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Questions & Answers

Side Effects & Adverse Reactions

There is currently no warning information available for this product. We apologize for any inconvenience.

Legal Issues

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FDA Safety Alerts

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Manufacturer Warnings

There is currently no manufacturer warning information available for this drug.

FDA Labeling Changes

There are currently no FDA labeling changes available for this drug.


1.1 Monotherapy and Combination Therapy

AVANDIA is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.

1.2 Important Limitations of Use
  • Due to its mechanism of action, AVANDIA is active only in the presence of endogenous insulin. Therefore, AVANDIA should not be used in patients with type 1 diabetes mellitus or for the treatment of diabetic ketoacidosis.
  • The coadministration of AVANDIA and insulin is not recommended.
  • The use of AVANDIA with nitrates is not recommended.


There is currently no drug history available for this drug.

Other Information

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:
image of chemical structure

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.

Avandia Manufacturers

  • Physicians Total Care, Inc.
    Avandia (Rosiglitazone Maleate) Tablet, Film Coated [Physicians Total Care, Inc.]
  • Cardinal Health
    Avandia (Rosiglitazone Maleate) Tablet, Film Coated [Cardinal Health]
  • Glaxosmithkline Llc
    Avandia (Rosiglitazone Maleate) Tablet, Film Coated Avandia 2mg (Rosiglitazone Maleate) Tablet, Film Coated Avandia 4mg (Rosiglitazone Maleate) Tablet, Film Coated Avandia 8mg (Rosiglitazone Maleate) Tablet, Film Coated [Glaxosmithkline Llc]

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