Drug-drug interactions and safety of linezolid, tedizolid, and other oxazolidinones

Expert Opinion on Drug Metabolism and Toxicology

Volumn 11, Issue 12, 2015, Pages 1849-1859

  Douros, Antonios ^a,b   Grabowski, Katja ^a   Stahlmann, Ralf ^a  

^a CHARITÉ UNIVERSITÄTSMEDIZIN BERLIN   (Germany)

^b LEIBNIZ INSTITUTE FOR PREVENTION RESEARCH AND EPIDEMIOLOGY BIPS   (Germany)

Author keywords

Gram positive; novel antimicrobials; tuberculosis treatment

Indexed keywords

ADRENERGIC RECEPTOR STIMULATING AGENT; ANTIBIOTIC AGENT; LINEZOLID; OXAZOLIDINONE DERIVATIVE; TEDIZOLID; ANTIINFECTIVE AGENT; ORGANOPHOSPHATE; OXAZOLE DERIVATIVE;

ANTIBIOTIC RESISTANCE; BACTERIAL SKIN DISEASE; BONE MARROW SUPPRESSION; CLINICAL PRACTICE; DRUG INDICATION; DRUG INTERACTION; DRUG MECHANISM; DRUG SAFETY; FERTILITY; FOOD AND DRUG ADMINISTRATION; GRAM POSITIVE INFECTION; HUMAN; HYPOGLYCEMIA; LACTIC ACIDOSIS; LIVER TOXICITY; METHICILLIN RESISTANT STAPHYLOCOCCUS AUREUS; NONHUMAN; OPTIC NERVE DISEASE; PERIPHERAL NEUROPATHY; PHARMACODYNAMICS; PHASE 3 CLINICAL TRIAL (TOPIC); POPULATION; RANDOMIZED CONTROLLED TRIAL (TOPIC); REVIEW; SEROTONIN SYNDROME; STRUCTURE ACTIVITY RELATION; TUBERCULOSIS; UNSPECIFIED SIDE EFFECT; ANIMAL; DRUG EFFECTS; GRAM POSITIVE BACTERIUM; GRAM-POSITIVE BACTERIAL INFECTIONS;

ANIMALS; ANTI-BACTERIAL AGENTS; DRUG INTERACTIONS; GRAM-POSITIVE BACTERIA; GRAM-POSITIVE BACTERIAL INFECTIONS; HUMANS; LINEZOLID; ORGANOPHOSPHATES; OXAZOLES; OXAZOLIDINONES; STRUCTURE-ACTIVITY RELATIONSHIP;

EID: 84949324154     PISSN: 17425255     EISSN: 17447607     Source Type: Journal    
DOI: 10.1517/17425255.2015.1098617     Document Type: Review

References (61)

