Patient leaflet - Prostin VR Sterile solution
1. What Prostin VR is and what it is used for
Prostin VR contains the active substance
alprostadil. Alprostadil is a synthetic copy of
a prostaglandin chemical that occurs naturally
in your body. Prostaglandins are a complex set
of chemicals made by the body tissues. Some
of them can cause muscles, which occur in the
walls of certain blood vessels, to relax.
Prostin VR is a medicine given to new born
babies through an injection into the vein or
a catheter (fine tube) into an artery.
While a baby is in the womb, before it is born,
it does not breathe. For this reason, in a baby’s
heart there is a special, small blood vessel
called the ductus arteriosus that allows blood to
pass through the heart without going through
the lungs. Once the baby is born and breathing
normally, this is no longer needed, and the
ductus arteriosus would close off.
If the baby has certain conditions affecting
the heart it may still be beneficial to keep this
channel (the ductus arteriosus) open until the
heart condition can be corrected by surgery.
This is what Prostin VR can do i.e. it relaxes
the muscles in the wall of the ductus arteriosus
while the baby still requires this. Once the
baby has had an operation to correct the heart
problem, then the ductus arteriosus will no
longer be needed and can be allowed to close.
Your baby may have one of several problems
in which it is necessary to keep the ductus
arteriosus open until an operation can take
place. Your baby’s doctor will explain which
problem affects your baby.
2. What you need to know before your baby is given Prostin VR
Children
Prostin VR contains alcohol (ethanol) and is
likely to affect children (see Prostin VR contains
alcohol (ethanol)).
All babies can have Prostin VR if they really need
it. The doctor will carry out tests before deciding
whether to give this medicine to your baby.
Do not use Prostin VR if your baby is allergic
to alprostadil (or any other prostaglandin) or any
of the other ingredients of this medicine (listed in
section 6). The symptoms of an allergic reaction
can be the following: wheezing, breathlessness,
swelling of the face, hands, itchy rash or redness
of the skin.
Warnings and precautions
There are some circumstances where special precautions may need to be taken. These include:
- if your baby has a tendency to bleed easily. The doctor will be cautious when using this medicine as it may prevent blood from clotting properly.
- if your baby suffers from an obstruction of the blood flow into the lungs, blood will be flowing through the ductus arteriosus from the main artery of the lungs. In this case, Prostin VR can be given through a catheter (fine tube) placed at or just above the junction between the main artery and the ductus arteriosus or can be given intravenously (by a drip into a vein).
- if your baby develops interrupted breathing (apnoea) or a slow heartbeat, this medicine should be stopped and appropriate medical treatment should be given. This most often occurs in babies weighing less than 2 kg at birth. It usually happens within the first hour of the medicine being given. Doctors and nurses will watch your baby carefully in case they need to ventilate him or her (give oxygen) until normal breathing starts again. This medicine will only be used where there are facilities to do this. If the baby develops a high temperature or low blood pressure, the drug should be given at a slower rate until these symptoms subside.
- if your baby suffers from feeding problems. This medicine may cause thickening of the stomach wall, such that emptying of the stomach contents may be difficult. This effect has been linked with the total amount of medicine given and the length of time it is given for. If your baby is given this medicine for more than 120 hours, the doctor will watch carefully for this problem which will cause the baby to vomit after feeds.
- if this medicine is given for a very long time period the walls of the ductus arteriosus and of the artery that connects the heart to the lungs (pulmonary artery) may weaken.
- this medicine may cause abnormalities of long bones. Your doctor will monitor your baby’s symptoms and may decide if this medicine needs to be withdrawn.
- if your baby has respiratory distress syndrome (hyaline membrane disease). This medicine must not be used in babies with this condition therefore your baby’s doctor will ensure correct diagnosis.
Other medicines and Prostin VR
Babies born with heart problems usually have to be given several different medicines. These medicines may be to:
- improve the pumping action of the heart. These drugs act directly on the heart muscle and belong to a group of drugs called cardiac glycosides, e.g. digoxin.
- raise the blood pressure, e.g. dopamine or isoproterenol.
- reduce the volume of the blood and hence the workload on the heart. These drugs are called diuretics or water tablets, e.g. furosemide.
- fight infections (antibiotics), e.g. penicillin or gentamicin.
Prostin VR can be given at the same time as these medicines as no interactions with these medicines have been reported.
Prostin VR contains alcohol (ethanol)
This medicinal product contains ethanol. Your doctor will take this into account when deciding to give this medicine to your baby.
Prostin® VR 500 micrograms/ml Concentrate for solution for infusion
alprostadil
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Prostin VR contains 790 mg alcohol (ethanol) in each 1 ml vial which is equivalent to 790 mg/ml (79 % w/v). The amount of alcohol in each 1 ml vial is equivalent to less than 20 ml beer or 8 ml wine.
The amount of alcohol in this medicine is likely to affect children. These effects may include feeling sleepy and changes in behaviour.
Because this medication is administered slowly over 24 hours the effects of ethanol may be reduced.
