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Pharmacokinetics and Safety of Tobramycin After Once-Daily Administration in Patients With Cystic Fibrosis

Richard D. Bates; Milap C. Nahata; James W. Jones; Karen McCoy; Gordon Young; Shareen Cox; William J. Barson
Author and Funding Information

Affiliations: From the College of Pharmacy, Ohio State University, the Department of Infectious Diseases, Wexner Institute for Pediatric Research, Children's Hospital, Columbus, Ohio,  From the Department of Pharmacy, Children's Hospital, Columbus, Ohio,  From the College of Medicine, Ohio Sate University, and the Department of Pulmonology, Children's Hospital, Columbus, Ohio,  From the Department of Laboratory Medicine, Children's Hospital, Columbus, Ohio,  From the College of Medicine, Ohio State University, the Department of Infectious Diseases, Wexner Institute for Pediatric Research, Children's Hospital, Columbus, Ohio

Affiliations: From the College of Pharmacy, Ohio State University, the Department of Infectious Diseases, Wexner Institute for Pediatric Research, Children's Hospital, Columbus, Ohio,  From the Department of Pharmacy, Children's Hospital, Columbus, Ohio,  From the College of Medicine, Ohio Sate University, and the Department of Pulmonology, Children's Hospital, Columbus, Ohio,  From the Department of Laboratory Medicine, Children's Hospital, Columbus, Ohio,  From the College of Medicine, Ohio State University, the Department of Infectious Diseases, Wexner Institute for Pediatric Research, Children's Hospital, Columbus, Ohio

Affiliations: From the College of Pharmacy, Ohio State University, the Department of Infectious Diseases, Wexner Institute for Pediatric Research, Children's Hospital, Columbus, Ohio,  From the Department of Pharmacy, Children's Hospital, Columbus, Ohio,  From the College of Medicine, Ohio Sate University, and the Department of Pulmonology, Children's Hospital, Columbus, Ohio,  From the Department of Laboratory Medicine, Children's Hospital, Columbus, Ohio,  From the College of Medicine, Ohio State University, the Department of Infectious Diseases, Wexner Institute for Pediatric Research, Children's Hospital, Columbus, Ohio

Affiliations: From the College of Pharmacy, Ohio State University, the Department of Infectious Diseases, Wexner Institute for Pediatric Research, Children's Hospital, Columbus, Ohio,  From the Department of Pharmacy, Children's Hospital, Columbus, Ohio,  From the College of Medicine, Ohio Sate University, and the Department of Pulmonology, Children's Hospital, Columbus, Ohio,  From the Department of Laboratory Medicine, Children's Hospital, Columbus, Ohio,  From the College of Medicine, Ohio State University, the Department of Infectious Diseases, Wexner Institute for Pediatric Research, Children's Hospital, Columbus, Ohio

Affiliations: From the College of Pharmacy, Ohio State University, the Department of Infectious Diseases, Wexner Institute for Pediatric Research, Children's Hospital, Columbus, Ohio,  From the Department of Pharmacy, Children's Hospital, Columbus, Ohio,  From the College of Medicine, Ohio Sate University, and the Department of Pulmonology, Children's Hospital, Columbus, Ohio,  From the Department of Laboratory Medicine, Children's Hospital, Columbus, Ohio,  From the College of Medicine, Ohio State University, the Department of Infectious Diseases, Wexner Institute for Pediatric Research, Children's Hospital, Columbus, Ohio


1997 by the American College of Chest Physicians


Chest. 1997;112(5):1208-1213. doi:10.1378/chest.112.5.1208
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Abstract

Study objective: Tobramycin is commonly used to treat respiratory tract infections in patients with cystic fibrosis. We designed a study to determine the pharmacokinetics and safety of once-daily dosing of tobramycin in this population.

Design: Multiple blood samples were collected from each patient, and serum concentrations of tobramycin were determined by a fluorescence polarization immunoassay. Blood urea nitrogen and serum creatinine levels were measured every 2 to 3 days, and audiometric evaluations were performed at the start and end of therapy.

Measurements and results: Eighteen patients (mean age, 24.6 years) received tobramycin at doses of 7 to 15 mg/kg/d as a single-dose infusion over 20 min. The maximum serum concentration of tobramycin ranged from 40.1 to 64.6 mg/L. A mean dose of 11.9±1.9 mg/kg was needed to obtain a theoretical mean peak serum concentration of 42.4±4.5 mg/L. The mean total body clearance, apparent volume of distribution, and elimination half-life was 1.7±0.4 mL/min/kg, 0.27±0.06 L/kg, and 1.8±0.3 h, respectively. The period of time that the serum concentration exceeded eight times the theoretical minimum inhibitory concentration of 1 mg/L ranged from 2.1 to 4.4 h, which was nearly five times longer compared with the use of divided daily doses in the same patients during previous hospitalizations. No nephrotoxicity, ototoxicity, or adverse effects occurred in any patient.

Conclusion: Based on our data, tobramycin may be used safely in once-daily doses to treat exacerbations of respiratory tract infections in patients with cystic fibrosis.


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