Brand Name

Avandamet {GlaxoSmithKline}

Generic Name

rosiglitazone and metformin, pronounced ROE zi GLI ta zone and met FORmin

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Drug Guide

The information contained in the following drug guide is intended as an educational resource only. This guide is not exhaustive and does not contain all available information about this drug.This guide is not intended as medical advice for individual conditions or treatment.

The information provided in this guide does not replace the need for the advice and services of medical professionals or the need for medical examination. Always talk to your physician or pharmacist before taking any prescription medication or over the counter drugs (including any supplements) or before making any changes to your treatment. Only your doctor, nurse or pharmacist can provide you with safe and effective advice regarding your drug treatment.

The use of the information in this guide is at your sole risk. This information is provided "AS IS" with no warranties to accuracy or timeliness.

**All trademarks and registered trademarks are the property of their respective owners.

What is Avandamet?

Avandamet is a combination of two oral diabetes medications to treat people with type 2diabetes. Avandamet has two medications, rosiglitazone and metformin, that help to control bloodsugar levels. Avandamet should not be used with insulin, and it is not for people with type 1diabetes.

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

Key Facts About Avandamet

Certain oral diabetes medications, like Avandamet, may increase your risk of developingserious heart problems, such as a heart attack or stroke. Avandamet is only available to certainpeople with type 2 diabetes, who cannot control their diabetes with other medications.

Avandamet is available under a special program called Avandamet-Rosiglitazone Medicines AccessProgram. To access Avandamet you must be registered in the program and sign certain documentsstating that you understand the risks and benefits of taking this medication.

Be aware that women may be more likely than men to have bone fractures in their hand, upperarm or foot while taking Avandamet. Tell your doctor if you are concerned about your potentialfor fractures, especially if you are a woman.

While you are taking Avandamet take care to monitor your blood sugar and not let it get toolow. Low blood sugar, or hypoglycemia, can occur if you exercise too long, drink alcohol, skip ameal or are under extreme stress. Be aware of the symptoms of low blood sugar while takingAvandamet, which include headache, hunger, sweating, tremors, trouble concentrating and weakness.You should have either hard candy or glucose tablets with you in case you have hypoglycemia. Yourdoctor can advise you of the correct product to take with you while you are out, and how exactlyto avoid hypoglycemia. Make sure your friends, family and co-workers are aware of your situationand know how to help you in an emergency.

Avandamet is in FDA pregnancy category C. You should not use Avandamet if you are pregnant,planning to become pregnant or nursing. We do not yet know the effects Avandamet has on an unbornbaby. Because we do not know if Avandamet passes into breast milk you should not breast-feedwhile taking Avandamet.

Some women who have taken Avandamet started having menstrual periods again, even after nothaving a period for a long time due to menopause or a medical condition. If you have not beenthrough menopause you may be able to get pregnant if your periods restart. Talk with your doctorif you find the need to revisit the idea of birth control.

Before You Take Avandamet

If you are allergic to rosiglitazone or metformin you should not take Avandamet.

If you have severe heart failure, congestive heart failure, a history of heart attack orstroke or heart disease you should not take Avandamet.

If you are in a state of diabetic ketoacidosis or if you have kidney disease you should not
take Avandamet.

If you need to have an x-ray or CT scan which uses a dye that is injected into your veins youwill need to temporarily stop taking Avandamet. Your doctor will tell you when you can resumetaking this medication.

A rare life-threatening condition called lactic acidosis can occur while you are takingAvandamet. You may be more likely to develop lactic acidosis if you have liver or kidney disease,congestive heart failure, if you are dehydrated, if you drink large amounts of alcohol or if youhave a severe infection. Talk with your doctor about your individual risk for developing lacticacidosis.

Avandamet Drug Interactions

You should inform your doctor if you are taking any of the following:

• allergy medications
• amiloride (Midamor)
• asthma medications
• birth control pills or hormones
• bosentan (Tracleer)
• cimetidine (Tagamet)
• cold medications
• delavirdine (Rescriptor)
• diet pills
• digoxin (Lanoxin)
• diuretics
• fluconazole (Diflucan)
• furosemide (Lasix)
• gemfibrozil (Lopid)
• heart medications like Cartia, Cardizem, Covera, Isoptin and Verelan
• insulin
• isoniazid
• ketoconazole (Nizoral)
• morphine (MS Contin, Kadian, Oramorph)
• niacin (Advicor, Niaspan, Niacor, Simcor, Slo-Niacin)
• nicardipine (Cardene)
• nifedipine (Nifedical, Procardia)
• NSAIDs like celecoxib (Celebrex), flurbiprofen (Ansaid), ibuprofen (Advil, Motrin),indomethacin (Indocin), mefenamic acid (Ponstel), and piroxicam (Feldene)
• phenothiazines (Compazine)
• procainamide (Procan, Pronestyl, Procanbid)
• quinidine (Quin-G)
• quinine (Qualaquin)
• ranitidine (Zantac)
• rifampin (Rifater, Rifadin, Rifamate)
• rifapentine (Priftin)
• seizure medications like carbamazepine (Carbatrol, Equetro, Tegretol), phenytoin (Dilantin),phenobarbital (Solfoton), and primidone (Mysoline)
• steroids, like prednisone
• thyroid medications, like Synthroid
• tolbutamide (Orinase)
• triamterene (Dyrenium)
• trimethoprim (Proloprim, Primsol, Bactrim, Cotrim, Septra)
• vancomycin (Vancocin, Lyphocin)

Other drugs you take that are not listed may interact with Avandamet. You should tell yourdoctor about all of the medications you use. This includes prescription drugs, vitamins,supplements and herbal products, and over the counter medications. You should not begin taking anew medication without telling your doctor first.

