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Population Pharmacokinetics of Amlodipine in Hypertensive Children and Adolescents

From the Division of Pediatric Nephrology, Children's Hospital at Montefiore/Albert Einstein College of Medicine, Bronx, New York (Dr Flynn); Division of Pediatric Nephrology, Columbus Children's Hospital, Ohio State University, Columbus, Ohio (Dr Nahata, Dr Mahan); and Division of Pediatric Nephrology and Hypertension, University of Texas Medical School, Houston, Texas (Dr Portman).

A population pharmacokinetic study was conducted in 74 hypertensive children (mean age 10.4 ± 4.4 years [mean ± SD]) receiving amlodipine (mean dose 0.17 ± 0.13 mg/kg/d) chronically. Multiple blood samples were obtained from each subject to characterize amlodipine pharmacokinetics. Plasma amlodipine concentrations were determined by liquid chromatography/mass spectrophotometry with multiple-reaction monitoring detection. Population pharmacokinetic analysis was performed using NONMEM. Amlodipine concentrations were similar in subjects dosed either once or twice daily. Amlodipine pharmacokinetics were well described by a 1-compartment model with first-order absorption and elimination. For a subject at the population median weight (45 kg), predicted apparent clearances (CL/F) were 23.7 L/h for males and 17.6 L/h for females, and the apparent volume of distribution (V/F) was 25.1 L/kg. Dosing frequency did not appear to affect amlodipine concentrations in children. Weight-adjusted CL/F and V/F of amlodipine in younger children were significantly greater than in older children, suggesting a need for higher doses when treating young children with amlodipine.

Key Words: Amlodipine • children • adolescents • hypertension • population pharmacokinetics

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