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EPOPROSTENOL SODIUM injection, powder, for solutionSTERILE DILUENT injection


  1. Patient Information
  2. Can Cause Serious Side Effects, Including:
  3. The Most Common Side Effects Of Epoprostenol Sodium For Injection Include:
  4. If The Mixed Solution Will Be Used At Room Temperature:
  5. If The Mixed Solution Will Be Used With A Cold Pouch:
  6. Active Ingredient:
  7. Inactive Ingredients:
  8. Advise Patients:

Patient Information 

Epoprostenol Sodium (e poe pros te nol soe dee um) for Injection,
for intravenous use

What isepoprostenol sodium for injection?

Epoprostenol sodium for injection is a prescription medicine used to treat people with certain types of pulmonary arterial hypertension (PAH), which is high blood pressure in the arteries of the lungs. Epoprostenol sodium for injection can improve your ability to be physically active.

It is not known if epoprostenol sodium for injection is safe and effective in children.
Do not useepoprostenol sodium for injectionif you:
  • have certain types of heart failure. Talk to your healthcare provider before using epoprostenol sodium for injection if you have heart failure.
  • are allergic to epoprostenol sodium for injection or any of the ingredients in epoprostenol sodium for injection.
    • Epoprostenol sodium for injection should only be given by infusion through a catheter placed in a vein (intravenous infusion) using an infusion pump.
    • Your first treatment will be given to you by your healthcare provider or nurse. This is so your healthcare provider can monitor you and find the best dose for you.
    • If your healthcare provider decides that you or your caregiver can give infusions of epoprostenol sodium for injection at home, you or your caregiver will receive training on the right way to mix and infuse epoprostenol sodium for injection. Do not try to infuse epoprostenol sodium for injection until you have been shown the right way to infuse epoprostenol sodium for injection by your healthcare provider.
    • Treatment will be needed for a long period of time, possibly years. You must be able to accept and care for a catheter and infusion pump in order to be treated with epoprostenol sodium for injection.
    • Use epoprostenol sodium for injection exactly as your healthcare provider tells you to.
    • Do not change your dose or stop your infusion without talking to your healthcare provider. Stopping epoprostenol sodium for injection suddenly can cause serious side effects.
    • You should have a backup infusion pump and extra supplies needed for your infusion of epoprostenol sodium for injection.
    • Follow your healthcare provider s instructions for taking blood thinner medicines, if prescribed for you.
    • Before you use epoprostenol sodium for injection, you must mix (reconstitute) epoprostenol sodium for injection powder with a diluent.STERILE DILUENT forepoprostenol sodium for injection(comes in a glass bottle).

    Do not mix epoprostenol sodium for injection with any other diluent. You must use STERILE DILUENT for epoprostenol sodium for injection.

    for more information about how to use and store epoprostenol sodium for injection the right way.

    • A mixed solution of epoprostenol sodium for injection is clear and colorless. Do not use epoprostenol sodium for injection if the mixed solution looks discolored or cloudy, or if the solution has flakes or particles in it.
    Using more than the prescribed dose of epoprostenol sodium for injection can lead to death. If you use more than the prescribed dose of epoprostenol sodium for injection, call your healthcare provider or go to the nearest emergency room right away.
What are the possible side effects ofepoprostenol sodium for injection?

Epoprostenol sodium for injection

Can Cause Serious Side Effects, Including: 

  • Fluid in your lungs (pulmonary edema). If you develop pulmonary edema after starting epoprostenol sodium for injection, your healthcare provider will stop your treatment and you should not receive epoprostenol sodium for injection again.
  • Worsening symptoms of pulmonary arterial hypertension (PAH) with a sudden decrease in the dose ofepoprostenol sodium for injection. Do not change your dose of epoprostenol sodium for injection or stop your infusion without talking to your healthcare provider. If you suddenly stop or decrease your dose of epoprostenol sodium for injection you may develop worsening symptoms of your PAH, including shortness of breath, dizziness, weakness, or loss of strength.
  • Widening of your blood vessels (vasodilation). Vasodilation reactions can happen after you start epoprostenol sodium for injection. These reactions are common and may cause low blood pressure (hypotension), flushing, nausea, vomiting, dizziness, and headache. Your healthcare provider should check your blood pressure regularly during treatment with epoprostenol sodium for injection, especially when you start epoprostenol sodium for injection and after your dose is changed.
  • Increased risk for bleeding. Epoprostenol sodium for injection affects how well your blood clots, so your risk for bleeding is increased. This is especially true if you have other risk factors for bleeding. Tell your healthcare provider if you develop any unusual bruising or bleeding.

