Pharmacokinetics of daily self-application of imiquimod 3.75% cream in adult patients with external anogenital warts.
J Clin Pharmacol
; 52(6): 828-36, 2012 Jun.
Article
en En
| MEDLINE
| ID: mdl-22232733
ABSTRACT
Imiquimod 3.75% cream is a new formulation intended for daily self-application. The objective of this study was to characterize serum imiquimod pharmacokinetics under maximal use conditions. Adults with ≥8 warts or total wart area ≥100 mm² applied up to 1 packet of imiquimod 3.75% cream (250 mg cream, 9.375 mg imiquimod) once daily for 3 weeks. Blood was obtained prior to doses 1, 7, 14, and 21 and at selected time points after doses 1 and 21. Eighteen patients (13 men and 5 women) with a median wart count of 16 and total wart area of 60 mm² were enrolled. Day 21 mean (SD) serum C(max) was 0.49 (0.37) ng/mL, AUC0â24 6.80 (3.59) ng·h/mL, and t(1/2) 24.1 (12.4) hours. Steady state was achieved by day 7 with ~2-fold increase in C(max) and AUC after multiple dosing. Overall, C(max) was higher and t(max) shorter in women, with comparable AUC0â24. Imiquimod metabolites were sporadically quantifiable. No patients discontinued for adverse events; 1 interrupted dosing for an application site ulcer. Treatment-related adverse events occurred in 16.7% of the patients. In conclusion, serum imiquimod concentrations were low after daily self-application to external anogenital warts of up to 1 packet of imiquimod 3.75% cream for 21 days.
Texto completo:
1
Colección:
01-internacional
Base de datos:
MEDLINE
Asunto principal:
Enfermedades del Ano
/
Verrugas
/
Condiloma Acuminado
/
Receptor Toll-Like 7
/
Aminoquinolinas
/
Factores Inmunológicos
Tipo de estudio:
Incidence_studies
/
Prognostic_studies
Idioma:
En
Revista:
J Clin Pharmacol
Año:
2012
Tipo del documento:
Article
País de afiliación:
Estados Unidos