Temafloxacin Explained

Temafloxacin (marketed by Abbott Laboratories as Omniflox) is a fluoroquinolone antibiotic drug which was withdrawn from sale in the United States shortly after its approval in 1992 because of serious adverse effects resulting in three deaths.^{[1] [2]} It is not marketed in Europe.

History

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]}

Clinical uses

The compound was indicated for treating lower respiratory tract infections (community-acquired pneumonia, exacerbations of chronic bronchitis), genital and urinary tract infections (prostatitis, gonococcal and non-gonococcal urethritis, cervicitis), skin and soft tissue infections.^{[6] [10] [11] [12]}

See also

• Quinolones

External links

• FDA press release June 5, 1992.

Notes and References

1. Web site: Recalling the Omniflox (Temafloxacin) Tablets . Food and Drug Administration . 1992-06-05 . 2014-10-15.
2. Web site: ABBOTT WITHDRAWS TEMAFLOXACIN - Pharmaceutical industry news . The Pharmaletter . 1992-06-15 . 2014-10-16.
3. History of quinolones and their side effects.. Chemotherapy. 47 Suppl 3. 3–8; discussion 44–8. 10.1159/000057838. 11549783. Rubinstein. E.. 2001. 3. 21890070.
4. Sorgel F, Naber KG, Kinzig M, Mahr G, Muth P . Comparative pharmacokinetics of ciprofloxacin and temafloxacin in humans: a review . Am. J. Med. . 91 . 6A . 51S–66S . December 1991 . 1662896 . 10.1016/0002-9343(91)90312-L .
5. Sörgel F . Penetration of temafloxacin into body tissues and fluids . Clin Pharmacokinet . 22 . 57–63 . 1992 . Suppl 1 . 1319872 . 10.2165/00003088-199200221-00010. 32791009 .
6. Pankey GA . Temafloxacin: an overview . Am. J. Med. . 91 . 6A . 166S–172S . December 1991 . 1662889 . 10.1016/0002-9343(91)90332-r .
7. Granneman GR, Carpentier P, Morrison PJ, Pernet AG . Pharmacokinetics of temafloxacin in humans after multiple oral doses . Antimicrob. Agents Chemother. . 36 . 2 . 378–86 . February 1992 . 1318680 . 188445 . 10.1128/aac.36.2.378.
8. Granneman GR, Braeckman R, Kraut J, Shupien S, Craft JC . Temafloxacin pharmacokinetics in subjects with normal and impaired renal function . Antimicrob. Agents Chemother. . 35 . 11 . 2345–51 . November 1991 . 1666497 . 245383 . 10.1128/aac.35.11.2345.
9. Dudley MN . A review of the pharmacokinetic profile of temafloxacin . J. Antimicrob. Chemother. . 28 Suppl C . 55–64 . December 1991 . 1664830 . 10.1093/jac/28.suppl_c.55. 2014-10-17.
10. Gentry LO . Review of quinolones in the treatment of infections of the skin and skin structure . J. Antimicrob. Chemother. . 28 Suppl C . 97–110 . December 1991 . 1787128 . 10.1093/jac/28.suppl_C.97. 2014-10-17.
11. Wise R . Comparative penetration of selected fluoroquinolones into respiratory tract fluids and tissues . Am. J. Med. . 91 . 6A . 67S–70S . December 1991 . 1662897 . 10.1016/0002-9343(91)90313-M.
12. Symonds WT, Nix DE . Lomefloxacin and temafloxacin: two new fluoroquinolone antimicrobials . Clin Pharm . 11 . 9 . 753–66 . September 1992 . 1325892 .