Pharmacokinetics of valsartan in pediatric and adolescent subjects with hypertension.
An open-label, single-dose study is conducted in 26 children with hypertension to characterize the pharmacokinetics of valsartan. Valsartan is administered as an oral suspension (dose of 2 mg/kg), with the maximum single dose being 80 mg. Subjects are stratified into 4 age categories: group 1, 1 to less than 4 years; group 2, 4 to less than 6 years; group 3, 6 to less than 12 years; group 4, 12 to 16 years. Blood samples are collected before and for 24 hours after dosing to quantitate valsartan. Because the body weight of most children in groups 3 and 4 exceeds 40 kg and they received a dose of less than 2 mg/kg, major pharmacokinetic parameters are dose normalized for comparison across the age groups. Dose-normalized maximum plasma concentration and area under the plasma-concentration curve and body weight-normalized apparent oral clearance are comparable for the 4 groups (P > or = .1011). Body weight-normalized apparent oral clearance ranges from 0.061 to 0.089 L/h/kg.
Blumer
Jeffrey
J
Case Western Reserve University School of Medicine, Cleveland, OH 44106, USA. Jeffrey.Blumer@UHhospitals.org
Batisky
Donald L
DL
Wells
Thomas
T
Shi
Victor
V
Solar-Yohay
Susan
S
Sunkara
Gangadhar
G
D000284:Administration, Oral; D000293:Adolescent; D000367:Age Factors; D000959:Antihypertensive Agents / Q000493:pharmacokinetics* / Q000627:therapeutic use; D019540:Area Under Curve; D001835:Body Weight; D002648:Child; D002675:Child, Preschool; D004305:Dose-Response Relationship, Drug; D005260:Female; D006801:Humans; D006973:Hypertension / Q000188:drug therapy*; D007223:Infant; D008297:Male; D013777:Tetrazoles / Q000493:pharmacokinetics* / Q000627:therapeutic use; D014633:Valine / Q000031:analogs & derivatives* / Q000493:pharmacokinetics / Q000627:therapeutic use; D000068756:Valsartan
D000959:Antihypertensive Agents; D013777:Tetrazoles; D000068756:Valsartan; D014633:Valine