Avandamet

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

Metformin and rosiglitazone is a combination of two oral diabetes medicines that help control blood sugar levels.

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

Metformin and rosiglitazone may also be used for other purposes not listed in this medication guide.

Before taking metformin and 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.

You may be more likely to develop lactic acidosis if you have liver disease, kidney disease, congestive heart failure, a serious infection, if you are dehydrated, or if you drink large amounts of alcohol. Talk with your doctor about your individual risk.

Before taking this medication, 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.

Take this medication exactly as it was prescribed for you. Do not take the medication in larger amounts, or take it for longer than recommended by your doctor. Follow the directions on your prescription label

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.

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

• hunger, headache, confusion, irritability;

• drowsiness, weakness, dizziness, tremors;

• sweating, fast heartbeat, seizure (convulsions); or

• fainting, coma (severe hypoglycemia can be fatal).

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.

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

Take the missed dose as soon as you remember (be sure to take the medicine with food). If it is almost time for your next dose, skip the missed dose and take the medicine at the next regularly scheduled time. Do not take extra medicine to make up the missed dose.

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

• 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;

• feeling short of breath, swelling or rapid weight gain;

• fever, chills, body aches, flu symptoms;

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

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

Less serious side effects may include:

• sneezing, runny nose, cough or other signs of a cold;

• back pain, joint or muscle pain; or

• mild diarrhea.

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.

You may be more likely to have hyperglycemia (high blood sugar) if you are taking metformin and rosiglitazone with other drugs that raise blood sugar:

• 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 are taking metformin and rosiglitazone with other drugs that lower blood sugar:

• some nonsteroidal anti-inflammatory drugs (NSAIDs);

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

• sulfa drugs (Bactrim, Cotrim, Septra, and others);

• a monoamine oxidase inhibitor (MAOI);

• beta-blockers (Tenormin and others); or

• probenecid (Benemid).

Some medications may interact with metformin and rosiglitazone:

• gemfibrozil (Gemcor);

• rifampin (Rifater, Rifadin, Rimactane), vancomycin (Vancocin, Lyphocin);

• nifedipine (Adalat, Procardia), procainamide (Procan, Pronestyl, Procanbid), quinidine (Cardioquin, Quinidex, Quinaglute);

• cimetidine (Tagamet) or ranitidine (Zantac);

• digoxin (Lanoxin); or

• morphine (MS Contin, Kadian, Oramorph).

This list is not complete and there may be other drugs that can interact with metformin and rosiglitazone. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.

• Your pharmacist can provide more information about metformin and rosiglitazone.

• 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.
• Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. 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. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

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