Generic Name: epoprostenol (Intravenous route)
Commonly used brand name(s):
In the U.S.
Available Dosage Forms:
Therapeutic Class: Peripheral Vasodilator
Pharmacologic Class: Prostaglandin
Epoprostenol belongs to a group of agents called prostaglandins. Prostaglandins occur naturally in the body and are involved in many biological functions. Epoprostenol is used to treat the symptoms of primary pulmonary hypertension, or the high blood pressure that occurs in the main artery that carries blood from the right side of the heart (the ventricle) to the lungs. When the smaller blood vessels in the lungs become more resistant to blood flow, the right ventricle must work harder to pump enough blood through the lungs. Epoprostenol works by relaxing blood vessels and increasing the supply of blood to the lungs, reducing the workload of the heart.
This medicine is available only with your doctor's prescription.
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.
Although there is no specific information comparing use of this medicine in children with use in other age groups, this medicine is not expected to cause different side effects or problems in children than it does in adults.
Many medicines have not been studied specifically in older people. Therefore, it may not be known whether they work exactly the same way they do in younger adults or if they cause different side effects or problems in older people. There is no specific information comparing use of epoprostenol in the elderly with use in other age groups.
|All Trimesters||B||Animal studies have revealed no evidence of harm to the fetus, however, there are no adequate studies in pregnant women OR animal studies have shown an adverse effect, but adequate studies in pregnant women have failed to demonstrate a risk to the fetus.|
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.
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.
Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. 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.
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:
Your doctor or nurse will teach you how to prepare the medicine and use the pump for administering the medicine. Epoprostenol must be administered continuously by a portable pump that is operated by a small computer. The medicine will be delivered directly to the heart through a catheter that will be inserted into a vein in the chest.
Epoprostenol should be reconstituted only with the sterile diluent that is supplied with this medicine. The reconstituted medicine should not be mixed with other solutions or medicines. Use the following procedure for reconstituting your daily supply:
The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.
The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.
The amount of medicine that you take depends on the concentration of the reconstituted medicine and the rate at which the infusion pump delivers the medicine.
Call your doctor or pharmacist for instructions.
Epoprostenol has to be administered by a continuous intravenous infusion and it must never be stopped suddenly.
Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.
Keep out of the reach of children.
Do not keep outdated medicine or medicine no longer needed.
Store the reconstituted injection in the refrigerator, away from direct light. However, keep the medicine from freezing. Any medicine that has been frozen should be thrown away. Reconstituted solutions should be kept either in the refrigerator or in a cold pouch, or a combination of the two, for no more than 48 hours. Do not expose reconstituted solution to temperatures higher than 25 °C (77 °F). If the reconstituted solution has particles in it or is discolored, it should be discarded.
It is important that your doctor check your progress at regular visits. This will allow your doctor to make sure the medicine is working properly and to change the dosage if needed.
Be sure to report any signs of infection at the catheter site to your doctor. Also, if you develop a sudden fever, contact your doctor as soon as possible.
Avoid the use of saunas, hot baths, or sunbathing, or other situations that may cause blood vessels to dilate, resulting in low blood pressure and increasing the possibility of dizziness, light-headedness, or fainting.
Do not suddenly stop using this medicine. Stopping suddenly may bring on symptoms of your condition and can be dangerous. Check with your doctor before stopping completely.
Your doctor may want you to carry a medical identification card stating that you are using 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 immediately if any of the following side effects occur:Signs and symptoms that can occur with initial dosage adjustments and/or dosage excess
Check with your doctor as soon as possible if any of the following side effects occur:More common
After you stop using this medicine, it may still produce some side effects that need attention. During this period of time, check with your doctor immediately if you notice the following side effects:
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.
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