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The Pharmacokinetics of Irbesartan in Hypertensive Children and Adolescents
Author(s) -
Sakarcan Abdullah,
Tenney Frank,
Wilson John T.,
Stewart John J.,
Adcock Kim G.,
Wells Thomas G.,
Vachharajani Nimish N.,
Hadjilambris Ophelia W.,
Slugg Peter,
Ford Neville F.,
Marino Maria R.
Publication year - 2001
Publication title -
the journal of clinical pharmacology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.92
H-Index - 116
eISSN - 1552-4604
pISSN - 0091-2700
DOI - 10.1177/00912700122010645
Subject(s) - irbesartan , hydrochlorothiazide , medicine , pharmacokinetics , blood pressure , dosing , nifedipine , plasma concentration , pharmacology , urology , calcium
An open‐label study was conducted to characterize the pharmacokinetics and antihypertensive response to irbesartan in children (1–12 years) and adolescents (13–16 years) with hypertension. Patients received single once‐daily oral doses of irbesartan 2 mg/kg (maximum of 150 mg once daily) for 2 to 4 weeks (nifedipine or hydrochlorothiazide). Plasma irbesartan concentrations were determined by a validated high‐performance liquid chromatography/fluorescence method from blood samples taken predose, up to 24 hours after dosing on Day1, and up to 48 hours after the final dose. The plasma concentration‐time profiles were similar between the 6‐ to 12‐year and the 13‐ to 16‐year age groups and to that previously determined from a study of adult subjects receiving 2 mg/kg (i.e., 150 mg) oral irbesartan once daily. Mean reductions in systolic/diastolic blood pressure were 16/10 mmHg at Day 28 with irbesartan monotherapy (n = 8). Irbesartan was well tolerated and maybe a treatment option for pediatric hypertensive patients.