DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more

Flolan (Epoprostenol Sodium) - Summary

 
 



FLOLAN SUMMARY

FLOLAN®
(epoprostenol sodium)
for Injection

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).


See all Flolan indications & dosage >>

NEWS HIGHLIGHTS

Media Articles Related to Flolan (Epoprostenol)

Potential to treat pulmonary hypertension with protein in 'good cholesterol'
Source: Cholesterol News From Medical News Today [2014.09.01]
Oxidized lipids are known to play a key role in inflaming blood vessels and hardening arteries, which causes diseases like atherosclerosis.

more news >>

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...

more studies >>

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.

Inhaled Nitric Oxide and Inhaled Prostacyclin After Cardiac Surgery for Heart Transplant or LVAD Placement [Recruiting]
Research study evaluating the individual and combined effects of inhaled medications, nitric oxide and prostacyclin, on the function of the right heart after surgery for either heart transplant or for left ventricular assist device (LVAD) placement. The investigators hope to learn if these two medications, when given together after surgery, improve right heart function by lowering blood vessel pressures in the lungs. The investigators hope to learn if the combined effects of these two medications are better than either medication used alone. Participants were selected as a possible participant in this study because right heart problems are common during and after surgery for heart transplant and for LVAD placement. In addition, the inhaled medication, nitric oxide, is always given during and after these two types of surgeries at Stanford to help improve how the right heart functions.

more trials >>

Reports of Suspected Flolan (Epoprostenol) Side Effects

Dyspnoea (74)Death (68)Diarrhoea (48)Pneumonia (40)Nausea (39)Vomiting (35)Device Related Infection (32)Pain in JAW (31)Ascites (30)Oedema Peripheral (29)more >>


Page last updated: 2014-09-01

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2014