DrugLib.com — Drug Information Portal

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

Inomax (Nitric Oxide Inhalation) - Summary



INOmax (nitric oxide gas) is a drug administered by inhalation. Nitric oxide, the active substance in INOmax, is a pulmonary vasodilator. INOmax is a gaseous blend of nitric oxide and nitrogen (0.08% and 99.92%, respectively for 800 ppm; 0.01% and 99.99%, respectively for 100 ppm). INOmax is supplied in aluminum cylinders as a compressed gas under high pressure (2000 pounds per square inch gauge [psig]).

Treatment of Hypoxic Respiratory Failure

INOmax ® is a vasodilator, which, in conjunction with ventilatory support and other appropriate agents, is indicated for the treatment of term and near-term (>34 weeks) neonates with hypoxic respiratory failure associated with clinical or echocardiographic evidence of pulmonary hypertension, where it improves oxygenation and reduces the need for extracorporeal membrane oxygenation.

Utilize additional therapies to maximize oxygen delivery with validated ventilation systems [ see Dosage and Administration ] . In patients with collapsed alveoli, additional therapies might include surfactant and high-frequency oscillatory ventilation.

The safety and effectiveness of INOmax have been established in a population receiving other therapies for hypoxic respiratory failure, including vasodilators, intravenous fluids, bicarbonate therapy, and mechanical ventilation. Different dose regimens for nitric oxide were used in the clinical studies [ see Clinical Studies ].

Monitor for PaO2, methemoglobin, and inspired NO2 during INOmax administration.

See all Inomax indications & dosage >>


Published Studies Related to Inomax (Nitric Oxide Inhalation)

Randomized controlled trial of inhaled nitric oxide for the treatment of microcirculatory dysfunction in patients with sepsis*. [2014]
and multiple organ dysfunction... CONCLUSIONS: Following macrocirculatory optimization, inhaled nitric oxide at 40

Management of asthma in pregnancy guided by measurement of fraction of exhaled nitric oxide: a double-blind, randomised controlled trial. [2011.09.10]
BACKGROUND: Asthma exacerbations during pregnancy are common and can be associated with substantial maternal and fetal morbidity. Treatment decisions based on sputum eosinophil counts reduce exacerbations in non-pregnant women with asthma, but results with the fraction of exhaled nitric oxide (F(E)NO) to guide management are equivocal. We tested the hypothesis that a management algorithm for asthma in pregnancy based on F(E)NO and symptoms would reduce asthma exacerbations... INTERPRETATION: Asthma exacerbations during pregnancy can be significantly reduced with a validated F(E)NO-based treatment algorithm. FUNDING: National Health and Medical Research Council of Australia. Copyright (c) 2011 Elsevier Ltd. All rights reserved.

Inhaled nitric oxide after left ventricular assist device implantation: a prospective, randomized, double-blind, multicenter, placebo-controlled trial. [2011.08]
BACKGROUND: Used frequently for right ventricular dysfunction (RVD), the clinical benefit of inhaled nitric oxide (iNO) is still unclear. We conducted a randomized, double-blind, controlled trial to determine the effect of iNO on post-operative outcomes in the setting of left ventricular assist device (LVAD) placement... CONCLUSIONS: Use of iNO at 40 ppm in the perioperative phase of LVAD implantation did not achieve significance for the primary end point of reduction in RVD. Similarly, secondary end points of time on mechanical ventilation, hospital or intensive care unit stay, and the need for RVAD support after LVAD placement were not significantly improved. Copyright (c) 2011 International Society for Heart and Lung Transplantation. Published by Elsevier Inc. All rights reserved.

Inhaled nitric oxide for the adjunctive therapy of severe malaria: protocol for a randomized controlled trial. [2011.07.13]
BACKGROUND: Severe malaria remains a major cause of global morbidity and mortality... DISCUSSION: Noteworthy aspects of this trial design include its efficient sample size supported by a computer simulation study to evaluate statistical power, meticulous attention to complex ethical issues in a cross-cultural setting, and innovative strategies for safety monitoring and blinding to treatment allocation in a resource-constrained setting in sub-Saharan Africa.

