WARNING
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.
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SUMMARY
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.
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NEWS HIGHLIGHTS
Published Studies Related to Prostin VR Pediatric (Alprostadil)
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.
Effects of pentoxifylline and alprostadil on ocular hemodynamics in healthy humans. [2007.02]
PURPOSE: Alprostadil, a prostaglandin (PG)E(1) analogue and pentoxifylline, an alkylxanthine derivate, have been shown to exert vasodilatory effects in several vascular beds. The purpose of the present study was to investigate the effect of PGE(1) and pentoxifylline on the ocular circulation... CONCLUSIONS: PGE(1) did not alter the parameters of retinal or choroidal circulation in healthy subjects. Pentoxifylline increased FPA, but did not change choroidal blood flow as measured with laser Doppler flowmetry and did not affect retinal blood flow parameters. Accordingly, neither pentoxifylline nor PGE(1) appears to be suitable to improve ocular blood flow in healthy subjects. Whether long-term treatment with alprostadil would improve choroidal blood flow in patients with vascular disease remains to be established.
[Intraurethrally applicated alprostadil for the treatment of organic erectile dysfunction in practice: a multicenter clinical monitoring study (noninterventional investigation)] [2007]
In a multicenter clinical monitoring study (observation of use investigation according to 67.6 of the German Drug Law), which was conducted between 2003 and 2005 in 105 urological practices in 314 patients with organic erectile dysfunction (ED), efficacy, safety, convenience and acceptance of intraurethral administered alprostadil (CAS 745-65-3; MUSE - Medicated Urethral System for Erection) was studied...
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
dinoprostone pessary.
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
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Page last updated: 2009-10-20
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