Glyburide/Metformin Hydrochloride, Oral

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KEY POINTS

• This medicine is taken by mouth to treat type 2 diabetes when diet and exercise have not controlled blood sugar levels. Take it exactly as directed.
• This medicine may cause lactic acidosis, increase your risk for heart disease, or cause other unwanted side effects. Tell your healthcare provider if you have any side effects that are serious, continue, or get worse.
• Tell all healthcare providers who treat you about all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take.

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What are other names for this medicine?

Type of medicine: antidiabetic

Generic and brand names: glyburide/metformin hydrochloride, oral; Glucovance

What is this medicine used for?

This is a combination of two medicines. It is taken by mouth to treat type 2 diabetes when diet and exercise have not controlled blood sugar levels.

This medicine may be used to treat other conditions as determined by your healthcare provider.

What should my healthcare provider know before I take this medicine?

Before taking this medicine, tell your healthcare provider if you have ever had:

• An allergic reaction to any medicine
• A blood disorder such as G6PD, anemia, or vitamin B12 deficiency
• A stroke or transient ischemic attack (TIA)
• Diabetic coma or ketoacidosis (increased ketones in the blood or urine) or type 1 diabetes
• Edema (fluid buildup)
• Heart failure or a heart attack
• Kidney or liver problems
• Thyroid, pituitary, or adrenal gland problems

Also tell your provider if you:

• Are going to have an X-ray procedure such as a CT scan with the injection of dyes
• Are scheduled to have surgery
• Drink alcohol a lot (all the time or short-term "binge" drinking)

Tell your provider if you have recently been injured, or if you have an illness that results in severe vomiting, diarrhea, or fever, or if you have not been drinking much liquid lately.

You should not take this medicine if you also take bosentan (Tracleer). Talk with your healthcare provider about this.

Women who do not have regular periods, due to menopause or other reasons, may be able to become pregnant while taking this medicine. Talk to your healthcare provider about effective birth control.

Females of childbearing age: Tell your healthcare provider if you are pregnant or plan to become pregnant while you are taking this medicine. Talk to your healthcare provider about whether you will need to use insulin to control your blood sugar during pregnancy. Do not breast-feed while taking this medicine without your healthcare provider's approval.

How do I take it?

Check the label on the medicine for directions about your specific dose. Take this medicine exactly as your healthcare provider prescribes. Do not take more than directed. Your healthcare provider will adjust your dosage over time to a level that best controls your blood sugar while causing the fewest side effects. Do not stop taking this medicine without your healthcare provider's approval.

Check with your healthcare provider before using this medicine in children under age 18 years.

Always take this medicine with a meal.

What if I miss a dose?

If you miss a dose, take it as soon as you remember (with food), unless it is almost time for the next scheduled dose. In that case, skip the missed dose and take the next one as directed. Do not take double doses. If you are not sure about what to do if you miss a dose, or if you miss more than 1 dose, contact your healthcare provider.

What if I overdose?

If you or anyone else has intentionally taken too much of this medicine, call 911 or go to the emergency room right away. If you pass out, have seizures, weakness or confusion, or have trouble breathing, call 911. If you think that you or anyone else may have taken too much of this medicine, call the poison control center. Do this even if there are no signs of discomfort or poisoning. The poison control center number is 800-222-1222.

Symptoms of an acute overdose may include: hunger, headache, confusion, irritability, drowsiness, dizziness, tremors, sweating, fast heartbeat, seizures, coma, weakness, increasing drowsiness, slow heartbeat, chills, muscle pain, shortness of breath, stomach pain, lightheadedness, fainting.

What should I watch out for?

Lactic acidosis is a rare but serious problem that can happen with use of this medicine. Your risk may be higher if you have liver or kidney problems, heart failure, or a severe infection. The risk may also be higher if you drink alcohol, are dehydrated, or are over the age of 65. Stop taking this medicine and contact your healthcare provider right away if you develop unexplained symptoms such as:

• Feeling weak or tired
• Unusual muscle pain
• Unusual sleepiness or sleep longer than usual
• Unexplained stomach pain with nausea and vomiting, and diarrhea
• Having trouble breathing
• Feeling cold
• Feeling dizzy or lightheaded
• Suddenly having a slow or irregular heartbeat

Some medicines used to treat diabetes have been shown to increase the risk of heart disease. It is not known if this medicine increases your risk. Talk with your healthcare provider about this.

