Description and Brand Names

Drug information provided by: Merative, Micromedex®

US Brand Name

  1. Prostin VR Pediatric

Descriptions


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.

This product is available in the following dosage forms:

  • Solution

Before Using

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.

Pediatric

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

Geriatric

Use of this medicine is not indicated for geriatric patients.

Breastfeeding

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.

Drug Interactions

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

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

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

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

  1. Bluish lips or skin
  2. chest pain or discomfort
  3. feeling of warmth
  4. fever
  5. lightheadedness, dizziness, or fainting
  6. not breathing
  7. redness of the face, neck, arms, and occasionally, upper chest
  8. slow or irregular heartbeat
  9. unusual tiredness

Less common

  1. Blood in the urine or stools
  2. bruising
  3. confusion
  4. convulsions
  5. coughing or vomiting blood
  6. decreased urine
  7. dry mouth
  8. fast, pounding, or irregular heartbeat or pulse
  9. increased thirst
  10. loss of appetite
  11. mood changes
  12. no blood pressure or pulse
  13. persistent bleeding or oozing from puncture sites, mouth, or nose
  14. rash
  15. seizures
  16. unconsciousness
  17. vomiting

Rare

  1. Abdominal or stomach pain
  2. anxiety
  3. black, tarry stools
  4. bleeding gums
  5. clumsiness
  6. cold clammy skin
  7. difficult or troubled breathing
  8. dilated neck veins
  9. fainting
  10. low body temperature
  11. neck is bent backward
  12. pale or blue lips, fingernails, or skin
  13. pale skin
  14. pinpoint red spots on the skin
  15. restlessness
  16. shivering or chills
  17. slow to respond
  18. sweating
  19. swelling of the face, fingers, feet, or lower legs
  20. unusual bleeding or bruising
  21. unusual drowsiness, dullness, tiredness, weakness, or sleepiness
  22. unusually irritable
  23. weak or feeble pulse
  24. 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

  1. 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.