FENOLDOPAM MESYLATE INJECTION USP
Fenoldopam Mesylate Injection USP is a dopamine D1-like receptor agonist. The product is formulated as a solution to be diluted for intravenous infusion.
Adult Patients: Fenoldopam is indicated for the in-hospital, short-term (up to 48 hours) management of severe hypertension when rapid, but quickly reversible, emergency reduction of blood pressure is clinically indicated, including malignant hypertension with deteriorating end-organ function. Transition to oral therapy with another agent can begin at anytime after blood pressure is stable during fenoldopam mesylate infusion.
Pediatric Patients: Information related to the indicated use of fenoldopam injection in pediatric patients is approved for Abbott Laboratories’ fenoldopam drug products. However, due to Abbott’s marketing exclusivity rights, this drug product is not labeled for pediatric use.
Media Articles Related to Fenoldopam
Source: MedicineNet Angina Specialty [2013.11.25]
Title: Pulmonary Hypertension
Category: Diseases and Conditions
Created: 12/31/1997 12:00:00 AM
Last Editorial Review: 11/25/2013 12:00:00 AM
Increased risk of alcohol-related hypertension in individuals who flush after drinking
Source: Alcohol / Addiction / Illegal Drugs News From Medical News Today [2013.11.21]
Excessive drinking is a known risk factor for hypertension. Drinking that results in facial flushing indicates high sensitivity or even intolerance to alcohol. A study of the relationship between drinking and these two conditions has found that drinking-related hypertension has a lower threshold value and higher risk in flushers than in non-flushers.
Some allergy suffers with hypertension may be at increased risk for severe reaction
Source: Allergy News From Medical News Today [2013.11.12]
Oral allergy syndrome sufferers that take high blood pressure medications may experience extreme facial swelling and difficulty breathing the next time they bite into a juicy apple.
In low-income urban neighborhoods the rates of diabetes, hypertension, heart disease and stroke are much higher
Source: Hypertension News From Medical News Today [2013.11.07]
There is more to the cost of living in a food desert than higher prices for the few fruits and vegetables sold nearby, according to a study by an Indiana University-Purdue University Indianapolis researcher and the Marion County Public Health Department.
Further positive Opsumit (macitentan) data in pulmonary arterial hypertension presented at CHEST 2013
Source: Hypertension News From Medical News Today [2013.10.31]
Actelion (SIX: ATLN) has announced that following the recent FDA approval and positive CHMP opinion for macitentan (Opsumit®) in pulmonary arterial hypertension (PAH), further positive data on the efficacy of macitentan from the SERAPHIN study were presented at CHEST 2013 in Chicago, USA (26-31 October 2013).
Published Studies Related to Fenoldopam
Fenoldopam in critically ill patients with early renal dysfunction. A crossover study. [2011.08]
BACKGROUND: Acute kidney injury is a frequent problem among many critically ill patients, commonly in the context of multiple organ failure and decreased renal perfusion. Its presence conveys a poor prognosis. Currently, effective therapeutic interventions are limited and dopaminergic agonists have been suggested as an option to prevent further damage... CONCLUSIONS: Our study showed that low-dose Fenoldopam increases creatinine clearance in the critically ill with renal insufficiency. Fenoldopam may be a useful drug in ICU patients with early renal dysfunction. (c) 2010 Blackwell Publishing Ltd.
High-dose fenoldopam reduces postoperative neutrophil gelatinase-associated lipocaline and cystatin C levels in pediatric cardiac surgery. [2011.06.29]
INTRODUCTION: The aim of the study was to evaluate the effects of high-dose fenoldopam, a selective dopamine-1 receptor, on renal function and organ perfusion during cardiopulmonary bypass (CPB) in infants with congenital heart disease (CHD)... CONCLUSIONS: The treatment with high-dose fenoldopam during CPB in pediatric patients undergoing cardiac surgery for CHD with biventricular anatomy significantly decreased urinary levels of NGAL and CysC and reduced the use of diuretics and vasodilators during CPB. TRIAL REGISTRATION: Clinical Trial.Gov NCT00982527.
The effect of fenoldopam and dopexamine on cytokine and endotoxin release following on-pump coronary artery bypass grafting: a prospective randomized double-blind trial. [2010.12]
BACKGROUND: Surgical trauma, exposure to an external circuit, and reduced organ perfusion contribute to the systemic inflammatory response following cardiopulmonary bypass (CPB). Reduced splanchnic perfusion causes disruption of the gastrointestinal mucosal barrier and the release of endotoxins. Fenoldopam (a new dopamine 1 receptor agonist) has been shown to be a specific renosplanchnic vasodilator in animal and human studies. We studied the effects of fenoldopam on the systemic inflammatory response and the release of endotoxins after CPB and compared the results with those for dopexamine... CONCLUSION: A partial attenuation in the inflammatory response is possible with fenoldopam infusion. The elevation in serum endotoxin levels was not affected by dopexamine or fenoldopam infusion.