Co-administration with medicines containing e.g. propylene glycol or ethanol may lead to accumulation of ethanol and induce adverse effects, particularly in young children with low or immature metabolic capacity.
If your baby have epilepsy or liver problems, talk to your doctor or pharmacist before taking this medicine.
The amount of alcohol in this medicine may alter the effects of other medicines. Talk to your doctor or pharmacist if your baby is taking other medicines.
3. How to use Prostin VR
This medicine must only be given by a doctor in a hospital or in a place where intensive care facilities are immediately available if needed.
This medicine can be given by an intravenous drip or through an artery by way of a tube (catheter).
The small volume (1 ml) of medicine must be diluted with larger volumes of a special salt or sugar solution. The amount of solution used will depend on how the medicine is to be given.
Different babies need different amounts of Prostin VR. Your doctor will give the smallest amount needed for the shortest length of time to give a good result. The doctor will have carefully worked out the risks of giving the medicine over a long period in a very ill baby, against the possible benefits that the baby will get from the treatment or the risks of reducing or stopping Prostin VR treatment early.
As soon as tests show that the baby is responding, the rate will be reduced to the lowest possible dose that will maintain the response. (If your baby has an obstruction to the flow of blood to the lungs, the doctor will be looking for an increase in the amount of oxygen in the blood; if your baby has an obstruction in the flow of blood to the rest of the body, the doctor will be looking for an increase in the blood pressure and a fall in the acidity of the blood).
As soon as the baby starts to have the medicine, the pressure of the blood in the arteries will be checked at regular intervals. As Prostin VR relaxes muscles in other blood vessels this may cause a lowering of the baby’s blood pressure. In order to do this, the doctor may use the catheter through which the drug is being given, or a stethoscope or an ultrasound device. If pressure falls significantly, the rate at which Prostin VR is being given will be reduced straight away.
If you have any further questions on the use of this medicine, as your baby’s doctor or nurse.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Starting with the most common and decreasing in frequency, the reactions that he or she may develop are:
Very common side effects (may affect more than 1 in 10 people)
- interrupted breathing (apnoea)
- a high temperature for a short time period (transient pyrexia).
Common side effects (may affect up to 1 in 10 people)
- fits (seizures)
- a heartbeat that is slower than normal (bradycardia)
- low blood pressure
- a heartbeat that is faster than normal (tachycardia)
diarrhoea
- flushing of the skin. This happens more often when the medicine is given by catheter into an artery and is usually relieved by repositioning the tip of the catheter
- low potassium levels in the blood (potassium deficiency).
Uncommon side effects (may affect up to 1 in 100 people)
narrowing of the stomach
outlet (gastric obstruction)
irregular thickening of the
stomach lining (gastric
mucosal hypertrophy)
growth of new bone upon
bone (exostosis)
blood vessels prone to
leaking (vascular fragility).
The following have occurred in babies given Prostin VR. It is possible that they are adverse reactions to the drug, but may not have been caused by it:
- infection
- stopping of the heart
- clotting and bleeding throughout the circulation (disseminated intravascular coagulation)
- low levels of potassium in the blood, which if not corrected can cause muscle weakness and an abnormal heart rhythm
- swelling caused by too much fluid in the body.
Reporting of side effects
If your baby gets any side effects, talk to your doctor or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.
5. How to store Prostin VR
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the label after EXP. The expiry date refers to the last day of that month.
Store in a refrigerator (2°C – 8°C).
Diluted solutions should be used within 24 hours.
6. Contents of the pack and other information
What Prostin VR contains
The active substance is alprostadil. Each ampoule contains 500 micrograms of alprostadil. The other ingredient is ethanol (see section 2 Prostin VR contains alcohol (ethanol)).
What Prostin VR looks like and contents of the pack
Prostin VR is a clear, colourless, sterile concentrate for solution for infusion contained in 1 ml glass ampoules.
Prostin VR is available in multipacks of 5 x 1 ml ampoules.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Pfizer Limited
Ramsgate Road
Sandwich
Kent
CT13 9NJ
UK
Manufacturer:
Pfizer Manufacturing Belgium NV
Rijksweg 12
2870 Puurs-Sint-Amands
Belgium
For further information on this medicine, please contact Pfizer Medical Information on: 01304 616161.
This leaflet was last revised in 03/2025.
Ref: PR 9_0
Sample dilution and infusion rates to provide a dosage of 0.1 micrograms/kg body weight/minute:
Add 1 ml ampoule
(500 micrograms alprostadil) to:
Concentration of resulting
solution (micrograms/ml) Infusion rate (ml/min/kg)
250 ml 2 0.05 100 ml 5 0.02
50 ml 10 0.01
25 ml 20 0.005
Example:
To provide 0.1 micrograms/kg/min to a 2.8 kg neonate, using a concentration of 5 micrograms/ml:
Infusion Rate = 0.02 ml/min/kg x 2.8 kg = 0.056 ml/min or 3.36 ml/hr
Change the dosage from 0.1 micrograms/kg/min to 0.05 micrograms/kg/min by reducing the pump rate to half of the original rate.
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.
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