Clinical Significance of the Pharmacokinetic and Pharmacodynamic Characteristics of Tigecycline

Falagas, Matthew E.; Karageorgopoulos, Drosos E.; Dimοpoulos, George

doi:10.2174/138920009787048356

Cited by 56 publications

(28 citation statements)

References 71 publications

(147 reference statements)

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“…Although experts have warned that offlabel use of tigecycline is increasing globally, [8][9][10] the adverse events suggested here were in agreement with the prescribing information provided by the manufacturer, 11) suggesting that off-label use hardly results in unexpected adverse events, presumably due to usage with extreme caution.…”

Section: Discussionsupporting

confidence: 68%

“…[8][9][10] Prescribing information provided by the manufacturer suggests that this new drug is well-tolerated with mild-tomoderate gastrointestinal adverse events, including nausea, vomiting, and diarrhea. 11) However, extensive off-label use may affect the safety profile of tigecycline.…”

Section: -7)mentioning

confidence: 99%

“…Additionally, pharmacokinetics-pharmacodynamics considerations, i.e., comparisons between the usual minimum inhibitory concentration for pathogens and plasma concentration after intravenous infusion, strongly suggest the need for dose escalation. 1,9,12) This may also accelerate the off-label use of tigecycline.…”

Section: -7)mentioning

confidence: 99%

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Adverse Event Profile of Tigecycline: Data Mining of the Public Version of the U.S. Food and Drug Administration Adverse Event Reporting System

Kadoyama

Sakaeda

Tamon³

et al. 2012

Biological & Pharmaceutical Bulletin

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The recent emergence of multidrug-resistant pathogens and/or pharmacokinetics-pharmacodynamics considerations may result in off-label use of a certain class of antibacterials, including tigecycline. This study was performed to clarify the safety profile of tigecycline in the user-derived manner and to compare it with the prescribing information provided by the manufacturer. Numerous spontaneous adverse event reports (AERs) submitted to the U.S. Food and Drug Administration (FDA) were analyzed after a revision of arbitrary drug names and the deletion of duplicated submissions. Standardized official pharmacovigilance tools were used for quantitative detection of signals, i.e., drug-associated adverse events, including the proportional reporting ratio, the reporting odds ratio, the information component given by a Bayesian confidence propagation neural network, and the empirical Bayes geometric mean. Based on 22017956 co-occurrences, i.e., drug-adverse event pairs, found in 1644220 AERs from 2004 to 2009, 248 adverse events were suggested as tigecycline-associated ones. Adverse events with a relatively high frequency included nausea, vomiting, pancreatitis, hepatic failure, hypoglycemia, and increase in levels of alanine aminotransferase, bilirubin, alkaline phosphatase, aspartate aminotransferase, and gamma-glutamyltransferase. It is noted that cholestasis, jaundice, an increase in International Normalized Ratio, and Stevens-Johnson syndrome were also, although they were infrequent. The adverse events suggested were in agreement with information provided by the manufacturer, suggesting that off-label use hardly results in unexpected adverse events, presumably due to usage with extreme caution.

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Section: Discussionsupporting

confidence: 68%

Section: -7)mentioning

confidence: 99%

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Adverse Event Profile of Tigecycline: Data Mining of the Public Version of the U.S. Food and Drug Administration Adverse Event Reporting System

Kadoyama

Sakaeda

Tamon³

et al. 2012

Biological & Pharmaceutical Bulletin

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“…In this setting, the initial dose should be 100 mg followed by a reduced maintenance dose of 25 mg every 12 h. No dosage adjustments are necessary in patients with mild-to-moderate hepatic impairment. 8,9 Finally, dosage adjustments are not required for doripenem and ceftaroline in patients with hepatic impairment. 4,10 In conclusion, we hope that this additional information can be included in this practical guide and can be useful to clinicians in the management of antibiotic-resistant bacterial infections in cirrhotic patients.…”

Section: Letters To the Editorsmentioning

confidence: 99%