AVANDIA Film-coated tablet Ref.[10540] Active ingredients: Rosiglitazone

Source: FDA, National Drug Code (US)  Revision Year: 2020 

Product 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:

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 or 4 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.

Dosage Forms and Strengths

Pentagonal film-coated TILTAB tablet contains rosiglitazone as the maleate as follows:

  • 2 mg – pink, debossed with GSK on one side and 2 on the other
  • 4 mg – orange, debossed with GSK on one side and 4 on the other
How Supplied

Each pentagonal film-coated TILTAB tablet contains rosiglitazone as the maleate as follows:

2 mg: pink, debossed with GSK on one side and 2 on the other; bottles of 60: NDC 0173-0861-18.

4 mg: orange, debossed with GSK on one side and 4 on the other; bottles of 30: NDC 0173-0863-13.

Distributed by: GlaxoSmithKline, Research Triangle Park, NC 27709

Drugs

Drug Countries
AVANDIA Lithuania, United States

© All content on this website, including data entry, data processing, decision support tools, "RxReasoner" logo and graphics, is the intellectual property of RxReasoner and is protected by copyright laws. Unauthorized reproduction or distribution of any part of this content without explicit written permission from RxReasoner is strictly prohibited. Any third-party content used on this site is acknowledged and utilized under fair use principles.