Rosiglitazone/Glimepiride, Oral

What are other names for this medicine?

Type of medicine: antihyperglycemic; antidiabetic

Generic and brand names: rosiglitazone maleate and glimepiride oral; Avandaryl

What is this medicine used for?

This medicine combines 2 medicines taken by mouth to treat type 2 diabetes. It should not be used to treat type 1 diabetes or diabetic ketoacidosis. It is taken when diet and exercise have not controlled blood sugar levels.

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

Tell your healthcare provider if you have ever had:

• an allergy to any medicine
• anemia
• edema (fluid retention)
• eye problems
• heart failure or other heart problems
• kidney or liver problems
• problems with low levels of sodium in your blood
• thyroid, pituitary, or adrenal gland problems

Tell your provider if you take nitrate medicines or insulin. This medicine is not recommended for people who are taking insulin or nitrates. Also tell your healthcare provider if you get sick, injured, or are scheduled to have surgery.

Females of childbearing age: Tell your healthcare provider if you are pregnant or plan to become pregnant. It is not known whether this medicine will harm an unborn baby. 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 you are 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 every day exactly as your healthcare provider prescribes. Take it with the first meal of the day. Follow carefully the diet and exercise plan your healthcare provider gives you. Diet and exercise affect your dosage. This medicine may start working in 1 to 2 weeks, but it may take 2 to 3 months to have full effect.

What if I miss a dose?

If you miss a dose, take it as soon as you remember 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 of what to do if you miss a dose, or if you miss more than one 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: strong hunger, headache, confusion, irritability, drowsiness, weakness, dizziness, tremors, sweating, fast heartbeat, seizures, fainting, coma.

What should I watch out for?

This medicine may increase your risk for a heart attack, heart failure, or other heart problems, especially if you also take insulin or nitrate medicines. Talk with your healthcare provider about this.

Tell your healthcare provider if you are taking any medicines for heart failure, high blood pressure, high cholesterol, or for prevention of heart disease or stroke.

You will need to have blood tests regularly to see if the medicine is working and to check for any signs of side effects that show up only on blood tests. You may be able to test your blood sugar levels on a small machine at home, but your healthcare provider will do other tests. You also need to have regular eye exams while taking this medicine.

Low blood sugar (hypoglycemia) can occur 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 confusion, shaking, weakness, strong hunger, cold sweats, headache, nausea, vision problems, and feeling faint. Treat the condition quickly by eating or drinking something with sugar in it such as candy, juice, or nondiet soda. You could also take glucose tablets or gels (available in drug stores) is another quick way to treat hypoglycemia. Be sure to talk about this with your healthcare provider.

This medicine may make birth control pills less effective. Some women who have gone through menopause and no longer have periods may be able to get pregnant while taking this medicine. Ask your healthcare provider if this applies to you. Talk with your healthcare provider if you need birth control.

If you need emergency care, surgery, or dental work, tell the healthcare provider or dentist you are taking this medicine. Wear some form of identification 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.

Rarely, this medicine may cause vision problems. You need to have regular eye exams while taking this medicine.

This medicine may increase the risk of fractures in women. You may also need bone scans or X-rays to see if this medicine is affecting your bones. Talk to your healthcare provider about how to keep your bones healthy.

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.

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.

Serious (report these to your healthcare provider right away): Chest pain or pressure; severe nausea or vomiting; severe abdominal pain; irregular heartbeat; severe dizziness; increasing tiredness; loss of appetite; dark urine; light-colored bowel movements; yellowing of your eyes or skin; swelling of legs or ankles or any unexplained swelling; shortness of breath; unusual bruising or bleeding; vision problems.

Other: Chest infection, nausea, vomiting, headache, diarrhea.

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:

• alcohol
• antibiotics such as levofloxacin (Levaquin), Ofloxacin (Floxin), norfloxacin (Noroxin), ciprofloxacin (Cipro), chloramphenicol (Chloromycetin), rifampin (Rifadin, Rimactane), and rifabutin (Mycobutin)
• antidepressants such as fluoxetine (Prozac, Sarafem), paroxetine (Paxil), and sertraline (Zoloft)
• antifungal medicines such as fluconazole (Diflucan) and ketoconazole (Nizoral)
• anti-HIV medicines such as amprenavir (Agenerase), atazanavir (Reyataz), indinavir (Crixivan), nelfinavir (Viracept), nevirapine (Viramune), delavirdine (Rescriptor), ritonavir (Norvir), and saquinavir (Fortovase, Invirase)
• antiseizure medicines such as carbamazepine (Tegretol), phenytoin (Dilantin), and valproic acid (Depakote, Depakene)
• aspirin and other salicylates
• beta blockers such as atenolol (Tenormin), carvedilol (Coreg), carteolol, labetalol (Trandate, Normodyne), metoprolol (Lopressor, Toprol XL), pindolol, propranolol (Inderal), sotalol (Betapace), and timolol
• birth control pills and hormones such as estradiol (Estrace, Estratab), conjugated estrogens (Premarin), norethindrone (Aygestin, Micronor), and norgestrel (Ovrette)
• calcium channel blockers such as amlodipine (Norvasc), bepridil (Vascor), diltiazem (Cardizem, Dilacor), felodipine (Plendil), nicardipine (Cardene), nifedipine (Procardia, Adalat), verapamil (Calan, Covera, Isoptin), and mibefradil (Posicor)
• cold medicines that contain pseudoephedrine or phenylephrine
• corticosteroids such as cortisone (Cortone), dexamethasone, hydrocortisone (Cortef, Hydrocortone), methylprednisolone (Medrol), prednisolone (Delta-Cortef, Prelone), prednisone (Meticorten), and triamcinolone (Aristocort, Kenacort)
• diuretics (water pills) such as furosemide (Lasix), hydrochlorothiazide (Microzide), amiloride (Midamor, Moduretic), and triamterene (Dyrenium, Dyazide)
• gemfibrozil (Lopid)
• insulin
• isoniazid
• MAO inhibitors such as phenelzine (Nardil), tranylcypromine (Parnate), and isocarboxazid (Marplan) (Do not take this medicine and an MAO inhibitor within 14 days of each other.)
• nicotinic acid
• nonsteroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen (Motrin, Motrin IB, Advil, Nuprin), naproxen (Naprosyn, Anaprox, Aleve, Naprelan), ketoprofen, nabumetone (Relafen), indomethacin (Indocin), ketorolac (Toradol), sulindac (Clinoril), piroxicam (Feldene), diclofenac (Voltaren, Cataflam), and oxaprozin (Daypro)
• phenothiazines such as chlorpromazine (Thorazine), fluphenazine (Prolixin, Permitil), perphenazine, prochlorperazine (Compazine), promazine (Sparine), thioridazine, and trifluoperazine (Stelazine)
• probenecid
• sulfonamides such as sulfadiazine, sulfisoxazole (Gantrisin), and sulfasalazine (Azulfidine)
• thyroid medicines such as levothyroxine (Levothroid, Levoxyl, Synthroid, Unithroid), liothyronine (Cytomel, Triostat), liotrix (Thyrolar), and thyroid (Armour Thyroid, Thyroid Extract, Thyroid USP)
• tricyclic antidepressants such as amitriptyline, nortriptyline (Aventyl, Pamelor), imipramine (Tofranil), and doxepin (Sinequan)
• warfarin (Coumadin)

Do not drink large amounts of alcohol while you are taking this medicine. Talk to your healthcare provider about this.

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 bright 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 medicines in the trash.

Keep all medicines out of the reach of children.

Do not share medicines with other people.

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