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 .
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.
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:
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.
Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of alprostadil injection in newborn babies.
Use of this medicine is not indicated for geriatric patients.
|All Trimesters||C||Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.|
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.
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.
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:
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.
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.
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:
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:
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.