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Rebound Pulmonary Hypertension Syndrome following Abrupt Discontinuation

Wean from INOmax [see DOSAGE AND ADMINISTRATION]. Abrupt discontinuation of INOmax may lead to worsening and increasing pressure, i.e., Rebound Pulmonary Hypertension Syndrome. Signs and symptoms of Rebound Pulmonary Hypertension Syndrome include , systemic, , and decreased . If Rebound Pulmonary Hypertension occurs, reinstate INOmax therapy immediately.

Hypoxemia from Methemoglobinemia

combines with to form , which does not transport oxygen, Methemoglobin levels increase with the dose of INOmax; it can take 8 hours or more before steady-state methemoglobin levels are attained. Monitor methemoglobin and adjust the dose of INOmax to optimize oxygenation.

If methemoglobin levels do not resolve with decrease in dose or discontinuation of INOmax, additional therapy may be warranted to treat [see OVERDOSAGE].

Airway Injury from Nitrogen Dioxide

Nitrogen dioxide (NO2) forms in gas mixtures containing NO and O2. Nitrogen dioxide may cause inflammation and damage to lung tissues. If the concentration of NO2 in the breathing circuit exceeds 0.5 ppm, decrease the dose of INOmax.

If there is an unexpected change in NO2 concentration, when measured in the breathing circuit, then the delivery system should be assessed in accordance with the Nitric Oxide Delivery System O&M Manual troubleshooting section, and the NO2 analyzer should be recalibrated. The dose of INOmax and/or FiO2 should be adjusted as appropriate.

Heart Failure

Patients with left dysfunction treated with INOmax may experience, increased pulmonary wedge pressure, worsening of left ventricular dysfunction, systemic hypotension, bradycardia and cardiac arrest. Discontinue INOmax while providing symptomatic care.

Carcinogenesis, Mutagenesis, Impairment of Fertility

No evidence of a effect was apparent, at inhalation exposures up to the recommended dose (20 ppm), in rats for 20 hr/day for up to two years. Higher exposures have not been investigated.

Nitric oxide has demonstrated genotoxicity in, human lymphocytes, and after in vivo exposure in rats. There are no animal or human studies to evaluate nitric oxide for effects on fertility.

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