Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2019 Publisher: Pfizer Limited, Ramsgate Road, Sandwich, Kent, CT13 9NJ, UK
Prostin VR is indicated to temporarily maintain the patency of the ductus arteriosus until corrective or palliative surgery can be performed in infants who have congenital 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, co-arctation of the aorta, aortic stenosis, aortic atresia, mitral atresia, or transposition of the great vessels with or without other defects.
The infusion is generally initiated at a rate of 0.05-0.1 micrograms/kg/min. The most experience has been with 0.1 micrograms/kg/min. After a therapeutic response (an increase in pO2 in neonates with restricted pulmonary blood flow or an increase in systemic blood pressure and blood pH in neonates with restricted systemic blood flow) has been obtained, the infusion rate should be reduced to the lowest possible dosage that will maintain the desired response.
Doses lower than 0.05 microgram/kg/min (as low as 0.005 microgram/kg/min) alprostadil have been used successfully in neonates, specifically when transport of the infant is necessary. No comparative trials exist and the efficacy and safety of this approach when compared to the generally initiated dosage rate of 0.05-0.1 micrograms/kg/min is currently unclear.
For administration by intravenous drip or constant rate infusion pump.
In infants with lesions restricting pulmonary blood flow (blood is flowing through the ductus arteriosus from the aorta to the pulmonary artery), Prostin VR may be administered by continuous infusion through an umbilical artery catheter placed at or just above the junction of the descending aorta and the ductus arteriosus, or intravenously. Adverse effects have occurred with both routes of administration, but the types of reactions are different. A higher incidence of flushing has been associated with intra-arterial than with intravenous administration.
For instructions on dilution, see section 6.6. The diluted solution should contain no more than 20 micrograms/ml alprostadil.
PARTICULAR CARE SHOULD BE TAKEN IN CALCULATING AND PREPARING DILUTIONS OF PROSTIN VR.
Apnoea, bradycardia, pyrexia, hypotension and flushing may be signs of drug overdose. If apnoea or bradycardia occur, the infusion should be discontinued and the appropriate medical treatment initiated. Caution should be used if the infusion is restarted. If pyrexia or hypotension occur, the infusion rate should be reduced until these symptoms subside. Flushing is usually attributed to incorrect intra-arterial catheter placement and is usually alleviated by repositioning the tip of the catheter.
Shelf life: 3 years.
Diluted solutions should be used within 24 hours.
Store in a refrigerator.
1ml Type I clear glass ampoule.
Multipacks containing 5 × 1 ml ampoules.
To prepare infusion solutions, dilute 1 ml of Prostin VR with sterile 0.9% sodium chloride intravenous infusion or sterile 5% dextrose intravenous infusion.
If undiluted Prostin VR comes in direct contact with a plastic container, plasticisers are leached from the side walls. The solution may turn hazy and the appearance of the container may change. Should this occur, the solution should be discarded and the plastic container should be replaced. This appears to be a concentration-dependent phenomenon. To minimise the possibility of haze formation, Prostin VR should be added directly to the intravenous infusion solution, avoiding contact with the walls of plastic containers. Dilute to volumes appropriate for the delivery system available. Prepare fresh infusion solutions every 24 hours. Discard any solution more than 24 hours old.
No special requirements for disposal. Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
© All content on this website, including data entry, data processing, decision support tools, "RxReasoner" logo and graphics, is the intellectual property of RxReasoner and is protected by copyright laws. Unauthorized reproduction or distribution of any part of this content without explicit written permission from RxReasoner is strictly prohibited. Any third-party content used on this site is acknowledged and utilized under fair use principles.
