Pharmacokinetic modelling of serum and bronchial concentrations for clarithromycin and telithromycin, and site-specific pharmacodynamic simulation for their dosages

Journal of Clinical Pharmacy and Therapeutics

Volumn 39, Issue 4, 2014, Pages 411-417

  Ikawa, K ^a   Kikuchi, E ^b   Kikuchi, J ^b   Nishimura, M ^b   Derendorf, H ^c   Morikawa, N ^a  

^a HIROSHIMA UNIVERSITY   (Japan)

^b HOKKAIDO UNIVERSITY   (Japan)

^c UNIVERSITY OF FLORIDA HEALTH   (United States)

Author keywords

macrolides; modelling; pharmacodynamics; pharmacokinetics; simulation

Indexed keywords

CLARITHROMYCIN; TELITHROMYCIN; ANTIINFECTIVE AGENT; KETOLIDE;

AREA UNDER THE CURVE; ARTICLE; BACTERIUM ISOLATION; BRONCHUS; DISTRIBUTION VOLUME; DRUG ABSORPTION; DRUG BLOOD LEVEL; DRUG CLEARANCE; EPITHELIUM; HAEMOPHILUS INFLUENZAE; HUMAN; LIMIT OF QUANTITATION; MINIMUM INHIBITORY CONCENTRATION; MORAXELLA CATARRHALIS; PLASMA CONCENTRATION-TIME CURVE; STAPHYLOCOCCUS AUREUS; STREPTOCOCCUS PNEUMONIAE; BACTERIA; BIOLOGICAL MODEL; COMPARATIVE STUDY; COMPUTER SIMULATION; DOSE RESPONSE; DRUG EFFECTS; METABOLISM; MICROBIAL SENSITIVITY TEST; MICROBIOLOGY; NONLINEAR SYSTEM; RESPIRATORY TRACT INFECTIONS; TISSUE DISTRIBUTION;

ANTI-BACTERIAL AGENTS; AREA UNDER CURVE; BACTERIA; BRONCHI; CLARITHROMYCIN; COMPUTER SIMULATION; DOSE-RESPONSE RELATIONSHIP, DRUG; EPITHELIUM; HUMANS; KETOLIDES; MICROBIAL SENSITIVITY TESTS; MODELS, BIOLOGICAL; NONLINEAR DYNAMICS; RESPIRATORY TRACT INFECTIONS; TISSUE DISTRIBUTION;

EID: 84904187892     PISSN: 02694727     EISSN: 13652710     Source Type: Journal    
DOI: 10.1111/jcpt.12157     Document Type: Article

References (32)

