Nitric oxide

Preview FDA label, INO Therapeutics LLC, respiratory (inhalation), effective 2025-12-12. Full label on DailyMed

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From MedlinePlus, U.S. National Library of Medicine

Quoted from the FDA label. Product labels differ by manufacturer and change over time; confirm against the label for the product you are using. Not yet reviewed by a ClinDose pharmacist.

Vasodilator

Dosing in kidney impairment

This label has no separate kidney-impairment dosing section. Check warnings and clinical pharmacology in the full label.

Dosing in liver impairment

Administration Nitric Oxide Delivery Systems INOmax must be administered using a calibrated, FDA-cleared Nitric Oxide Delivery System (NODS). There are various FDA-cleared NODS; refer to the NODS labeling to determine which NODS to use with this drug product and for needed information on training and technical support for users of this drug product with the NODS.

When utilizing a nitric oxide delivery system specifically cleared for use in the MRI suite (e.g., the INOmax DSIR ® Plus MRI) only use INOmax MR conditional cylinders at 100 gauss or less [see How Supplied/Storage and Handling ]. Keep available a backup battery power supply and an independent reserve nitric oxide delivery system to address power and system failures .

Monitoring Measure methemoglobin within 4-8 hours after initiation of treatment with INOmax and periodically throughout treatment [see Warnings and Precautions ] . Monitor for PaO 2 and inspired NO 2 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.

Drug interactions

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Label text (2 paragraphs)

Nitric oxide donor compounds may increase the risk of developing methemoglobinemia ( 7 ).

7.1 Nitric Oxide Donor Agents Nitric oxide donor agents such as prilocaine, sodium nitroprusside and nitroglycerine may increase the risk of developing methemoglobinemia.

Contraindications

4 CONTRAINDICATIONS INOmax is contraindicated in neonates dependent on right-to-left shunting of blood. Neonates dependent on right-to-left shunting of blood ( 4 ).

Supply and cost

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Recalls (last 24 months)

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