loss of consciousness

Call your doctor immediately if you have any of the following symptoms of hyperglycemia (high blood sugar):

• extreme thirst
• frequent urination
• extreme hunger
• weakness
• blurred vision

If high blood sugar is not treated, a serious, life-threatening condition called diabetic ketoacidosis could develop. Call your doctor immediately if you have any of the these symptoms:

• dry mouth
• upset stomach and vomiting
• shortness of breath
• breath that smells fruity
• decreased consciousness

Glyburide and metformin may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• headache
• nasal congestion
• runny nose
• stomach pain
• cough
• diarrhea

Severe side effects

If you experience any of the following symptoms or those listed in the IMPORTANT WARNING section, call your doctor immediately:

• skin rash or hives
• itching or redness
• exaggerated sunburn
• yellowing of the skin or eyes
• light-colored stools
• dark or clay-colored urine
• unusual bleeding or bruising
• fever
• sore throat

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online [at http://www.fda.gov/MedWatch/report.htm] or by phone [1-800-332-1088].

Storage conditions needed for this medication

Keep this medication in the container it came in (which is light resistant), tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom). Throw away any medication that is outdated or no longer needed. Talk to your pharmacist about the proper disposal of your medication.

In case of emergency/overdose

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.

Other information

Keep all appointments with your doctor and the laboratory. Your blood sugar and glycosylated hemoglobin (HbA1c) should be checked regularly to determine your response to glyburide and metformin. Your doctor may order other lab tests to check your response to glyburide and metformin. 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.

Keep yourself and your clothes clean. Wash cuts, scrapes, and other wounds quickly, and do not let them get infected.

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.

Brand names

• Glucovance®