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Original Research

Multiple-dose pharmacokinetics and safety of amoxicillin/clavulanate in healthy elderly subjects 

Sang Won Lee, Yewon Choi, Kyungho Jang, Seo Hyun Yoon, and Jae-Yong Chung

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Volume 58 (2020) p. 634 - 641

Abstract

International Journal of Clinical Pharmacology and Therapeutics, Vol. 58 – No. 11/2020 (634-641)

Multiple-dose pharmacokinetics and safety of amoxicillin/clavulanate in healthy elderly subjects 

Sang Won Lee¹, Yewon Choi², Kyungho Jang³, Seo Hyun Yoon¹, and Jae-Yong Chung⁴

¹Department of Clinical Pharmacology and Therapeutics, Seoul National University College of Medicine and Hospital, Seoul, Republic of Korea, ²Genosco Inc., Cambridge, MA, USA, ³Center for Clinical Pharmacology, Biomedical Research Institute, Chonbuk National University Hospital, Jeonju, Jeonbuk, and ⁴Department of Clinical Pharmacology and Therapeutics, Seoul National University College of Medicine and Bundang Hospital, Seongnam, Republic of Korea
Background: Amoxicillin/clavulanate is a widely used oral formulation of penicillin combined with a β-lactamase inhibitor. When using amoxicillin/clavulanate in the elderly, the risk of adverse drug reaction may be greater. This study aimed to evaluate the pharmacokinetics (PKs) and safety of multiple-dose amoxicillin/clavulanate administration in healthy elderly subjects and to compare the observed PK profiles with those in healthy younger adults. An open-label, one-sequence, multiple administration study was conducted in 16 healthy elderly subjects.
Materials and methods: Subjects orally received amoxicillin and clavulanate 750/187.5 twice daily for 9 days. For PK analysis, serial blood samples were collected up to 12 hours after the last administration of amoxicillin/clavulanate. The demographic and PK data of this study were compared to those of healthy young adults from a separate study with a similar design. Safety assessments including clinical laboratory tests, physical examination, vital signs, and adverse event (AE) monitoring were performed throughout the study.
Results: All AEs were mild, and no serious AEs were reported in this study. The systemic exposure of amoxicillin and clavulanate was ~ 90% and 60% higher, respectively, in the elderly subjects than in the younger subjects. However, the time required to reach maximum concentration at steady state and the elimination half-life were similar in the two age groups.
Conclusion: Although multiple administration of amoxicillin/clavulanate 750/187.5 mg was safe and well-tolerated, the systemic exposure of amoxicillin and clavulanate was higher in elderly subjects than in younger subjects.Correspondence to:
Jae-Yong Chung, MD, PhD 
Department of Clinical Pharmacology and Therapeutics
Seoul National University College of Medicine  and Bundang Hospital
Seongnam, Republic  of Korea
Email: [email protected]

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