rosiglitazone

Pronunciation: row zi GLI ta zone

Brand: Avandia

Avandia 2 mg

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Avandia 4 mg

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Avandia 8 mg

pentagonal, brown, imprinted with SB, 8, SKB

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What is the most important information I should know about rosiglitazone?

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Taking rosiglitazone may increase your risk of serious heart problems, such as heart attack or stroke. Therefore, rosiglitazone is available only to certain people with type 2 diabetes that cannot be controlled with other diabetes medications.

Rosiglitazone is available only under a special program called Avandia-Rosiglitazone Medicines Access Program. You must be registered in the program and sign documents stating that you understand the risks and benefits of taking this medication.

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Do not use rosiglitazone if you have type 1 diabetes, or if you are in a state of diabetic ketoacidosis (call your doctor for treatment with insulin).

Before taking rosiglitazone, tell your doctor if you have congestive heart failure or heart disease, a history of heart attack or stroke, liver disease, or eye problems caused by diabetes.

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Know the signs of low blood sugar (hypoglycemia) and how to recognize them: headache, hunger, weakness, sweating, tremors, irritability, or trouble concentrating.

Women may also be more likely than men to have bone fractures in the upper arm, hand, or foot while taking rosiglitazone. Talk with your doctor if you are concerned about this possibility.

What is rosiglitazone?

Rosiglitazone is an oral diabetes medicine that helps control blood sugar levels.

Rosiglitazone is for people with type 2 diabetes. Rosiglitazone is sometimes used in combination with other medicines, but it is not for treating type 1 diabetes.

Rosiglitazone is not recommended for use with insulin.

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Taking rosiglitazone may increase your risk of serious heart problems, such as heart attack or stroke. Therefore, rosiglitazone is available only to certain people with type 2 diabetes that cannot be controlled with other diabetes medications.

Rosiglitazone is available only under a special program called Avandia-Rosiglitazone Medicines Access Program. You must be registered in the program and sign documents stating that you understand the risks and benefits of taking this medication.

Rosiglitazone may also be used for purposes not listed in this medication guide.

What should I discuss with my healthcare provider before taking rosiglitazone?

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Do not use rosiglitazone if you have type 1 diabetes, or if you are in a state of diabetic ketoacidosis (call your doctor for treatment with insulin).

To make sure you can safely take rosiglitazone, tell your doctor if you have any of these other conditions:

  • congestive heart failure or heart disease;
  • a history of heart attack or stroke;
  • liver disease; or
  • eye problems caused by diabetes.

Women may be more likely than men to have bone fractures in the upper arm, hand, or foot while taking rosiglitazone. Talk with your doctor if you are concerned about this possibility.

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FDA pregnancy category C. It is not known whether rosiglitazone will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication.

Some women using rosiglitazone have started having menstrual periods, even after not having a period for a long time due to a medical condition. You may be able to get pregnant if your periods restart. Talk with your doctor about the need for birth control.

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It is not known whether rosiglitazone passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

How should I take rosiglitazone?

Take exactly as prescribed by your doctor. Do not take in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label. Your doctor may occasionally change your dose to make sure you get the best results.

Rosiglitazone is usually taken in the morning and evening. You may take the medicine with or without food.

Rosiglitazone is only part of a complete program of treatment that also includes diet, exercise, and weight control. Your doctor may also recommend other medicines to treat your diabetes.

Use rosiglitazone regularly to get the most benefit. Get your prescription refilled before you run out of medicine completely.

Your blood sugar will need to be checked often, and you may need other blood tests at your doctor's office. Visit your doctor regularly.

Your medication needs may change if you become sick or injured, if you have a serious infection, or if you have any type of surgery. Your doctor may want you to stop taking rosiglitazone for a short time if any of these situations affect you.

Take care not to let your blood sugar get too low. You may have hypoglycemia if you skip a meal, exercise too long, drink alcohol, or are under stress.

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Know the signs of low blood sugar (hypoglycemia) and how to recognize them: headache, hunger, weakness, sweating, tremors, irritability, or trouble concentrating.

Always keep a source of sugar available in case you have symptoms of low blood sugar. Sugar sources include orange juice, glucose gel, candy, or milk. If you have severe hypoglycemia and cannot eat or drink, use an injection of glucagon. Your doctor can give you a prescription for a glucagon emergency injection kit and tell you how to give the injection.

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Store at room temperature away from moisture, heat, and light.

What happens if I miss a dose?

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

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Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Symptoms of severe hypoglycemia include extreme weakness, confusion, tremors, sweating, trouble speaking, blurred vision, nausea, fainting, and seizure (convulsions).

What should I avoid while taking rosiglitazone?

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Avoid drinking alcohol. It can lower your blood sugar.

What are the possible side effects of rosiglitazone?

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Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

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Stop using rosiglitazone and call your doctor at once if you have a serious side effect such as:

  • feeling short of breath, even with mild exertion;
  • swelling or rapid weight gain;
  • chest pain or heavy feeling, pain spreading to the arm or shoulder, sweating, general ill feeling;
  • nausea, stomach pain, low fever, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
  • blurred vision;
  • increased thirst or hunger, urinating more than usual; or
  • pale skin, easy bruising or bleeding, weakness.

Less serious side effects may include:

  • cold symptoms such as stuffy nose, sneezing, sore throat;
  • headache; or
  • back pain.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect rosiglitazone?

You may be more likely to have hyperglycemia (high blood sugar) if you take rosiglitazone with other drugs that can raise blood sugar, such as:

  • isoniazid;
  • diuretics (water pills);
  • steroids (prednisone and others);
  • phenothiazines (Compazine and others);
  • thyroid medicine (Synthroid and others);
  • birth control pills and other hormones;
  • seizure medicines (Dilantin and others); and
  • diet pills or medicines to treat asthma, colds, or allergies.

You may be more likely to have hypoglycemia (low blood sugar) if you take rosiglitazone with other drugs that can lower blood sugar, such as:

  • probenecid (Benemid);
  • some nonsteroidal anti-inflammatory drugs (NSAIDs);
  • aspirin or other salicylates (including Pepto-Bismol);
  • a blood thinner (warfarin, Coumadin, Jantoven, and others);
  • sulfa drugs (Bactrim, Septra, Sulfatrim, SMX-TMP, and others);
  • a monoamine oxidase inhibitor (MAOI); or
  • other oral diabetes medications, especially acarbose (Precose), metformin (Glucophage), miglitol (Glyset), pioglitazone (Actos, Duetact, Actoplus Met), or other drugs that contain rosiglitazone (Avandaryl, Avandamet).

Some medications may interact with rosiglitazone. Tell your doctor if you are using any of the following drugs:

  • delavirdine (Rescriptor);
  • gemfibrozil (Lopid);
  • nicardipine (Cardene);
  • tolbutamide (Orinase);
  • antifungal medications such as fluconazole (Diflucan), ketoconazole (Nizoral), or miconazole (Oravig);
  • pain or arthritis medicine such as flurbiprofen (Ansaid), ibuprofen (Advil, Motrin), indomethacin (Indocin), mefenamic acid (Ponstel), or piroxicam (Feldene);
  • antibiotics such as rifampin (Rifater, Rifadin, Rifamate) or sulfisoxazole (Pediazole, and others); or
  • seizure medicine such as carbamazepine (Carbatrol, Equetro, Tegretol) or phenobarbital (Solfoton).

This list is not complete and other drugs may interact with rosiglitazone. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

Where can I get more information?

Your pharmacist has additional information about rosiglitazone written for health professionals that you may read.


Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

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