Population pharmacokinetics of sildenafil in extremely premature infants.

ABSTRACT:

Aims

To characterize the population pharmacokinetics (PK) of sildenafil and its active metabolite, N-desmethyl sildenafil (DMS), in premature infants.

Methods

We performed a multicentre, open-label trial to characterize the PK of sildenafil in infants ≤28 weeks gestation and < 365 postnatal days (cohort 1) or < 32 weeks gestation and 3-42 postnatal days (cohort 2). In cohort 1, we obtained PK samples from infants receiving sildenafil as ordered per the local standard of care (intravenous [IV] or enteral). In cohort 2, we administered a single IV dose of sildenafil and performed PK sampling. We performed a population PK analysis and dose-exposure simulations using the software NONMEM®.

Results

We enrolled 34 infants (cohort 1 n = 25; cohort 2 n = 9) and collected 109 p

SUBMITTER: Gonzalez D 

PROVIDER: S-EPMC6955411 | biostudies-literature | 2019 Dec

REPOSITORIES: biostudies-literature