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Glyburide and Metformin HCl oral
GLYBURIDE/METFORMIN TABLETS - ORAL

Important Note

The following information is intended to supplement, not substitute for, the expertise and judgment of your physician, pharmacist or other healthcare professional. It should not be construed to indicate that use of the drug is safe, appropriate, or effective for you. Consult your healthcare professional before using this drug.

GLYBURIDE/METFORMIN TABLETS - ORAL

(GLEYE-byou-ride/met-FOR-min)

COMMON BRAND NAME(S): Glucovance

WARNING: The metformin in this combination medication can rarely cause a condition called lactic acidosis, which can be fatal. Seek immediate medical attention if you develop any of the following symptoms of lactic acidosis: unusual tiredness (fatigue) or severe drowsiness, cold skin, muscle pain, breathing trouble or rapid breathing, unusually slow or irregular heartbeat. Lactic acidosis is more likely to occur in patients who have: kidney or liver disease, conditions that may cause a low oxygen blood level or poor circulation (e.g., severe congestive heart failure, recent heart attack, recent stroke), excessive alcohol use, a lack of body fluids (dehydration), x-ray or scanning procedures that require an injectable iodinated contrast drug, surgery, or a serious infection. Also at higher risk are those who are elderly, especially if you are over 80 years of age and have not had kidney and liver tests.

Uses

This anti-diabetic medication is a combination of two drugs (a sulfonylurea and a biguanide). It is used along with a diet and exercise program to control high blood sugar in patients with type 2 diabetes (non-insulin-dependent diabetes). This medication works by stimulating the release of your body's natural insulin and by restoring your body's proper response to insulin. Controlling high blood sugar helps prevent heart disease, strokes, kidney disease, blindness and circulation problems, as well as sexual function problems (impotence).

How To Use

Take this medication by mouth, usually twice daily with meals; or as directed by your doctor. Drink plenty of fluids while taking this medication. Use this medication regularly in order to get the most benefit from it. To help you remember, use it at the same times each day. Your dosage is based on your medical condition and response to therapy. This medication may come with a Patient Information Leaflet. Read it carefully and ask your doctor or pharmacist any questions you may have about your medication.

Side Effects

Also see Warning section. Nausea, stomach upset, diarrhea, or weight gain may occur initially as your body adjusts to the medication. If stomach symptoms recur later (after you are on the same dose for several days or weeks), tell your doctor immediately. A late recurrence of stomach symptoms may be due to lactic acidosis. Tell your doctor immediately if any of these highly unlikely but very serious side effects occur: persistent sore throat or fever, easy bleeding or bruising, severe stomach pain, yellowing eyes or skin, dark urine, unusual tiredness or weakness, unusual or sudden weight gain, mental/mood changes, swelling of the hands or feet, seizures. This medication can cause low blood sugar (hypoglycemia). This effect may occur if you do not consume enough calories (from food, juices, fruit, etc.). The symptoms include chills, cold sweat, blurred vision, dizziness, drowsiness, shaking, rapid heartbeat, weakness, headache, fainting, tingling of the hands or feet, or hunger. It is a good habit to carry glucose tablets or gel to treat low blood sugar. If you are in a situation where you don't have these reliable forms of glucose, eat a quick source of sugar such as table sugar, honey, or candy, or drink a glass of orange juice or non-diet soda 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. 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. An allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of an allergic reaction include: rash, itching, swelling, dizziness, trouble breathing. If you notice other effects not listed above, contact your doctor or pharmacist.

