Acute and twenty-eight days repeated oral dose toxicity study of besifloxacin in Wistar albino rats

Environmental Toxicology and Pharmacology

Volumn 32, Issue 1, 2011, Pages 82-101

  Roy, Bikash ^a   Nandi, Utpal ^a   Das, Anjan ^a   Pal, Tapan Kumar ^a  

^a JADAVPUR UNIVERSITY   (India)

Author keywords

Acute toxicity; Besifloxacin; Fluoroquinolones; Repeated oral dose toxicity; Wistar albino rats

Indexed keywords

BESIFLOXACIN; BILIRUBIN; PROTEIN;

ACUTE TOXICITY; ANIMAL CELL; ANIMAL EXPERIMENT; ANIMAL MODEL; ANIMAL TISSUE; ARTICLE; BILIRUBIN BLOOD LEVEL; CHOLANGITIS; CONTROLLED STUDY; DRUG ADMINISTRATION ROUTE; DRUG CYTOTOXICITY; DRUG DOSE COMPARISON; DRUG MEGADOSE; DRUG REEXPOSURE; DRUG STRUCTURE; FEMALE; GASTROINTESTINAL TOXICITY; HISTOPATHOLOGY; LEUKOCYTE COUNT; LIVER INJURY; MALE; NONHUMAN; PERICHOLANGITIS; PRIORITY JOURNAL; PROTEIN BLOOD LEVEL; RAT; REPEATED DRUG DOSE; SEX DIFFERENCE; STOMACH MUCOSA; TOXICITY TESTING;

ACHILLES TENDON; ANIMALS; ANTI-BACTERIAL AGENTS; AZEPINES; BILIRUBIN; BLOOD PLATELETS; DISEASE MODELS, ANIMAL; DRUG-INDUCED LIVER INJURY; FEMALE; FLUOROQUINOLONES; GLYCOGEN; JOINTS; LEUKOCYTE COUNT; LIVER; MALE; PHOTOSENSITIVITY DISORDERS; RATS; RATS, WISTAR; STOMACH ULCER; THROMBOCYTOSIS; TOXICITY TESTS, ACUTE; TOXICITY TESTS, SUBACUTE;

RATTUS;

EID: 79957864070     PISSN: 13826689     EISSN: 18727077     Source Type: Journal    
DOI: 10.1016/j.etap.2011.03.015     Document Type: Article

References (33)

