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Adverse Reactions to Antibiotics in the Critical Care Unit
Published in Cheston B. Cunha, Burke A. Cunha, Infectious Diseases and Antimicrobial Stewardship in Critical Care Medicine, 2020
Diane M. Parente, Cheston B. Cunha, Michael Lorenzo
Serotonin toxicity is due to impaired serotonin metabolism and is characterized by agitation, neuromuscular hyperactivity, fever, hypotension, and even death. Linezolid is a weak, reversible inhibitor of monoamine oxidase. Using linezolid in combination with other monoamine oxidase inhibitors can potentially cause serotonin toxicity. A small percentage (<5%) of patients on selective serotonin reuptake inhibitors who are given linezolid develop serotonin toxicity [109–112]. Serotonin toxicity is reversible on discontinuation of the offending agents. Onset and recognition of serotonin toxicity in published cases range from 30 minutes to 21 days from the combination of linezolid and serotonergic agents [113,114]. The average time to symptom resolution is 48 hours and ranges from 2 hours to 9 days. Unlike linezolid, tedizolid does not appear to markedly inhibit monoamine oxidase and, therefore, may not have clinically important interactions with serotonergic agents. However, in phase III clinical trials evaluating tedizolid, patients on serotonergic agents were not included. Hence, clinicians should proceed with caution until more evidence is available when using tedizolid with serotonergic agents.
Tedizolid
Published in M. Lindsay Grayson, Sara E. Cosgrove, Suzanne M. Crowe, M. Lindsay Grayson, William Hope, James S. McCarthy, John Mills, Johan W. Mouton, David L. Paterson, Kucers’ The Use of Antibiotics, 2017
Tedizolid has undergone a number of pharmacodynamic evaluations for antibacterial effect. These will be divided into two groups: murine thigh infection models as a surrogate for ABSSSI and murine pneumonia models as a surrogate for HABP.
Serious adverse events with tedizolid and linezolid: pharmacovigilance insights through the FDA adverse event reporting system
Published in Expert Opinion on Drug Safety, 2021
Milo Gatti, Michele Fusaroli, Emanuel Raschi, Ugo Moretti, Elisabetta Poluzzi, Fabrizio De Ponti
Overall, proportion of concomitant septic shock or multi-organ failure for selected AEs reported in at least three cases with tedizolid was 16.4%, being the greatest for hepatic failure (100.0%). Concomitant drugs potentially implicated in the selected AEs were retrieved in all cases of serotonin syndrome, and in 66.7% of reports mentioning bone marrow failure. Skin and soft tissue infections accounted only for 16.4% of reported indications, while off-label therapeutic use was performed in 83.6% of cases, being mycobacterial infections (26.2%) and osteomyelitis/joint infections (14.8%) the most frequent. Median onset ranged from 3.5 days for serotonin syndrome to 21 days for neuropathy peripheral, being longer than approved 6 days for eight out of nine investigated AEs. Tedizolid was mainly administered orally (79.5%), being the approved dosage of 200 mg/day used in 97.0% of cases. Dechallenge was performed in 18.7% of overall cases, ranging from 0.0% in hepatic failure to 100.0% in pancytopenia. The overall proportion of deaths was 13.1%, showing lactic acidosis (50.0%) and hepatic failure (100.0%) the highest mortality (Table 2). Clinical features of selected AEs reported with tedizolid and linezolid are showed in Table 3.
Construction and evaluation in vitro and in vivo of tedizolid phosphate loaded cationic liposomes
Published in Journal of Liposome Research, 2018
Zhenlei Yang, Liu Tian, Jingjing Liu, Guihua Huang
Tedizolid phosphate, as the prodrug of tedizolid, will be converted to tedizolid by phosphatase after administration (Shaw and Barbachyn 2011, Rybak and Roberts 2015). Tedizolid is the second generation of oxazolidinone antibiotics and it is a protein synthesis inhibitor which plays an antibacterial effect through binding with 50 S subunit of bacterial ribosome to inhibit bacterial protein synthesis. And it is hard to give rise to cross-resistance with other types of antibiotics (Shaw and Barbachyn 2011, Kanafani and Corey 2012, Thomson and Goering 2013). Tedizolid phosphate has a longer half-life compared to linezolid (the first-generation oxazolidinone antibiotic). Clinical studies have shown that tedizolid has a better clinical efficacy and the treatment cycle is reduced by 40% compared with linezolid (Prokocimer et al.2013). However, tedizolid phosphate is unstable at room temperature, easy to hydrolyze, which results in the inconvenience of storage and transportation.
Clinical safety and tolerability of tedizolid phosphate in the treatment of acute bacterial skin and skin structure infections
Published in Expert Opinion on Drug Safety, 2018
Cathy Hardalo, Thomas P. Lodise, Monique Bidell, Shawn Flanagan, Carisa De Anda, Steven Anuskiewicz, Philippe Prokocimer
The most common drug-related AEs with tedizolid in phase 2/3 were nausea, diarrhea, vomiting, dizziness, and headache (Table 2). Drug-related AEs led to treatment discontinuation in only 3/925 (0.3%) of patients treated with tedizolid and 5/662 (0.8%) of those treated with linezolid. The great majority of tedizolid-related AEs were mild to moderate in intensity, and all tedizolid-related AEs for which information on resolution was available were eventually considered resolved by the investigator (Supplementary Table 6). In total, 193/925 (20.9%) of phase 2/3 patients receiving tedizolid had at least one mild drug-related AE and 32/925 (3.5%) at least one moderate drug-related AE; 2/925 (0.2%) patients reported a total of 2 severe drug-related AEs, i.e. insomnia and nausea. Two phase 2/3 participants on tedizolid (both elderly with multiple comorbidities) suffered an AE leading to death; these AEs were unrelated to study drug, i.e. septic shock in one and myocardial infarction in the other patient. One linezolid-treated patient (with HIV infection and very low CD4+ cell counts) died due to tuberculous meningitis unrelated to study drug.