Lactic acidosis associated with standard dose linezolid in a kidney recipient with impaired renal function

Chen, Chien‐Chou; Liu, Wei-Ting; Lin, Shih‐Hua

doi:10.1016/j.bjid.2021.101701

Cited by 4 publications

(2 citation statements)

References 21 publications

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“…Cheng et al reported a patient with severe hepatic disease (Child-Pugh class C) and renal failure necessitating intermittent hemodialysis treated with a standard dose of linezolid 600 mg twice daily who developed lactic acidosis. 44 The linezolid trough concentration was markedly elevated to 49 mg/L. Drug cessation and reintroduction at lower doses resulted in resolution of the lactic acidosis.…”

Section: Linezolid Underexposure: Missing From the Pimentioning

confidence: 98%

Why Product Information Should not be Set in Stone: Lessons from a Decade of Linezolid Therapeutic Drug Monitoring: An Opinion Paper

Marriott

Cattaneo

2023

Therapeutic Drug Monitoring

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WHAT IS 'PRODUCT INFORMATION'?The "product information" (PI) for a medicine contains the documents providing officially approved information for health care professionals and patients. The regulatory agencies for drugs (eg, the European Medicines Agency, the Food and Drug Administration, Therapeutic Goods of Australia) provide guidance and templates to give marketing authorization applicants practical advice on how to develop the PI for human medicines. A summary of the product characteristics, labelling, and package leaflets is included.The information in a PI document is written by the pharmaceutical company responsible for the medicine and approved by regulatory agencies. It provides objective information regarding the quality, safety, and effectiveness of the medicine, as demonstrated in the data provided by the pharmaceutical company. This information is intended to assist physicians, pharmacists, and other health care professionals in prescribing and dispensing medicines. In addition, health professionals in their consultations with patients can use this information so that patients are better informed about their medicines.A list of information that should be contained in the PI is highlighted in the box below. CAN A PHARMACEUTICAL COMPANY ALTER THE PI AFTER A MEDICINE IS MARKETED?As discussed above, the information in a PI document is written by the pharmaceutical company responsible for the medicine, based on the results of phase I-III registration trials. However, it is widely recognized that pharmacological and clinical data (efficacy/safety) may change when a drug is administered in real-world clinical practice. This is in large part because most complex patients, such as the elderly, patients with comorbidities receiving polypharmacy, patients with impairment of the excretory organs, or those undergoing renal replacement therapy are usually excluded from phase I-III clinical trials. In real life, these patients generally have access to the medicine in question, generating novel pharmacokinetic/pharmacodynamic (PK/PD) data when appropriate research is undertaken with the potential to reverse the key concepts provided in the PI. In addition, regulatory agencies require phase I studies aimed at characterizing the pharmacokinetics and safety of a new drug, which is conducted in healthy volunteers and typically after a single-dose administration. This is poorly representative of real-life scenarios in clinical practice and is an additional limitation to the applicability of the PI to all patients receiving a drug.In general, researchers who are independent of the pharmaceutical company that marketed the drug generate most of the data pertaining to a drug in real-life settings. It is presently unclear who should undertake periodic revisions of the PI, taking into consideration new evidence reported in the literature. If new data are generated during patent coverage, the pharmaceutical company responsible for the marketing of the medicine is expected to submit amended versions of the PI to regulatory agenci...

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Section: Linezolid Underexposure: Missing From the Pimentioning

confidence: 98%

Why Product Information Should not be Set in Stone: Lessons from a Decade of Linezolid Therapeutic Drug Monitoring: An Opinion Paper

Marriott

Cattaneo

2023

Therapeutic Drug Monitoring

View full text Add to dashboard Cite

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“…Dose reduction is required in patients with renal impairment to avoid myelosuppression and lactic acidosis [87 ▪▪ ,88]. Thrombocytopenia has been reported when linezolid trough concentrations exceed 7–10 mg/l or a 24-h AUC of 300–350 mg∗h/l, especially when used for prolonged periods (e.g.…”

Section: Linezolidmentioning

confidence: 99%

Optimal drug therapy for Staphylococcus aureus bacteraemia in adults

Legg,

Davis,

Roberts

2023

Current Opinion in Critical Care

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Purpose of review Staphylococcus aureus is a significant human pathogen, causing a variety of infections, from skin and soft tissue infections to endocarditis, bone and joint infections and deep tissue abscesses. Mortality from S. aureus bacteraemia remains high, without major therapeutic advances in recent decades. Recent findings In recent years, optimized dosing of antibiotics is increasingly being recognized as a cornerstone of management for severe infections including S. aureus bacteraemia. This comprehensive review details the pharmacokinetics/pharmacodynamics (PK/PD) targets for commonly used antistaphylococcal antibiotics and the doses predicted to achieve them in clinical practice. Recent advances in dosing of teicoplanin and use of cefazolin in CNS infections and findings from combination therapy studies are discussed. Drug exposure relationships related to toxicity are also detailed. Summary This review details the different PK/PD targets for drugs used to treat S. aureus bacteraemia and how to apply them in various scenarios. The drug doses that achieve them, and the risks of toxicity are also provided.

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Azithromycin/linezolid interaction

2022

Reactions Weekly

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Lactic acidosis associated with standard dose linezolid in a kidney recipient with impaired renal function

Cited by 4 publications

References 21 publications

Why Product Information Should not be Set in Stone: Lessons from a Decade of Linezolid Therapeutic Drug Monitoring: An Opinion Paper

Why Product Information Should not be Set in Stone: Lessons from a Decade of Linezolid Therapeutic Drug Monitoring: An Opinion Paper

Optimal drug therapy for Staphylococcus aureus bacteraemia in adults

Azithromycin/linezolid interaction

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