Updated US and European Dose Recommendations for Intravenous Colistin: How Do They Perform?

Clinical Infectious Diseases

Volumn 62, Issue 5, 2016, Pages 552-558

  Nation, Roger L ^a   Garonzik, Samira M ^b   Li, Jian ^a   Thamlikitkul, Visanu ^c   Giamarellos Bourboulis, Evangelos J ^d   Paterson, David L ^e   Turnidge, John D ^f   Forrest, Alan ^b   Silveira, Fernanda P ^g  

^a MONASH UNIVERSITY   (Australia)

^b UNIVERSITY AT BUFFALO   (United States)

^c MAHIDOL UNIVERSITY   (Thailand)

^d UNIVERSITY OF ATHENS MEDICAL SCHOOL   (Greece)

^e UNIVERSITY OF QUEENSLAND   (Australia)

^f UNIVERSITY OF ADELAIDE   (Australia)

^g UNIVERSITY OF PITTSBURGH MEDICAL CENTER   (United States)

Author keywords

Clinical breakpoints; Intravenous colistin; Plasma colistin concentrations achieved; Therapeutic implications; Updated FDA and EMA approved dosing suggestions

Indexed keywords

COLISTIMETHATE; COLISTIN; CREATININE;

ADULT; AGED; ARTICLE; BLOODSTREAM INFECTION; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; CREATININE BLOOD LEVEL; CREATININE CLEARANCE; CRITICALLY ILL PATIENT; DRUG BLOOD LEVEL; DRUG DOSE REGIMEN; DRUG TARGETING; FEMALE; FOOD AND DRUG ADMINISTRATION; HUMAN; KIDNEY FUNCTION; MAINTENANCE DRUG DOSE; MAJOR CLINICAL STUDY; MALE; MULTICENTER STUDY; PNEUMONIA; PRIORITY JOURNAL; RECOMMENDED DRUG DOSE; RENAL REPLACEMENT THERAPY; STEADY STATE; UNITED STATES; VERY ELDERLY; BLOOD; DOSE RESPONSE; EUROPE; INTRAVENOUS DRUG ADMINISTRATION; MIDDLE AGED; YOUNG ADULT;

ADMINISTRATION, INTRAVENOUS; ADULT; AGED; AGED, 80 AND OVER; COLISTIN; DOSE-RESPONSE RELATIONSHIP, DRUG; EUROPE; FEMALE; HUMANS; MALE; MIDDLE AGED; UNITED STATES; YOUNG ADULT;

EID: 84960191949     PISSN: 10584838     EISSN: 15376591     Source Type: Journal    
DOI: 10.1093/cid/civ964     Document Type: Article

References (31)

