- Dosages
- Side effects in children
- Warnings & precautions in children
- Contra-indications in children
-
Interactions - PK
- Renal impairment
- References
Pharmacokinetics in children
No information
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dose recommendation of formulary compared to licensed use (on-label versus off-label)
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Available formulations
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Dosages
| Keeping the ductus arteriosus open while waiting for an operation |
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Renal impaiment in children > 3 months
No information available on dose adjustment in renal impairment.
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The complete list of all undesirable drug reactions can be found in the national Summary of Product Characteristics (SmPC) – click here
Side effects in children
Very common (> 10%): apnea (especially in newborns weighing less than 2 kg and in the first hour after intravenous administration). Fever.
Common (1-10%): bradycardia, hypotension, tachycardia, cardiac arrest. Convulsions. Disseminated intravascular coagulation (DIC). Diarrhea. Superficial vasodilation (more common with intra-arterial administration), edema. Septicemia. Hypokalemia.
Rare (0.01-0.1%): vascular fragility. Gastric obstruction, hypertrophy of the gastric mucosa. Exostosis.
[SmPC]
Also reported: reversible cortical proliferation of the long bones / /hyperostosis (after long-term use) [Aykanat 2016; Gardiner 1995; Nadroo 2000; Velaphi 2004], hyperthermia [Naiyananon 2024; Ofek Shlomai 2023], and hypertrophy pyloric stenosis [Soyer 2014; Kosiak 2009]
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The complete list of all contra-indications can be found in the national Summary of Product Characteristics (SmPC) – click here
Contra-indications in children
Spontaneous patent ductus arteriosus botalli as an isolated defect in neonates [SmPC Minprog®]; Do not use in "Respiratory Distress Syndrome" (RDS) due to hyaline membrane disease.
The complete list of all warnings and precautions can be found in the national Summary of Product Characteristics (SmPC) – click here
Warnings & precautions in children
Administer via central venous catheter, or if peripheral, initiate a second infusion.
Only to be used by qualified staff able to monitor and handle side effects. Due to the risk of apnea, monitor breathing and intubate and ventilate if necessary. Treat for as short a period as possible at the lowest possible dose.
Also check arterial pressure regularly and reduce the rate of administration immediately if there is a significant drop.
In neonates with impaired pulmonary circulation, the effectiveness of alprostadil is measured by monitoring the increase in blood oxygenation; in cases of impaired systemic circulation, the effectiveness is determined by monitoring the increase in systemic blood pressure and blood pH.
Be cautious in cases of increased bleeding tendency, as prostaglandin E1 is a potent inhibitor of platelet aggregation.
When used for longer than 120 hours, carefully monitor for antral hyperplasia and obstruction of the gastric outlet.
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Interactions
The complete list of all interactions can be found in the national Summary of Product Characteristics (SmPC) – click here
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| Other cardiac preparations | ||
|---|---|---|
| C01EB10 | ||
| C01EB06 | ||
| C01EB16 | ||
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References
- Rademaker C.M.A. et al, Geneesmiddelen-Formularium voor Kinderen, 2007
- Pfizer BV, SmPC Prostin VR (RVG 10041) 12-05-2017, www.geneesmiddeleninformatiebank.nl
- Pfizer BV, SmPC Prostin VR (RVG 10041) 8 juli 2021, www.geneesmiddeleninformatiebank.nl
- Soyer T, et al., Transient hypertrophic pyloric stenosis due to prostoglandin infusion, J Perinatol, 2014, 34(10), 800-1
- Kosiak W, et al., Gastric outlet obstruction due to an iatrogenic cause in a neonatal period - report of two cases., Ultraschall Med., 2009, 30(4), 401-3
- Nadroo AM, et al., Prostaglandin induced cortical hyperostosis in neonates with cyanotic heart disease., J Perinat Med., 2000, 28(6), 447-52
- Gardiner JS, et al., Prostaglandin-induced cortical hyperostosis. Case report and review of the literature., J Bone Joint Surg Am., 1995, 77(6), 932-6
- Velaphi S, et al., Cortical hyperostosis in an infant on prolonged prostaglandin infusion: case report and literature review., J Perinatol., 2004, 24(4), 263-5
- Kramer HH, et al., Evaluation of low dose prostaglandin E1 treatment for ductus dependent congenital heart disease., Eur J Pediatr., 1995, 154(9), 700-7
- Huang FK, et al., Reappraisal of the prostaglandin E1 dose for early newborns with patent ductus arteriosus-dependent pulmonary circulation, Pediatr Neonatol, 201, 3;54(2), 102-6
- Vari D, et al., Low-dose prostaglandin E1 is safe and effective for critical congenital heart disease: is it time to revisit the dosing guidelines?, Cardiol Young, 2021, 31(1), 63-70
- Yucel IK, et al., Efficacy of very low-dose prostaglandin E1 in duct-dependent congenital heart disease., Cardiol Young, 2015, 25(1), 56-62
- Aykanat A, et al., Long-Term Prostaglandin E1 Infusion for Newborns with Critical Congenital Heart Disease., Pediatr Cardiol, 2016, 37(1), 131-4
- Naiyananon F, et al., Predictors of high maintenance prostaglandin E1 doses in neonates with critical congenital heart disease-ductal-dependent pulmonary circulation during preoperative care., Pediatr Neonatol., 2024, Sep;65(5), 464-468
- Ofek Shlomai N, et al., Cumulative Dose of Prostaglandin E1 Determines Gastrointestinal Adverse Effects in Term and Near-Term Neonates Awaiting Cardiac Surgery: A Retrospective Cohort Study., Children (Basel), 2023, 10(9), 1572
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Changes
Changes
