Prostin VR Pediatric

Prostin VR Pediatric is used to treat certain heart, lung and blood vessel problems in infants. It is used to temporarily keep the ductus arteriosus (blood vessel in the heart) open before having surgery.

This medication is only to be given under the direct supervision of your doctor. This product is available in the following forms:

• Solution

Before using Prostin VR pediatric, you must know all about the risks and complications associated with it. This is a decision that you and your doctor will make together.

For this medication, there are many things that need to be considered:

Allergies

Inform your doctor if you have ever had an allergic reaction to any other medications. It is also important to inform your doctor of any non-medicine allergies such as foods, dyes, preservatives or animals.

Pediatric

Up-to-date Pediatric Appropriate studies have not indicated any problems that would limit the use of this medication.

Geriatric

This medication is not indicated for use in the geriatric population.

Pregnancy

This medication is listed as Pregnancy Category C. This means that animal studies have shown an adverse effect and no studies have been performed on pregnant women OR there are no adequate studies on pregnant animals and pregnant women.

Breastfeeding

There are no up-to-date studies in women for determining infant risk when using this medication while breastfeeding. Weigh the potential risks with the benefits before taking this medication while breastfeeding.

Drug Interactions

Certain medications should not be used together. However, in certain cases, two medications may be used together, even if an interaction might occur. In these cases, your doctor may want to change your dose or take other precautions.

When taking this medication, it is important that you inform your doctor if you are taking any of the medications listed below. The following interactions were selected on the basis of potential significance and are not all-inclusive.

Using this medication with any of the following medication is not recommended, but may be unavoidable in some cases. Your doctor may make the decision not to treat you with this medication or change some of the other medications you take:

• Heparin

Other Interactions

Certain medications should not be used while eating, or while eating certain foods in case of negative interactions. Using alcohol or tobacco with certain medications may also cause negative interactions. Talk with your doctor about the use of your medication with food, alcohol or tobacco.

Other Medical Problems

Pre-existing medical problems may affect the use of this medication.

Be sure to tell your doctor if you have any other medical problems, especially:

• Bleeding problems
• Blood vessel problems (i.e. an aneurysm)
• Heart disease
• Lung disease or breathing problems (i.e. respiratory distress syndrome)
• Stomach blockage - Use with caution. May increase risk for more serious side effects

Proper usage of Prostin VR pediatric requires strict adherence to your doctor’s orders. A nurse or other trained health professional will give your baby this medication.

It is given through a needle or a catheter placed in a vein (intravenously). It may also be given through a catheter in your baby’s umbilical cord.

Before using Prostin VR pediatric, there are some precautions you must take. The doctor will check your child’s progress closely while receiving this medication.

This will allow the doctor to see if the medication is working properly and to check for unwanted effects. This medication may cause apnea (temporary stopping of breathing) in newborn babies.

Inform your doctor immediately if your child has bluish lips or skin or not breathing after receiving this medication. Using this medication long-term may cause unwanted effects (i.e. bone problems). Ask your doctor if you have concerns about this.

Make sure you meet with your doctor in using Prostin VR pediatric to avoid unwanted potential side effects. A medication may produce unwanted effects along with the intended effects. Although not all of these side-effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if you experience any of the following side-effects:

More common:

• Bluish lips or skin (cyanosis)
• Chest pain or discomfort
• Feeling of warmth
• Fever
• Lightheadedness, dizziness or fainting (syncope)
• Not breathing
• Redness of the face, neck, arms or upper chest
• Slow or irregular heartbeat (bradycardia, arrhythmias)
• Unusual fatigue

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 (tachycardia, palpitations, arrhythmias)
• Increased thirst (polydipsia)
• 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 (syncope)
• Low body temperature
• Neck is bent backward
• Pale or blue lips, fingernails, or skin (cyanosis)
• Pale skin
• 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 (jaundice)

Some side effects that may occur do not normally need medical attention. These may leave as your body becomes accustomed to treatment. Ask your doctor about ways to prevent or reduce some of these side effects.

Talk to your doctor if any of the following side effects continue or are bothersome, or if you have questions:

Less common:

• Diarrhea

Some patients may experience other side effects that are not listed. Check with your doctor if you notice any other side effects.

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