Directions for Taking Avandamet

You should take Avandamet exactly as directed by your doctor. It is important that you do nottake Avandamet in larger or smaller amounts, or for longer or shorter than recommended. Followthe directions on your prescription label and follow any dose changes carefully if your doctorinstructs you to change your dose.

Avandamet is usually taken in the morning and in the evening.

Avandamet should be taken with food , especially for your first few weeks of treatment.

While you are taking Avandamet you will need to have your blood sugar checked regularly. Planto see your doctor often to be sure that Avandamet is working for you.

You will need to check your blood sugar often, particularly during a time of illness, if youtravel, exercise more than usual, drink alcohol, skip meals or are under great stress. Thesefactors can affect your glucose levels. Tell your doctor if your levels are not where they shouldbe and you may need a dose adjustment of Avandamet. Your doctor will decide if you need a dosagechange, and how much of a change you may need. Do not attempt to change your dose of Avandametwithout consulting your doctor first.

Be aware that Avandamet is just a part of a complete program of treatment to help your bloodsugar condition. Your doctor may prescribe a treatment plan for you which includes diet,exercise, weight control, foot care, eye care, and dental care, as well as regular testing ofyour blood sugar. You should follow your doctor’s instructions carefully.

Your doctor may prescribe extra vitamin B12 while you are taking Avandamet. Only take whatyour doctor has prescribed and not extra.

Avandamet should be stored at room temperature, and away from both moisture and heat.

If you miss a dose of Avandamet you should attempt to take the missed dose as soon as youremember. However, if it is almost time for your next scheduled dose, or if your next dose isless than 12 hours away you should skip the dose you missed.

Avandamet Side Effects

If you experience any of the following adverse effects you should stop taking Avandamet andseek emergency medical help immediately:

• allergic reaction including breathing difficulties, hives and swelling of your face, lips,throat or tongue
• chest pain with a heavy feeling and pain spreading to your arm or shoulder, sweating
• confusion
• faint feeling or lightheadedness
• fever
• general ill feeling
• jaundice or yellowing of your skin
• lactic acidosis signs, with symptoms like muscle pain or weakness, a numb or cold feeling inyour arms and legs, trouble breathing, stomach pain, nausea with vomiting, a slow or irregularheart rate, dizziness or feeling very weak or tired
• pale skin
• rapid weight gain from swelling
• shortness of breath, even with mild exercise
• skin rash that is red, severe and blistering
• weakness with numbness that is sudden, and problems with your speech or balance

Less serious side effects of Avandamet may include:

• cold symptoms, such as a stuffy nose or sore throat
• headache
• nausea
• tired feeling
• upset stomach
• vomiting

It should be noted that this is not a complete list of possible side effects of Avandamet. Youshould contact your physician for a complete list and medical advice regarding these effects.

Avandamet Description and Dosing

Avandamet is available as film coated tablets in the following dosages:

2 mg/500 mg tablets are pale pink, debossed with gsk on one side and 2/500 on the otherside.

4 mg/500 mg tablets are orange, debossed with gsk on one side and 4/500 on the otherside.

2 mg/1,000 mg tablets are yellow, debossed with gsk on one side and 2/1000 on the otherside.

4 mg/1,000 mg tablets are pink, debossed with gsk on one side and 4/1000 on the otherside.

Avandamet is typically prescribed as a starting dose of 4 mg, to be taken either as a singledaily dose or in 2 divided doses. You should not exceed 8 mg daily of Avandamet. Your doctor willdecide what dose of Avandamet is right for you. Do not attempt to alter or change your dosewithout your physician’s consent.

If you suspect that you have overdosed with Avandamet you should seek emergency helpimmediately.

Ingredients in Avandamet

The main ingredients in Avandamet are rosiglitazone maleate and metformin hydrochloride.Inactive ingredients are Hypromellose 2910, lactose monohydrate, magnesium stearate,microcrystalline cellulose, polyethylene glycol 400, povidone 29-32, sodium starch glycolate,titanium dioxide, and 1 or more of the following: Red and yellow iron oxides.

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The information contained in this drug guide is intended as an educational resource only. This guide is not exhaustive and does not contain all available information about this drug.This guide is not intended as medical advice for individual conditions or treatment.

The information provided in this guide does not replace the need for the advice and services of medical professionals or the need for medical examination. Always talk to your physician or pharmacist before taking any prescription medication or over the counter drugs (including any supplements) or before making any changes to your treatment. Only your doctor, nurse or pharmacist can provide you with safe and effective advice regarding your drug treatment.

The use of the information in this guide is at your sole risk. This information is provided "AS IS" with no warranties to accuracy or timeliness.

**All trademarks and registered trademarks are the property of their respective owners.