1. Barnett M, Bushby SR, Wilkinson S. Sodium sulphomethyl derivatives of polymyxins. Br J Pharmacol Chemother 1964; 23:552-74.
2. Bergen PJ, Li J, Rayner CR, Nation RL. Colistin methanesulfonate is an inactive prodrug of colistin against Pseudomonas aeruginosa. Antimicrob Agents Chemother 2006; 50:1953-8.
3. Li J, Nation RL, Turnidge JD, et al. Colistin: the re-emerging antibiotic for multidrug-resistant Gram-negative bacterial infections. Lancet Infect Dis 2006; 6:589-601.
4. Falagas ME, Kasiakou SK. Colistin: the revival of polymyxins for the management of multidrug-resistant gram-negative bacterial infections. Clin Infect Dis 2005; 40:1333-41.
5. Falagas ME, Kasiakou SK. Toxicity of polymyxins: a systematic review of the evidence from old and recent studies. Crit Care 2006; 10:R27.
6. Cheah SE, Wang J, Nguyen VT, Turnidge JD, Li J, Nation RL. New pharmacokinetic/pharmacodynamic studies of systemically administered colistin against Pseudomonas aeruginosa and Acinetobacter baumannii in mouse thigh and lung infection models: smaller response in lung infection. J Antimicrob Chemother 2015; 70:3291-7.
7. Sorli L, Luque S, Grau S, et al. Trough colistin plasma level is an independent risk factor for nephrotoxicity: a prospective observational cohort study. BMC Infect Dis 2013; 13:380.
8. Forrest A, Silveira FP, Thamlikitkul V, et al. Toxicodynamics for Colistin-Associated Changes in Creatinine Clearance. In: Interscience Conference on Antimicrobial Agents and Chemotherapy 2014. Washington, DC, 2014.
9. Bergen PJ, Landersdorfer CB, Lee HJ, Li J, Nation RL. 'Old' antibiotics for emerging multidrug-resistant bacteria. Curr Opin Infect Dis 2012; 25:626-33.
10. Couet W, Gregoire N, Marchand S, Mimoz O. Colistin pharmacokinetics: the fog is lifting. Clin Microbiol Infect 2012; 18:30-9.
11. Landersdorfer CB, Nation RL. Colistin: how should it be dosed for the critically ill? Semin Respir Crit Care Med 2015; 36:126-35.
12. Theuretzbacher U. Product information for parenteral colistin varies substantially across Europe. J Antimicrob Chemother 2014; 69:1987-92.
13. Nation RL, Li J, Cars O, et al. Framework for optimisation of the clinical use of colistin and polymyxin B: the Prato polymyxin consensus. Lancet Infect Dis 2015; 15:225-34.
14. European Medicines Agency completes review of polymyxin-based medicines: Recommendations issued for safe use in patients with serious infections resistant to standard antibiotics. Available at: http://www.ema.europa.eu/docs/en-GB/docu ment-library/Referrals-document/Polymyxin-31/WC500176333.pdf. Accessed 2 December 2015.
15. FDA Approved Drug Products. Label and approval history for Coly-Mycin M, NDA 050108. Available at: http://www.accessdata.fda.gov/drugsatfda-docs/label/2013/050108s030lbl.pdf. Accessed 2 December 2015.
16. Garonzik SM, Li J, Thamlikitkul V, et al. Population pharmacokinetics of colistin methanesulfonate and formed colistin in critically ill patients from a multicenter study provide dosing suggestions for various categories of patients. Antimicrob Agents Chemother 2011; 55:3284-94.
17. Jelliffe R. Estimation of creatinine clearance in patients with unstable renal function, without a urine specimen. Am J Nephrol 2002; 22:320-4.
18. Devine BJ. Gentamicin therapy. Drug Intell Clin Pharm 1974; 8:650-5.
19. Nation RL, Velkov T, Li J. Colistin and polymyxin B: peas in a pod, or chalk and cheese? Clin Infect Dis 2014; 59:88-94.
20. Li J, Rayner CR, Nation RL, et al. Pharmacokinetics of colistin methanesulfonate and colistin in a critically ill patient receiving continuous venovenous hemodiafiltration. Antimicrob Agents Chemother 2005; 49:4814-5.
21. Spapen HD, Honore PM, Gregoire N, et al. Convulsions and apnoea in a patient infected with New Delhi metallo-beta-lactamase-1 Escherichia coli treated with colistin. J Infect 2011; 63:468-70.
22. Bode-Boger SM, Schopp B, Troger U, Martens-Lobenhoffer J, Kalousis K, Mailander P. Intravenous colistin in a patient with serious burns and borderline syndrome: the benefits of therapeutic drug monitoring. Int J Antimicrob Agents 2013; 42:357-60.
23. Clinical and Laboratory Standards Institute. Performance Standards for Antimicrobial Susceptibility Testing: Twenty-fifth Informational Supplement M100-S25. In: CLSI, Wayne, PA, USA, 2015.
24. European Committee on Antimicrobial Susceptibility Testing. Clinical breakpoints-bacteria (v 5.0). Available at: http://www.eucast.org/clinical-break points/. Accessed 2 December 2015.
25. Giamarellos-Bourboulis EJ, Xirouchaki E, Giamarellou H. Interactions of colistin and rifampin on multidrug-resistant Acinetobacter baumannii. Diagn Microbiol Infect Dis 2001; 40:117-20.
26. Bergen PJ, Tsuji BT, Bulitta JB, et al. Synergistic killing of multidrug-resistant Pseudomonas aeruginosa at multiple inocula by colistin combined with doripenem in an in vitro pharmacokinetic/pharmacodynamic model. Antimicrob Agents Chemother 2011; 55:5685-95.
27. Deris ZZ, Yu HH, Davis K, et al. The combination of colistin and doripenem is synergistic against Klebsiella pneumoniae at multiple inocula and suppresses colistin resistance in an in vitro pharmacokinetic/pharmacodynamic model. Antimicrob Agents Chemother 2012; 56:5103-12.
28. Kumar A, Roberts D,Wood KE, et al. Duration of hypotension before initiation of effective antimicrobial therapy is the critical determinant of survival in human septic shock. Crit Care Med 2006; 34:1589-96.
29. Falagas ME, Rafailidis PI. Nephrotoxicity of colistin: new insight into an old antibiotic. Clin Infect Dis 2009; 48:1729-31.
30. Fryar CD, Gu Q, Ogden CL. Anthropometric reference data for children and adults: United States, 2007-2010. Vital Health Stat 2012; 11: 1-48.
31. Plachouras D, Karvanen M, Friberg LE, et al. Population pharmacokinetic analysis of colistin methanesulfonate and colistin after intravenous administration in critically ill patients with infections caused by gram-negative bacteria. Antimicrob Agents Chemother 2009; 53:3430-6.