You will need to have blood tests regularly while you are taking this medicine to check your liver and kidney functions. Keep all appointments for these tests.

Follow carefully the diet and exercise program prescribed for you. Test your blood sugar on the schedule your provider recommends and keep track of it. See your provider regularly for an A1c test to check the average of your blood sugar over 2 to 3 months. This average is different from your day to day blood sugar. Keep all appointments for these tests.

Low blood sugar (hypoglycemia) can happen if you miss or delay meals, drink too much alcohol, take too much medicine, or exercise more than usual. Symptoms of low blood sugar include shaking, anxiety, cold sweats, irritability, fast heartbeat, feeling faint, strong hunger, vision problems, headache, nausea, slurred speech, confusion, unusual mood changes, tingling in the lips or tongue, and weakness. Treat the condition quickly by eating or drinking something with sugar in it such as candy, juice, or nondiet soda. Taking glucose tablets or gels (available in drug stores) is another quick way to treat hypoglycemia.

Alcohol may affect the way your body responds to this medicine and to food. Do not drink alcohol unless your healthcare provider approves.

This medicine may make you dizzy or drowsy. Also, low blood sugar may affect your ability to drive or operate machinery. Do not drive or operate machinery unless you are fully alert and can see clearly.

This medicine may make your skin more sensitive to the sun and may make you sunburn more easily. Wear protective clothing and sunscreen lotion when you are exposed to the sun. Do not use a sunlamp. If you get a severe sunburn, contact your healthcare provider right away.

Adults over the age of 65 may be at greater risk for side effects. Talk with your healthcare provider about this.

If you need emergency care, surgery, X-rays, lab tests, or dental work, tell the healthcare provider or dentist you are taking this medicine. You may have to stop taking this medicine until after the procedure. Wear some form of ID stating that you are a diabetic (such as a Medic Alert bracelet). If you become unconscious, the ID tells emergency healthcare providers that you are a diabetic and need special care.

What are the possible side effects?

Along with its needed effects, your medicine may cause some unwanted side effects. Some side effects may be very serious. Some side effects may go away as your body adjusts to the medicine. Tell your healthcare provider if you have any side effects that continue or get worse.

Life-threatening (Report these to your healthcare provider right away. If you cannot reach your healthcare provider right away, get emergency medical care or call 911 for help.): Allergic reaction (hives; itching; rash; trouble breathing; chest pain or tightness in your chest; swelling of your lips, tongue, and throat).

Serious (Report these to your healthcare provider right away.): Symptoms of hypoglycemia (shaking, anxiety, cold sweats, irritability, fast heartbeat, feeling faint, strong hunger, vision problems, headache, nausea, slurred speech, confusion, unusual mood changes, tingling in the lips or tongue, weakness); feeling very weak or tired; unexplained muscle pain; trouble breathing; extreme thirst; feeling cold, dizzy, or lightheaded; severe dizziness; feeling very ill generally; suddenly developing a slow or irregular heartbeat; decreased urination or trouble urinating, dark urine; unexplained fever; sore throat; unusual bruising or bleeding; light-colored bowel movements; yellowing of your skin or eyes; severe back pain; severe or constant stomach pain; severe nausea, vomiting, or diarrhea.

Other: Mild diarrhea, nausea, loss of appetite, rash, itching, sensitivity to the sun, gas, change in sense of taste, weight gain.

What products might interact with this medicine?

