November 25, 2015
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How Supplied


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



Term and Near-Term Neonates with Hypoxic Respiratory Failure

The recommended dose of INOmax is 20 ppm. Maintain treatment up to 14 days or until the underlying oxygen desaturation has resolved and the neonate is ready to be weaned from INOmax therapy.

Doses greater than 20 ppm are not recommended [see WARNINGS AND PRECAUTIONS].


Training in Administration

The user of INOmax and Nitric Oxide Delivery Systems must satisfactorily complete a comprehensive periodic training program for health care professionals provided by the delivery system and drug manufacturers. Health professional staff that administers nitric oxide therapy have access to supplier-provided 24 hour/365 days per year technical support on the delivery and administration of INOmax at 1-877-566-9466.

Nitric Oxide Delivery Systems

INOmax must be administered using a calibrated INOmax DSIR ® Nitric Oxide Delivery System. Only validated ventilator systems should be used in conjunction with INOmax. Consult the Nitric Oxide Delivery System label or call 877.566.9466/visit for a current list of validated systems.

Keep available a backup battery power supply and an independent reserve nitric oxide delivery system to address power and system failures.


Measure methemoglobin within 4-8 hours after initiation of treatment with INOmax and periodically throughout treatment [see WARNINGS AND PRECAUTIONS].

Monitor for PaO2 and inspired NO2 during INOmax administration [see WARNINGS AND PRECAUTIONS].

Weaning and Discontinuation

Avoid abrupt discontinuation of INOmax [see WARNINGS AND PRECAUTIONS]. To wean INOmax, downtitrate in several steps, pausing several hours at each step to monitor for hypoxemia.


Dosage Forms And Strengths

INOmax (nitric oxide) gas is available in an 800 ppm concentration.

Storage And Handling

INOmax (nitric oxide) is available in the following sizes:

Size D Portable aluminum cylinders containing 353 liters at STP of nitric oxide gas in 800 ppm concentration in nitrogen (delivered volume 344 liters) (NDC 64693-002-01)
Size 88 Aluminum cylinders containing 1963 liters at STP of nitric oxide gas in 800 ppm concentration in nitrogen (delivered volume 1918 liters) (NDC 64693-002-02)

Store at 25°C (77°F) with excursions permitted between 15–30°C (59–86°F) [see USP Controlled Room Temperature].

All regulations concerning handling of pressure vessels must be followed.

Protect the cylinders from shocks, falls, oxidizing and flammable materials, moisture, and sources of heat or ignition.

Occupational Exposure

The exposure limit set by the Occupational Safety and Health Administration (OSHA) for nitric oxide is 25 ppm, and for NO2 the limit is 5 ppm.

Distributed by INO Therapeutics LLC 675 McDonnell Blvd. Hazelwood, MO 63042, USA. Revised: Oct 2015

This monograph has been modified to include the generic and brand name in many instances.

Last reviewed on RxList: 10/26/2015

How Supplied

Report Problems to the Food and Drug Administration


You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.

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