The Pharmacokinetics of Irbesartan in Hypertensive Children and Adolescents

Autor: Maria R. Marino, Frank Tenney, Peter H. Slugg, Neville F. Ford, John J. Stewart, Abdullah Sakarcan, Kim G. Adcock, Ophelia W. Hadjilambris, Nimish N. Vachharajani, John T. Wilson, Thomas G. Wells
Rok vydání: 2001
Předmět:
Zdroj: The Journal of Clinical Pharmacology. 41:742-749
ISSN: 0091-2700
DOI: 10.1177/00912700122010645
Popis: 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 Day 1, 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 approximately 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 may be a treatment option for pediatric hypertensive patients.
Databáze: OpenAIRE