Avandamet

DRUG DESCRIPTION

AVANDAMET contains 2 oral antidiabetic drugs: rosiglitazone maleate and metformin hydrochloride.

Rosiglitazone maleate is an oral antidiabetic agent, which acts primarily by increasing insulin sensitivity. Rosiglitazone improves glycemic control while reducing circulating insulin levels. Rosiglitazone maleate is not chemically or functionally related to the sulfonylureas, the biguanides, or the alpha-glucosidase inhibitors. Chemically, rosiglitazone maleate is ()-5-[[4-[2-(methyl-2-pyridinylamino)ethoxy]phenyl]methyl]-2,4-thiazolidinedione, (Z)-2-butenedioate (1:1) with a molecular weight of 473.52 (357.44 free base). The molecule has a single chiral center and is present as a racemate. Due to rapid interconversion, the enantiomers are functionally indistinguishable. The molecular formula is C18H19N3O3SC4H4O4. Rosiglitazone maleate is a white to off-white solid with a melting point range of 122 to 123C. The pKa values of rosiglitazone maleate are 6.8 and 6.1. It is readily soluble in ethanol and a buffered aqueous solution with pH of 2.3; solubility decreases with increasing pH in the physiological range. The structural formula of rosiglitazone maleate is:

Rosiglitazone maleate Structural Formula Illustration

Metformin hydrochloride (N,N-dimethylimidodicarbonimidic diamide hydrochloride) is not chemically or pharmacologically related to any other classes of oral antidiabetic agents. Metformin hydrochloride is a white to off-white crystalline compound with a molecular formula of C4H11N5HCl and a molecular weight of 165.63. Metformin hydrochloride is freely soluble in water and is practically insoluble in acetone, ether, and chloroform. The pKa of metformin is 12.4. The pH of a 1% aqueous solution of metformin hydrochloride is 6.68. The structural formula of metformin hydrochloride is:

AVANDAMET is available for oral administration as film-coated tablets containing rosiglitazone maleate and metformin hydrochloride equivalent to: 2 mg rosiglitazone with 500 mg metformin hydrochloride (2 mg/500 mg), 4 mg rosiglitazone with 500 mg metformin hydrochloride (4 mg/500 mg), 2 mg rosiglitazone with 1,000 mg metformin hydrochloride (2 mg/1,000 mg), and 4 mg rosiglitazone with 1,000 mg metformin hydrochloride (4 mg/1,000 mg). 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.

What are the possible side effects of metformin and rosiglitazone (Avandamet)?

Stop using metformin and rosiglitazone and get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

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...

Read All Potential Side Effects and See Pictures of Avandamet

What are the precautions when taking rosiglitazone maleate and metformin hcl (Avandamet)?

Before taking rosiglitazone/metformin, tell your doctor or pharmacist if you are allergic to it; or to other "glitazones" such as pioglitazone; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Promptly talk with your doctor or pharmacist about the benefits and possible risks of this medication, even if you have been taking it for awhile, especially if you have heart problems. Do not stop taking it unless directed to do so.

This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: kidney disease, history of liver disease, conditions that may cause a low...

Read All Potential Precautions of Avandamet


Avandamet Consumer (continued)

SIDE EFFECTS: See also Warning section.

Nausea, stomach upset, diarrhea and metallic taste may occur at the beginning of treatment as your body adjusts to the medication. If stomach symptoms return later (after you are on the same dose for several days or more), tell your doctor immediately. Returning stomach symptoms may be due to lactic acidosis.

Headache, joint pain, weight gain, loss of appetite, cough and fever may also occur. If any of these effects persist or worsen, notify your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor immediately if this unlikely but serious side effect occurs: bone fracture.

Seek immediate medical attention if any of these rare but very serious side effects occur: vomiting, stomach pain, yellowing eyes/skin, dark urine, vision changes (e.g., color or night vision problems).

This medication usually does not cause low blood sugar (hypoglycemia), but this effect may occur if you do not consume enough calories (from food, juices, fruit, etc.). The symptoms include chills, cold sweat, dizziness, drowsiness, shaking, rapid heart rate, weakness, headache, fainting, tingling of the hands/feet, or hunger. It is a good habit to carry glucose tablets or gel to treat low blood sugar. If you are in a situation where you don't have these reliable forms of glucose, eat a quick source of sugar such as table sugar, honey, or candy, or drink a glass of orange juice or non-diet soda to quickly raise your blood sugar level. Tell your doctor immediately about the reaction. To help prevent hypoglycemia, eat meals on a regular schedule and do not skip meals.

