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Rosiglitazone/glimepiride (By mouth)

Glimepiride (glye-MEP-ir-ide), Rosiglitazone Maleate (roe-zi-GLI-ta-zone MAL-ee-ate)

Treats type 2 diabetes. Used together with proper diet and exercise to help control your blood sugar.

Brand Name(s):

Avandaryl

There may be other brand names for this medicine.

When This Medicine Should Not Be Used:

You should not use this medicine if you have had an allergic reaction to glimepiride or rosiglitazone, or if you have type 1 diabetes, diabetic ketoacidosis (ketones in the blood), or severe heart failure. You should not use this medicine if you are having angina-type chest pain or if you recently had a heart attack.

How to Use This Medicine:

Tablet

  • This medicine is only available through a restricted access program. Both you and your doctor must enroll in this program. You might have to sign a consent form in order to receive this medicine and your doctor will closely monitor your progress while you are taking this medicine. Talk to your doctor if you have questions about this.
  • Take your medicine as directed. Your dose may need to be changed several times to find what works best for you.
  • It is best to take this medicine with food or milk. Take this medicine with the first meal of the day.
  • It may take up to 2 weeks for this medicine to start lowering your blood sugar. It may be 2 to 3 months before you get the full effect from the medicine.
  • Carefully follow your doctor's instructions about a special diet, exercise, or weight loss. Check your blood sugar on a regular basis at home.
  • This medicine should come with a Medication Guide. Ask your pharmacist for a copy if you do not have one.

If a dose is missed:

  • Take a dose as soon as you remember. If it is almost time for your next dose, wait until then and take a regular dose. Do not take extra medicine to make up for a missed dose.

How to Store and Dispose of This Medicine:

  • Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light.
  • Ask your pharmacist, doctor, or health caregiver about the best way to dispose of any outdated medicine or medicine no longer needed.
  • Keep all medicine out of the reach of children. Never share your medicine with anyone.

Drugs and Foods to Avoid:

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

  • Make sure your doctor knows if you are using other medicines to treat your diabetes, such as insulin. Tell your doctor if you are using a blood pressure medicine (such as metoprolol, propranolol, Inderal®, Lopressor®, or Tenormin®), pain or arthritis medicines (such as aspirin, diclofenac, ibuprofen, mefenamic acid, naproxen, Advil®, Celebrex®, Ecotrin®, or Voltaren®), cotrimoxazole (Bactrim®, Cotrim®, or Septra®), gemfibrozil (Lopid®), isoniazid (Nydrazid®), nicotinic acid (Nicobid®, Nicolar®), or rifampin (Rifadin®, Rimactane®).
  • Make sure your doctor knows if you are using chloramphenicol (Chloromycetin®, Chloroptic®), phenytoin (Dilantin®), probenecid (Benemid®), warfarin (Coumadin®), a steroid medicine (such as methylprednisolone, prednisone, or Medrol®), or a phenothiazine medicine (such as prochlorperazine, Compazine®, Phenergan®, or Thorazine®). Tell your doctor if you are also using certain cough and cold medicines (such as phenylephrine, pseudoephedrine, Neo-Synephrine®, Sudafed®, Sudafed® PE, or Sudodrine®), fluconazole (Diflucan®), miconazole (Lotrimin® AF, Monistat® 3), hormone replacement therapy, thyroid replacement therapy, diuretics or "water pills" (such as Dyazide® or Lasix®), birth control pills, or an MAO inhibitor (such as Eldepryl®, Marplan®, Nardil®, or Parnate®).
  • Do not drink alcohol while you are using this medicine.

Warnings While Using This Medicine:

  • Make sure your doctor knows if you are pregnant or breastfeeding, or if you have any kind of heart or blood vessel disease, heart failure, or a history of heart attack. Also tell your doctor if you have kidney disease, liver disease, an adrenal gland disorder, a pituitary gland disorder, edema (fluid retention or swelling), macular edema (swelling of the back of the eye), or fragile bones (especially women). Tell your doctor if you have a condition called glucose-6-phosphate dehydrogenase (G6PD) deficiency.
  • Call your doctor right away if you have chest pain or discomfort; nausea; pain or discomfort in the arms, jaw, back, or neck; shortness of breath; sweating; or vomiting. These may be symptoms of a heart attack.
  • Check with your doctor right away if you start having chest pain; shortness of breath; excessive swelling of the hands, wrist, ankles, or feet; or if you are rapidly gaining weight. These may be symptoms of a serious heart problem or edema (fluid retention).
  • This medicine may not work as well if you have surgery, get hurt, or get sick. If you have severe vomiting, diarrhea, or fever, call your doctor for instructions.
  • Tell your doctor right away if you have a loss of appetite, nausea, vomiting, stomach pain, unusual tiredness or weakness, dark urine, or yellow eyes or skin. These may be symptoms of a serious liver problem.
  • Certain women may be at an increased risk for pregnancy while taking this medicine. If you had problems ovulating and had irregular periods in the past, this medicine may cause you to ovulate. This could increase your chance of becoming pregnant. If you are a woman of childbearing potential, you should discuss birth control options with your doctor.
  • Check with your doctor if blurred vision, decreased vision, or any other change in vision occurs during your treatment. Your doctor may want you to have your eyes checked by an ophthalmologist (eye doctor).
  • This medicine may increase the risk for bone fractures in women. Ask your doctor about ways to keep your bones strong to help prevent fractures.
  • Your doctor will do lab tests at regular visits to check on the effects of this medicine. Keep all appointments. You will also need to check your blood sugar on a regular basis at home.
  • Some things that can lead to low blood sugar are exercising more than normal or waiting too long to eat. Tell your doctor about any sudden change in your medical condition.
  • This medicine may make your skin more sensitive to sunlight. Wear sunscreen. Do not use sunlamps or tanning beds.
  • Tell any doctor or dentist who treats you that you are using this medicine. This medicine may affect certain medical test results.

Possible Side Effects While Using This Medicine:

Call your doctor right away if you notice any of these side effects:

  • Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
  • Blistering, peeling, or red skin rash.
  • Blurred vision or other changes in vision.
  • Chest pain, which may spread to your arm, jaw, or back.
  • Confusion, body weakness, and muscle twitching.
  • Dark-colored urine or pale stools.
  • Fast, pounding, or uneven heartbeat.
  • Fever, chills, runny or stuffy nose, cough, sore throat, and body aches.
  • Lightheadedness, dizziness, shakiness, or hunger.
  • Nausea, vomiting, diarrhea, loss of appetite, or pain in your stomach.
  • Pale skin or troubled breathing.
  • Rapid weight gain.
  • Shortness of breath, cold sweats, and bluish-colored skin.
  • Swelling in your hands, ankles, or feet.
  • Unusual bleeding or bruising.
  • Unusual tiredness or weakness.
  • Yellowing of your skin or the whites of your eyes.

If you notice these less serious side effects, talk with your doctor:

  • Back or joint pain.
  • Headache.
  • Mild skin rash or itching.

If you notice other side effects that you think are caused by this medicine, tell your doctor

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088


Last Updated: 7/4/2014


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