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    Online Resource
    Online Resource
    Oxford University Press (OUP) ; 2024
    In:  Journal of Antimicrobial Chemotherapy Vol. 79, No. 3 ( 2024-03-01), p. 589-594
    In: Journal of Antimicrobial Chemotherapy, Oxford University Press (OUP), Vol. 79, No. 3 ( 2024-03-01), p. 589-594
    Abstract: Amoxycillin/clavulanic acid is the most common antimicrobial cause of drug-induced liver injury in adults. It is a less common cause of severe drug-related hepatotoxicity in children despite its frequent use. We studied the incidence, characteristics and predictive factors for amoxycillin/clavulanic acid hepatoxicity in children. Design Retrospective cohort study of children who received oral or intravenous amoxycillin/clavulanic acid at a quaternary children’s hospital over a 5-year period. Children were included if they had liver function tests (LFTs) determined at baseline, during and within 3 months after the treatment course. Causality was assessed using the Naranjo criteria for adverse drug reactions and Roussel Uclaf Causality Assessment Method. Results Of 3271 children prescribed amoxycillin/clavulanic acid, 374 were included. Forty-nine (13%) had LFT abnormalities related to amoxycillin/clavulanic acid. Fourteen (3.6%) fulfilled Common Terminology Criteria for Adverse Events (CTCAE) grade 2 criteria with clinically significant hepatotoxicity. Age & lt;2 years, sepsis, post-gastrointestinal surgical indications, prolonged treatment course of & gt;7 days and higher cumulative amoxycillin ( & gt;10 g) and clavulanic acid dose ( & gt;1 g) were predictive of hepatotoxicity. The median time to resolution of LFT abnormalities was 4 weeks (range 3–7). Conclusions The incidence of amoxycillin/clavulanic acid related LFT abnormalities (CTCAE Grade 2 or above) in children was 3.6%. A prolonged treatment course & gt;7 days, high cumulative amoxycillin (10 g) and clavulanic acid ( & gt;1 g) doses, those aged & lt;2 years, and patients with sepsis or post-gastrointestinal surgery were predictive of a higher likelihood of abnormal LFTs. LFT monitoring should be considered in children receiving ≥7 days of treatment, particularly in those with other predisposing factors.
    Type of Medium: Online Resource
    ISSN: 0305-7453 , 1460-2091
    Language: English
    Publisher: Oxford University Press (OUP)
    Publication Date: 2024
    detail.hit.zdb_id: 1467478-6
    SSG: 15,3
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