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Avandamet

Generic Name: metformin and rosiglitazone (Oral route)

met-FOR-min hye-droe-KLOR-ide, roe-zi-GLI-ta-zone MAL-ee-ate

Oral routeTablet

Congestive Heart Failure and Myocardial Ischemia
- Thiazolidinediones, including rosiglitazone, cause or exacerbate congestive heart failure in some patients. After initiation of rosiglitazone maleate/metformin hydrochloride, and after dose increases, observe patients carefully for signs and symptoms of heart failure (including excessive, rapid weight gain, dyspnea, and/or edema). If these signs and symptoms develop, the heart failure should be managed according to current standards of care. Furthermore, discontinuation or dose reduction of rosiglitazone maleate/metformin hydrochloride must be considered.
- Rosiglitazone maleate/metformin hydrochloride is not recommended in patients with symptomatic heart failure. Initiation of rosiglitazone maleate/metformin hydrochloride in patients with established NYHA Class III or IV heart failure is contraindicated.
- A meta-analysis of 42 studies (mean duration 6 months; 14,237 total patients), most of which compared rosiglitazone to placebo, showed rosiglitazone to be associated with an increased risk of myocardial ischemic events. Three other studies (mean duration 41 months; 14,067 total patients), comparing rosiglitazone to some other approved oral antidiabetic agents or placebo, have not confirmed or excluded this risk. Available data on the risk of myocardial ischemia are inconclusive.
Lactic Acidosis
- Lactic acidosis can occur due to metformin accumulation. The risk increases with conditions such as sepsis, dehydration, excess alcohol intake, hepatic insufficiency, renal impairment, and acute congestive heart failure.
- Symptoms include malaise, myalgias, respiratory distress, increasing somnolence, and nonspecific abdominal distress. Laboratory abnormalities include low pH, increased anion gap and elevated blood lactate.
- If acidosis is suspected, discontinue rosiglitazone maleate/metformin hydrochloride and hospitalize the patient immediately .

May cause or worsen congestive heart failure, is not recommended in patients with symptomatic heart failure, and is contraindicated in patients with established NYHA Class III or IV heart failure. Monitor patients for signs and symptoms of heart failure after initiation or dose increases and if heart failure occurs, consider dose reducing or discontinuing rosiglitazone maleate and manage according to current standards of care. Overall, the available data on the risk of myocardial ischemia are inconclusive.

Lactic acidosis can occur due to metformin accumulation during treatment with rosiglitazone maleate/metformin hydrochloride. The risk of lactic acidosis increases with conditions such as sepsis, dehydration, excess alcohol intake, hepatic insufficiency, renal impairment, and acute congestive heart failure. Symptoms include malaise, myalgias, respiratory distress, increasing somnolence, and nonspecific abdominal distress. Laboratory abnormalities include low pH, increased anion gap, and elevated blood lactate. Discontinue therapy immediately and institute supportive measures promptly for suspected lactic acidosis .

Commonly used brand name(s):

In the U.S.

Avandamet

Available Dosage Forms:

Tablet

Therapeutic Class: Hypoglycemic

Chemical Class: Metformin

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Uses For Avandamet

Metformin and rosiglitazone combination is used to treat high blood sugar levels that are caused by a type of diabetes mellitus or sugar diabetes called type 2 diabetes. In type 2 diabetes, your body does not work properly to store excess sugar and the sugar remains in your bloodstream. Chronic high blood sugar can lead to serious health problems in the future. Proper diet is the first step in managing type 2 diabetes, but often medicines are needed to help your body. Rosiglitazone helps your body use the insulin better and it reduces the amount of insulin in your body. Metformin reduces the absorption of sugar, reduces the release of stored sugar from the liver, and helps your body's cells use sugar better.

This medicine is available only with your doctor's prescription.

Before Using Avandamet

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Studies on this medicine have been done only in adult patients, and there is no specific information comparing use of metformin and rosiglitazone in children with use in other age groups.

Geriatric

Some older adults may be more sensitive than younger adults to the effects of these medicines. Older adults are more likely to have age-related problems such as kidney problems. Metformin and rosiglitazone should be used carefully as age increases and older adults may need a lower dose of this medicine.

