Metformin can rarely cause a serious (sometimes fatal) condition called lactic acidosis. Stop taking metformin and get medical help right away if you develop any of the following symptoms of lactic acidosis: unusual tiredness, dizziness, severe drowsiness, chills, blue/cold skin, muscle pain, fast/difficult breathing, slow/irregular heartbeat, stomach pain with nausea/vomiting/diarrhea.
Lactic acidosis is more likely to occur in patients who have certain medical conditions, including kidney or liver disease, recent surgery, a serious infection, conditions that may cause a low level of oxygen in the blood or poor circulation (such as congestive heart failure, recent heart attack, recent stroke), heavy alcohol use, a severe loss of body fluids (dehydration), or X-ray or scanning procedures that require an injectable iodinated contrast drug. Tell your doctor immediately if any of these conditions occur or if you notice a big change in your overall health. You may need to stop taking this medication temporarily. The elderly are also at higher risk, especially those older than 80 years who have not had kidney tests. (See also Side Effects and Precautions sections.)Who should not take glyburide-metformin?
This product contains 2 medications. Glyburide belongs to the class of drugs known as sulfonylureas. It lowers blood sugar by causing the release of your body's natural insulin and by decreasing the amount of sugar that your liver makes. Metformin works by decreasing the amount of sugar that your liver makes and that your stomach/intestines absorb. Both of these medications work by helping to restore your body's proper response to the insulin you naturally produce.
Controlling high blood sugar helps prevent kidney damage, blindness, nerve problems, loss of limbs, and sexual function problems. Proper control of diabetes may also lessen your risk of a heart attack or stroke.
Read the Patient Information Leaflet if available from your pharmacist before you start taking this medication and each time you get a refill. If you have any questions, ask your doctor or pharmacist.
Take this medication by mouth with meals as directed by your doctor, usually once or twice a day. Drink plenty of fluids while taking this medication unless otherwise directed by your doctor.
The dosage is based on your medical condition and response to treatment. To reduce your risk of side effects (such as upset stomach and low blood sugar), your doctor may direct you to start this medication at a low dose and gradually increase your dose. Your doctor will adjust your dose based on your blood sugar levels to find the best dose for you. Follow your doctor's instructions carefully.
If you are already taking another anti-diabetic drug (such as chlorpropamide), follow your doctor's directions carefully for stopping the old drug and starting this combination medication.
If you are also taking colesevelam, take glyburide/metformin at least 4 hours before colesevelam.
Use this medication regularly to get the most benefit from it. To help you remember, take it at the same time(s) each day.
It may take up to 2 weeks before you get the full benefit of this drug. Tell your doctor if your condition does not improve or if it worsens (your blood sugar levels are too high or too low).
See also Warning section.
Nausea, stomach upset, diarrhea, or weight gain may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly. If stomach symptoms return later (after you are on the same dose for several days or weeks), tell your doctor immediately. Stomach symptoms that occur after the first days of your treatment may be a sign of lactic acidosis.
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.
Tell your doctor right away if you have any serious side effects, including: easy bleeding/bruising, signs of infection (such as persistent sore throat, fever), persistent nausea, severe stomach/abdominal pain, yellowing eyes/skin, dark urine.
This medication can cause low blood sugar (hypoglycemia). This may occur if you do not consume enough calories from food or if you do unusually heavy exercise. Symptoms of low blood sugar include sudden sweating, shaking, fast heartbeat, hunger, blurred vision, dizziness, or tingling hands/feet. It is a good habit to carry glucose tablets or gel to treat low blood sugar. If you don't have these reliable forms of glucose, rapidly raise your blood sugar by eating a quick source of sugar such as table sugar, honey, or candy, or drink fruit juice or non-diet soda. Tell your doctor immediately about the reaction and the use of this product. To help prevent low blood sugar, eat meals on a regular schedule, and do not skip meals. Check with your doctor or pharmacist to find out what you should do if you miss a meal.
Symptoms of high blood sugar (hyperglycemia) include thirst, increased urination, confusion, drowsiness, flushing, rapid breathing, and fruity breath odor. If these symptoms occur, tell your doctor immediately. Your dosage may need to be increased.
A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: 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.
Before taking this medication, tell your doctor or pharmacist if you are allergic to glyburide or metformin; 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.