When you take this medicine with other medicines, it can change the way this or any of the other medicines work. Nonprescription medicines, vitamins, natural remedies, and certain foods may also interact. Using these products together might cause harmful side effects. Talk to your healthcare provider if you are taking:

• ACE inhibitors such as benazepril (Lotensin), captopril, enalapril (Vasotec), fosinopril, lisinopril (Prinivil, Zestril), quinapril (Accupril), and ramipril (Altace)
• Alcohol
• Allergy, cold, or cough medicines that contain phenylephrine (Neo-Synephrine, Sudafed PE) or pseudoephedrine (Sudafed)
• Angiotensin receptor blockers (ARBs) such as azilsartan (Edarbi), candesartan (Atacand), eprosartan (Teveten), irbesartan (Avapro), losartan (Cozaar), olmesartan (Benicar), telmisartan (Micardis), and valsartan (Diovan)
• Antiarrhythmic medicines (to treat irregular heartbeat) such as amiodarone (Cordarone, Pacerone), disopyramide (Norpace), dofetilide (Tikosyn), dronedarone (Multaq), procainamide, and quinidine
• Antibiotics such as cephalexin (Keflex), chloramphenicol, ciprofloxacin (Cipro), clarithromycin (Biaxin), isoniazid, levofloxacin (Levaquin), linezolid (Zyvox), ofloxacin, rifampin (Rifadin), and vancomycin (Vancocin)
• Antidepressants such as amitriptyline, citalopram (Celexa), desipramine (Norpramin), escitalopram (Lexapro), fluoxetine (Prozac), fluvoxamine (Luvox), imipramine (Tofranil), nortriptyline (Pamelor), and sertraline (Zoloft)
• Antifungal medicines such as fluconazole (Diflucan), ketoconazole (Nizoral), miconazole (Monistat, Oravig), and voriconazole (Vfend)
• Antipsychotic medicines such as chlorpromazine, perphenazine, prochlorperazine (Compro), thioridazine, and trifluoperazine
• Antiseizure medicines such as carbamazepine (Carbatrol, Epitol, Equetro, Tegretol), phenytoin (Dilantin, Phenytek), topiramate (Qudexy, Topamax, Trokendi), and zonisamide (Zonegran)
• Aspirin and other salicylates
• Beta blockers such as acebutolol (Sectral), atenolol (Tenormin), carvedilol (Coreg), labetalol (Trandate), metoprolol (Lopressor, Toprol), nadolol (Corgard), pindolol, and sotalol (Betapace, Sorine)
• Bosentan (Tracleer)
• Calcium channel blockers such as diltiazem (Cardizem, Cartia, Tiazac), felodipine, isradipine (DynaCirc), nicardipine (Cardene), nifedipine (Adalat CC, Procardia), and verapamil (Calan, Covera, Verelan)
• Carbonic anhydrase inhibitors such as acetazolamide (Diamox) and methazolamide (Neptazane)
• Cholesterol-lowering medicines such as cholestyramine (Prevalite), colesevelam (Welchol), colestipol (Colestid), fenofibrate (Antara, Fenoglide, Lipofen, TriCor, Triglide), and gemfibrozil (Lopid) (Take colesevelam at least 4 hours after you take this medicine.)
• Corticosteroids such as betamethasone, cortisone, dexamethasone, fludrocortisone, hydrocortisone (A-Hydrocort, Cortef), methylprednisolone (Medrol, Solu-Medrol), prednisolone (Omnipred, Orapred, Prelone), prednisone (Prednisone Intensol), and triamcinolone (Aristospan, Kenalog)
• Digoxin (Lanoxin)
• Diuretics (water pills) such as amiloride, bumetanide, chlorothiazide (Diuril), chlorthalidone, furosemide (Lasix), hydrochlorothiazide (Microzide), spironolactone (Aldactone), torsemide (Demadex), and triamterene (Dyrenium)
• HIV medicines such as atazanavir (Reyataz), darunavir (Prezista), delavirdine (Rescriptor), dolutegravir (Tivicay), efavirenz (Sustiva), etravirine (Intelence), fosamprenavir (Lexiva), indinavir (Crixivan), lopinavir/ritonavir (Kaletra), nelfinavir (Viracept), nevirapine (Viramune), ritonavir (Norvir), saquinavir (Invirase), stavudine (Zerit), and tipranavir (Aptivus)
• Hormonal birth control pills, implants, shots, patches, vaginal rings, and IUDs, and hormones such as conjugated estrogens (Premarin), estradiol (Climara, Estrace, Estraderm, Vivelle), medroxyprogesterone (Depo-Provera, Provera), and norethindrone (Aygestin, Micronor)
