EPOPROSTENOL SODIUM

Absorption/

DistributionEpoprostenol is rapidly hydrolyzed at neutral pH in blood and is also subject to enzymatic degradation. No available chemical assay is sufficiently sensitive and specific to assess the in vivo human pharmacokinetics of epoprostenol. Animal studies using tritium‑labeled epoprostenol have indicated a high clearance (93 mL/kg/min), small volume of distribution (357 mL/kg), and a short half‑life (2.7 minutes). During infusions in animals, steady‑state plasma concentrations of...

14.1 Chronic Infusion in Idiopathic or Heritable PAH Hemodynamic Effects Chronic continuous infusions of FLOLAN in patients with idiopathic or heritable PAH were studied in 2 prospective, open, randomized trials of 8 and 12 weeks’ duration comparing FLOLAN plus conventional therapy with conventional therapy alone. Dosage of FLOLAN was determined as described in Dosage and Administration ( 2 ) and averaged 9.2 ng/kg/min at trials’ end. Conventional therapy varied among patients and included some or all of the following: anticoagulants in essentially all patients; oral vasodilators, diuretics, a...

The most common adverse reactions are dizziness, jaw pain, headache, musculoskeletal pain, and nausea/vomiting, and are generally associated with vasodilation. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact GlaxoSmithKline at 1-888-825-5249 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared with ra...

FLOLAN is contraindicated in patients with heart failure caused by reduced left ventricular ejection fraction [see Clinical Studies ( 14.3 )] . FLOLAN is contraindicated in patients with a hypersensitivity to the drug or any of its ingredients.

• Heart failure with reduced ejection fraction. ( 4 )
• Hypersensitivity to FLOLAN or any of its ingredients. ( 4 )

• Pulmonary edema: Discontinue therapy if pulmonary edema occurs. ( 5.1 )
• Rebound pulmonary hypertension: Do not abruptly discontinue or decrease the dose. ( 5.2 )
• Vasodilation reactions: Monitor blood pressure and symptoms regularly during initiation and after dose change. ( 5.3 )
• Increased risk for bleeding: Increased risk for hemorrhagic complications, particularly for patients with other risk factors for bleeding. ( 5.4 ) 5.1 Pulmonary Edema If the patient develops pulmonary edema duri...