Patient Medication Information: uses, side effects, how to take - Prostin Vr Sterile Solution
Serious warnings and precautions box
What PROSTIN VR STERILE SOLUTION is used for:
PROSTIN VR STERILE SOLUTION is used in newborns that have congenital heart defects. It is used to keep a blood vessel called the ductus arteriosus open for a short time after your child is born. The ductus arteriosus is a temporary blood vessel found in unborn babies. It normally closes soon after birth. For babies born with some congenital heart defects this blood vessel needs to be kept open for a longer time until surgery can be done to fix or treat the heart condition.
How PROSTIN VR STERILE SOLUTION works:
PROSTIN VR STERILE SOLUTION relaxes the muscle in the wall of the ductus arteriosus to keep it open until surgery can be done.
The ingredients in PROSTIN VR STERILE SOLUTION are:
Medicinal ingredient: alprostadil
Non-medicinal ingredient: anhydrous ethanol
PROSTIN VR STERILE SOLUTION comes in the following dosage form:
Solution for injection: 500 mcg/mL
Your newborn must not receive PROSTIN VR STERILE SOLUTION if they:
About 10 to 12% of newborns that received PROSTIN VR STERILE SOLUTION had interrupted breathing (apnea). Apnea is seen most often in newborns weighing less than 2 kg at birth. It usually appears during the first hour of drug infusion. PROSTIN VR STERILE SOLUTION should be used by trained healthcare professionals in places where your newborn has access to the proper equipment for intensive care.
- Have blueness or lividness of the skin with persistent pulmonary hypertension.
- Have a rare congenital defect of the pulmonary veins.
- Have multiple small accessory spleens or absence of normal spleen function in whom the pulmonary valve of the heart does not form properly and that have a rare heart defect that occurs when the pulmonary veins fail to form normally.
To help avoid side effects and ensure proper use, talk to your newborn’s healthcare professional before your newborn receives PROSTIN VR STERILE SOLUTION. Talk about any health conditions or problems they may have, including:
- Respiratory distress syndrome (a breathing problem that makes it hard for your newborn to breathe).
- A history of bleeding tendencies.
Other warnings you should know about:
Antral hyperplasia (increased cell numbers at the lower part of the stomach): PROSTIN VR STERILE SOLUTION may cause an increase in cell numbers at the lower part of your newborn’s stomach if it is given for more than 5 days. This can cause a blockage between the stomach and the small intestine. Your newborn’s healthcare professional will closely monitor your newborn for this condition if PROSTIN VR STERILE SOLUTION is given for more than 5 days.
Weakening of blood vessels: PROSTIN VR STERILE SOLUTION may cause the weakening of the temporary blood vessel called ductus arteriosus and the arteries going from the heart to the lungs.
Bone and tissue changes: If given for a long period, PROSTIN VR STERILE SOLUTION may cause an increase in cell numbers in long bones such as the femur (thigh bone) and humerus (upper arm bone). This can lead to thick bones, joint pain and skin changes. This effect usually reverts after stopping the medication.
Alcohol content: PROSTIN VR STERILE SOLUTION contains alcohol (ethanol) in an amount that could affect your newborn. Side effects that may result include drowsiness. Your newborn’s healthcare professional will take this into account when deciding on the use of this medicine.
Testing and check-ups: Your newborn’s healthcare professional will monitor your newborn’s blood pressure during PROSTIN VR STERILE SOLUTION infusion. They may also monitor how well your newborn’s blood is oxygenated and the pH of their blood.
Tell your newborn’s healthcare professional about all the medicines they take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.
How PROSTIN VR STERILE SOLUTION is given:
PROSTIN VR STERILE SOLUTION will be given:
- by a trained healthcare professional;
- in a place with the proper equipment available to your newborn for intensive care.
Treatment will usually start within 4 days after birth. It will be given to your newborn for the shortest time possible to decrease the risk of side effects.
It will be given to your newborn as a continuous infusion into either their:
- vein (intravenously); or
- umbilical artery through a long, soft, hollow tube (called a catheter).
Usual dose:
Your newborn’s healthcare professional will decide on the dose and for how long PROSTIN VR STERILE SOLUTION will be given.
