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INDICATION: FLOLAN is indicated for the long-term intravenous treatment of primary pulmonary hypertension and pulmonary hypertension associated with the scleroderma spectrum of disease in NYHA Class III and Class IV patients who do not respond adequately to conventional therapy.
Pulmonary hypertension is high blood pressure in the arteries of the lungs.
IMPORTANT SAFETY INFORMATION: FLOLAN should not be used by patients with congestive heart failure due to severe left ventricular systolic dysfunction. It should also not be used by patients who develop pulmonary edema, or fluid in their lungs, during the initiation of therapy.
Patients should not use FLOLAN if they have an allergy to the drug or similar compounds.
FLOLAN should only be mixed with STERILE DILUENT for FLOLAN. FLOLAN must not be mixed with any other medications or solutions prior to or during administration.
Any sudden interruption of therapy with FLOLAN, even for a brief period, may result in symptoms associated with rebound pulmonary hypertension, including difficulty breathing, dizziness, and a lack of energy. In severe cases, rebound pulmonary hypertension can lead to death.
FLOLAN can pose an increased risk for bleeding complications, particularly in people who have other risk factors for bleeding.
The most common side effects associated with FLOLAN include headache, jaw pain, flushing, diarrhea, nausea and vomiting, flu-like symptoms, anxiety, and nervousness.
Serious adverse events have been reported during post-approval use of FLOLAN. These include bloodstream infection, anemia, overactivity and enlargement of the spleen, a reduction in red and white blood cells and platelets, and overactivity of the thyroid gland.
Some side effects that may be caused by excessive doses of FLOLAN include flushing, headache, low blood pressure, a rise in heart rate, nausea, vomiting, and diarrhea.
Over time, excessive doses of FLOLAN can also weaken the heart by causing it to pump too large a volume of blood.
Other side effects can occur and patients should let their healthcare professional know of any side effects that they are experiencing when on therapy with FLOLAN.
Please click here for full prescribing information.