1. Shaw KJ, Barbachyn MR. The oxazolidinones: past, present, and future. Ann N Y Acad Sci. 2011; 1241: 48-70.
2. Livermore DM. Quinupristin/dalfopristin and linezolid: where, when, which and whether to use? J Antimicrob Chemother. 2000; 46 (3): 347-350.
3. Full prescribing information-SIVEXTRO®. 2015 Mar. [ cited 25 Jun 2015[. Available from: http://sivextro.com/pdf/sivextro-prescribing-info.pdf
4. European public assessment report summary for the public-SIVEXTRO®. 2015 Mar. [ cited 25 Jun 2015[. Available from: http://www.ema.europa.eu/docs/en-GB/document-library/EPAR-Summary-for-the-public/human/002846/WC500184804.pdf
5. Full prescribing information-ZYVOX®. 2015 Jun. [ cited 25 Jun 2015[. Available from: http://labeling.pfizer.com/ShowLabeling.aspx?id=649
6. Weiss T, Schonfeld N, Otto-Knapp R., et al. Low minimal inhibitory concentrations of linezolid against multidrug-resistant tuberculosis strains. Eur Respir J. 2015; 45 (1): 285-287.
7. Cynamon MH, Klemens SP, Sharpe CA., et al. Activities of several novel oxazolidinones against mycobacterium tuberculosis in a murine model. Antimicrob Agents Chemother. 1999; 43 (5): 1189-1191.
8. Lee M, Lee J, Carroll MW., et al. Linezolid for treatment of chronic extensively drug-resistant tuberculosis. N Engl J Med 2012; 367 (16): 1508-1518
9. Olaru ID, von Groote-Bidlingmaier F, Heyckendorf J., et al. Novel drugs against tuberculosis: a clinicians perspective. Eur Respir J. 2015; 45 (4): 1119-1131.
10. Wallis RS, Dawson R, Friedrich SO., et al. Mycobactericidal activity of sutezolid (PNU-100480) in sputum (EBA) and blood (WBA) of patients with pulmonary tuberculosis. Plos One. 2014; 9 (4): e94462.
11. Jungbluth GL, Welshman IR, Hopkins NK. Linezolid pharmacokinetics in pediatric patients: an overview. Pediatr Infect Dis J. 2003; 22 (9 Suppl): S153-7.
12. Cojutti P, Maximova N, Crichiutti G., et al. Pharmacokinetic/pharmacodynamic evaluation of linezolid in hospitalized paediatric patients: a step toward dose optimization by means of therapeutic drug monitoring and Monte Carlo simulation. J Antimicrob Chemother. 2015; 70 (1): 198-206.
13. Dotis J, Iosifidis E, Ioannidou M., et al. Use of linezolid in pediatrics: a critical review. International Journal of Infectious Diseases: IJID: official Publication of the International Society for Infectious Diseases. 2010; 14 (8): e638-48.
14. Shinabarger D. Mechanism of action of the oxazolidinone antibacterial agents. Expert Opin Investig Drugs. 1999; 8 (8): 1195-1202.
15. Leach KL, Swaney SM, Colca JR., et al. The site of action of oxazolidinone antibiotics in living bacteria and in human mitochondria. Molecular Cell 2007; 26 (3): 393-402
16. Shaw KJ, Poppe S, Schaadt R., et al. In vitro activity of TR-700, the antibacterial moiety of the prodrug TR-701, against linezolid-resistant strains. Antimicrob Agents Chemother. 2008; 52 (12): 4442-4447.
17. Gonzales RD, Schreckenberger PC, Graham MB., et al. Infections due to vancomycin-resistant Enterococcus faecium resistant to linezolid. Lancet (London, England). 2001; 357 (9263): 1179.
18. Tsiodras S, Gold HS, Sakoulas G., et al. Linezolid resistance in a clinical isolate of Staphylococcus aureus. Lancet (London, England) 2001, 21; 358 (9277): 207-208
19. Rybak JM, Roberts K. Tedizolid phosphate: a next-generation oxazolidinone. Infect Dis Ther. 2015;4:1-14.
20. Dryden MS. Linezolid pharmacokinetics and pharmacodynamics in clinical treatment. J Antimicrob Chemother. 2011; 66 (Suppl 4): iv7-iv15.
21. Slatter JG, Stalker DJ, Feenstra KL., et al. Pharmacokinetics, metabolism, and excretion of linezolid following an oral dose of [(14)C]linezolid to healthy human subjects. Drug Metab Dispos. 2001; 29 (8): 1136-1145.
22. Norrby R. Linezolid-a review of the first oxazolidinone. Expert Opin Pharmacother. 2001; 2 (2): 293-302.
