FLOLAN (epoprostenol sodium) for Injection is a sterile sodium salt 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, 2.93 mg sodium chloride, and 50 mg mannitol. Sodium hydroxide may have been added to adjust pH.
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 (see CLINICAL TRIALS IN PULMONARY HYPERTENSION).
Published Studies Related to Flolan (Epoprostenol)
IVI epoprostenol as salvage therapy in pulmonary arterial hypertension: an Australian perspective. [2011.03]
BACKGROUND: IVI epoprostenol is the only therapy for pulmonary arterial hypertension (PAH) with a randomized controlled trial demonstrating improved survival, when used as first-line monotherapy. In Australia it is used as salvage therapy for those failing treatment with other targeted therapies or presenting in World Health Organization functional class (FC) IV. AIMS: Report experience with IVI epoprostenol, administered as salvage therapy for the treatment of adults with PAH in a single Australian PAH centre... CONCLUSION: Findings support efficacy of epoprostenol as salvage therapy for patients with PAH. (c) 2011 The Authors. Internal Medicine Journal (c) 2011 Royal Australasian College of Physicians.
No effect of epoprostenol on right ventricular diameter in patients with acute pulmonary embolism: a randomized controlled trial. [2010.03.30]
BACKGROUND: Right ventricular dilatation in the setting of acute pulmonary embolism is associated with an adverse prognosis. Treatment with a pulmonary vasodilator has never been studied systematically. We evaluated the effect of epoprostenol on right ventricular diameter and function in patients with acute pulmonary embolism and right ventricular dilatation... CONCLUSION: In patients with acute pulmonary embolism and right ventricular overload, treatment with epoprostenol did not improve right ventricular dilatation or any other measured variables of right ventricular overload. TRIAL REGISTRATION: Registration: URL: NCT01014156Medical ethical committee: Medisch-ethische toetsingscommissie (METc) from the VUmc (free university medical centre).
Prostaglandin I2 (epoprostenol) triggers migraine-like attacks in migraineurs. [2010.02]
Prostacyclin [prostaglandin I(2) (PGI(2))] activates and sensitizes meningeal sensory afferents...
Addition of sildenafil to long-term intravenous epoprostenol therapy in patients with pulmonary arterial hypertension: a randomized trial. [2008.10.21]
BACKGROUND: Oral sildenafil and intravenous epoprostenol have independently been shown to be effective in patients with pulmonary arterial hypertension. OBJECTIVE: To investigate the effect of adding oral sildenafil to long-term intravenous epoprostenol in patients with pulmonary arterial hypertension... CONCLUSION: In some patients with pulmonary arterial hypertension, the addition of sildenafil to long-term intravenous epoprostenol therapy improves exercise capacity, hemodynamic measurements, time to clinical worsening, and quality of life, but not Borg dyspnea score. Increased rates of headache and dyspepsia occurred with the addition of sildenafil.
Prostacyclin (epoprostenol) induces headache in healthy subjects. [2008.09.30]
The role of prostanoids in nociception is well established...
Clinical Trials Related to Flolan (Epoprostenol)
Epoprostenol for Injection in Pulmonary Arterial Hypertension [Recruiting]
This is a prospective, multi-center, open-label, randomized, Phase IV exploratory study
comparing safety, tolerability, pharmacokinetics, and effectiveness of ACT-385781A and
Flolan (epoprostenol sodium) in patients with pulmonary arterial hypertension who are na´ve
to injectable prostanoid treatment and in need of such treatment. Approximately 30 patients
from 8 U. S. clinical sites will be randomized to receive either ACT-385781A or Flolan (2: 1
respectively) for 28 days of treatment.
Study of a New Thermo Stable Formulation of Epoprostenol Sodium to Treat Pulmonary Arterial Hypertension (PAH) [Not yet recruiting]
The purpose of this multicentre, open label, single-arm study in approximately 20 adult
patients is to evaluate the Impact on lifestyle of a new thermo stable formulation of
epoprostenol sodium in subjects with Pulmonary Arterial Hypertension (PAH).
Effects of Prostacyclin Infusion on Cerebral Vessels and Metabolism in Patients With Subarachnoid Haemorrhage [Recruiting]
The purpose of this study is to determine whether prostacyclin is effective in prevention of
cerebral vasospasm in patients with subarachnoidal hemorrhage (SAH).
Safety, Efficacy and Treatment Satisfaction Switching From Flolan to Remodulin Using the CronoFive Ambulatory Pump in Patients With PAH [Recruiting]
The purpose of this 8-week study is to compare the effects of switching from intravenous
Flolan to intravenous Remodulin therapy. Remodulin (treprostinil sodium) is an approved
therapy for pulmonary arterial hypertension. Unlike Flolan, Remodulin does not need to be
mixed daily and is stable at room temperature, so there is no need for ice packs. In
addition, Remodulin is changed every 48hrs, instead of every 12-24 (with ice packs) or every
8 hours (without ice packs) with Flolan. Flolan is given using a type of portable
medication pump called the CADD Legacy infusion pump. In this study, Remodulin will be given
using a smaller and lighter medication pump called the Crono Five infusion pump. This study
will also assess the effect that changing to Remodulin will have on treatment satisfaction
and patient quality of life.
Rapid Switch From Flolan to Remodulin in the Outpatient Clinic [Recruiting]
The purpose of this 8-week study is to compare the effects of switching from therapy with
epoprostenol or Flolan to IV Remodulin. This study will also assess the effect that
changing to Remodulin will have on patient satisfaction with their treatment and impact on
quality of life.
Reports of Suspected Flolan (Epoprostenol) Side Effects
Device Related Infection (32),
Pain in JAW (31),
Oedema Peripheral (29), more >>
Page last updated: 2011-12-09