Symptoms of high blood sugar (hyperglycemia) include thirst, increased urination, confusion, drowsiness, flushing, rapid breathing, and fruity breath odor. If these symptoms occur, tell your doctor immediately. Your medication dosage may need to be increased.

A very serious allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction may include: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: Before taking rosiglitazone/metformin, tell your doctor or pharmacist if you are allergic to it; or to other "glitazones" such as pioglitazone; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Promptly talk with your doctor or pharmacist about the benefits and possible risks of this medication, even if you have been taking it for awhile, especially if you have heart problems. Do not stop taking it unless directed to do so.

This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: kidney disease, history of liver disease, conditions that may cause a low oxygen blood level or poor circulation (e.g., severe congestive heart failure, recent heart attack, recent stroke), lack of body fluids (dehydration), serious infection, metabolic acidosis (e.g., diabetic ketoacidosis), type 1 diabetes (insulin-dependent diabetes).

Before using this medication, tell your doctor or pharmacist your medical history, especially of: severe breathing problems (e.g., obstructive lung disease, severe asthma), heart disease (e.g., chronic congestive heart failure, heart attack, angina), blood problems (e.g., anemia, vitamin B-12 deficiency), swelling (edema), fertility problems (e.g., ovulation problems), high cholesterol, upcoming surgery, alcohol use, eye (retina) problems, bone problems (e.g., osteoporosis, osteopenia).

You may experience blurred vision, dizziness, or drowsiness due to extremely low or high blood sugar levels. Do not drive, use machinery, or do any activity that requires alertness or clear vision until you are sure you can perform such activities safely.

Limit alcohol while taking this medication because it can increase the risk of developing low blood sugar.

During times of stress, such as fever, infection, injury or surgery, it may be more difficult to control your blood sugar. Consult your doctor, as a change in your medication or how often you test your blood sugar may be required.

This medication may increase the risk of bone fracture (upper arm, hand, foot) in female patients. To lower the chance of getting injured, use caution when doing activities such as contact sports.

Kidney function declines as you grow older. The metformin in this product is removed by the kidneys. Therefore, elderly people may be at a greater risk for low blood sugar and lactic acidosis while using this drug.

Children may be more sensitive to the effects of this drug, especially low blood sugar.

This medication can cause changes in the menstrual cycle (promote ovulation) in women with certain fertility problems, increasing the risk of becoming pregnant. Consult your doctor or pharmacist about the use of reliable birth control while using this medication.

This medication should be used only when clearly needed during pregnancy. Discuss the risks and benefits with your doctor. Your doctor may substitute insulin for this drug during your pregnancy. Follow all instructions carefully.

This medication passes into breast milk. Consult your doctor before breast-feeding.


Avandamet Patient Information Including Side Effects

Brand Names: Avandamet

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

  • What is metformin and rosiglitazone (Avandamet)?
  • What are the possible side effects of metformin and rosiglitazone (Avandamet)?
  • What is the most important information I should know about metformin and rosiglitazone (Avandamet)?
  • What should I discuss with my healthcare provider before taking metformin and rosiglitazone (Avandamet)?
  • How should I take metformin and rosiglitazone (Avandamet)?
  • What happens if I miss a dose (Avandamet)?
  • What happens if I overdose (Avandamet)?
  • What should I avoid while taking metformin and rosiglitazone (Avandamet)?
  • What other drugs will affect metformin and rosiglitazone (Avandamet)?
  • Where can I get more information?

What is metformin and rosiglitazone (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.

What are the possible side effects of metformin and rosiglitazone (Avandamet)?

Stop using metformin and rosiglitazone and get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

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 report side effects to FDA at 1-800-FDA-1088.

What is the most important information I should know about metformin and rosiglitazone (Avandamet)?

Do not use metformin and rosiglitazone if you have severe heart failure, kidney disease, or if you are in a state of diabetic ketoacidosis (call your doctor for treatment with insulin).

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.

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 metformin and rosiglitazone. Be sure the surgeon knows ahead of time that you are using this medication.

Some people have developed a life-threatening condition called lactic acidosis while taking metformin. Get emergency medical help if you have any of these symptoms of lactic acidosis: 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.

Related Drug Centers
  • Avandamet


Related Drugs Index: