Pharmacokinetics of amoxicillin in obese and nonobese subjects

Aims To compare the pharmacokinetics of amoxicillin (AMX) in obese and nonobese subjects, given as single dose 875‐mg tablets. Methods A prospective, single‐centre, open‐label, clinical study was carried out involving 10 nonobese and 20 obese subjects given a dose of an AMX 875‐mg tablet. Serial blo...

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Bibliographic Details
Published in:	British journal of clinical pharmacology Vol. 87; no. 8; pp. 3227 - 3233
Main Authors:	Soares, Ana Luiza P.P.d.P., Montanha, Maiara C., Alcantara, Conrado d.S., Silva, Sandra R.B., Kuroda, Cristina M., Yamada, Sérgio S., Nicacio, Antônio E., Maldaner, Liane, Visentainer, Jesui V., Simões, Caroline F., Locatelli, João Carlos, Lopes, Wendell A., Mazucheli, Josmar, Diniz, Andrea, Paixão, Paulo J.P.A., Kimura, Elza
Format:	Journal Article
Language:	English
Published:	England 01-08-2021
Subjects:	amoxicillin obesity pharmacokinetics pharmacokinetics amoxicillin obesity
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Summary:	Aims To compare the pharmacokinetics of amoxicillin (AMX) in obese and nonobese subjects, given as single dose 875‐mg tablets. Methods A prospective, single‐centre, open‐label, clinical study was carried out involving 10 nonobese and 20 obese subjects given a dose of an AMX 875‐mg tablet. Serial blood samples were collected between 0 and 8 hours after administration of AMX and plasma levels were quantified by liquid chromatography–tandem mass spectrometry. The pharmacokinetic parameters (PK) were calculated by noncompartmental analysis and means of the 2 groups were compared using Student t‐test. Analysis of correlation between covariates and PK was performed using Pearson's correlation coefficient. Results Ten nonobese subjects (mean age 30.6 ± 7.12 y; body mass index 21.56 ± 1.95 kg/m2) and 20 obese subjects (mean age 34.47 ± 7.03 y; body mass index 33.17 ± 2.38 kg/m2) participated in the study. Both maximum concentration (Cmax; 12.12 ± 4.06 vs. 9.66 ± 2.93 mg/L) and area under the curve (AUC)0‐inf (34.18 ± 12.94 mg.h/L vs. 26.88 ± 9.24 mg.h/L) were slightly higher in nonobese than in obese subjects, respectively, but differences were not significant. The volume of distribution (V/F) parameter was statistically significantly higher in obese compared to nonobese patients (44.20 ± 17.85 L vs. 27.57 ± 12.96 L). Statistically significant correlations were observed for several weight metrics vs. AUC, Cmax, V/F and clearance, and for creatinine clearance vs. AUC, Cmax and clearance. Conclusion In obese subjects, the main altered PK was V/F as a consequence of greater body weight. This may result in antibiotic treatment failure if standard therapeutic regimens are administered.
Bibliography:	Funding information The authors confirm that the PI for this paper is Sérgio Seiji Yamada and that he had direct clinical responsibility for the patients. Conselho Nacional de Desenvolvimento Científico e Tecnológico; Coordenação de Aperfeiçoamento de Pessoal de Nível Superior
ISSN:	0306-5251 1365-2125
DOI:	10.1111/bcp.14739