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Signs and symptoms of excessive doses of FLOLAN (epoprostenol sodium) during clinical trials are the expected dose-limiting pharmacologic effects of FLOLAN (epoprostenol sodium) , including flushing, headache, hypotension, tachycardia, nausea, vomiting, and diarrhea. Treatment will ordinarily require dose reduction of FLOLAN (epoprostenol sodium) .
One patient with PAH/CTD accidentally received 50 mL of an unspecified concentration of FLOLAN (epoprostenol sodium) . The patient vomited and became unconscious with an initially unrecordable blood pressure. FLOLAN (epoprostenol sodium) was discontinued and the patient regained consciousness within seconds. In clinical practice, fatal occurrences of hypoxemia, hypotension, and respiratory arrest have been reported following overdosage of FLOLAN (epoprostenol sodium) .
Single intravenous doses of FLOLAN (epoprostenol sodium) at 10 and 50 mg/kg (2,703 and 27,027 times the recommended acute phase human dose based on body surface area) were lethal to mice and rats, respectively. Symptoms of acute toxicity were hypoactivity, ataxia, loss of righting reflex, deep slow breathing, and hypothermia.
A large study evaluating the effect of FLOLAN (epoprostenol sodium) on survival in NYHA Class III and IV patients with congestive heart failure due to severe left ventricular systolic dysfunction was terminated after an interim analysis of 471 patients revealed a higher mortality in patients receiving FLOLAN (epoprostenol sodium) plus conventional therapy than in those receiving conventional therapy alone. The chronic use of FLOLAN (epoprostenol sodium) in patients with congestive heart failure due to severe left ventricular systolic dysfunction is therefore contraindicated.
Some patients with pulmonary hypertension have developed pulmonary edema during dose initiation, which may be associated with pulmonary veno-occlusive disease. FLOLAN (epoprostenol sodium) should not be used chronically in patients who develop pulmonary edema during dose initiation.
FLOLAN (epoprostenol sodium) is also contraindicated in patients with known hypersensitivity to the drug or to structurally related compounds.
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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