Pregnancy

	Pregnancy Category	Explanation
All Trimesters	C	Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

Acetrizoic Acid
Diatrizoate
Ethiodized Oil
Iobenzamic Acid
Iobitridol
Iocarmic Acid
Iocetamic Acid
Iodamide
Iodipamide
Iodixanol
Iodohippuric Acid
Iodopyracet
Iodoxamic Acid
Ioglicic Acid
Ioglycamic Acid
Iohexol
Iomeprol
Iopamidol
Iopanoic Acid
Iopentol
Iophendylate
Iopromide
Iopronic Acid
Ioseric Acid
Iosimide
Iotasul
Iothalamate
Iotrolan
Iotroxic Acid
Ioversol
Ioxaglate
Ioxitalamic Acid
Ipodate
Metrizamide
Metrizoic Acid
Tyropanoate Sodium

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

Alatrofloxacin
Balofloxacin
Cimetidine
Ciprofloxacin
Clinafloxacin
Dofetilide
Enoxacin
Fleroxacin
Flumequine
Gatifloxacin
Gemifloxacin
Grepafloxacin
Levofloxacin
Lomefloxacin
Moxifloxacin
Norfloxacin
Ofloxacin
Pefloxacin
Prulifloxacin
Rufloxacin
Sparfloxacin
Temafloxacin
Tosufloxacin
Trovafloxacin Mesylate

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

Acebutolol
Alprenolol
Atenolol
Betaxolol
Bevantolol
Bisoprolol
Bitter Melon
Bucindolol
Carteolol
Carvedilol
Celiprolol
Cephalexin
Clorgyline
Dilevalol
Enalaprilat
Enalapril Maleate
Esmolol
Fenugreek
Gemfibrozil
Glucomannan
Guar Gum
Iproniazid
Isocarboxazid
Labetalol
Levobunolol
Mepindolol
Metipranolol
Metoprolol
Moclobemide
Nadolol
Nebivolol
Nialamide
Oxprenolol
Pargyline
Penbutolol
Phenelzine
Pindolol
Procarbazine
Propranolol
Psyllium
Rifampin
Selegiline
Sotalol
St John's Wort
Talinolol
Tertatolol
Timolol
Toloxatone
Topiramate
Tranylcypromine
Trimethoprim

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Proper Use of Avandamet

Follow carefully the special meal plan your doctor gave you. This is the most important part of controlling your condition, and is necessary if the medicine is to work properly. Also, exercise regularly and test for sugar in your blood or urine as directed.

Metformin and rosiglitazone combination should be taken with meals to help reduce the stomach and intestinal side effects that may occur while you are taking this medicine.

You may notice improvement in your blood glucose control in 1 to 2 weeks, but the full effect of blood glucose control may take up to 2 to 3 months. Ask your healthcare professional if you have any questions about this.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

For oral dosage form (tablets):
- For type 2 diabetes:
  - For patients on metformin therapy:
    - Adults—4 milligrams (mg) rosiglitazone per day plus the dose of metformin already being taken, divided into two doses. Your doctor may gradually increase your dose until your blood sugar is controlled.
    - Children—Use and dose must be determined by your doctor.
  - For patients on rosiglitazone therapy:
    - Adults—1000 milligrams (mg) of metformin per day plus the dose of rosiglitazone already being taken, divided into two doses. Your doctor may gradually increase your dose until your blood sugar is controlled.
    - Children—Use and dose must be determined by your doctor.
  - For patients not on metformin or rosiglitazone therapy:
    - Adults—2 milligrams (mg) rosiglitazone and 500 mg metformin combination one or two times a day as directed by your doctor. Your doctor may gradually increase your dose as needed to control your blood sugar up to a maximum of 8 mg rosiglitazone and 2000 mg metformin per day, divided into two doses .
    - Children—Use and dose must be determined by your doctor .
  - For patients previously treated with rosiglitazone and metformin:
    - Adults—The dose is the same as the dose you are already taking. Your doctor may gradually increase your dose until your blood sugar is controlled.
    - Children—Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Precautions While Using Avandamet

It is very important that your doctor see you at regular visits to check your blood sugar control, and to check your kidneys and liver.

Seek medical attention immediately if you experience chest pain or discomfort; nausea; pain or discomfort in arms, jaw, back or neck; shortness of breath; sweating; or vomiting. These may be symptoms of a heart attack.

This medicine may cause women to ovulate, which could increase the chances of pregnancy. If you are a woman of childbearing potential, you should discuss birth control options with your doctor .

Make sure your doctor knows if you are using insulin or nitrate medicines (e.g., Isordil®, Imdur®, or Sorbitrate®) before you start taking this medicine. Using any of them together with this medicine may increase your risk of having serious side effects .

It is very important to follow carefully any instructions from your health care team about:

Alcohol—Drinking alcohol may cause severe low blood sugar. Discuss this with your health care team.
Other medicines—Do not take other medicines unless they have been discussed with your doctor.
Counseling—Other family members need to learn how to prevent side effects or help with side effects if they occur. Also, patients with diabetes may need special counseling about diabetes medicine dosing changes that might occur because of lifestyle changes, such as changes in exercise and diet. Furthermore, counseling on contraception and pregnancy may be needed because of the problems that can occur in patients with diabetes during pregnancy.
Travel—Keep your recent prescription and your medical history with you. Be prepared for an emergency as you would normally. Make allowances for changing time zones and keep your meal times as close as possible to your usual meal times.