Before using this medication, tell your doctor or pharmacist your medical history, especially of: kidney disease, liver disease, conditions that may cause a low level of oxygen in the blood or poor circulation (such as severe congestive heart failure, recent heart attack, recent stroke), serious infection, severe loss of body fluids (dehydration), alcohol use, severe breathing problems (such as obstructive lung disease, severe asthma), blood problems (such as anemia, vitamin B12 deficiency), electrolyte imbalance (hyponatremia), fertility problems (such as ovulation problems), certain hormonal conditions (adrenal/pituitary insufficiency, thyroid disease, syndrome of inappropriate antidiuretic hormone-SIADH), a certain nervous system problem (autonomic neuropathy).
Before having surgery or any X-ray/scanning procedure using injectable iodinated contrast material, tell your doctor about all the products you use (including prescription drugs, nonprescription drugs, and herbal products). You will need to temporarily stop this medication before the time of your surgery/procedure. Consult your doctor for further instructions.
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 alcohol while taking this medication because it can increase the risk of developing low blood sugar and lactic acidosis. 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 using alcohol safely.
It may be harder to control your blood sugar when your body is stressed (such as due to fever, infection, injury, or surgery). Consult your doctor because this may require a change in your treatment plan, medications, or blood sugar testing.
This medication may make you more sensitive to the sun. Avoid prolonged sun exposure, tanning booths, and sunlamps. Use a sunscreen and wear protective clothing when outdoors.
Older adults may be more sensitive to the side effects of this drug, especially lactic acidosis or low blood sugar.
This medication can cause changes in the menstrual cycle (promote ovulation) and increase the risk of becoming pregnant. Consult your doctor or pharmacist about the use of reliable birth control while using this medication.
During pregnancy, this medication should be used only when clearly needed. Pregnancy may cause or worsen diabetes. Discuss a plan with your doctor for managing your blood sugar while pregnant. Your doctor may substitute insulin for this product during pregnancy. If you are using glyburide during your pregnancy, your doctor may switch you to insulin at least 2 weeks before the expected delivery date because of glyburide's risk of causing low blood sugar in your newborn. Discuss the risks and benefits with your doctor.
It is unknown if glyburide passes into breast milk. Metformin passes into breast milk. Consult your doctor before breast-feeding.
See also How To Use section.
Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.
A product that may interact with this drug is: bosentan.
Many drugs can affect your blood sugar levels, making it more difficult to control your blood sugar. Before you start, stop, or change any medication, talk with your doctor or pharmacist about how the medication may affect your blood sugar. Check your blood sugar levels regularly as directed by your doctor. Tell your doctor about the results and of any symptoms of high or low blood sugar. (See also Side Effects section.) Your doctor may need to adjust your anti-diabetic medication, exercise program, or diet.
Beta-blocker medications (including metoprolol, propranolol, glaucoma eye drops such as timolol) may prevent the fast/pounding heartbeat you would usually feel when your blood sugar level falls too low (hypoglycemia). Other symptoms of low blood sugar such as dizziness, hunger, or sweating are unaffected by these drugs.
Check the labels on all your medicines (such as cough-and-cold products) because they may contain ingredients that could affect your blood sugar. Ask your pharmacist about using those products safely.
If overdose is suspected, contact a poison control center or emergency room immediately. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center. Symptoms of overdose may include: rapid breathing, severe drowsiness, slow/irregular heartbeat.
Do not share this medication with others.
Attend a diabetes education program to learn more about diabetes and the important aspects of its treatment, including medications, diet, exercise, and getting regular eye/foot/medical exams.
Learn the symptoms of high and low blood sugar and how to treat low blood sugar. Check your blood sugar levels regularly as directed.
Keep all regular medical and laboratory appointments. Laboratory and/or medical tests (such as liver and kidney function tests, fasting blood glucose, hemoglobin A1c, complete blood counts) should be performed periodically to monitor your progress or check for side effects.
If you miss a dose, take 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.
Store at room temperature away from light and moisture. Do not store in the bathroom. Keep all medications away from children and pets.
Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.
MEDICAL ALERT: Your condition can cause complications in a medical emergency. For information about enrolling in MedicAlert, call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).
Information last revised November 2013. Copyright(c) 2013 First Databank, Inc.
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