Avandamet

Generic Name: metformin and rosiglitazone (met FOR min and ROE zi GLI ta zone)
Brand Names: Avandamet

What is Avandamet?

Avandamet contains a combination of metformin and rosiglitazone, two oral diabetes medicines that help control blood sugar levels. Avandamet works by decreasing the amount of sugar that the liver produces and the intestines absorb. It also helps to make your body more sensitive to the insulin that you naturally produce.

Avandamet is for people with type 2 diabetes who do not use daily insulin injections. This medication is not for treating type 1 diabetes.

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

Avandamet 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.

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

Important information about Avandamet

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

You should not use Avandamet if you are allergic to metformin (Glucophage) or rosiglitazone (Avandia), or if you advanced heart failure, kidney disease, or if you are in a state of diabetic ketoacidosis (call your doctor for treatment with insulin).

Slideshow: Top 10 Ways to Save on Your Medication Costs

If you need to have any type of x-ray or CT scan using a dye that is injected into your veins, you will need to temporarily stop taking Avandamet.

Before taking Avandamet, 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.

Some people develop lactic acidosis while taking metformin. Early symptoms may get worse over time and this condition can be fatal. Get emergency medical help if you have even mild symptoms such as: muscle pain or weakness, numb or cold feeling in your arms and legs, trouble breathing, stomach pain, nausea with vomiting, slow or uneven heart rate, dizziness, or feeling very weak or tired.

Before taking Avandamet

Some people develop a life-threatening condition called lactic acidosis while taking Avandamet. You may be more likely to develop lactic acidosis if you have liver or kidney disease, congestive heart failure, a severe infection, if you are dehydrated, or if you drink large amounts of alcohol. Talk with your doctor about your individual risk. You should not use Avandamet if you are allergic to metformin (Glucophage) or rosiglitazone (Avandia), or if you have:

• advanced heart failure; or

• kidney disease;

• if you are in a state of diabetic ketoacidosis (call your doctor for treatment with insulin).

If you need to have any type of x-ray or CT scan using a dye that is injected into your veins, you will need to temporarily stop taking Avandamet.

To make sure you can safely take Avandamet, 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.

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.

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

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

Some women using Avandamet 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.

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

It is not known whether metformin and rosiglitazone passes into breast milk or if it could harm a nursing baby. Do not take Avandamet without first talking to your doctor if you are breast-feeding a baby.

How should I take Avandamet?

Take Avandamet 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 Avandamet with meals, especially during the first few weeks of therapy.

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.

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 Avandamet 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.

Your doctor may have you take extra vitamin B12 while you are taking Avandamet. Take only the amount of vitamin B12 that your doctor has prescribed.

Store Avandamet at room temperature away from moisture and heat.

See also: Avandamet dosage (in more detail)

What happens if I miss a dose?

Take the missed dose as soon as you remember (be sure to take the medicine with food). 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.

What should I avoid while taking Avandamet?

Avoid drinking alcohol. It can lower your blood sugar and may increase your risk of lactic acidosis while taking this medicine.

Avandamet side effects

Avandamet may cause lactic acidosis (a build-up of lactic acid in the body, which can be fatal). Lactic acidosis can start slowly and get worse over time. Get emergency medical help if you have even mild symptoms of lactic acidosis, such as: muscle pain or weakness, numb or cold feeling in your arms and legs, trouble breathing, stomach pain, nausea with vomiting, slow or irregular heart rate, dizziness, or feeling very weak or tired.

Get emergency medical help if you have any of these signs of an allergic reaction to Avandamet: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Call your doctor at once if you have any other serious side effects, such as:

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

• sudden numbness, weakness, headache, confusion, or problems with vision, speech, or balance;

• swelling or rapid weight gain, feeling short of breath, (even with mild exertion);

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

• severe blistering, peeling, and red skin rash; or

• jaundice (yellowing of the skin or eyes).

Less serious Avandamet side effects may include:

• headache, tired feeling;

• nausea, vomiting, upset stomach, diarrhea; 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: Avandamet side effects (in more detail)

What other drugs will affect Avandamet?

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

• bosentan (Tracleer);

• delavirdine (Rescriptor);

• digoxin (Lanoxin);

• gemfibrozil (Lopid);

• morphine (MS Contin, Kadian, Oramorph);

• tolbutamide (Orinase);

• trimethoprim (Proloprim, Primsol, Bactrim, Cotrim, Septra);

• vancomycin (Vancocin, Lyphocin);

• amiloride (Midamor), furosemide (Lasix), or triamterene (Dyrenium);

• cimetidine (Tagamet) or ranitidine (Zantac);

• fluconazole (Diflucan) or ketoconazole (Nizoral);

• nicardipine (Cardene) or nifedipine (Nifedical, Procardia);

• procainamide (Procan, Pronestyl, Procanbid), quinidine (Quin-G), or quinine (Qualaquin);

• rifampin (Rifater, Rifadin, Rifamate) or rifapentine (Priftin);

• a non-steroidal anti-inflammatory drug (NSAID) such as flurbiprofen (Ansaid), ibuprofen (Advil, Motrin), indomethacin (Indocin), mefenamic acid (Ponstel), or piroxicam (Feldene); or

• seizure medication such as carbamazepine (Carbatrol, Equetro, Tegretal), phenytoin (Dilantin), phenobarbital (Solfoton), primidone (Mysoline), and others.

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

• isoniazid;

• diuretics (water pills);

• steroids (prednisone and others);

• heart or blood pressure medication (Cartia, Cardizem, Covera, Isoptin, Verelan, 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;

• seizure medicines (Dilantin and others); and

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

These lists are not complete and there are many other medicines that can increase or decrease the effects of Avandamet on lowering your blood sugar. 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 Avandamet.

• Disclaimer: Every effort has been made to ensure that the information provided is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects.

Copyright 1996-2011 Cerner Multum, Inc. Version: 10.01. Revision Date: 8/10/2011 1:48:18 PM.