Tedizolid Phosphate: A Comprehensive Review
Keywords:
Acute bacterial skin & skin structure infections, Analytical method development, Clinical trials, Methicillin-resistant Staphylococcus aureus, OxazolidinoneAbstract
Tedizolid phosphate is a highly effective antimicrobial therapy that is mainly used in the treatment of Acute Bacterial Skin and Skin Structure Infections (ABSSSI), particularly those involving Methicillin-Resistant Staphylococcus Sureus (MRSA) infections. The review systematically reviews its pharmacokinetics, pharmacodynamics, clinical efficacy, safety profile, and analytical techniques. Compared to its ancestor, linezolid, tedizolid has lower toxicity, a longer half-life, and enhanced in vitro activity. Tedizolid is a notable improvement in the therapy for ABSSSIs, thanks to its high oral bioavailability of 91%, once-daily dosing, and efficiency against drug-resistant gram-positive pathogens. Pharmacokinetic trials show that drug exposure is stable among different groups of patients with hepatic or renal impairment. Tedizolid was shown to be noninferior to linezolid by clinical studies like ESTABLISH-1 and ESTABLISH-2, which showed equivalent or superior clinical response rates with lower side effects, especially with respect to hematologic parameters. To determine stability and drug quantification, several analytical techniques like HPLC, UPLC-MS/MS, and TLC were used; out of these, the highest sensitivity and accuracy was seen for UPLC-MS/MS. Tedizolid phosphate was stable against thermal and photolytic stress but was shown to degrade in the presence of oxidative and hydrolytic stress. In summary, tedizolid phosphate is a worthwhile addition to the antimicrobial armamentarium, providing increased safety, efficacy, and dosing convenience. More research would be beneficial to investigate its use in various infectious disease scenarios and in immunocompromised patients.
References
Pollack CV, Amin A, Ford WT, Finley R, Kaye KS, Nguyen HH, et al. Acute Bacterial Skin and Skin Structure Infections (ABSSSI): Practice Guidelines for Management and Care Transitions in the Emergency Department and Hospital. The Journal of Emergency Medicine. 2015 Apr; 48(4):508–19. https://doi.org/10.1016/j.jemermed.2014.12.001
Shah M, Shah HD. Acute bacterial skin and skin structure infections: Current perspective. Indian. J. Dermatol. 2011 ;56(5):510-2. https://doi.org/10.4103/0019-5154.87134
Fala L. Sivextro (tedizolid phosphate) approved for the treatment of adults with acute bacterial skin and skin-structure infections. Am. Health Drug Benefits.2015; 8(Spec Feature):111. https://pmc.ncbi.nlm.nih.gov/articles/PMC4665048/
Golan Y. Current Treatment Options for Acute Skin and Skin-structure Infections. Clin. Infect .Dis. 2019; 68(Suppl 3):S206-S212. https://doi.org/10.1093/cid/ciz004
Pulido-Cejudo A, Guzmán-Gutierrez M, Jalife-Montaño A, Ortiz-Covarrubias A, Martínez-Ordaz JL, Noyola-Villalobos HF, et al. Management of acute bacterial skin and skin structure infections with a focus on patients at high risk of treatment failure. Ther. Adv. Infect. Dis. 2017; 4(5):143-161. https://doi.org/10.1177/2049936117723228
Shah M, Shah HD. Acute bacterial skin and skin structure infections: current perspective. Indian. J. Dermatol. 2011; 56(5):510-2. https://doi.org/10.4103/0019-5154.87134
Kaye KS, Petty LA, Shorr AF, Zilberberg MD. Current Epidemiology, Etiology, and Burden of Acute Skin Infections in the United States. Clin. Infect. Dis. 2019;68 (Suppl 3): S193-S199. https://doi.org/10.1093/cid/ciz002
Bassetti M, Castaldo N, Carnelutti A, Peghin M, Giacobbe DR. Tedizolid phosphate for the treatment of acute bacterial skin and skin-structure infections: an evidence-based review of its place in therapy. Core Evid. 2019; 14:31-40. https://doi.org/10.2147/ce.s187499