23. Rybak JM, Marx K, Martin CA. Early experience with tedizolid: clinical efficacy, pharmacodynamics, and resistance. Pharmacotherapy. 2014; 34 (11): 1198-1208.
24. Stalker DJ, Jungbluth GL. Clinical pharmacokinetics of linezolid, a novel oxazolidinone antibacterial. Clin Pharmacokinet. 2003; 42 (13): 1129-1140.
25. Housman ST, Pope JS, Russomanno J., et al. Pulmonary disposition of tedizolid following administration of once-daily oral 200-milligram tedizolid phosphate in healthy adult volunteers. Antimicrob Agents Chemother. 2012; 56 (5): 2627-2634.
26. Conte JE Jr., Golden JA, Kipps J., et al. Intrapulmonary pharmacokinetics of linezolid. Antimicrob Agents Chemother. 2002; 46 (5): 1475-1480.
27. Gandelman K, Zhu T, Fahmi OA., et al. Unexpected effect of rifampin on the pharmacokinetics of linezolid: in silico and in vitro approaches to explain its mechanism. J Clin Pharmacol. 2011; 51 (2): 229-236.
28. Iqbal MM, Basil MJ, Kaplan J., et al. Overview of serotonin syndrome. Ann Clin Psychiatry Off J Am Acad Clin Psychiatrists. 2012; 24 (4): 310-318.
29. Fachinformation-Sivextro® 200 mg. 2015 Jun. [ cited 15 Jul 2015[. Available from: http://www.fachinfo.de/suche/fi/020638
30. Woytowish MR, Maynor LM. Clinical relevance of linezolid-associated serotonin toxicity. Ann Pharmacother. 2013; 47 (3): 388-397.
31. Flanagan S, Bartizal K, Minassian SL., et al. In vitro, in vivo, and clinical studies of tedizolid to assess the potential for peripheral or central monoamine oxidase interactions. Antimicrob Agents Chemother. 2013; 57 (7): 3060-3066.
32. Hendershot PE, Antal EJ, Welshman IR., et al. Linezolid: pharmacokinetic and pharmacodynamic evaluation of coadministration with pseudoephedrine HCl, phenylpropanolamine HCl, and dextromethorpan HBr. J Clin Pharmacol. 2001; 41 (5): 563-572.
33. Wicha SG, Kees MG, Kuss J., et al. Pharmacodynamic and response surface analysis of linezolid or vancomycin combined with meropenem against Staphylococcus aureus. Pharm Res. 2015; 32 (7): 2410-2418.
34. Rey-Jurado E, Tudo G, Soy D., et al. Activity and interactions of levofloxacin, linezolid, ethambutol and amikacin in three-drug combinations against mycobacterium tuberculosis isolates in a human macrophage model. Int J Antimicrob Agents. 2013; 42 (6): 524-530.
35. Gerson SL, Kaplan SL, Bruss JB., et al. Hematologic effects of linezolid: summary of clinical experience. Antimicrob Agents Chemother. 2002; 46 (8): 2723-2726.
36. Fachinformation-ZYVOXID® 600mg. 2014 Sep. [ cited 25 Jun 2015[. Available from: http://www.fachinfo.de/suche/fi/014360
37. Wu VC, Wang YT, Wang CY., et al. High frequency of linezolid-associated thrombocytopenia and anemia among patients with end-stage renal disease. Clin Infect Dis Off Publ Infect Dis Soc America 2006, 1; 42 (1): 66-72
38. Narita M, Tsuji BT, Yu VL. Linezolid-associated peripheral and optic neuropathy, lactic acidosis, and serotonin syndrome. Pharmacotherapy. 2007; 27 (8): 1189-1197.
39. De Bus L, Depuydt P, Libbrecht L., et al. Severe drug-induced liver injury associated with prolonged use of linezolid. J Med Toxicol: Off J Am Coll Med Toxicol. 2010; 6 (3): 322-326.
40. Douros A, Bronder E, Andersohn F., et al. Drug-induced liver injury: results from the hospital-based Berlin case-control surveillance study. Br J Clin Pharmacol. 2015; 79 (6): 988-999.
41. Prokocimer P, De Anda C, Fang E., et al. Tedizolid phosphate vs linezolid for treatment of acute bacterial skin and skin structure infections: the ESTABLISH-1 randomized trial. Jama. 2013; 309 (6): 559-569.
42. FDA-Safety warning on linezolid-associated hypoglycaemia. 28 Mar 2012 [ cited 30 Jun 2015[. Available from: http://www.fda.gov/Safety/MedWatch/SafetyInformation/ucm295978.htm
