Alprostadil Injection 500mcg/1mL is a prescription prostaglandin E1 (PGE1) medicine containing 500 micrograms of alprostadil in each 1mL ampoule. This high-strength formulation is used by specialist healthcare teams to temporarily maintain patency of the ductus arteriosus in neonates and infants with certain critical congenital heart defects, helping maintain pulmonary or systemic blood flow until definitive corrective or palliative treatment can be performed.
Current U.S. FDA labeling identifies PROSTIN VR PEDIATRIC® as alprostadil injection containing 500 micrograms per mL. UK medicines information lists Prostin VR 500 micrograms/mL, while Australia’s TGA lists both PROSTIN VR and the newer NEUPEDIX 500 microgram/1mL presentations.
Alprostadil is the generic medicine name, not a brand name. Prostin VR, Prostin VR Pediatric and Neupedix are specific branded/product presentations in particular markets. Brand names, manufacturers and regulatory registrations vary by country.
The UK SmPC specifies that each 1mL ampoule contains 500 micrograms of alprostadil. The U.S. FDA label likewise describes 500 micrograms of alprostadil in 1mL.
The 500mcg/1mL alprostadil formulation is primarily a specialist neonatal cardiovascular medicine.
It is used to temporarily maintain ductus arteriosus patency in infants whose circulation depends on the ductus remaining open. Conditions listed in UK product information include certain cases of:
The precise indication depends on the infant’s cardiac anatomy and the applicable product authorization.
The ductus arteriosus is a fetal blood vessel connecting the pulmonary artery and aorta. It normally begins to close after birth.
In some neonates with critical congenital heart disease, however, continued ductal patency is essential for maintaining adequate pulmonary or systemic circulation.
Alprostadil can relax the smooth muscle of the ductus arteriosus and temporarily maintain its patency. This can provide a bridge to cardiac catheterization, surgery or other definitive treatment.
Alprostadil is a synthetic form of prostaglandin E1 (PGE1).
It produces several pharmacological effects, including vasodilation and relaxation of susceptible smooth muscle. The ductus arteriosus is particularly sensitive to prostaglandin E1.
In neonates with ductal-dependent congenital heart disease, this effect can help prevent or reverse ductal closure and maintain blood flow while definitive treatment is arranged.
Each 1mL ampoule contains:
500 micrograms alprostadil / 1mL
This is equivalent to:
The formulation is highly concentrated and is generally diluted before administration according to the applicable product instructions and the infusion system used. UK product information specifically requires careful preparation of dilutions.
This product should not be self-administered or dosed outside a specialist neonatal/cardiac setting.
The UK SmPC states that infusion is generally initiated at 0.05–0.1 micrograms/kg/minute, followed by reduction to the lowest rate that maintains the desired therapeutic response. Lower infusion rates may be used in selected circumstances under specialist supervision.
Because alprostadil dosing is weight-based and depends on the infant’s cardiac physiology and response, the actual infusion rate must be determined and monitored by the treating specialist team.
Alprostadil 500mcg/mL is a concentrate for solution for infusion, rather than a routine direct-dose injection for general outpatient use.
The UK product information specifies administration by:
The diluted solution should be prepared according to the manufacturer’s instructions.
Alprostadil can cause clinically significant adverse effects, particularly in critically ill neonates.
Reported or clinically important reactions include:
Apnoea is particularly important. The FDA label reports that apnoea occurs in approximately 10–12% of neonates treated with PROSTIN VR PEDIATRIC, with higher risk in neonates weighing less than 2kg at birth.
Apnoea is a major safety consideration with neonatal alprostadil infusion.
The FDA states that apnoea most often occurs during the first hour of infusion and that treatment should be administered where ventilatory assistance is immediately available. UK prescribing information similarly requires use by appropriately trained healthcare professionals with access to pediatric intensive care.
Because alprostadil is used in critically ill neonates, treatment requires continuous specialist monitoring.
Depending on the clinical situation, the medical team may monitor:
The treatment objective is to use the lowest effective infusion rate for the shortest appropriate period while the infant receives definitive management.
This distinction is very important for ecommerce and SEO.
