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INOmax®


(nitric oxide gas)


Brief Summary of Prescribing Information INDICATIONS AND USAGE


is indicated to improve oxygenation and reduce the need for extracorporeal membrane oxygenation in term and near-term (>34 weeks) neonates with hypoxic respiratory failure associated with clinical or echocardiographic evidence of pulmonary hypertension in conjunction with ventilator support and other appropriate agents.


Treatment of Hypoxic Respiratory Failure INOmax®


CONTRAINDICATIONS INOmax is contraindicated in neonates dependent on right-to-left shunting of blood.


WARNINGS AND PRECAUTIONS


Rebound Pulmonary Hypertension Syndrome following Abrupt Discontinuation Wean from INOmax. Abrupt discontinuation of INOmax may lead to worsening oxygenation and increasing pulmonary artery pressure, i.e., Rebound Pulmonary Hypertension Syndrome. Signs and symptoms of Rebound Pulmonary Hypertension Syndrome include hypoxemia, systemic hypotension, bradycardia, and decreased cardiac output. If Rebound Pulmonary Hypertension occurs, reinstate INOmax therapy immediately.


Hypoxemia from Methemoglobinemia


Nitric oxide combines with hemoglobin to form methemoglobin, 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 methemoglobinemia.


Airway Injury from Nitrogen Dioxide Nitrogen dioxide (NO2


Nitrogen dioxide may cause airway infl ammation and damage to lung tissues.


) forms in gas mixtures containing NO and O2


circuit, then the delivery system should be assessed in accordance with the Nitric Oxide Delivery System O&M Manual troubleshooting section, and the NO2 INOmax and/or FiO2


If there is an unexpected change in NO2 NO2


concentration, or if the concentration reaches 3 ppm when measured in the breathing


analyzer should be recalibrated. The dose of should be adjusted as appropriate.


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


.


ADVERSE REACTIONS Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not refl ect the rates observed in practice. The adverse reaction information from the clinical studies does, however, provide a basis for identifying the adverse events that appear to be related to drug use and for approximating rates.


Controlled studies have included 325 patients on INOmax doses of 5 to 80 ppm and 251 patients on placebo. Total mortality in the pooled trials was 11% on placebo and 9% on INOmax, a result adequate to exclude INOmax mortality being more than 40% worse than placebo.


In both the NINOS and CINRGI studies, the duration of hospitalization was similar in INOmax and placebo-treated groups.


From all controlled studies, at least 6 months of follow-up is available for 278 patients who received INOmax and 212 patients who received placebo. Among these patients, there was no evidence of an adverse effect of treatment on the need for rehospitalization, special medical services, pulmonary disease, or neurological sequelae.


In the NINOS study, treatment groups were similar with respect to the incidence and severity of intracranial hemorrhage, Grade IV hemorrhage, periventricular leukomalacia, cerebral infarction, seizures requiring anticonvulsant therapy, pulmonary hemorrhage, or gastrointestinal hemorrhage.


In CINRGI, the only adverse reaction (>2% higher incidence on INOmax than on placebo) was hypotension (14% vs. 11%).


Based upon post-marketing experience, accidental exposure to nitric oxide for inhalation in hospital staff has been associated with chest discomfort,


dizziness,


and headache. DRUG INTERACTIONS


Nitric Oxide Donor Agents Nitric oxide donor agents such as prilocaine,


sodium


nitroprusside and nitroglycerine may increase the risk of developing methemoglobinemia.


Elevations in methemoglobin reduce the oxygen delivery capacity of the circulation. In clinical studies, NO2


Elevated NO2


OVERDOSAGE Overdosage with INOmax is manifest by elevations in methemoglobin and pulmonary toxicities associated with inspired NO2


.


may cause acute lung injury. levels >3 ppm


or methemoglobin levels >7% were treated by reducing the dose of, or discontinuing, INOmax.


Methemoglobinemia that does not resolve after reduction or discontinuation of therapy can be treated with intravenous vitamin C, intravenous methylene blue, or blood transfusion, based upon the clinical situation.


INOMAX® is a registered trademark of a Mallinckrodt


Pharmaceuticals company. © 2018 Mallinckrodt.


US-1800236 August 2018 dry throat, dyspnea,


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