Comparison of inhaled nitric oxide with aerosolized iloprost for treatment of pulmonary hypertension in children after cardiopulmonary bypass surgery. [2011.07]
OBJECTIVES: Pilot study to compare the effect of inhaled nitric oxide (iNO) and aerosolized iloprost in preventing perioperative pulmonary hypertensive crises (PHTCs). BACKGROUND: Guidelines recommend the use of iNO to treat PHTCs, but treatment with iNO is not an ideal vasodilator. Aerosolized iloprost may be a possible alternative to iNO in this setting... CONCLUSIONS: In this pilot study, aerosolized iloprost had a favorable safety profile. Larger trials are needed to compare its efficacy to iNO for the treatment of perioperative pulmonary hypertension. However, neither treatment alone abolished the occurrence of PHTCs.

more studies >>

Clinical Trials Related to Inomax (Nitric Oxide Inhalation)

Nitric Oxide Therapy for Acute Chest Syndrome in Sickle Cell Disease Children [Completed]
Acute chest syndrome is a severe sickle cell disease complication in children requiring blood transfusion therapy to prevent acute respiratory failure and death. Nitric oxide is a potent vasodilator that could reverse pulmonary vascular occlusion and restore normal oxygenation. The randomized trial will test that hypothesis.

Comparison of Inhaled Nitric Oxide and Oxygen in Patient Reactivity During Acute Pulmonary Vasodilator Testing [Completed]
A minimum of 100 patients will be enrolled in the study to demonstrate which diagnostic treatment (oxygen or nitric oxide) is most capable of identifying patients with a reactive pulmonary vascular bed. Each patient will be given all three treatment regimen, nitric oxide, oxygen, and the comparison treatment (nitric oxide plus oxygen), with a wash out period of 10 minutes between each dose. Patients will be randomized at the time of enrollment to determine which comparison treatment they will receive.

Effect of Nitric Oxide (NO) on Ischemic/Reperfusion Injury During Extended Donor Criteria (EDC) Liver Transplantation [Recruiting]
In this study, the researchers propose to investigate the efficacy of inhaled nitric oxide to prevent ischemia-reperfusion (I/R) hepatocyte injury in patients who receive extended donor criteria(EDC)liver grafts based on changes in proteomic and metabolomic markers following revascularization of the donor graft. In reviewing the literature, no uniform extended criteria donor classification exists. The characteristics most associated with liver graft failure appear to be cold ischemia time greater than 10 hours, warm ischemia time greater than 40 minutes, donor age > 55 years of age, donor hospitalization > 5 days, a donation after cardiac death (DCD) graft, and a split graft. The researchers will exclude warm ischemia time as this is impossible to predict prior to the transplantation. Any donor meeting at least one of the other criteria will be classified as an EDC donor. Hypothesis 1: Inhaled nitric oxide will improve overall outcome of liver recipients after EDC liver transplantation

- Suppression of oxidative injury will improve graft function postoperatively as measured

by International Normalized Ratio (INR) bilirubin, transaminases, and duration of hospital stay. Hypothesis 2: The mechanisms of therapeutic efficacy of inhaled nitric oxide is based on reduction in post-reperfusion oxidative injury as readily measured by the detectable changes in the protein and metabolic profiles in plasma of patients treated with inhaled-NO

- Nuclear Magnetic Resonance (NMR)-based metabolic markers (xanthine end-products,

lactate, and hepatic osmolytes) that are consistent with acute liver injury will be decreased in NO-treated recipients.

- Protein markers of reperfusion injury (argininosuccinate synthase (ASS) and estrogen

sulfotransferase (EST-1) will be greater in the plasma of patients who are not treated with inhaled-NO

- Reduced oxidative injury will be reflected by a decrease in the number of mitochondrial

peroxiredoxins isoforms and the number that are oxidized in NO-treated liver recipients.

Nitric Oxide Administration for Acute Respiratory Distress Syndrome [Completed]
This research project is an open-label, randomized study for the use of Nitric Oxide in pediatric patients with acute respiratory distress syndrome (ARDS). The study examines whether nitric oxide (NO) treatment impacts the the P: F ratio (arterial partial pressure of oxygen (PaO2) divided by fraction of inspired oxygen (FiO2) in patients with ARDS. The goal of the study is to evaluate whether the order of NO therapy will have any effect on response, and evaluate the characteristics of patients who respond to NO compared to those who do not.

Inhaled Nitric Oxide (INO) In Hypoxic Respiratory Failure [Withdrawn]
This Phase 3, Double-blind, Randomized, Placebo controlled, multicenter study is to confirm the efficacy of inhaled nitric oxide for the management of hypoxic respiratory failure associated with pulmonary hypertension in preterm infants. Study subjects will be administered either inhaled nitric oxide or placebo to determine if there is a change in oxygenation.

more trials >>

Reports of Suspected Inomax (Nitric Oxide Inhalation) Side Effects

Oxygen Saturation Decreased (17)Cardio-Respiratory Arrest (9)Device Failure (8)OFF Label USE (5)Device Malfunction (4)Acidosis (3)Pneumothorax (3)Blood Pressure Decreased (3)Pulmonary Hypertension (2)Patent Ductus Arteriosus (2)more >>

Page last updated: 2015-08-10

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

All Rights reserved - Copyright DrugLib.com, 2006-2017