In case of emergency—There may be a time when you need emergency help for a problem caused by your diabetes. You need to be prepared for these emergencies. It is a good idea to wear a medical identification (ID) bracelet or neck chain at all times. Also, carry an ID card in your wallet or purse that says that you have diabetes and a list of all of your medicines.

Under certain conditions, too much metformin and rosiglitazone can cause lactic acidosis. Symptoms of lactic acidosis are severe and quick to appear and usually occur when other health problems not related to the medicine are present and are very severe, such as a heart attack or kidney failure. Symptoms of lactic acidosis include abdominal or stomach discomfort; decreased appetite; diarrhea; fast, shallow breathing; general feeling of discomfort; muscle pain or cramping; and unusual sleepiness, tiredness, or weakness.

If symptoms of lactic acidosis occur, you should check your blood sugar and get immediate emergency medical help.

Symptoms of hypoglycemia (low blood sugar) include anxiety; behavior change similar to being drunk; blurred vision; cold sweats; confusion; cool, pale skin; difficulty in thinking; drowsiness; excessive hunger; fast heartbeat; headache (continuing); nausea; nervousness; nightmares; restless sleep; shakiness; slurred speech; or unusual tiredness or weakness.

Metformin and rosiglitazone combination can cause low blood sugar. However, it also can occur if you delay or miss a meal or snack, drink alcohol, exercise more than usual, cannot eat because of nausea or vomiting, take certain medicines, or take metformin and rosiglitazone with another type of diabetes medicine. Symptoms of low blood sugar must be treated before they lead to unconsciousness (passing out). Different people feel different symptoms of low blood sugar. It is important that you learn which symptoms of low blood sugar you usually have so that you can treat it quickly.

If symptoms of low blood sugar occur, eat glucose tablets or gel, corn syrup, honey, or sugar cubes; or drink fruit juice, non-diet soft drink, or sugar dissolved in water. Also, check your blood for low blood sugar. Glucagon is used in emergency situations when severe symptoms such as seizures (convulsions) or unconsciousness occur. Have a glucagon kit available, along with a syringe or needle, and know how to use it. Members of your household also should know how to use it.

Symptoms of hyperglycemia (high blood sugar) include blurred vision; drowsiness; dry mouth; flushed, dry skin; fruit-like breath odor; increased urination (frequency and amount); ketones in urine; loss of appetite; sleepiness; stomachache, nausea, or vomiting; tiredness; troubled breathing (rapid and deep); unconsciousness; or unusual thirst.

High blood sugar may occur if you do not exercise as much as usual, have a fever or infection, do not take enough or skip a dose of your diabetes medicine, or overeat or do not follow your meal plan.

If symptoms of high blood sugar occur, check your blood sugar level and then call your health care professional for instructions.

Tell your healthcare provider right away if you have any of these symptoms: chest pain or discomfort, extreme tiredness or weakness, irregular breathing, irregular heartbeat, shortness of breath, swelling of your face, fingers, feet or lower legs, weight gain and wheezing.

It is important to tell your healthcare professional that you are taking this medicine if you are going to have any medical procedures or surgical procedures.

Check with your doctor immediately if blurred vision, difficulty in reading, or any other change in vision occurs during or after treatment. Your doctor will want you to have your eyes checked by an ophthalmologist (eye doctor) .

Avandamet Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common

Pale skin
troubled breathing with exertion
unusual bleeding or bruising
unusual tiredness or weakness

Less common

Anxiety
blurred vision
chest pain or discomfort
chills
cold sweats
coma
confusion
cool pale skin
depression
dilated neck veins
dizziness
extreme fatigue
fast heartbeat
headache
increased hunger
irregular breathing
irregular heartbeat
nausea
nervousness
nightmares
seizures
shakiness
shortness of breath
slurred speech
swelling of face, fingers, feet, or lower legs
weight gain
wheezing

Rare

Abdominal discomfort
decreased appetite
diarrhea
fast, shallow breathing
general feeling of discomfort
muscle pain or cramping
sleepiness

Incidence not known

Change in vision
dark urine
decreased urine output
hives or welts
itching
large, hive-like swelling on face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
nausea
pain or discomfort in arms, jaw, back, or neck
redness of skin
skin rash
stomach pain
sweating
vomiting

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

Body aches or pain
cough, fever, sneezing, or sore throat
difficulty in breathing
ear congestion
fever
loss of voice
nasal congestion
pain or tenderness around eyes and cheekbones
stuffy or runny nose
tightness of chest

Less common

Back pain
cold or flu-like symptoms
difficulty in moving
pain in joints

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

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