Omniflox was approved to treat lower respiratory tract infections, genital and urinary infections like prostatitis, and skin infections in the United States by the Food and Drug Administration in January 1992. Severe adverse reactions, including allergic reactions and hemolytic anemia,[3] developed in over 100 patients during the first four months of its use, leading to three patient deaths. Abbott withdrew the drug from sale in June 1992.
Pharmacokinetics
Following oral administration the compound is well absorbed from the gastrointestinal tract. The oral bioavailability is greater than 90%. Temafloxacin has a good tissue penetration in various biological fluids and tissues, particularly in the respiratory tissues, nasal secretions, tonsils, prostate and bone.[4] In these districts the concentrations achieved are equal to or higher than those in serum.[5] The fluoroquinolone has a 7-8 hour half-life.[6]
The penetration into the central nervous system (CNS)is less pronounced.[6] The excretion from the body is primarily due to glomerular filtration in the kidneys.[7][8][9]
^Sorgel F, Naber KG, Kinzig M, Mahr G, Muth P (December 1991). "Comparative pharmacokinetics of ciprofloxacin and temafloxacin in humans: a review". Am. J. Med. 91 (6A): 51S–66S. doi:10.1016/0002-9343(91)90312-L. PMID1662896.
^Wise R (December 1991). "Comparative penetration of selected fluoroquinolones into respiratory tract fluids and tissues". Am. J. Med. 91 (6A): 67S–70S. doi:10.1016/0002-9343(91)90313-M. PMID1662897.
^Symonds WT, Nix DE (September 1992). "Lomefloxacin and temafloxacin: two new fluoroquinolone antimicrobials". Clin Pharm. 11 (9): 753–66. PMID1325892.