Fenoldopam use in a burn intensive care unit: a retrospective study. [2010.06.24]
ABSTRACT: BACKGROUND: Fenoldopam mesylate is a highly selective dopamine-1 receptor agonist approved for the treatment of hypertensive emergencies that may have a role at low doses in preserving renal function in those at high risk for or with acute kidney injury (AKI). There is no data on low-dose fenoldopam in the burn population. The purpose of our study was to describe our use of low-dose fenoldopam (0.03-0.09 mug/kg/min) infusion in critically ill burn patients with AKI... CONCLUSIONS: These findings suggest that renal function was preserved and that urine output improved without a decrease in systolic blood pressure, increase in vasoactive medication use, or an increase in resuscitation requirement in patients treated with low-dose fenoldopam. A randomized controlled trial is required to establish the efficacy of low-dose fenoldopam in critically ill burn patients with AKI.
Effects of fenoldopam infusion in complex cardiac surgical operations: a prospective, randomized, double-blind, placebo-controlled study. [2010.04]
AIM: Fenoldopam mesylate is a short-acting dopamine-1 agonist that has been suggested to be a possible reno-protective agent in patients undergoing cardiac surgery. The present study is a prospective, randomized, double-blind placebo controlled trial conducted to determine the effects of fenoldopam in a population of patients undergoing complex cardiac operations... CONCLUSION: Fenoldopam improves the quality of perfusion during CPB. In patients receiving catecholamines to treat a postoperative low cardiac output state, fenoldopam significantly improves renal function and prevents AKI and major morbidity.
Clinical Trials Related to Fenoldopam
Fenoldopam and Acute Renal Failure [Recruiting]
Patients undergoing cardiac surgery could develop postoperative acute renal failure
requiring renal replacement therapy.
Fenoldopam, already used for patients with hypertensive emergencies, could improve renal
function in critically ill patients with or at risk for acute renal failure.
Fenoldopam and Ketanserin for Acute Kidney Failure Prevention After Cardiac Surgery [Recruiting]
The purpose of the study is to compare the effect of fenoldopam and ketanserin on kidney
function preservation in patients at high risk for renal failure after cardiac surgery.
Acute, oliguric renal failure develops in up to 2% of patients undergoing cardiac surgery.
Some of them require renal replacement therapy and despite that mortality in this group
exceeds 30-60%. The investigators await that the use of fenoldopam and/or ketanserin may
decrease the rate of severe renal failure.
Fenoldopam in Pediatric Cardiac Surgery [Recruiting]
The purpose of this study is to determine whether fenoldopam infusion during cardiopulmonary
bypass in young children with congenital heart disease is able to reduce indicators of acute
kidney injury (biomarkers reduction, diuresis increase) compared to a control group.
Intra-Renal Therapy of Diuretic Unresponsive Acute Kidney Injury [Not yet recruiting]
Randomized prospective trial of patients with diuretic unresponsive acute kidney injury
where patients will receive standard supportive therapy with diuretics versus intra-renal
delivery of the vasodilator fenoldopam mesylate.
Patients with rising creatinine who fail to respond to bolus diuretics will be treated with
a prolonged course of diuretics or undergo placement of a catheter within the renal arteries
that allows for infusion of fenoldopam mesylate. The rational is that early delivery of a
high dose vasodilator may reverse the decline of renal function in patients with severe
acute kidney injury.
Vasodilators and Anti-Oxidant Therapy in Early ATN [Not yet recruiting]
Patients developing kidney failure after open heart surgery experience an abrupt decrease in
blood flow to the kidney. We hypothesize that administration of fenoldopam mesylate (a drug
that increases blood flow to the kidney) to patients early in the course of their disease
could reduce progression to dialysis-dependent acute renal failure. We also hypothesize that
restoring blood flow could induce additional injury to the kidney through the release of
reactive oxygen species. Therefore, patients in this protocol will be randomized to receive
a fenoldopam or the anti-oxidant MESNA. We hypothesize that combination treatment with
Fenoldopam and MESNA will decrease the incidence of death or dialysis at 21 days in patients
with early post-operative acute renal failure.