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Famotidine Disposition in Children and Adolescents with Chronic Renal Insufficiency

From the University of Arkansas for Medical Sciences and Arkansas Children's Hospital, Little Rock, Arkansas (Dr. Maples, Dr. James, Dr. Stowe, Dr. Wells); University of Tennessee at Memphis and LeBonheur Children's Medical Center, Memphis, Tennessee (Dr. Jones, Dr. Hak); Case Western Reserve University and Rainbow Babies and Children's Hospital, Cleveland, Ohio (Dr. Blumer, Dr. Vogt); Louisiana State University Health Services, Shreveport, Louisiana (Dr. Wilson); University of Missouri-Kansas City and Children's Mercy Hospital and Clinics, Kansas City, Missouri (Dr. Kearns); and National Institute of Child Health and Human Development (NICHD), National Institutes of Health, Bethesda, Maryland (Network of Pediatric Pharmacology Research Units).

The pharmacokinetics of intravenous famotidine (0.5 mg/kg, maximum 20 mg) were evaluated in 18 pediatric patients (ages 1-18 years) with stable, chronic renal insufficiency. Subjects were stratified by calculated creatinine clearance (Cl_cr) into mild (Cl_cr 50 to < 90 mL/min/1.73 m²), moderate (Cl_cr 25 to < 50 mL/min/1.73 m²), and severe (Cl_cr 10 mL/min/1.73 m²) renal insufficiency groups. Significant differences between the mild, moderate, and severe groups were found for elimination rate (K_el), apparent elimination half-life (t_1/2), area under the curve (AUC), and total plasma clearance (Cl_p) (p < 0.01). Famotidine renal clearance (Cl_r) was found to be significantly different between the mild and severe groups (p < 0.05). A linear relationship was observed between Cl_cr and Cl_p (p < 0.0001; R² = 0.70). No significant differences in nonrenal clearance (Cl_nr) were found between groups; however, Cl_nr as a percentage of Cl_p was significantly different in the severe group (92.9% ± 7.3% Cl_nr) compared to the combined mild and moderate groups (21.9% ± 45.6% Cl_nr) (p < 0.05). It was concluded that the pharmacokinetics of famotidine are significantly altered in children with chronic renal insufficiency; accordingly, dosing should be based on glomerular filtration rate (i.e., Cl_cr).

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