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Rare cases of severe idiosyncratic hepatocellular injury have been reported during marketed use (see ADVERSE REACTIONS). The hepatic injury is usually reversible, but very rare cases of hepatic failure, leading to death or liver transplant, have been reported. Injury has occurred after both short- and long- term troglitazone treatment.
During all clinical studies in North America, a total of 48 of 2510 (1.9%) Rezulin (troglitazone removed from the us market 3/21/00) -treated patients and 3 of 475 (0.6%) placebo-treated patients had ALT levels greater than 3 times the upper limit of normal. Twenty of the Rezulin (troglitazone removed from the us market 3/21/00) -treated and one of the placebo-treated patients were withdrawn from treatment. Two of the 20 Rezulin (troglitazone removed from the us market 3/21/00) -treated patients developed reversible jaundice; one of these patients had a liver biopsy which was consistent with an idiosyncratic drug reaction. An additional Rezulin (troglitazone removed from the us market 3/21/00) -treated patient had a liver biospy which was also consistent with an idiosyncratic drug reaction. (See ADVERSE REACTIONS, Laboratory Abnormalities)
It is recommended that serum transaminase levels be checked at the start of therapy, monthly for the first six months of therapy, every two months for the remainder of the first year of troglitazone therapy, and periodically thereafter. Liver function tests also should be obtained for patients at the first symptoms suggestive of hepatic dysfunction, e.g., nausea, vomiting, abdominal pain, fatigue. anorexia, dark urine. Rezulin (troglitazone removed from the us market 3/21/00) therapy should not be initiated if the patient exhibits clinical or laboratory evidence of active liver disease (e.g., ALT> 3 times the upper limit of normal) and should be discontinued if the patient has jaundice or laboratory measurements suggest liver injury (e.g., ALT> 3 times the upper limit of normal).
Rezulin (troglitazone) is an oral antihyperglycemic agent which acts primarily by decreasing insulin resistance. Rezulin (troglitazone removed from the us market 3/21/00) is used in the management of type II diabetes (noninsulin-dependent diabetes mellitus (NIDDM) also known as adult-onset diabetes). It improves sensitivity to insulin in muscle and adipose tissue and inhibits hepatic gluconeogenesis. Troglitazone (+-5[[4-[(3,4-dihydro-6- hydroxy-2,5.7,8-tetramethyl-2H-1-benzopyran-2-yl) methoxy]phenyl]methyl]-2,4- thiazolidinedione) is not chemically or functionally related to either the sulfonylureas, the biguanides, or the (g-glucosidase inhibitors. The molecule contains 2 chiral centers, with each of the 4 stereoisomers having similar pharmacologic effects.
Troglitazone is a white to yellowish crystalline compound: it may have a faint. characteristic odor Troglitazone has a molecular formula of C24H2NO5S and a molecular weight of 441.55 daltons. It is soluble in N, N-dimethylformamide or acetone; sparingly soluble in ethyl acetate; slightly soluble in acetonitrile, anhydrous ethanol, or ether; and practically insoluble in water.
Rezulin (troglitazone removed from the us market 3/21/00) is available as 200, 300 and 400 mg tablets for oral administration formulated with the following excipients: croscarmellose sodium, hydroxypropyl methylcellulose, magnesium stearate, microcrystalline cellulose, polyethylene glycol 400, polysorbate 80, povidone, purified water, silicon dioxide, titanium dioxide, and synthetic iron oxides.
Last reviewed on RxList: 12/8/2004
This monograph has been modified to include the generic and brand name in many instances.
Additional Rezulin Information
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