Pronunciation:

al-PROS-ta-dil

Brand Names:

• Prostin VR Pediatric

Dosage Forms:

• Solution

Warnings:

Apnea, which generally occurs during the first hour of infusion and most often in neonates weighing less than 2 kg at birth, develops in approximately 10% to 12% of neonates with congenital heart defects treated with Prostin VR Pediatric(R) IV solution. Monitor respiratory status throughout treatment and use only where ventilatory assistance is immediately available .

Classifications:

Therapeutic—

Endocrine-Metabolic Agent

Pharmacologic—

Prostaglandin

Uses of This Medicine:

Alprostadil injection 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 a surgery.

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

Before Using This Medicine:

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Children—

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of alprostadil injection in newborn babies.

Older adults—

Use of this medicine is not indicated for geriatric patients.

Breast-feeding—

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Other medicines—

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are receiving this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Heparin

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other medical problems—

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

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

Proper Use of This Medicine:

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.

Precautions While Using This Medicine:

The doctor will check your child's progress closely while your child is receiving this medicine. This will allow the doctor to see if the medicine is working properly and to check for unwanted effects.

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

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

Side Effects of This Medicine:

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor or nurse immediately 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 occasionally, 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. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or 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.