Avandaryl

Generic Name: glimepiride and rosiglitazone (glye MEP ir ide and ROE si GLI ta zone)
Brand Names: Avandaryl

What is Avandaryl ?

Avandaryl (glimepiride and rosiglitazone) is a combination of two oral diabetes medicines that help control blood sugar levels.

Avandaryl is for people with type 2 diabetes. This medication is not for treating type 1 diabetes. Avandaryl is not recommended for use with insulin.

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

Avandaryl 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.

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

Important information about Avandaryl

Taking Avandaryl may increase your risk of serious heart problems, such as heart attack or stroke. Therefore, Avandaryl is available only to certain people with type 2 diabetes that cannot be controlled with other diabetes medications. Do not use Avandaryl 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 Avandaryl, tell your doctor if you have congestive heart failure or heart disease, a history of heart attack or stroke, liver or kidney disease, an enzyme deficiency called G6PD, adrenal or pituitary gland disorders, 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 Avandaryl. Talk with your doctor if you are concerned about this possibility.

Before taking Avandaryl

You should not use Avandaryl if you have advanced heart failure if you are in a state of diabetic ketoacidosis (call your doctor for treatment).

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

• congestive heart failure, heart disease, a history of heart attack or stroke;

• an enzyme deficiency called glucose-6-phosphate dehydrogenase deficiency (G6PD);

• liver disease or kidney disease;

• adrenal or pituitary gland disorders; or

• eye problems caused by diabetes.

Certain oral diabetes medications may increase your risk of serious heart problems. However, not treating your diabetes can damage your heart and other organs. Talk to your doctor about the risks and benefits of treating your diabetes with Avandaryl. Women may be more likely than men to have bone fractures in the upper arm, hand, or foot while taking Avandaryl. Talk with your doctor if you are concerned about this possibility.

FDA pregnancy category C. Do not use Avandaryl if you are pregnant. It is not known whether Avandaryl will harm an unborn baby. Similar diabetes medications have caused severe hypoglycemia in newborn babies whose mothers had used the medication near the time of delivery. Tell your doctor if you are pregnant or plan to become pregnant while using this medication. Some women using Avandaryl 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. It is not known whether glimepiride and rosiglitazone passes into breast milk or if it could harm a nursing baby. You should not breast-feed while you are using Avandaryl.

See also: Avandaryl pregnancy and breastfeeding warnings (in more detail)

How should I take Avandaryl?

Take Avandaryl 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.

Take Avandaryl with your first meal of the day.

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.

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.

Check your blood sugar carefully during a time of stress or illness, if you travel, exercise more than usual, drink alcohol, or skip meals. These things can affect your glucose levels and your dose needs may also change.

Your doctor may want you to stop taking Avandaryl for a short time if you become ill, have a fever or infection, or if you have surgery or a medical emergency.

Ask your doctor how to adjust your dose if needed. Do not change your medication dose or schedule without your doctor's advice.

Store Avandaryl at room temperature, protected from moisture, heat, and light.

See also: Avandaryl dosage (in more detail)

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?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. A Avandaryl overdose can cause life-threatening hypoglycemia.

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

What should I avoid while taking Avandaryl?

Avoid drinking alcohol. It can lower your blood sugar. Avoid exposure to sunlight or tanning beds. Avandaryl can make you sunburn more easily. Wear protective clothing and use sunscreen (SPF 30 or higher) when you are outdoors.

See also: Avandaryl and alcohol (in more detail)

Avandaryl side effects

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

Call your doctor at once if you have any of these serious side effects while taking Avandaryl:

• feeling short of breath, even with mild exertion;

• swelling or rapid weight gain;

• pale skin, feeling light-headed, rapid heart rate, trouble concentrating, fever, confusion or weakness;

• changes in your vision;

• chest pain or heavy feeling, pain spreading to the arm or shoulder, nausea, sweating, general ill feeling; or

• nausea, upper stomach pain, itching, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

Less serious Avandaryl side effects may include:

• headache;

• gradual weight gain; or

• cold symptoms such as stuffy nose, sneezing, sore throat.

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.

See also: Avandaryl side effects (in more detail)

What other drugs will affect Avandaryl?

Tell your doctor about all other medications you use, especially:

• delavirdine (Rescriptor);

• gemfibrozil (Lopid);

• any other diabetes medications you use;

• antibiotics such as rifampin (Rifater, Rifadin, Rifamate) or sulfisoxazole (Pediazole, and others);

• antifungal medications such as fluconazole (Diflucan), ketoconazole (Nizoral), miconazole (Oravig), or voriconazole (Vfend);

• heart or blood pressure medication such as amiodarone (Cordarone, Pacerone), carvedilol (Coreg), losartan (Hyzaar, Cozaar), nicardipine (Cardene), or torsemide (Demadex);

• pain or arthritis medicine such as flurbiprofen (Ansaid), ibuprofen (Advil, Motrin), indomethacin (Indocin), mefenamic acid (Ponstel), or piroxicam (Feldene); or

• seizure medicine such as carbamazepine (Carbatrol, Equetro, Tegretol) or phenobarbital (Solfoton).

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

• isoniazid;

• diuretics (water pills);

• steroids (prednisone and others);

• niacin (Advicor, Niaspan, Niacor, Simcor, Slo-Niacin, and others);

• phenothiazines (Compazine and others);

• thyroid medicine (Synthroid and others);

• birth control pills and other hormones; and

• diet pills or medicines to treat asthma, colds or allergies.

You may be more likely to have hypoglycemia (low blood sugar) if you also take:

• exenatide (Byetta);

• probenecid (Benemid);

• aspirin or other salicylates (including Pepto-Bismol);

• a blood thinner such as warfarin (Coumadin, Jantoven);

• sulfa drugs (Bactrim, Septra, Sulfatrim, SMX-TMP, and others);

• a monoamine oxidase inhibitor (MAOI);

• other oral diabetes medications, especially acarbose (Precose), metformin (Glucophage), miglitol (Glyset), pioglitazone (Actos, Duetact, Actoplus Met), or other drugs that contain rosiglitazone (Avandia, Avandamet).

This list is not complete and other drugs may interact with Avandaryl. 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 can provide more information about Avandaryl.