The Most Common Side Effects Of Epoprostenol Sodium For Injection Include: 

  • dizziness
  • jaw pain
  • headache
  • muscle or bone pain
  • nausea or vomiting

These are not all the possible side effects of epoprostenol sodium for injection. For more information, ask your healthcare provider or pharmacist.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.How should I store and useepoprostenol sodium for injection?
  • Store epoprostenol sodium for injection powder at room temperature between 68 F to 77 F (20 C to 25 C).
  • Protect epoprostenol sodium for injection powder from light. Keep unopened vial of epoprostenol sodium for injection in the carton until you are ready to mix.
  • Store the STERILE DILUENT for epoprostenol sodium for injection at room temperature, 68 F to 77 F (20 C to 25 C). Do not freeze.
  • Vial of STERILE DILUENT forepoprostenol sodium for injectionis for one-time use only.Throw away any unused diluent.
  • Throw away any vials of epoprostenol sodium for injection powder, STERILE DILUENT for epoprostenol sodium for injection that are out of date or that you no longer need.

    How to store mixed solutions ofepoprostenol sodium for injection:
  • Once epoprostenol sodium for injection and the diluent are mixed together, you may use right away or store in the refrigerator. Refrigerate at 36 F to 46 F (2 C to 8 C).
  • Protect the mixed solution of epoprostenol sodium for injection from light until you are ready to use it.
  • Do not freeze mixed solutions. Throw away any mixed solution that has been frozen.

If you are using STERILE DILUENT forepoprostenol sodium for injection

If The Mixed Solution Will Be Used At Room Temperature: 

  • Use the mixed solution over a period ofno longer than 8 hoursafter mixingif not stored in the refrigerator.
  • If the mixed solution has been stored in the refrigerator, infuse it over a period ofno longer than 8 hours after removing it from the refrigerator.
  • You may store the mixed solution for up to40 hoursin the refrigerator.
  • Throw away any mixed solution if it has been refrigerated for more than 40 hours.

If The Mixed Solution Will Be Used With A Cold Pouch: 


  • You may store the mixed solution in the refrigerator forup to 24 hours.
  • Take the mixed solution out of the refrigerator and use it with the cold pouch over a period ofno longer than 24 hours. Change the cold pouch every 12 hours.

    The mixed solution may be kept either in the refrigerator or in the cold pouch, or a combination of the two, for no more than 48 hours. After 48 hours, throw away any mixed solution.

Keepepoprostenol sodium for injection and all medicines out of the reach of children.

General information about the safe and effective use ofepoprostenol sodium for injection

Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use epoprostenol sodium for injection for a condition for which it was not prescribed. Do not give epoprostenol sodium for injection to other people, even if they have the same symptoms that you have. It may harm them.

This leaflet summarizes the most important information about epoprostenol sodium for injection. You can ask your healthcare provider or pharmacist for information about epoprostenol sodium for injection that is written for health professionals.

For more information, go to www.tevagenerics.com or call 1-888-838-2872.

What are the ingredients inepoprostenol sodium for injection?

Active Ingredient: 

epoprostenol sodium.

Inactive Ingredients: 

glycine, mannitol, sodium chloride. Sodium hydroxide may have been added.

The STERILE DILUENT for epoprostenol sodium for injection contains: glycine, sodium chloride, sodium hydroxide, and Water for Injection.Teva Pharmaceuticals USA, Inc.
North Wales, PA 19454This Patient Information has been approved by the U.S. Food and Drug Administration. Rev. B 3/2019

Advise Patients: 

  • Epoprostenol sodium for injection must be reconstituted only with STERILE DILUENT for epoprostenol sodium for injection.
  • Reconstituted solution prepared with STERILE DILUENT for epoprostenol sodium for injection must be used with a cold pouch if not administered within 8 hours.
  • Epoprostenol sodium for injection is infused continuously through a permanent indwelling central venous catheter via a small, portable infusion pump. Thus, therapy with epoprostenol sodium for injection requires commitment by the patient to drug reconstitution, drug administration, and care of the permanent central venous catheter. Patients must adhere to sterile technique in preparing the drug and in the care of the catheter, and even brief interruptions in the delivery of epoprostenol sodium for injection may result in rapid symptomatic deterioration. A patient s decision to receive epoprostenol sodium for injection should be based upon the understanding that there is a high likelihood that therapy with epoprostenol sodium for injection will be needed for prolonged periods, possibly years. Consider the patient's ability to accept and care for a permanent intravenous catheter and infusion pump.
  • To adjust infusion rates of epoprostenol sodium for injection only under the direction of a physician.
  • To avoid interruptions in drug delivery, the patient should have access to a backup infusion pump and intravenous infusion sets.
  • To contact their healthcare providers if any unusual bruising or bleeding develops.

Teva Pharmaceuticals USA, Inc.

North Wales, PA 19454

Rev. E 3/2019



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