Clarridge KE, Chin SJ, Stone KD. Overview of FDA drug approval and labeling. The Journal of Allergy and Clinical Immunology: In. Practice. 2022; 10(12):3051-6. https://doi.org/10.1016/j.jaip.2022.09.005
Rybak JM, Roberts K. Tedizolid Phosphate: a Next-Generation Oxazolidinone. Infect. Dis. Ther. 2015; 4(1):1–14. https://doi.org/10.1007/s40121-015-0060-3
Iqbal K, Milioudi A, Wicha SG. Pharmacokinetics and Pharmacodynamics of Tedizolid. Clin. Pharmacokinet. 2022; 61(4):489-503. https://doi.org/10.1007/s40262-021-01099-7
Hall RG 2nd, Michaels HN. Profile of tedizolid phosphate and its potential in the treatment of acute bacterial skin and skin structure infections. Infect. Drug. Resist. 2015; 8:75-82. https://doi.org/10.2147/idr.s56691
Moaaz EM, Abdel-Moety EM, Rezk MR, Fayed AS. Stability-Indicating Determination of Tedizolid Phosphate in the Presence of its Active Form and Possible Degradants. J. Chromatogr. Sci. 2022; 60(1):51-60. https://doi.org/10.1093/chromsci/bmab045
Santini DA, Sutherland CA, Nicolau DP. Development of a high-performance liquid chromatography method for the determination of tedizolid in human plasma, human serum, saline and mouse plasma. J. Chromatogr. Sep. Tech. 2015; 6:270. https://doi.org/10.4172/2157-7064.1000270
Anerao A, Dighe V, John S, Pradhan N. Enantioseparation of Tedizolid phosphate by RP-HPLC, using ß-Cyclodextrin as a Chiral Mobile Phase Additive. J. Appl. Pharm. Sci. 2017;7(10):030-036. https://dx.doi.org/10.7324/JAPS.2017.71005
Alam P, Shakeel F, Alqarni MH, Foudah AI. A rapid and highly sensitive stability-indicating high-performance thin-layer chromatography technique for the determination of tedizolid phosphate with a classical univariate calibration. JPC-J. Planar. Chromat. 2021; 34:271–278. https://doi.org/10.1002/bmc.3749
Iqbal M. A highly sensitive and efficient UPLC-MS/MS assay for rapid analysis of tedizolid (a novel oxazolidinone antibiotic) in plasma sample. Biomed. Chromatogr. 2016;30(11):1750-1756. https://doi.org/10.1002/bmc.3749
Yu HC, Pan CW, Xie QP, Zheng Y, Hu YZ, Lin YM. Simultaneous determination of tedizolid and linezolid in rat plasma by ultra performance liquid chromatography tandem mass spectrometry and its application to a pharmacokinetic study. J. Chromatogr. B. 2016; 1011:94-8. https://doi.org/10.1016/j.jchromb.2015.12.056
Kalam MA, Iqbal M, Alshememry A, Alkholief M, Alshamsan A. UPLC-MS/MS assay of Tedizolid in rabbit aqueous humor: Application to ocular pharmacokinetic study. J. Chromatogr. B. 2021; 1171:122621. https://doi.org/10.1016/j.jchromb.2021.122985
Kai M, Tanaka R, Suzuki Y, Goto K, Ohchi Y, Yasuda N, et al. UHPLC-MS/MS method for simultaneous quantification of doripenem, meropenem, ciprofloxacin, levofloxacin, pazufloxacin, linezolid, and tedizolid in filtrate during continuous renal replacement therapy. J. Clin. Lab. Anal. 2023 ;37(1): e24815. https://doi.org/10.1002/jcla.24815
Tsuji Y, Numajiri M, Ogami C, Kurosaki F, Miyamoto A, Aoyama T, et al. Development of a simple method for measuring tedizolid concentration in human serum using HPLC with a fluorescent detector. Medicine (Baltimore). 2021;100(49):e28127. https://doi.org/10.1097/md.0000000000028127
Anerao A, Patil B, Jaguste R, Pradhan N. Determination of residual methyl iodide in tedizolid phosphate and alogliptin benzoate by static headspace gas chromatography with electron capture detection. Indian Drugs. 2017;54(11). https://doi.org/10.53879/id.54.11.11175
Alam P, Shakeel F, Alqarni MH, Foudah AI. A rapid and highly sensitive stability-indicating high-performance thin-layer chromatography technique for the determination of tedizolid phosphate with a classical univariate calibration. JPC - J Planar. Chromat. 2021;34(4):271–278. https://doi.org/10.1007/s00764-021-00104-w