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FDA Labeling Changes
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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 (2.2)]. 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 (14)].
Monitor for PaO2, methemoglobin, and inspired NO2 during INOmax administration.
There is currently no drug history available for this drug.
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]).
The structural formula of nitric oxide (NO) is shown below: