Avandia (Rosiglitazone Maleate) Drug Information: Description, User Reviews, Drug Side Effects, Interactions

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May 25, 2012

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Diabetes mellitus is a condition in which the body does not produce enough insulin or the insulin that is produced is ineffective. Insulin is produced and secreted by the pancreas and is needed for the proper storage and utilization of nutrients (glucose, proteins, and fat) by the cells of the body. Insulin allows nutrients to enter the cells of the body. For example, insulin allows cells to remove glucose from the blood, and the glucose is used to generate the energy that is necessary to fuel the activities of the cells. When insulin is absent or ineffective and the cells receive inadequate amounts of glucose, the body releases more glucose into the blood in an attempt to overcome the block to glucose entering the cells. The additional glucose cannot penetrate the cells, of course, and the glucose levels in the blood rise. High levels of blood and urine glucose is what causes the symptoms and signs of diabetes. For more, please re...

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AVANDIA
(rosiglitazone maleate) Tablets

WARNING: CONGESTIVE HEART FAILURE AND MYOCARDIAL INFARCTION

Thiazolidinediones, including rosiglitazone, cause or exacerbate congestive heart failure in some patients [see WARNINGS AND PRECAUTIONS]. After initiation of AVANDIA, 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 AVANDIA must be considered.
AVANDIA is not recommended in patients with symptomatic heart failure. Initiation of AVANDIA in patients with established NYHA Class III or IV heart failure is contraindicated. [See CONTRAINDICATIONS and WARNINGS AND PRECAUTIONS.]
A meta-analysis of 52 clinical trials (mean duration 6 months; 16,995 total patients), most of which compared AVANDIA to placebo, showed AVANDIA to be associated with a statistically significant increased risk of myocardial infarction. Three other trials (mean duration 46 months; 14,067 total patients), comparing AVANDIA to some other approved oral antidiabetic agents or placebo, showed a statistically non-significant increased risk of myocardial infarction, and a statistically non-significant decreased risk of death. There have been no clinical trials directly comparing cardiovascular risk of AVANDIA and ACTOS® (pioglitazone, another thiazolidinedione), but in a separate trial, pioglitazone (when compared to placebo) did not show an increased risk of myocardial infarction or death. [See WARNINGS AND PRECAUTIONS.]
Because of the potential increased risk of myocardial infarction, AVANDIA is available only through a restricted distribution program called the AVANDIA-Rosiglitazone Medicines Access Program. Both prescribers and patients need to enroll in the program. To enroll, call 1-800-AVANDIA or visit www.AVANDIA.com. [See WARNINGS AND PRECAUTIONS.]

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 C₁₈H₁₉N₃O₃S•C₄H₄O₄. Rosiglitazone maleate is a white to off-white solid with a melting point range of 122° to 123°C. 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,...

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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...

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Last reviewed on RxList: 11/30/2011
This monograph has been modified to include the generic and brand name in many instances.