Avandia

DRUG DESCRIPTION

AVANDIA (rosiglitazone maleate) is an oral antidiabetic agent which acts primarily by increasing insulin sensitivity. AVANDIA 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 structural formula of rosiglitazone maleate is:

AVANDIA
  (rosiglitazone maleate) Structural Formula Illustration

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.

Each pentagonal film-coated TILTAB tablet contains rosiglitazone maleate equivalent to rosiglitazone, 2 mg, 4 mg, or 8 mg, for oral administration. Inactive ingredients are: Hypromellose 2910, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol 3000, sodium starch glycolate, titanium dioxide, triacetin, and 1 or more of the following: Synthetic red and yellow iron oxides and talc.

What are the possible side effects of rosiglitazone (Avandia)?

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.

Stop using rosiglitazone and call your doctor at once if you have any of these serious side effects:

  • feeling short of breath, even with mild exertion;
  • swelling or rapid weight gain;
  • chest pain or heavy feeling, pain spreading to the arm or shoulder, sweating, general ill feeling;
  • nausea, stomach pain, low fever, loss of appetite,...

Read All Potential Side Effects and See Pictures of Avandia

What are the precautions when taking rosiglitazone maleate (Avandia)?

Before taking rosiglitazone, 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: type 1 diabetes (insulin-dependent diabetes), very high blood glucose (diabetic...

Read All Potential Precautions of Avandia


Avandia Consumer (continued)

SIDE EFFECTS: See also Warning section.

Headache or cough may 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 any of these unlikely but serious side effects occur: fast/pounding heartbeat, changes in menstrual cycles, bone fracture.

Tell your doctor immediately if any of these highly unlikely but very serious side effects occur: dark urine, yellowing of eyes/skin, persistent nausea/vomiting, stomach/abdominal pain, 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 or 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, or fruity breath odor. If these symptoms occur, tell your doctor immediately. Your medication dosage may need to be increased.

A serious allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction include: rash, itching/swelling (especially of the face/tongue/throat), 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, 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: type 1 diabetes (insulin-dependent diabetes), very high blood glucose (diabetic ketoacidosis), newly diagnosed or worsening heart failure (acute congestive heart failure), history of liver disease, active liver disease.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: heart disease (e.g., chronic congestive heart failure, heart attack, angina), fluid in your lungs, swelling (edema), anemia, high blood cholesterol, 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 your blood sugar getting too low (hypoglycemia).

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 additional medication 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.

This medication can cause changes in the menstrual cycle (ovulation) in women with certain fertility problems. Consult your doctor or pharmacist about the use of reliable birth control while taking 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.

It is unknown if this medication passes into breast milk. Consult your doctor before breast-feeding.


Avandia Patient Information Including Side Effects

Brand Names: Avandia

Generic Name: rosiglitazone (oral) (Pronunciation: row zi GLI ta zone)

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

What is rosiglitazone (Avandia)?

Rosiglitazone is an oral diabetes medicine that helps control blood sugar levels.

Rosiglitazone is for people with type 2 (non-insulin-dependent) diabetes. Rosiglitazone is sometimes used in combination with insulin or other medications, but it is not for treating type 1 diabetes.

Rosiglitazone is not recommended for use with insulin.

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

What are the possible side effects of rosiglitazone (Avandia)?

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.

Stop using rosiglitazone and call your doctor at once if you have any of these serious side effects:

  • feeling short of breath, even with mild exertion;
  • swelling or rapid weight gain;
  • chest pain or heavy feeling, pain spreading to the arm or shoulder, sweating, general ill feeling;
  • nausea, stomach pain, low fever, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
  • blurred vision;
  • increased thirst or hunger, urinating more than usual; or
  • pale skin, easy bruising or bleeding, weakness.

Less serious side effects may include:

  • sneezing, runny nose, cough or other signs of a cold;
  • headache;
  • gradual weight gain;
  • mild diarrhea; or
  • back pain.

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.

What is the most important information I should know about rosiglitazone (Avandia)?

Do not use rosiglitazone if you have type 1 diabetes, or if you are in a state of diabetic ketoacidosis (call your doctor for treatment with insulin).

Before taking 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.

Know the signs of low blood sugar (hypoglycemia) and how to recognize them, including hunger, headache, confusion, irritability, drowsiness, weakness, dizziness, tremors, sweating, fast heartbeat, seizure (convulsions), fainting, or coma (severe hypoglycemia can be fatal). Always keep a source of sugar available in case you have symptoms of low blood sugar.

Some women using rosiglitazone 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 rosiglitazone. Talk with your doctor if you are concerned about this possibility.

Taking 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 with rosiglitazone.

Related Drug Centers
  • Avandia


Related Drugs Index: