Comparison of adverse drug reaction profiles of two tacrolimus formulations in rats.
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| Abstract |
Tacrobell(®) (TB) is a generic tacrolimus which showed the comparable efficacy to original product, Prograf(®) (PG) in renal transplantation, but toxicity between two drugs is unclear. The aim of this study was to compare the toxicity between these two formulations. TB and PG (0.5, 1 and 2 mg/kg/day) was administered to rats for 4 weeks. The rat survival rate, kidney, liver and pancreas injury was investigated. The survival rate was similar between TB- and PG-treated rats. TB and PG induced renal dysfunction in a dose-dependent manner. Compared to PG treatment in equal dose, TB treatment reduced urinary creatinine clearance in a less degree and renal interstitial fibrosis was comparable between two regimens. The r-glutamyl transpeptidase was aggravated by tacrolimus treatment, and this was not different between TB and PG treatment. In the intraperitoneal glucose tolerance test, a significant diabetogenic effect was observed in all tacrolimus treated-rats. The glucose tolerance of TB-treated rats was similar to those of PG-treated rats in each dose. The decrement in pancreatic β-cell mass by tacrolimus showed the dose-dependent response and it was comparable between TB and PG treatment. In conclusion, TB is similar to PG in terms of nephrotoxicity, hepatoxicity and diabetogenic effect.
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| Authors | HyeonSeok Hwang, Jung Yeon Ghee, Ji Hyun Song, ShangGuo Piao, Chul Woo Yang |
| Journal | Immunopharmacology and immunotoxicology (Immunopharmacol Immunotoxicol) Vol. 34 Issue 3 Pg. 434-42 (Jun 2012) ISSN: 1532-2513 [Electronic] England |
| PMID | 21970589 (Publication Type: Comparative Study, Journal Article, Research Support, Non-U.S. Gov't) |
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