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- Title
Prostatic Pharmacokinetic/Pharmacodynamic Evaluation of Ampicillin‐Sulbactam for Bacterial Prostatitis and Preoperative Prophylaxis.
- Authors
Onita, Tetsushu; Ikawa, Kazuro; Nakamura, Kogenta; Nishikawa, Genya; Kobayashi, Ikuo; Ishihara, Noriyuki; Tamaki, Hiroki; Yano, Takahisa; Naora, Kohji; Morikawa, Norifumi
- Abstract
This study aims to define the penetration of ampicillin and sulbactam into prostate tissue, develop a prostatic pharmacokinetic model of each drug, and assess the appropriateness of ampicillin‐sulbactam regimens for the treatment of prostatitis and the prophylaxis of postoperative infection, based on a pharmacokinetic and pharmacodynamic simulation. Subjects were prostatic hyperplasia patients prophylactically receiving a 0.5‐hour infusion of 1.5 g (1:0.5 g) or 3 g (2:1 g) ampicillin‐sulbactam before transurethral resection of the prostate. Ampicillin and sulbactam concentrations in plasma and prostate tissue were measured. The prostate tissue/plasma ratios of both ampicillin and sulbactam were approximately 0.37 (area under the drug concentration‐time curve), and penetration was similar. The prostatic population pharmacokinetic model, which included a covariate analysis, adequately predicted prostate tissue concentrations in our patient population. For therapeutic use, aiming for a bactericidal target of 50% of time above minimum inhibitory concentration (T > MIC) in prostate tissue, 3 g ampicillin‐sulbactam 4 times daily achieved ≥90% expected probability against only Enterococcus faecalis in typical patients with a creatinine clearance (CLcr) of 30 mL/min. For prophylactic use, aiming for a bacteriostatic target of 30% T > MIC, 3 g ampicillin‐sulbactam 4 times daily achieved ≥90% expected probability of attaining the bacteriostatic target against E. faecalis and Proteus species when CLcr was 30 mL/min. Based on prostatic simulations, the present study provides helpful recommendations for the treatment of bacterial prostatitis and preoperative prophylaxis in prostatectomy.
- Subjects
TRANSURETHRAL prostatectomy; PROSTATITIS; PREOPERATIVE period; BLOOD plasma; PHARMACOKINETICS; ANTIBIOTIC prophylaxis; AMPICILLIN; BACTERIAL diseases; ANTIBIOTICS; CREATININE; PROBABILITY theory; PHARMACODYNAMICS
- Publication
Journal of Clinical Pharmacology, 2021, Vol 61, Issue 6, p820
- ISSN
0091-2700
- Publication type
Article
- DOI
10.1002/jcph.1800