"The U.S. Food and Drug Administration today notified Ranbaxy Laboratories, Ltd., that it is prohibited from manufacturing and distributing active pharmaceutical ingredients (APIs) from its facility in Toansa, India, for FDA-regulated drug product"...
FLOLAN (epoprostenol sodium) for injection is sterile sodium salt that is a white or off-white powder formulated for intravenous (IV) administration. Each vial of FLOLAN 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, 50 mg mannitol, and 2.93 mg sodium chloride. 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. The chemical name of epoprostenol is (5Z,9α,11α,13E,15S)-6,9-epoxy-11,15dihydroxyprosta-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 must be reconstituted with either STERILE DILUENT for FLOLAN or pH 12 STERILE DILUENT for FLOLAN.
STERILE DILUENT for FLOLAN is supplied in glass vials and pH 12 STERILE DILUENT for FLOLAN is supplied in plastic vials each containing 50 mL of 94 mg glycine, 73.3 mg sodium chloride, sodium hydroxide (added to adjust pH), and Water for Injection. The stability of reconstituted solutions of FLOLAN is pH-dependent, and is greater at higher pH.
- STERILE DILUENT for FLOLAN has sodium hydroxide added to adjust the pH to 10.2 to 10.8.
- pH 12 STERILE DILUENT for FLOLAN has sodium hydroxide added to adjust the pH to 11.7 to 12.3.
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...
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...
Last reviewed on RxList: 12/1/2016
This monograph has been modified to include the generic and brand name in many instances.
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