A multicenter study of the pharmacokinetics of lisinopril in pediatric patients with hypertension

Abstract

The pharmacokinetic (PK) parameters of lisinopril were obtained in 46 children aged 6 months to 15 years. A lisinopril suspension (0.15 mg/kg per day) was administered to patients <6 years of age; the remaining children received lisinopril tablets, the daily dose being adjusted according to body weight, i.e., 2.5 mg if <25 kg, 5 mg if 25-45 kg, and 10 mg if >45 kg. Blood was drawn predose and on eight occasions postdose in children aged 4-15 years, and on five occasions in those aged <4 years. PK data are reported for the 46 children in terms of age groups: Group I (n=9), aged 6-23 months; Group II (n=8), aged 2-5 years; Group III (n=12), aged 6-11 years; Group IV (n=17), aged 12-15 years. The dose of lisinopril ranged from 3.07 mg/m(2) per day in Group I to 4.78 mg/m(2) per day in Group IV. C(max) of lisinopril, which occurred 5-6 h postdose, varied from 22 ng/ml in Groups I and II to 44 ng/ml in Groups III and IV; AUC(0-24 h) ranged from 301-311 ng.h/ml in Groups I and II to 550-570 ng.h/ml in Groups III and IV. No serious adverse events related to lisinopril were reported.

Management of high blood pressure in children and adolescents: recommendations of the European Society of Hypertension

“…Some of these have been studied recently in children [120]. Placebo-controlled efficacy results are available for enalapril [131], fosinopril [132] and lisinopril [133], whereas pharmacokinetic studies have been carried out for enalapril [134], lisinopril [135] and quinapril [136]. The enalapril [131] and lisinopril [133] trials have established minimum effective doses of 0.08 mg/kg per day, but doses of 0.6 mg/kg per day were well tolerated.…”

Pharmacokinetics, Pharmacodynamics, and Safety of Lisinopril in Pediatric Kidney Transplant Patients: Implications for Starting Dose Selection

“…In adults, peak serum concentrations of lisinopril are seen ∼7 hours after oral dosing . The disposition of lisinopril in children is similar to adults, with peak concentrations observed within 6 hours after dosing and the extent of drug absorption ∼28% . The drug is not appreciably bound to plasma proteins and, thus, its disposition appears to be unaltered by low serum albumin levels .…”

Efficacy and safety of lisinopril for mild childhood IgA nephropathy: a pilot study

“…There is a possibility that the same result could be obtained with a lower dose or that at least the remission could be maintained for long-term treatment with a lower dose. In a multicenter study of the pharmacokinetics of lisinopril in 52 pediatric patients with hypertension, no serious adverse events related to lisinopril were reported [15]. These findings support the safety of lisinopril in children.…”