43. Bodnar T, Starr K, Halter JB. Linezolid-associated hypoglycemia in a 64-year-old man with type 2 diabetes. Am J Geriat Pharmacother. 2011; 9 (1): 88-92.
44. Viswanathan P, Iarikov D, Wassel R., et al. Hypoglycemia in patients treated with linezolid. Clin Infect Dis Off Publ Infect Dis Soc America. 2014; 59 (8): e93-5.
45. Parker RM. Reproductive toxicity testing-methodology. In: Hood RD., editor. Developmental and reproductive toxicology-a practical approach. 3rd ed. London, UK: Informa Healthcare; 2012. p. 870.
46. Martin JH, Ferro A. From an evolutionary perspective, all new antimicrobial targets are old: time to think outside the box. Br J Clin Pharmacol. 2015; 79 (2): 165-167.
47. Pollack CV Jr., Amin A, Ford WT Jr., et al. Acute bacterial skin and skin structure infections (ABSSSI): practice guidelines for management and care transitions in the emergency department and hospital. J Emerg Med. 2015; 48 (4): 508-519.
48. Moran GJ, Fang E, Corey GR., et al. Tedizolid for 6 days versus linezolid for 10 days for acute bacterial skin and skin-structure infections (ESTABLISH-2): a randomised, double-blind, phase 3, non-inferiority trial. Lancet Infect Dis. 2014; 14 (8): 696-705.
49. Anger HA, Dworkin F, Sharma S., et al. Linezolid use for treatment of multidrug-resistant and extensively drug-resistant tuberculosis, New York City, 2000-06. J Antimicrob Chemother. 2010; 65 (4): 775-783.
50. Peyrani P, Wiemken TL, Kelley R., et al. Higher clinical success in patients with ventilator-associated pneumonia due to methicillin-resistant Staphylococcus aureus treated with linezolid compared with vancomycin: results from the IMPACT-HAP study. Crit Care. 2014; 18 (3): R118.
51. Rubinstein E, Cammarata S, Oliphant T., et al. Linezolid (PNU-100766) versus vancomycin in the treatment of hospitalized patients with nosocomial pneumonia: a randomized, double-blind, multicenter study. Clin Infect Dis Off Publ Infect Dis Soc America. 2001; 32 (3): 402-412.
52. Wunderink RG, Niederman MS, Kollef MH., et al. Linezolid in methicillin-resistant Staphylococcus aureus nosocomial pneumonia: a randomized, controlled study. Clin Infect Dis Off Publ Infect Dis Soc America 2012, 1; 54 (5): 621-629
53. Stevens DL, Herr D, Lampiris H., et al. Linezolid versus vancomycin for the treatment of methicillin-resistant Staphylococcus aureus infections. Clin Infect Dis Off Publ Infect Dis Soc America. 2002; 34 (11): 1481-1490.
54. Flanagan S, Fang E, Munoz KA., et al. Single-and multiple-dose pharmacokinetics and absolute bioavailability of tedizolid. Pharmacotherapy. 2014; 34 (9): 891-900.
55. Bolhuis MS, Van Altena R, Uges DR., et al. Clarithromycin significantly increases linezolid serum concentrations. Antimicrob Agents Chemother. 2010; 54 (12): 5418-5419.
56. Bolhuis MS, van Altena R, van Soolingen D., et al. Clarithromycin increases linezolid exposure in multidrug-resistant tuberculosis patients. Eur Respir J. 2013; 42 (6): 1614-1621.
57. Egle H, Trittler R, Kummerer K., et al. Linezolid and rifampin: drug interaction contrary to expectations? Clin Pharmacol Ther. 2005; 77 (5): 451-453.
58. Gebhart BC, Barker BC, Markewitz BA. Decreased serum linezolid levels in a critically ill patient receiving concomitant linezolid and rifampin. Pharmacotherapy. 2007; 27 (3): 476-479.
59. Hoyo I, Martinez-Pastor J, Garcia-Ramiro S., et al. Decreased serum linezolid concentrations in two patients receiving linezolid and rifampicin due to bone infections. Scand J Infect Dis. 2012; 44 (7): 548-550.
60. Pea F, Cadeo B, Cojutti PG., et al. Linezolid underexposure in a hypothyroid patient on levothyroxine replacement therapy: a case report. Ther Drug Monit. 2014; 36 (5): 687-689.
61. Sakai Y, Naito T, Arima C., et al. Potential drug interaction between warfarin and linezolid. Intern Med. 2015; 54 (5): 459-464.