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Pharmacokinetics of Famotidine in Patients with Cystic Fibrosis

Department of Clinical Pharmacy Services, Loyola University Medical Center, Maywood, Illinois; Department of Pharmacy Practice, University of Illinois at Chicago College of Pharmacy, Little Rock, Arkansas; Arkansas Children's Hospital, Little Rock, Arkansas

Michael M. McCubbin, MD

Departments of Pediatrics, Little Rock, Arkansas; University of Missouri-Kansas City, Kansas City, Missouri; the Sections of Pediatric Pulmonology, Little Rock, Arkansas; Arkansas Children's Hospital, Little Rock, Arkansas

Lynda G. Letzig, BA

The Children's Mercy Hospital, Kansas City, Missouri; Department of Pediatrics, University of Arkansas for Medical Sciences, Little Rock, Arkansas; Sections of Pediatric Clinical Pharmacology and Toxicology, Little Rock, Arkansas; Arkansas Children's Hospital, Little Rock, Arkansas

Henry C. Farrar, III, MD

The Children's Mercy Hospital, Kansas City, Missouri; Department of Pediatrics, University of Arkansas for Medical Sciences, Little Rock, Arkansas; Sections of Pediatric Clinical Pharmacology and Toxicology, Little Rock, Arkansas; Emergency Medicine, Little Rock, Arkansas; Arkansas Children's Hospital, Little Rock, Arkansas

Gregory L. Kearns, PharmD, FCP

Departments of Pediatrics, Little Rock, Arkansas; Departments of Pharmacology, Little Rock, Arkansas; Clinical Pharmacology and Experimental Therapeutics, Little Rock, Arkansas; Arkansas Children's Hospital, Little Rock, Arkansas

Famotidine pharmacokinetics were studied in 13 patients with severe cystic fibrosis (CF) ranging from 10 to 47 years of age and 25 to 72 kg in weight. Patients were randomized to first receive famotidine either 20 mg intravenously or 40 mg orally. Twelve patients were crossed over to the altenate treatment. Repeated blood samples were obtained over 12 hours after intravenous and oral administration and urine was collected over 24 hours for quantitation of famotidine by means of high-performance liquid chromtography (HPLC). A compartment model-dependent aproach was used to characterize the disposition of famtidine. From the intravenous data, the mean + standard deviation elimination half-life (t,2) was 2.1 0.75 hours, the total clearance (Cl) was0.79 0.41 L/kg/hr, the renal clearance was 0.57 + 0.26 L/kg/hr, the fraction elimninated unchanged in the urine was 83 16%, and the apparent volume of distribution (Vds) was 1.33 0.53 L/kg. The bioavailability determined from comparison of intravnous and oral area under the curve data was 71 27%. Results of this study support an initial famotidine dose of 20 mg intravenously or 40 mg orally every 12 hours in patients with CF who are older than 9 years of age.

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				H. D. Maples, L. P. James, C. D. Stowe, D. P. Jones, E. B. Hak, J. L. Blumer, B. Vogt, J. T. Wilson, G. L. Kearns, T. G. Wells, et al. Famotidine Disposition in Children and Adolescents with Chronic Renal Insufficiency J. Clin. Pharmacol., January 1, 2003; 43(1): 7 - 14. [Abstract] [Full Text] [PDF]