Alprostadil Injection, Pediatric

________________________________________________________________________

KEY POINTS

• This medicine is given by IV to treat problems in newborn infants caused by certain birth defects related to the heart.
• This medicine may cause unwanted side effects. Tell your healthcare provider if you have any side effects that are serious, continue, or get worse.
• Tell all healthcare providers who treat you about all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take.

________________________________________________________________________

What are other names for this medicine?

Type of medicine: prostaglandin

Generic and brand names: alprostadil injection, pediatric; Prostin VR Pediatric

What is this medicine used for?

This medicine is given by IV infusion for a short time to treat problems in newborn infants caused by certain birth defects related to the heart. This medicine is used only until surgery can be done to permanently correct the condition.

This medicine may be used to treat other conditions as determined by your healthcare provider.

How do I use it?

This medicine is given by IV infusion (slow drip through a needle into a large vein). The medicine is given by medical personnel trained in its use.

What should I watch out for?

This medicine may cause long pauses in a baby’s breathing, especially if the baby is very small at birth. The baby's healthcare provider will closely monitor the treatment to make sure it is working and to avoid side effects.

If your baby needs emergency care or surgery, tell the healthcare provider your child has received this medicine.

What are the possible side effects?

Along with its needed effects, this medicine may cause some unwanted side effects. Some side effects may be very serious. Some side effects may go away as the baby's body adjusts to the medicine. The baby will be watched carefully to make sure that there are no serious side effects. Tell your healthcare provider if the baby has any side effects that continue or get worse.

Life-threatening (Report these to your healthcare provider right away. If you cannot reach your healthcare provider right away, get emergency medical care or call 911 for help.): Allergic reaction (hives; itching; rash; trouble breathing; chest pain or tightness in your chest; swelling of your lips, tongue, and throat).

Serious (Report these to your healthcare provider right away.): slowed breathing or pauses in breathing, trouble breathing, unusual bruising or bleeding, fast heartbeat, seizures.

Other: Flushing, diarrhea, fever.

What products might interact with this medicine?

The baby will be closely monitored for other medicines that may react with this medicine. Do not give the baby any medicines without the healthcare provider's approval.

If you are not sure if your child's medicines might interact, ask your pharmacist or healthcare provider. Keep a list of all your baby's medicines with you. List all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that your child takes. Be sure that you tell all healthcare providers who treat your child about all the products your baby is taking.

---

This advisory includes selected information only and may not include all side effects of this medicine or interactions with other medicines. Ask your healthcare provider or pharmacist for more information or if you have any questions.

Keep all medicines out of the reach of children.

Do not share medicines with other people.