Apnea is experienced by about 10 to 12% of neonates with congenital heart defects treated with PROSTIN VR PEDIATRIC Sterile Solution. Apnea is most often seen in neonates weighing less than 2 kg at birth and usually appears during the first hour of drug infusion. Therefore, respiratory status should be monitored throughout treatment, and PROSTIN VR PEDIATRIC should be used where ventilatory assistance is immediately available.
Prostin VR Pediatric®
alprostadil injection, USP
PROSTIN VR PEDIATRIC Sterile Solution for intravascular infusion contains 500 micrograms alprostadil, more commonly known as prostaglandin E1, in 1.0 mL dehydrated alcohol.
PROSTIN VR PEDIATRIC Sterile Solution is indicated for palliative, not definitive, therapy to temporarily maintain the patency of the ductus arteriosus until corrective or palliative surgery can be performed in neonates who have congenital heart defects and who depend upon the patent ductus for survival. Such congenital heart defects include pulmonary atresia, pulmonary stenosis, tricuspid atresia, tetralogy of Fallot, interruption of the aortic arch, coarctation of the aorta, or transposition of the great vessels with or without other defects.
In infants with restricted pulmonary blood flow, the increase in blood oxygenation is inversely proportional to pretreatment pO2 values; that is, patients with low pO2 values respond best, and patients with pO2 values of 40 torr or more usually have little response.
PROSTIN VR PEDIATRIC should be administered only by trained personnel in facilities that provide pediatric intensive care.
Published Studies Related to Prostin VR Pediatric (Alprostadil)
[Clinical effects of alprostadil injection on acute kidney injury after cardiac surgical procedures]. [2010.08.24]
OBJECTIVE: To explore the clinical effects of alprostadil injection on acute kidney injury (AKI) after cardiac surgical procedures by a prospective randomized controlled trial... CONCLUSION: On the basis of routine therapy, alprostadil injection may promote the recovery of renal function in AKI-patients after cardiac surgical procedures.
Recovery of erectile function after nerve sparing radical prostatectomy and penile rehabilitation with nightly intraurethral alprostadil versus sildenafil citrate. [2010.06]
PURPOSE: To our knowledge we report the first large, randomized, prospective penile rehabilitation clinical trial to compare the effectiveness of nightly intraurethral alprostadil vs sildenafil citrate after nerve sparing prostatectomy... CONCLUSIONS: This is the first study to directly compare the ability of alprostadil and a phosphodiesterase-5 inhibitor to enhance penile recovery subsequent to bilateral nerve sparing radical prostatectomy. The use of nightly subtherapeutic intraurethral alprostadil is well tolerated after radical prostatectomy. The benefit to return of erectile function of nightly sildenafil citrate and subtherapeutic intraurethral alprostadil appears to be comparable within the first year of surgery. Copyright 2010 American Urological Association Education and Research, Inc. Published by Elsevier Inc. All rights reserved.
Long-term, multicenter study of the safety and efficacy of topical alprostadil cream in male patients with erectile dysfunction. [2009.02]
INTRODUCTION: Alprostadil is approved for treatment of male erectile dysfunction (ED) by injection or urethral insertion. Topical delivery of alprostadil offers an improved alternative. AIM: To evaluate the long-term safety and efficacy of topical alprostadil cream... CONCLUSIONS: Topical alprostadil cream was considered effective and safe by most patients and their partners, with most AEs limited to the application site. Dose adjustment to 300 mcg alprostadil facilitated the greatest improvement in erectile function in the majority of patients. A separate report will integrate patient data from the open-label extension and prior double-blind studies.
[Effects of alprostadil and ulinastatin on inflammatory response and lung injury after cardiopulmonary bypass in pediatric patients with congenital heart diseases] [2008.11.11]
OBJECTIVE: To investigate the therapeutic effects of alprostadil (Lipo-PGE1) and Ulinastatin on inflammatory response and lung injury after cardiopulmonary bypass (CPB) in pediatric patients with congenital heart diseases... CONCLUSION: Decreasing the inflammatory response after CPB, alprostadil and ulinastatin used during CPB effectively reduce the pulmonary injury via inhibition of the neutrophil activation and cytokines release.
Injection therapy for the treatment of erectile dysfunction: a comparison between alprostadil and a combination of vasoactive intestinal polypeptide and phentolamine mesilate. [2007.10]
OBJECTIVE: To compare two injectable treatments, alprostadil 5-20 microg powder for injection and a combination of vasoactive intestinal polypeptide (VIP) and phentolamine in patients with erectile dysfunction (ED)... CONCLUSIONS: VIP/phentolamine and alprostadil were effective treatments for ED, however the VIP/phentolamine combination was preferred by more patients, which may be because it was much less likely to cause pain.
Clinical Trials Related to Prostin VR Pediatric (Alprostadil)
Combined Agent Randomized Trial of Induction of Labor [Completed]
To compare sequential dinoprostone and oxytocin for induction of labor at term with intact
membranes and an unripe cervix to two simultaneous regimens. Our aim was to confirm findings
from smaller trials and add to data on fetal safety.
Trial Of Misoprostol And Dinoprostone Vaginal Pessaries for Cervical Priming (TROMAD Study) [Completed]
Most studies of labour induction with misoprostol used doses higher than 25mg and intervals
of 3-4 hours. We studied a low-dose regime of 25mg misoprostol and compared its efficacy as
single dose or double dose with dosing interval of 6 hours to our current regime of 3 mg
Comparing the Effect of Vaginal Misoprostol With Dinoprostone in Term Pregnancies [Not yet recruiting]
Safety/Efficacy Study Comparing the Misoprostol Vaginal Insert to Cervidil for Cervical Ripening and Induction of Labor [Completed]
The purpose of this study is to determine whether the misoprostol vaginal insert (50 mcg and
100 mcg) can safely and effectively speed time to vaginal delivery compared to Cervidil (R)
in women who need to have their labor induced.
Cervical Ripening Before Induction of Labour at Term: a Randomised Comparison of Prostin vs Propess [Completed]
The aim of this study is to compare two different preparation
Page last updated: 2011-12-09