Preclinical toxicology studies with azithromycin: Acute and subchronic studies in rodents

Pharmacometrics

Volumn 51, Issue 2, 1996, Pages 53-63

  Mayne, James ^c   Walsh, Alexander ^c   Johnson, Nancy ^c   Roesler, Alfred ^a   Shepard, Richard ^b   Tachibana, Masakatsu ^a  

^a PFIZER INC   (United States)

^b PFIZER GLOBAL RESEARCH AND DEVELOPMENT   (United States)

^c NONE

Author keywords

(rats and mice); Antibiotic; Azithromycin; Toxicology

Indexed keywords

AMINOTRANSFERASE; AZITHROMYCIN;

AMINOTRANSFERASE BLOOD LEVEL; ANIMAL EXPERIMENT; ANIMAL MODEL; ANTIMICROBIAL ACTIVITY; ARTICLE; CHEMICAL STRUCTURE; CONTROLLED STUDY; DRUG CLEARANCE; DRUG SAFETY; DRUG TISSUE LEVEL; HIGH PERFORMANCE LIQUID CHROMATOGRAPHY; INTESTINE FLORA; INTRAPERITONEAL DRUG ADMINISTRATION; LIVER NECROSIS; MOUSE; NONHUMAN; ORAL DRUG ADMINISTRATION; RAT;

EID: 0029985513     PISSN: 03008533     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Article

References (21)

1. Amacher, D., Ellis, Jr., J., Joyce, A , Muehlbauer, P., Turner, G., Wahrenburg, M., Holden, H. and Ray, V. (1993): Preclinical toxicology studies with azithromycin: genetic toxicology evaluation, Mutation Res., 300, 79-90.
2. Cox, J., Ulrich, R., Larson, P. and Cramer, C. (1988): Acute hepatocellular effects of erythromycin, gentamycin, and trospectomycin in the perfused rat liver: Lack of correlation between lamellar body induction potency and cytotoxicity, Pharmacol. Toxicol., 62, 337-343.
3. Drew, R. and Gallis, H. (1992): Azithromycin: spectrum of activity, pharmacokinetics, and clinical applications, Pharmacotherapy, 12, 161-173.
4. Fortner, J., Milisen, W., Lundeen, G., Jakowski, A. and Marsh, P. (1993) Tapetal effect of an azalide antibiotic following oral administration in beagle dogs, Fundam. Appl. Toxicol., 21, 164-173.
5. Girard, A., Girard, D., English, A., Gootz, T., Cimochowski, C., Faiella, J., Haskell, S. and Retsema, J. (1987): Pharmacokinetic and in vivo studies with azithromycin (CP-62, 993), a new macrolide with an extended half-life and excellent tissue distribution, Antimicrob. Agents Chemother., 31, 1948-1954.
6. Gladue, R., Bright, G., Issacson, R. and Newborg, M. (1989): In vitro and in vivo uptake of azithromycin, CP-62, 993, by phagocytic cells: possible mechanism of delivery and release at sites of infection, Antimicrob. Agents Chemother., 33, 277-282.
7. Gray, J., Purmalis, A., Purmalis, B and Mathews, J. (1971): Ultrastructural studies of the hepatic changes brought about by clindamycin and erythromycin in animals, Toxicol. Appl. Pharmacol., 19, 217-233.
8. Gray, J., Weaver, R., Stern, K. and Phillips, W. (1978): Foam cell response in the lung and lymphatic tissues during long-term high-level treatment with erythromycin, Toxicol. Appl. Pharmacol., 45, 701-711
9. Hopkins, S. (1991) Clinical toleration and safety of azithromycin, Am. J. Med., 91(3A), 40S-45S.
10. Hostetler, K., Reasor, M. and Yazaki, P. (1985): Chloroquine-induced phospholipid fatty liver: Measurement of drug and lipid concentrations in rat liver lysosomes, J. Biol. Chem., 206, 215-219.
11. Hostetler, K (1986): Phospholipid fatty liver: an acquired disease of impaired phospholipid catabolism. In: J.A.F. Op den Kamp, B. Roelofsen, and K.W.A. Wirtz (eds.): Lipids and Membranes: Past, Present and Future. Elsevier Science Publishers B.V., Amsterdam, 307-324.
12. Kubo, M. and Hostetler, K (1985): Mechanism of cationic amphiphilic drug inhibition of purified lysosomal phospholipase A, Biochemistry, 24(23), 6515-6520.
13. Lundeen, G., Milisen, W., Shepard, R., Foulds, G , Walsh, A., Stadnicki, S. and Tachibana, M. (1996): Preclinical Toxicology Studies in Beagle Dogs with Azithromycin, Ōyō Yakuri/Pharmacometrics, 51, 65-74.
14. Ohkuma, S and Poole, B. (1978): Fluorescence probe measurement of the intralysosomal pH in living cells and the perturbation of pH by various agents, Proc. Natl. Acad. Sci., 75, 3327-3331.
15. Reasor, M. and Walker, E. (1981) Recovery from chlorphentermine-induced phospholipidosis in rat alveolar macrophages: Morphological features. Exp. Mol. Pathol., 35, 370-379.
16. Reasor, M. (1989): A review of the biology and toxicologic implications of the induction of lysosomal lamellar bodies by drugs, Toxicol. Appl. Pharmacol., 97, 47-56.
17. Seydel, J. and Wasserman, O. (1976): NMR studies on the molecular basis of drug-induced phospholipidosis II. Interaction between several amphiphilic drugs and phospholipids. Biochem. Pharmacol., 25, 2357-2364.
18. Shepard, R. and Falkner, F. (1990): Pharmacokinetics of azithromycin in rats and dogs, J. Antimicro. Chemother., 25, suppl. A, 49-60.
19. Shepard, R., Amacher, D , Mullins, M , Ferraina, R., Higgins, C., Jakowski, A. and Milisen, W. (1992): Mechanism of azithromycin tissue uptake and accumulation: subcellular localization of azithromycin in rat liver. In: Program and Abstracts of the First International Conference on the Macrolides, Azalides and Streptogramins, Santa Fe, NM, Abstract 217, 50.
20. Shikata, T., Kanetaka, T., Endo, Y. and Nagashima, K. (1972): Drug-induced generalized phospholipidosis, Acta Path. Jap., 22(3), 517-531.
21. Stadnicki, S., Kessedjian, M., Stadler, J. and Tachibana, M. (1996): Preclinical Reproductive and Teratology Studies with Azithromycin, Ōyō Yakuri/Pharmacometrics, 51, 85-95.