Prostin VR Pediatric (Intravenous)

Alprostadil injection is used to treat specific heart, lung, and blood vessel issues in infants. It is used to temporarily keep the ductus arteriosus (a blood vessel in the heart) open before surgery.

This medicine must be given only by or under the supervision of your child's doctor.

The doctor will monitor your child's progress carefully while they are receiving this medicine. This will help the doctor determine if the medicine is effective and check for side effects.

This medicine may cause apnea (temporary stopping of breathing) in newborn babies. Contact the doctor immediately if your child has bluish lips or skin or is not breathing after receiving the medicine.

Using this medicine for a long time may lead to unwanted effects (for example, bone problems). Ask your doctor if you have any concerns about this.

In deciding to use a medicine, you need to think about the risks of taking it compared to the benefits it may provide. This is a choice you will make with your doctor. For this medicine, consider the following:

Allergies

Inform your doctor if you have ever had any unusual or allergic reactions to this medicine or any other medicines. Also, let your healthcare professional know about any other allergies you have, such as to foods, dyes, preservatives, or animals. For over-the-counter products, read the label or package ingredients carefully.

Pediatric

So far, studies have not shown any specific problems in children that would limit the use of alprostadil injection in newborns.

Geriatric

This medicine is not intended for use in older patients.

Breast Feeding

There are no sufficient studies in women to determine the risk to infants when using this medication while breastfeeding. Consider the potential benefits and risks before using this medication during breastfeeding.

Interactions with Medicines

Some medicines should not be used together at all, while in other cases, two different medicines may be used together even if an interaction could happen. In these situations, your doctor may need to adjust the dose or take other precautions. When you are receiving this medicine, it is crucial that your healthcare professional knows if you are taking any of the medicines listed below. The following interactions are highlighted for their potential importance but are not necessarily a complete list.

Using this medicine with any of the following medicines is generally not recommended, but may be necessary in some cases. If both medicines are prescribed together, your doctor may adjust the dose or frequency of one or both medicines.

• Heparin

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be taken around the time of eating food or certain types of food because interactions may happen. Using alcohol or tobacco with some medicines may also lead to interactions. Talk to your healthcare professional about using your medicine with food, alcohol, or tobacco.

Other Medical Problems

Having other medical issues may affect how you can use this medicine. Make sure to tell your doctor if you have any other medical problems, especially:

• Bleeding problems or
• Blood vessel issues (e.g., aneurysm) or
• Heart disease or
• Lung disease or breathing issues (e.g., respiratory distress syndrome) or
• Stomach blockage—Use with caution. May increase the risk of more serious side effects.

Along with its necessary effects, this medicine may cause some unwanted effects. Not everyone will experience these side effects, but if they do happen, they may require medical attention.

Check with your doctor or nurse right away if any of the following side effects occur:

More common

• Bluish lips or skin
• Chest pain or discomfort
• Feeling of warmth
• Fever
• Lightheadedness, dizziness, or fainting
• Not breathing
• Redness of the face, neck, arms, and sometimes, upper chest
• Slow or irregular heartbeat
• Unusual tiredness

Less common

• Blood in the urine or stools
• Bruising
• Confusion
• Convulsions
• Coughing or vomiting blood
• Decreased urine
• Dry mouth
• Fast, pounding, or irregular heartbeat or pulse
• Increased thirst
• Loss of appetite
• Mood changes
• No blood pressure or pulse
• Persistent bleeding or oozing from puncture sites, mouth, or nose
• Rash
• Seizures
• Unconsciousness
• Vomiting

Rare

• Abdominal or stomach pain
• Anxiety
• Black, tarry stools
• Bleeding gums
• Clumsiness
• Cold clammy skin
• Difficult or troubled breathing
• Dilated neck veins
• Fainting
• Low body temperature
• Neck is bent backward
• Pale or blue lips, fingernails, or skin
• Pale skin
• Pinpoint red spots on the skin
• Restlessness
• Shivering or chills
• Slow to respond
• Sweating
• Swelling of the face, fingers, feet, or lower legs
• Unusual bleeding or bruising
• Unusual drowsiness, dullness, tiredness, weakness, or sleepiness
• Unusually irritable
• Weak or feeble pulse
• Yellow eyes or skin

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Your health care professional may also have suggestions to help prevent or lessen some of these side effects. Check with your health care professional if any of the following side effects continue, are bothersome, or if you have any questions about them:

Less common

• Diarrhea

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

In the U.S.

• Prostin VR Pediatric

Available Dosage Forms:

• Solution

Therapeutic Class: Endocrine-Metabolic Agent

Pharmacologic Class: Prostaglandin

A nurse or other health provider will give your baby this medicine. It is given through a needle or a catheter placed in a vein. It may also be given through a catheter in your baby's umbilical cord.