Overdose:
Signs of an overdose with PROSTIN VR STERILE SOLUTION may include:
- interrupted breathing (apnea)
- a slow heart rate
- fever
- low blood pressure
- flushing
If you think you, or a person you are caring for, have been given too much PROSTIN VR STERILE SOLUTION, contact a healthcare professional, hospital emergency department, regional poison control centre or Health Canada’s toll-free number, 1-844 POISON-X (1-844-764-7669) immediately, even if there are no signs or symptoms.
Possible side effects from using PROSTIN VR STERILE SOLUTION:
These are not all the possible side effects your newborn may have when given PROSTIN VR STERILE SOLUTION. If your newborn experiences any side effects not listed here, tell their healthcare professional.
Side effects with PROSTIN VR STERILE SOLUTION include:
- flushing
- fever
- feeling irritable
- feeling tired or sleepy
- feeling jittery
- stiffness
- diarrhea
- gastric regurgitation
Serious side effects and what to do about them
| Frequency/Side Effect/Symptom | Talk to your healthcare professional | Stop taking this drug and get immediate medical help | |
|---|---|---|---|
| Frequency/Side Effect/Symptom | Talk to your healthcare professional | Stop taking this drug and get immediate medical help | |
| Frequency/Side Effect/Symptom | Talk to your healthcare professional | Stop taking this drug and get immediate medical help | |
| Frequency/Side Effect/Symptom | Talk to your healthcare professional | Stop taking this drug and get immediate medical help | |
| Frequency/Side Effect/Symptom | Talk to your healthcare professional | Stop taking this drug and get immediate medical help | |
| Only if severe | In all cases | ||
| Only if severe | In all cases | ||
| Only if severe | In all cases | ||
| Only if severe | In all cases | ||
| Only if severe | In all cases | ||
| Very common | |||
| Apnea (interrupted breathing) | ✓ | ||
| Common | |||
| Bradycardia (slower than normal heartbeat): dizziness, feeling tired, shortness of breath, chest pains, memory problems | ✓ | ||
| Hypotension (low blood pressure): dizziness or lightheadedness, fainting, blurred vision, nausea, feeling tired. | ✓ | ||
| Tachycardia (faster than normal heartbeat): shortness of breath, lightheadedness, rapid pulse rate, irregular heartbeat, chest pain, fainting. | ✓ | ||
| Cardiac arrest (heart stops beating suddenly) | ✓ | ||
| Edema: swelling of the arms and legs | ✓ | ||
| Seizures (fits): muscle twitching, changes in emotions, confusion, uncontrollable shaking with or without loss of consciousness | ✓ | ||
| Disseminated intravascular coagulation (blood clots forming throughout the body, blocking small blood vessels): bleeding which may be severe | ✓ | ||
| Sepsis (extreme, life-threatening immune reaction to an infection in the body): fever or dizziness, chills, high or very low body temperature, little or no urine, low blood pressure, palpitations, rapid breathing, rapid heartbeat | ✓ | ||
| Hypokalemia (low level of potassium in the blood): muscle weakness, feeling tired and muscle cramps | ✓ | ||
| Uncommon | |||
| Congestive heart failure (heart does not pump blood as well as it should): shortness of breath, feeling tired, weakness, swelling in your legs, ankle and feet, rapid or irregular heartbeat | ✓ | ||
| Spasm of the right infundibulum [conus arteriosus] (upper right ventricle of the heart): bluish tint to the skin, lips and nails, rapid breathing, fast heart rate, fainting, difficulty breathing, seizures | ✓ | ||
| Second degree heart block (a disease of the heart’s electrical system): dizziness, fainting, shortness of breath, fatigue, nausea, heart skipping beats | ✓ | ||
| Ventricular fibrillation (heart beats with rapid, erratic electrical impulses): chest pain, rapid heartbeat, dizziness, shortness of breath, loss of consciousness | ✓ | ||
| Ventricular hypertrophy (enlargement and thickening of the walls of the heart (left ventricle)): shortness of breath, feeling tired, sensation of rapid, fluttering or pounding heartbeats, dizziness or fainting | ✓ | ||
| Intracranial bleeding (bleeding in the brain): sudden, extremely severe headache | ✓ | ||
| Hypothermia (abnormal low body temperature): shivering, slow, shallow breathing; slurred speech, drowsiness, confusion or memory loss, loss of consciousness | ✓ | ||