1. Zhanel GG, Dueck M, Hoban DJ, Vercaigne LM, Embil JM, Gin AS, Karlowsky JA,. Review of macrolides and ketolides: focus on respiratory tract infections. Drugs, 2001; 61: 443-498.
2. Rodvold KA,. Clinical pharmacokinetics of clarithromycin. Clin Pharmacokinet, 1999; 37: 385-398.
3. Shi J, Montay G, Bhargava VO,. Clinical pharmacokinetics of telithromycin, the first ketolide antibacterial. Clin Pharmacokinet, 2005; 44: 915-934.
4. Honeybourne D, Kees F, Andrews JM, Baldwin D, Wise R,. The levels of clarithromycin and its 14-hydroxy metabolite in the lung. Eur Respir J, 1994; 7: 1275-1280.
5. Conte JE Jr, Golden JA, Duncan S, McKenna E, Zurlinden E,. Intrapulmonary pharmacokinetics of clarithromycin and of erythromycin. Antimicrob Agents Chemother, 1995; 39: 334-338.
6. Conte JE Jr, Golden J, Duncan S, McKenna E, Lin E, Zurlinden E,. Single-dose intrapulmonary pharmacokinetics of azithromycin, clarithromycin, ciprofloxacin, and cefuroxime in volunteer subjects. Antimicrob Agents Chemother, 1996; 40: 1617-1622.
7. Patel KB, Xuan D, Tessier PR, Russomanno JH, Quintiliani R, Nightingale CH,. Comparison of bronchopulmonary pharmacokinetics of clarithromycin and azithromycin. Antimicrob Agents Chemother, 1996; 40: 2375-2379.
8. Rodvold KA, Gotfried MH, Danziger LH, Servi RJ,. Intrapulmonary steady-state concentrations of clarithromycin and azithromycin in healthy adult volunteers. Antimicrob Agents Chemother, 1997; 41: 1399-1402.
9. Kikuchi E, Yamazaki K, Kikuchi J, Hasegawa N, Hashimoto S, Ishizaka A, Nishimura M,. Pharmacokinetics of clarithromycin in bronchial epithelial lining fluid. Respirology, 2008; 13: 221-226.
10. Hasegawa N, Nishimura T, Watabnabe M, et al,. Concentrations of clarithromycin and active metabolite in the epithelial lining fluid of patients with Mycobacterium avium complex pulmonary disease. Pulm Pharmacol Ther, 2009; 22: 190-193.
11. Khair OA, Andrews JM, Honeybourne D, Jevons G, Vacheron F, Wise R,. Lung concentrations of telithromycin after oral dosing. J Antimicrob Chemother, 2001; 47: 837-840.
12. Muller-Serieys C, Soler P, Cantalloube C, Lemaitre F, Gia HP, Brunner F, Andremont A,. Bronchopulmonary disposition of the ketolide telithromycin (HMR 3647). Antimicrob Agents Chemother, 2001; 45: 3104-3108.
13. Kadota J, Ishimatsu Y, Iwashita T, et al,. Intrapulmonary pharmacokinetics of telithromycin, a new ketolide, in healthy Japanese volunteers. Antimicrob Agents Chemother, 2002; 46: 917-921.
14. Ong CT, Dandekar PK, Sutherland C, Nightingale CH, Nicolau DP,. Intrapulmonary concentrations of telithromycin: clinical implications for respiratory tract infections due to Streptococcus pneumoniae. Chemotherapy, 2005; 51: 339-346.
15. Kikuchi J, Yamazaki K, Kikuchi E, Ishizaka A, Nishimura M,. Pharmacokinetics of telithromycin using bronchoscopic microsampling after single and multiple oral doses. Pulm Pharmacol Ther, 2007; 20: 549-555.
16. Zeitlinger M, Wagner CC, Heinisch B,. Ketolides-the modern relatives of macrolides: the pharmacokinetic perspective. Clin Pharmacokinet, 2009; 48: 23-38.
17. Drusano GL, Preston SL, Gotfried MH, Danziger LH, Rodvold KA,. Levofloxacin penetration into epithelial lining fluid as determined by population pharmacokinetic modeling and Monte Carlo simulation. Antimicrob Agents Chemother, 2002; 46: 586-589.
18. Lodise TP, Kinzig-Schippers M, Drusano GL, et al,. Use of population pharmacokinetic modeling and Monte Carlo simulation to describe the pharmacodynamic profile of cefditoren in plasma and epithelial lining fluid. Antimicrob Agents Chemother, 2008; 52: 1945-1951.
19. Lodise TP Jr, Gotfried M, Barriere S, Drusano GL,. Telavancin penetration into human epithelial lining fluid determined by population pharmacokinetic modeling and Monte Carlo simulation. Antimicrob Agents Chemother, 2008; 52: 2300-2304.
20. Lodise TP, Sorgel F, Melnick D, Mason B, Kinzig M, Drusano GL,. Penetration of meropenem into epithelial lining fluid of patients with ventilator-associated pneumonia. Antimicrob Agents Chemother, 2011; 55: 1606-1610.
21. Lodise TP, Drusano GL, Butterfield JM, Scoville J, Gotfried M, Rodvold KA,. Penetration of vancomycin into epithelial lining fluid in healthy volunteers. Antimicrob Agents Chemother, 2011; 55: 5507-5511.
22. Lindbom L, Pihlgren P, Jonsson EN,. PsN-Toolkit-a collection of computer intensive statistical methods for non-linear mixed effect modeling using NONMEM. Comput Methods Programs Biomed, 2005; 79: 241-257.
23. Housman ST, Pope JS, Russomanno J, Salerno E, Shore E, Kuti JL, Nicolau DP,. Pulmonary disposition of tedizolid following administration of once-daily oral 200-milligram tedizolid phosphate in healthy adult volunteers. Antimicrob Agents Chemother, 2012; 56: 2627-2634.
24. Zhanel GG, Johanson C, Hisanaga T, et al,. Pharmacodynamic activity of telithromycin against macrolide-susceptible and macrolide-resistant Streptococcus pneumoniae simulating clinically achievable free serum and epithelial lining fluid concentrations. J Antimicrob Chemother, 2004; 54: 1072-1077.
25. Noreddin AM, El-Khatib WF, Aolie J, Salem AH, Zhanel GG,. Pharmacodynamic target attainment potential of azithromycin, clarithromycin, and telithromycin in serum and epithelial lining fluid of community-acquired pneumonia patients with penicillin-susceptible, intermediate, and resistant Streptococcus pneumoniae. Int J Infect Dis, 2009; 13: 483-487.
26. Lodise TP, Preston S, Bhargava V, et al,. Pharmacodynamics of an 800-mg dose of telithromycin in patients with community-acquired pneumonia caused by extracellular pathogens. Diagn Microbiol Infect Dis, 2005; 52: 45-52.
27. Zhanel GG, Johanson C, Laing N, Hisanaga T, Wierzbowski A, Hoban DJ,. Pharmacodynamic activity of telithromycin at simulated clinically achievable free-drug concentrations in serum and epithelial lining fluid against efflux (mefE)-producing macrolide-resistant Streptococcus pneumoniae for which telithromycin MICs vary. Antimicrob Agents Chemother, 2005; 49: 1943-1948.
28. MIC distributions. European Committee on Antimicrobial Susceptibility Testing, European Society of Clinical Microbiology and Infectious Diseases (Basel, Switzerland). Available at: http://mic.eucast.org/Eucast2/ (accessed 31 October 2013).
29. Frei CR, Wiederhold NP, Burgess DS,. Antimicrobial breakpoints for gram-negative aerobic bacteria based on pharmacokinetic-pharmacodynamic models with Monte Carlo simulation. J Antimicrob Chemother, 2008; 61: 621-628.
30. Biaxin Tablets package insert. Abbott Laboratories (North Chicago, IL, USA). Available at: http://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid= aa44552c-3cfe-4111-8aa5-4251aeed9be9 (accessed 31 October 2013).
31. Ketek Tablets package insert. Sanofi-Aventis (Bridgewater, NJ, USA). Available at: http://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=4471223e- 9023-457e-be2e-8e4e0c2d94d1 (accessed 31 October 2013).
32. Zhanel GG, Palatnick L, Nichol KA, Bellyou T, Low DE, Hoban DJ,. Antimicrobial resistance in respiratory tract Streptococcus pneumoniae isolates: results of the Canadian Respiratory Organism Susceptibility Study, 1997 to 2002. Antimicrob Agents Chemother, 2003; 47: 1867-1874.