Generic name: nitric oxide
Dosage form: gas, for inhalation
The information at Drugs.com is not a substitute for medical advice. ALWAYS consult your doctor or pharmacist.
To ensure safe and effective administration of INOmax to avoid adverse events associated with nitric oxide or NO2, administration of INOmax should only be performed by a health care professional who has completed and maintained training on the safe and effective use of a Nitric Oxide Delivery System provided by the manufacturer of the delivery system and the drug.
Term and near-term neonates with hypoxic respiratory failure
The recommended dose of INOmax is 20 ppm. Treatment should be maintained up to 14 days or until the underlying oxygen desaturation has resolved and the neonate is ready to be weaned from INOmax therapy.
As the risk of methemoglobinemia and elevated NO2 levels increases significantly when INOmax is administered at doses >20 ppm; doses above this level are not recommended.
Methemoglobin should be measured within 4-8 hours after initiation of treatment with INOmax and periodically throughout treatment [see Warnings and Precautions (5.2)].
Nitric Oxide Delivery Systems
INOmax must be administered using the INOmax DSIR®, INOmax® DS, or INOvent® Nitric Oxide Delivery Systems, which deliver operator-determined concentrations of nitric oxide in conjunction with a ventilator or breathing gas administration system after dilution with an oxygen/air mixture. A Nitric Oxide Delivery System includes a nitric oxide administration apparatus, a nitric oxide gas analyzer and a nitrogen dioxide gas analyzer. Failure to calibrate the Nitric Oxide Delivery System could result in under- or over- dosing of nitric oxide.
To address potential power failure, keep available a backup battery power supply. To address potential system failure, keep available an independent reserve nitric oxide delivery system. Failure to transition to a reserve nitric oxide delivery system can result in abrupt or prolonged discontinuation of nitric oxide [see Warnings and Precautions (5.1)].
Training in Administration
The user of INOmax and Nitric Oxide Delivery Systems must complete a comprehensive 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.
Weaning and Discontinuation
Abrupt discontinuation of INOmax may lead to increasing pulmonary artery pressure (PAP) and worsening oxygenation even in neonates with no apparent response to nitric oxide for inhalation. To wean INOmax, downtitrate in several steps, pausing several hours at each step to monitor for hypoxemia.