| Shock (a sudden drop in blood flow through the body): cool, clammy skin, paleness, rapid pulse, rapid breathing, nausea or vomiting, enlarged pupils, weakness, dizziness or fainting | ✓ | ||
| Bradypnea (abnormally slow breathing): lightheadedness, dizziness, feeling tired | ✓ | ||
| Pneumothorax (collapsed lung): sudden chest pain and shortness of breath | ✓ | ||
| Peritonitis (inflammation of the membrane covering the inside of the abdomen and its organs): abdominal pain, bloating, fever, nausea and vomiting, loss of appetite, diarrhea, thirst, inability to pass stool or gas, feeling tired | ✓ | ||
| Peritonsillitis (inflammation of the connective tissue above and behind the tonsil): fever, chills, difficulty swallowing or opening the mouth fully, swelling of the face and neck, headache | ✓ | ||
| Thrombocytopenia (low levels of platelets in the blood): easy or excessive bruising, a rash of pinpoint-sized reddish-purple spots usually on the legs, prolonged bleeding from cuts, bleeding from the gums or nose | ✓ | ||
| Anuria (failure of the kidneys to produce urine): no or very little urine production, swelling in the legs and feet, weakness or dizziness | ✓ | ||
| Hematuria (blood in the urine) | ✓ | ||
| Whiplash (hyperextension of the neck): neck pain and stiffness, pain that gets worse with neck movement, headaches most often starting at the base of the skull | ✓ | ||
| Bronchial wheezing: a high-pitched whistling sound while breathing | ✓ | ||
| Hyperkalemia (high level of potassium in the blood): feeling tired or weak, a feeling of | ✓ | ||
| numbness or tingling, nausea or vomiting, chest pain, irregular heartbeats | |||
| Anemia (low levels of red blood cells in the blood): feeling tired, weakness, pale or yellowish skin, shortness of breath, dizziness or lightheadedness, chest pain, irregular heartbeats | ✓ | ||
| Hypoglycemia (low blood sugar): feeling tired, pale skin, sweating, chills and clammy skin, feeling shaky, confusion, fast heartbeat, feeling weak or having no energy | ✓ | ||
| Hypercapnia (too much carbon dioxide in the blood): flushed skin, drowsiness, headache, feeling dizzy, shortness of breath, feeling exhausted | ✓ | ||
| Hyperemia (excess blood in parts of your body) | ✓ | ||
| Pneumopericardium (air entering the cavity surrounding the heart): chest pain, rapid heart rate, pain in the upper abdomen, nausea, shortness of breath, fainting, drop in blood pressure | ✓ | ||
| Tachyphylaxis (a decrease in response to the medicine) | ✓ | ||
| Tachypnea (abnormally rapid breathing) | ✓ | ||
| Kidney failure (severe kidney problems): weakness, trouble breathing, tiredness, swelling in the legs, ankles or feet, irregular heartbeat, confusion, decrease or inability to urinate, loss of appetite, nausea, itching, coma | ✓ | ||
| Unknown | |||
| Difficulty breathing | ✓ | ||
| Hypoventilation: bluish colour of the skin, feeling tired | ✓ | ||
| Jaundice (liver condition that causes yellowing of a newborn's skin and eyes) | ✓ | ||
If your newborn has a troublesome symptom or side effect that is not listed here or their side effects worsen, tell their healthcare professional.
Reporting side effects
You can report any suspected side effects associated with the use of health products to Health Canada by:
- Visiting the Web page on Adverse Reaction Reporting (canada.ca/drug-device-reporting) for information on how to report online, by mail or by fax; or
- Calling toll-free at 1-866-234-2345.
NOTE: Contact your newborn’s healthcare professional if you need information about how to manage her or his side effects. The Canada Vigilance Program does not provide medical advice.
Storage:
PROSTIN VR STERILE SOLUTION will be stored in the refrigerator (2°C - 8°C) by your healthcare professional.
Keep out of reach and sight of children.
If you want more information about PROSTIN VR STERILE SOLUTION:
- Talk to your healthcare professional
- Find the full product monograph that is prepared for healthcare professionals and includes the Patient Medication Information by visiting the Health Canada Drug Product Database website (https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html); the manufacturer’s website (http://www.pfizer.ca); or by calling 1-800-463-6001.
Date of Authorization: 2026-01-05