Volume 23, Issue 102 (7-2013)                   J Mazandaran Univ Med Sci 2013, 23(102): 9-17 | Back to browse issues page

XML Persian Abstract Print


Download citation:
BibTeX | RIS | EndNote | Medlars | ProCite | Reference Manager | RefWorks
Send citation to:

Rafati M R, Shiran M R, Badiee A, Rashidi Ghader F, Saeedi M. Determination of Pharmacokinetics Properties of Sildenafil Syrup in Pediatric Pulmonary Hypertension. J Mazandaran Univ Med Sci 2013; 23 (102) :9-17
URL: http://jmums.mazums.ac.ir/article-1-2389-en.html
Abstract:   (11523 Views)
Background and purpose: Pulmonary arterial hypertension (PAH) is a fatal disease affecting patients in all ages that could result in acute and chronic heart failure with high mortality rate. Oral sildenafil is approved to treat PAH in adults and recently in children. There are limited studies on the pharmacokinetics parameters of sildenafil, therefore, this study was designed to determine the pharmacokinetics properties of sildenafil syrup in pediatric pulmonary hypertension. Materials and methods: In this interventional open-label prospective study, 20 children aged between two months to 12 years with PAH were included. The patients received sildenafil syrup 0.5 mg/kg every 12 hour, which was increased to 2 mg/kg every 12 hour (if necessary) to control the pulmonary hypertension. Minimum treatment period was 12 weeks. A week after initiating therapy or dose change five plasma samples were obtained to determine the pharmacokinetic parameters of sildenafil. The samples were determined by HPLC and the data was analyzed using P-Pharm software. Results: Among the subjects, 17 including nine boys and eight girls completed the study. The mean of sildenafil dose was 1.6 mg/kg/day and the opened one-compartment was considered as the best pharmacokinetic model. The sildenafil pharmacokinetic parameters were Cl=4.19±1.35L/h, t1/2=4.94±1.49h and Vd=27.86±7.39L. The most prevalent side effect of the drug was hot flash. Conclusion: Pharmacokinetic parameters of sildenafil in children with pulmonary hypertension were similar to adults. The patients easily tolerated sildenafil syrup and no severe or serious side effect was observed. Therefore, sildenafil could be considered as a safe and cheap drug to manage pediatric pulmonary hypertension.
Full-Text [PDF 232 kb]   (2727 Downloads)    
Type of Study: Research(Original) | Subject: Pharmacy

Add your comments about this article : Your username or Email:
CAPTCHA

Send email to the article author


Rights and permissions
Creative Commons License This work is licensed under a Creative Commons Attribution-NonCommercial 4.0 International License.

© 2024 CC BY-NC 4.0 | Journal of Mazandaran University of Medical Sciences

Designed & Developed by : Yektaweb