Uses of Alprostadil:

• It is used to keep the wall inside the heart open in newborns before surgery.

What do I need to tell my doctor BEFORE I take Alprostadil?

• If your child has an allergy to any part of alprostadil (prostin VR).
• If your child is allergic to alprostadil (prostin VR); any part of alprostadil (prostin VR); or any other drugs, foods, or substances. Tell the doctor about the allergy and what signs your child had.
• If your child has a breathing problem called hyaline membrane disease or respiratory distress syndrome.

This is not a list of all drugs or health problems that interact with alprostadil (prostin VR).

Tell the doctor and pharmacist about all of your child's drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for your child to take alprostadil (prostin VR) with all of his/her drugs and health problems. Do not start, stop, or change the dose of any drug your child takes without checking with the doctor.

What are some things I need to know or do while I take Alprostadil?

• Tell all of your child's health care providers that your child is taking alprostadil (prostin VR). This includes your child's doctors, nurses, pharmacists, and dentists.

How is this medicine (Alprostadil) best taken?

Give alprostadil (prostin VR) as ordered by your child's doctor. Read all information given to you. Follow all instructions closely.

• It is given as an infusion into a vein over a period of time.

What do I do if I miss a dose?

• Call your child's doctor to find out what to do.

What are some side effects that I need to call my doctor about right away?

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your child's doctor or get medical help right away if your child has any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Trouble breathing.
• Seizures.
• Any unexplained bruising or bleeding.
• Long stops between breaths.
• Fast or slow heartbeat.
• Passing out.

What are some other side effects of Alprostadil?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your child's doctor or get medical help if any of these side effects or any other side effects bother your child or do not go away:

• Flushing.
• Fever.

These are not all of the side effects that may occur. If you have questions about side effects, call your child's doctor. Call your child's doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-332-1088. You may also report side effects at https://www.fda.gov/medwatch.

If OVERDOSE is suspected:

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

How do I store and/or throw out Alprostadil?

• If you need to store alprostadil (prostin VR) at home, talk with your child's doctor, nurse, or pharmacist about how to store it.

Consumer Information Use and Disclaimer

• If your child's symptoms or health problems do not get better or if they become worse, call your child's doctor.
• Do not share your child's drug with others and do not give anyone else's drug to your child.
• Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
• Throw away unused or expired drugs. Do not flush down a toilet or pour down a drain unless you are told to do so. Check with your pharmacist if you have questions about the best way to throw out drugs. There may be drug take-back programs in your area.
• Some drugs may have another patient information leaflet. If you have any questions about alprostadil (prostin VR), please talk with your child's doctor, nurse, pharmacist, or other health care provider.
• Some drugs may have another patient information leaflet. Check with your pharmacist. If you have any questions about alprostadil (prostin VR), please talk with your doctor, nurse, pharmacist, or other health care provider.
• If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.