1. Bae C.S., Oh D.M., Bae J.G., Kim J.C., Kim S.H., Kim S.G., Jeong M.J., Kim Y.S., Lim S.C. Ultrastructural changes of the gemifloxacin on achilles tendon in immature rats: comparison with those of ciproxacin and ofloxacin. BCPT 2006, 98(4):406-410.
2. Ball P. Adverse drug reactions: implications for the development of fluoroquinolones. J. Antimicrob. Chemother. 2003, 51(Suppl. S1):21-27.
3. Barry A.L., Fuchs P.C., Brown S.D. In vitro activities of three nonfluorinated quinolones against representative bacterial species. Antimicrob. Agents Chemother. 2001, 45:1923-1927.
4. Bauch & Incorporated, 2009. Product Monograph of Besifloxacin. 1400 north Goodman Street, Rochester, NY 14609, October23.
5. Cambau E., Matrat S., Pan X., Bettoni R.R.D., Corbel C., Aubry A., Lascols C., Driot J.Y., Fisher M.L. Target specificity of the new fluoroquinolone besifloxacin in Streptococcus pneumoniae, Staphylococcus aureus and Escherichia coli. J. Antimicrob. Chemother. 2009, 63:443-450.
6. Comstock T.L., Karpecki P.M., Morris T.W., Zhang J.Z. Besifloxacin: a novel anti-infective for the treatment of bacterial conjunctivitis. Clin. Ophthalmol. 2010, 4:215-225.
7. Eliseo P., Enrique B.G., Agustin M., Jose R., Paloma V. Synovial fluid analysis for diagnosis of intercritical gout. Ann. Intern. Med. 1999, 131:756-759.
8. Gellert M., Mizuuchi K., O'Dea M.H. Nalidixic acid resistance: a second genetic character involved in DNA gyrase activity. Proc. Natl. Acad. Sci. U.S.A. 1977, 74:4772-4776.
9. Guzman A., Garcia C., Demestre I. Subchronic toxicity of the new quinolone antibacterial agent irloxacin in Beagle dogs. Arzneim. Forsch./Drug res. 2000, 50:485-494.
10. Haas W., Pillar C.M., Hesje C.K., Sanfilippo C.M., Morris T.W. Bactericidal activity of besifloxacin against Staphylococci, Streptococcus pneumoniae and Haemophilus influenzae. J. Antimicrob. Chemother. 2010, 65:1441-1447.
11. Haas W., Pillar C.P., Zurenko G.E. Besifloxacin, a novel fluoroquinolone, has broad-spectrum in vitro activity against aerobic and anaerobic bacteria. Antimicrob. Agents Chemother. 2009, 53:3552-3560.
12. Hooper D.C., Wolfson J.S. The fluoroquinolones: Pharmacology, clinical uses, and toxicities in human. Antimicrob. Agents Chemother. 1985, 28:716-721.
13. Hussy P., Maass G., Tmmler B., Grosse F., Schomburg U. Effect of 4-quinolones and novobiocin on calf thymus DNA polymerase a primase complex, topoisomerases I and II, and growth of mammalian lymphoblasts. Antimicrob. Agents Chemother. 1986, 29:1073-1108.
14. Jones M.E., Critchley I.A., Karlowsky J.A., Blosser-Middleton R.S., Schmitz F.J., Thornsberry C., Sahm D.F. In vitro activities of novel nonfluorinated quinolones PGE 9262932 and PGE 9509924 against clinical isolates of Staphylococcus aureus and Streptococcus pneumoniae with defined mutations in DNA gyrase and topoisomerase IV. Antimicrob. Agents Chemother. 2002, 46(6):1651-1657.
15. Khodursky A.B., Zechiedrich E.L., Cozzarelli N.R. Topoisomerase IV is a target of quinolones in Escherichia coli. Proc. Natl. Acad. Sci. U.S.A. 1995, 92:11801-11805.
16. Lu G.C., She J.H., Jiang H., Li Z.Y., Yuan B.J. Sixty-day repeated dose toxicity of sinafloxacin in rat and dogs. Food Chem. Toxicol. 2008, 46:575-580.
17. Mandell L., Tillotson G. Safety of fluoroquinolones: an update. J. Infect. Dis. 2002, 13(1):54-61.
18. Marutani K., Matsumoto M., Otabe Y., Nagamuta M., Tanaka K., Miyoshi A., Hasegawa T., Nagano H., Matsubara S., Kamide R., Yokota T., Matsumoto F., Ueda Y. Reduced phototoxicity of a fluoroquinolone antibacterial agent with a methoxy group at the 8 position in mice irradiated with long-wavelength UV light. Antimicrob. Agents Chemother. 1993, 37:2217-2223.
19. OECD (Organization for Economic Co-operation and Development), 1995. Guideline for the testing of chemicals. Guideline 407: Repeated dose 28-day oral toxicity study in rodents. Adopted 27 July, 1995.
20. OECD (Organization for Economic Co-operation and Development), 1987. Guideline for the testing of chemicals. Guideline 401: Acute oral toxicity study in rodents. Adopted 24 February 1987.
21. Phelps P., Steele A.D., McCarty D.J. Compensated polarized light microscopy, identification of crystals in synovial fluids from gout and pseudogout. JAMA 1968, 203:508-512.
22. Proksch J.W., Granvil C.P., Siou-Mermet R., Comstock T.L., Paterno M.R., Ward K.W. Ocular pharmacokinetics of besifloxacin following topical administration to rabbits, monkeys, and humans. J. Ocul. Pharmacol. Ther. 2009, 25(4):335-344.
23. Roy B., Bose A., Bhaumik U., Das A., Chatterjee N., Ghosh A., Darbar S., Sarkar A.K., Sengupta P., Pal T.K. Convulsant activity and pharmacokinetic-pharmacodynamic modeling of the electroencephalogram effect of gemifloxacin in rats. J. Pharm. Sci. 2010, 99:1535-1547.
24. Roy B., Sarkar A.K., Sengupta P., Dey G., Das A.K., Pal T.K. Twenty-eight days repeated oral dose toxicity study of gemifloxacin in Wistar albino rats. Regul. Toxicol. Pharmacol. 2010, 58:196-207.
25. Roychoudhury S., Twimen T.L., Makin K.M., McIntosh E.J., Ledoussal B., Catrenich C.E. Activity of non-fluorinated quinolones (NFQs) against quinolone-resistant Escherichia coli and Streptococcus pneumoniae. J. Antimicrob. Chemother. 2001, 48:29-36.
26. Roychoudury S., Catrenich C.E., McKeever H.D., Makin K.M., Koenigs P.M., Ledoussal B. Quinolone resistance in staphylococci: activities of the new nonfluorinated quinolones against molecular targets in whole cells and clinical isolates. Antimicrob. Agents Chemother. 2001, 45:1115-1120.
27. Sanders M.E., Norcross E.W., Moore Q.C., Shafiee A., Marquart M.E. Effecacy of besifloxacin in a rabbit model of methicillin-resistant Staphylococcus aureus keratitis. Cornea 2009, 28(9):1055-1060.
28. US Food and Drug Administration, 1978. Good laboratory practice Regulations (Part 58 of 21 Code of Federal Regulations (CFR)). Federal Register 22 December 1979 and subsequent amendments.
29. Vousden M., Ferguson J., Richards J., Bird N., Allen A. Evaluation of phototoxic potential of gemifloxacin in healthy volunteers compared with ciprofloxacin. Chemotherapy 1999, 45:512-520.
30. Wagai N., Tawara K. Quinolone antibacterial-agent-induced cutaneous phototoxicity: ear swelling reactions in Balb/c mice. Toxicol. Lett. 1991, 58:215-223.
31. Wagai N., Yamaguchi F., Sekiguchi M., Tawara K. Phototoxic potential of quinolone antibacterial agents in Balb/c mice. Toxicol. Lett. 1990, 54:299-308.
32. Ward K.W., Lepage J.F., Driot J.Y. Nonclinical pharmacodynamics, pharmacokinetics, and safety of BOL-03224-A, a novel fluoroquinolone antimicrobial agent for topical ophthalmic use. J. Ocul. Pharmacol. Ther. 2007, 23:243-256.
33. Woodman D.D. Assessment of Hepatotoxicity 1996, 71-86. Animal Clinical Chemistry. G.O. Evants (Ed.).