• Immunosuppressants such as cyclosporine (Gengraf, Neoral, Sandimmune) and tacrolimus (Astagraf, Prograf, Protopic)
• MAO inhibitors such as isocarboxazid (Marplan), phenelzine (Nardil), selegiline (Eldepryl, Emsam, Zelapar), and tranylcypromine (Parnate) (Do not take this medicine and an MAO inhibitor within 14 days of each other.)
• Medicines to block or prevent stomach acid such as cimetidine (Tagamet) and ranitidine (Zantac)
• Methotrexate (Otrexup, Rasuvo, Rheumatrex, Trexall)
• Morphine (Kadian, MS Contin)
• Natural remedies such as aloe, bilberry, bitter melon, chromium, fenugreek, garcinia, garlic, ginger, ginseng, gotu kola, green tea, gymnema, horse chestnut, St. John's wort, and stinging nettle
• Niacin
• Nonsteroidal anti-inflammatory medicines (NSAIDs) such as diclofenac (Cambia, Voltaren, Zipsor), ibuprofen (Advil, Motrin), indomethacin (Indocin), ketoprofen, ketorolac, nabumetone (Relafen), naproxen (Aleve, Anaprox, Naprelan), oxaprozin (Daypro), piroxicam (Feldene), and sulindac (Clinoril)
• Octreotide (Sandostatin)
• Other diabetes medicines such as alogliptin (Nesina), alogliptin/metformin (Kazano), canagliflozin/metformin (Invokamet), chlorpropamide, dapagliflozin/metformin (Xigduo), glimepiride (Amaryl), glipizide (Glucotrol), glipizide/metformin, glyburide (Glynase), insulin, linagliptin (Tradjenta), linagliptin/metformin (Jentadueto), nateglinide (Starlix), pioglitazone/metformin (Actoplus Met), repaglinide (Prandin), repaglinide/metformin (PrandiMet), rosiglitazone/metformin (Avandamet), saxagliptin (Onglyza), saxagliptin/metformin (Kombiglyze), sitagliptin (Januvia), sitagliptin/metformin (Janumet), and tolbutamide
• Paroxetine (Brisdelle, Paxil, Pexeva)
• Pegvisomant (Somavert)
• Probenecid
• Propranolol (Hemangeol, Inderal, InnoPran)
• Psyllium (Take psyllium 2 hours before or 2 hours after you take this medicine.)
• Quinine
• Ranolazine (Ranexa)
• Somatropin (Genotropin, Humatrope, Nutropin, Serostim)
• Sulfa antibiotics such as sulfadiazine, sulfamethoxazole/trimethoprim (Bactrim, Septra), and sulfasalazine (Azulfidine)
• Thyroid medicines such as levothyroxine (Levo-T, Levothroid, Levoxyl, Synthroid, Unithroid), liothyronine (Cytomel, Triostat), liotrix (Thyrolar), and thyroid USP (Armour Thyroid, Nature-Throid)
• Trospium
• Warfarin (Coumadin)

Do not drink alcohol while you are taking this medicine unless your healthcare provider approves.

Many medicines may change how well this medicine controls your blood sugar. Tell any healthcare providers who treat you that you are taking this medicine for diabetes.

Many nonprescription products contain sugar, alcohol, or other ingredients that may interfere with this medicine or increase your blood sugar. Check product labels for warnings for diabetics or ask your healthcare provider or pharmacist for advice.

If you are not sure if your medicines might interact, ask your pharmacist or healthcare provider. Keep a list of all your medicines with you. List all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take. Be sure that you tell all healthcare providers who treat you about all the products you are taking.

How should I store this medicine?

Store this medicine at room temperature. Keep the container tightly closed. Protect it from heat, high humidity, and light.

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This advisory includes selected information only and may not include all side effects of this medicine or interactions with other medicines. Ask your healthcare provider or pharmacist for more information or if you have any questions.

Ask your pharmacist for the best way to dispose of outdated medicine or medicine you have not used. Do not throw medicine in the trash.

Keep all medicines out of the reach of children.

Do not share medicines with other people.