Precautions

This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: kidney disease, liver disease, conditions that may cause a low oxygen blood level or poor circulation (e.g., severe congestive heart failure, recent heart attack, recent stroke), metabolic conditions (e.g., diabetic ketoacidosis), serious infection, lack of body fluids (dehydration). Before using this medication, tell your doctor or pharmacist your medical history, especially of: severe breathing problems (e.g., obstructive lung disease, severe asthma), thyroid disease, blood problems (e.g., anemia, vitamin B-12 deficiency), scheduled upcoming surgery, scheduled upcoming x-ray or scanning procedures, alcohol use, certain hormonal conditions (adrenal/pituitary insufficiency, SIADH-syndrome of inappropriate secretion of antidiuretic hormone), electrolyte imbalance (hyponatremia), high blood pressure, fertility problems (e.g., ovulation problems), any allergies. You may experience blurred vision, dizziness, or drowsiness due to extremely low or high blood sugar levels; use caution engaging in activities requiring alertness such as driving or using machinery. Limit alcohol while taking this medication because it can increase the risk of developing hypoglycemia. Rarely, alcohol can interact with glyburide and cause a serious reaction (disulfiram-like reaction) with symptoms such as facial flushing, nausea, vomiting, dizziness, or stomach pain. Consult your doctor or pharmacist about the safe use of alcohol. 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 may be required. This medication may make you more sensitive to the sun. Avoid prolonged sun exposure, tanning booths or sunlamps. Use a sunscreen and wear protective clothing when outdoors. Caution is advised when using this drug in the elderly because they may be more sensitive to the effects of the drug. This medication can cause changes in the menstrual cycle (promote ovulation) in women with certain fertility problems, increasing the risk of becoming pregnant. Consult your doctor or pharmacist about the use of reliable birth control while using this medication. This medication should be used only when clearly needed during pregnancy. It is not recommended for use for at least 2 weeks before delivery due to the potential for fetal harm. Insulin may be preferred during pregnancy. Discuss the risks and benefits with your doctor. Based on information from related drugs, this medication may pass into breast milk. Breast-feeding is not recommended while using this drug.

Drug Interactions

This drug should not be used with the following medications because very serious interactions may occur: bosentan. If you are currently using any of these medications, tell your doctor or pharmacist before starting glyburide/metformin. Before using this medication, tell your doctor or pharmacist of all prescription and nonprescription products you may use, especially of: other diabetes drugs (e.g., insulin, rosiglitazone), aspirin or aspirin-like drugs (e.g., salicylates, NSAIDs such as ibuprofen, phenylbutazone), azole antifungals (e.g., fluconazole), cimetidine, birth control pills, "blood thinners" (e.g., warfarin), chloramphenicol, clofibrate, clomiphene, corticosteroids (e.g., prednisone), decongestants (e.g., pseudoephedrine), diazoxide, diet pills, epinephrine, estrogens, high blood pressure drugs (beta-blockers -- including glaucoma eye drops such as propranolol, timolol, metoprolol; calcium channel blockers such as nifedipine; ACE inhibitors such as captopril), isoniazid, MAO inhibitors (e.g., furazolidone, linezolid, moclobemide, phenelzine procarbazine, selegiline, isocarboxazid, tranylcypromine), niacin, phenothiazines (e.g., chlorpromazine), phenytoin, probenecid, quinolone antibiotics (e.g., ciprofloxacin), rifampin, sulfonamides (e.g., sulfa antibiotics), thyroid drugs, "water pills" (diuretics such as hydrochlorothiazide, furosemide), fenugreek, ginseng. If you are scheduled to undergo any x-ray or scanning procedure using injectable iodinated contrast material, be sure to inform your doctor that you are taking this medication. You will need to temporarily stop this medication around the time of your procedure. Consult your doctor for further instructions. Do not start or stop any medicine without doctor or pharmacist approval.

Overdose

If overdose is suspected, contact your local poison control center or emergency room immediately. Symptoms of overdose may include: rapid or trouble breathing, severe drowsiness, fast/slow/irregular heartbeat, shakiness, sweating, loss of consciousness.

Notes

Do not share this medication with others. It is recommended you attend a diabetes education program to understand diabetes and all the important aspects of its treatment including meals/diet, exercise, personal hygiene, medications and getting regular eye, foot, and medical exams. Consult your doctor or pharmacist. Keep all medical appointments. Laboratory and/or medical tests (e.g., liver and kidney function tests, fasting blood glucose, hemoglobin A1c, complete blood counts) will be performed to monitor for side effects and response to therapy. Regularly check your blood or urine for sugar, as directed by your doctor or pharmacist.

Missed Dose

If you miss a dose, use it as soon as you remember. If it is near the time of the next dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.

Storage

Store at room temperature (77 degrees F or 25 degrees C) away from light and moisture. Do not store in the bathroom. Keep all medicines away from children and pets.

Medical Alert

Your condition can cause complications in a medical emergency. For enrollment information call MedicAlert at 1-800-854-1166 (USA), or 1-800-668-1507 (Canada).