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Flolan

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Flolan

FLOLAN®
(epoprostenol sodium) for Injection

Flolan

DRUG DESCRIPTION

FLOLAN (epoprostenol sodium) for Injection is a sterile sodium salt formulated for intravenous (IV) administration. Each vial of FLOLAN (epoprostenol sodium) contains epoprostenol sodium equivalent to either 0.5 mg (500,000 ng) or 1.5 mg (1,500,000 ng) epoprostenol, 3.76 mg glycine, 2.93 mg sodium chloride, and 50 mg mannitol. Sodium hydroxide may have been added to adjust pH.

Epoprostenol (PGI2, PGX, prostacyclin), a metabolite of arachidonic acid, is a naturally occurring prostaglandin with potent vasodilatory activity and inhibitory activity of platelet aggregation.

Epoprostenol is (5Z,9α,11α,13E,15S)-6,9-epoxy-11,15-dihydroxyprosta-5,13-dien-1-oic acid.

Epoprostenol sodium has a molecular weight of 374.45 and a molecular formula of C20H31NaO5. The structural formula is:

FLOLAN® (epoprostenol sodium) Structural Formula Illustration

FLOLAN (epoprostenol sodium) is a white to off-white powder that must be reconstituted with STERILE DILUENT for FLOLAN (epoprostenol sodium) . STERILE DILUENT for FLOLAN (epoprostenol sodium) is supplied in glass vials containing 50 mL of 94 mg glycine, 73.3 mg sodium chloride, sodium hydroxide (added to adjust pH), and Water for Injection, USP.

The reconstituted solution of FLOLAN (epoprostenol sodium) has a pH of 10.2 to 10.8 and is increasingly unstable at a lower pH.

What are the possible side effects of epoprostenol (Flolan, Veletri)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have a serious side effect such as:

  • fever, flu symptoms, mouth and throat ulcers, rapid heart rate, rapid and shallow breathing, fainting;
  • chest pain, trouble breathing;
  • fast, slow, or uneven heart rate;
  • pale skin, easy bruising, unusual bleeding (nose, mouth, vagina, or rectum), purple or red pinpoint spots under your skin;
  • blood in your...

Read All Potential Side Effects and See Pictures of Flolan »

What are the precautions when taking epoprostenol sodium (Flolan)?

Before using epoprostenol, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: heart failure (on the left side of the heart), bleeding problems (such as bleeding of the stomach/intestines), blood disorders (such as thrombocytopenia), liver disease.

This drug may make you dizzy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Limit alcoholic beverages.

To lower your risk of dizziness and lightheadedness, get...

Read All Potential Precautions of Flolan »

Last reviewed on RxList: 5/24/2011
This monograph has been modified to include the generic and brand name in many instances.

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Flolan - User Reviews

Flolan User Reviews

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Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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