Alprostadil is also used in completely different formulations for erectile dysfunction. Those products are generally supplied at much lower microgram strengths, such as 10mcg, 20mcg or 40mcg formulations.
For example, UK Caverject products contain 10mcg or 20mcg of alprostadil per dose after reconstitution and are indicated for erectile dysfunction.
Alprostadil 500mcg/1mL should therefore not be described as a standard erectile-dysfunction injection. The 500mcg/mL formulation identified in current U.S. and UK product information is a specialist neonatal infusion product for maintaining ductus arteriosus patency.
Because alprostadil is the generic medicine name, the brand name should be kept separate from the generic product description.
Examples include:
Current UK medicines information lists both Neupedix 500 micrograms/mL and Prostin VR 500 micrograms/mL under alprostadil, while Australia’s TGA lists NEUPEDIX 500 microgram/1mL and PROSTIN VR 500 microgram/1mL as registered medicines.
Alprostadil Injection 500mcg/1mL has strong specialist pharmaceutical search intent around the generic ingredient, concentration, ampoule presentation and established branded equivalents.
Commercial search themes include:
Alprostadil Injection 500mcg, Alprostadil 500mcg/1mL, Alprostadil 500 Micrograms Injection, Alprostadil 500mcg Injection, Alprostadil 500mcg/mL, Alprostadil Injection Ampoule, Alprostadil 500mcg Ampoule, Generic Alprostadil Injection, Prostin VR 500mcg, Prostin VR Pediatric 500mcg and Neupedix 500mcg.
Availability, manufacturer, prescription classification, packaging and authorization differ between the USA, UK, UAE/Dubai, Australia, Singapore, Thailand, China and Russia.
For international pharmaceutical ecommerce, the actual manufacturer and regulatory authorization of the product should be verified for the destination market. Alprostadil 500mcg/mL is a specialist hospital medicine and should not be presented as an ordinary consumer injectable.
It is a concentrated alprostadil formulation containing 500 micrograms of alprostadil in each 1mL ampoule. It is used in specialist neonatal care to temporarily maintain ductus arteriosus patency in infants with selected critical congenital heart defects.
The 500mcg/mL formulation is used primarily to maintain ductus arteriosus patency in neonates with congenital heart defects that depend on continued ductal blood flow until definitive treatment can be performed.
Prostin VR is a specific branded product containing alprostadil 500mcg/mL. Alprostadil is the generic active ingredient name, whereas Prostin VR is a product/brand name.
Yes. Alprostadil is the generic name of the active medicine. Different manufacturers market alprostadil under different product or brand names.
The 500mcg/mL formulation discussed here is not the standard alprostadil erectile-dysfunction formulation. ED products such as Caverject use much lower microgram doses and have separate product information.
The concentration is 500 micrograms per mL, equivalent to 0.5mg/mL.
It is supplied as a concentrated solution for infusion and is generally diluted and administered using a controlled infusion system according to the applicable product information. It is a specialist hospital medicine.
Yes. Apnoea is a clinically important adverse effect in neonates receiving alprostadil. The U.S. FDA label reports an incidence of approximately 10–12% in treated neonates.
Yes. Australia’s TGA lists PROSTIN VR alprostadil 500 microgram/1mL injection ampoule and NEUPEDIX alprostadil 500 microgram/1mL solution for injection ampoule as registered medicines.
Yes. The UK electronic medicines compendium lists Prostin VR 500 micrograms/mL and Neupedix 500 micrograms/mL.
This is a prescription-only specialist medicine intended for use by trained healthcare professionals. Any online supply must comply with the licensing, prescription and import requirements of the destination country.
Medical Disclaimer: This product information is provided for educational and informational purposes only and is not a substitute for professional medical advice, diagnosis or treatment. Alprostadil 500mcg/mL is a specialist prescription medicine used in critically ill neonates and must be administered under appropriate medical supervision. The indication, formulation, dosing, dilution, route of administration, contraindications, monitoring requirements and product authorization may vary by country and manufacturer. Do not administer or alter treatment without direction from a qualified healthcare professional.
Last Updated: September 1, 2026
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