Medically reviewed by Drugs.com. Last updated on Oct 7, 2021.
Generic name: NITRIC OXIDE 0.98mg in 1L
Dosage form: gas
Term and near-term neonates with hypoxic respiratory failure
The recommended dose of GENOSYL 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 GENOSYL therapy.
Doses greater than 20 ppm are not recommended [see Warnings and Precautions (5.2)].
Nitric Oxide Delivery System
GENOSYL must be administered using a calibrated GENOSYL Delivery System. Only validated ventilator systems should be used in conjunction with GENOSYL [see Description (11)].
Consult the GENOSYL Delivery System Operator's Manual or call 1-877-337-4118 or visit www.vero-biotech.com for needed information on training and technical support for users of GENOSYL with the GENOSYL Delivery System .
Keep available a backup power supply to address power failures. The GENOSYL Delivery System consists of a primary system and a fully functional second system that can be used as backup in the event of primary system failure.
Measure methemoglobin within 4-8 hours after initiation of treatment with GENOSYL and periodically throughout treatment [see Warnings and Precautions (5.2)].
Monitor for PaO2 and inspired NO2 during GENOSYL administration [see Warnings and Precautions (5.3)].
The concentration of nitric oxide, nitrogen dioxide and air is constantly monitored. The GENOSYL Delivery System will shutdown if nitrogen dioxide reaches 3 ppm.
Weaning and Discontinuation
Avoid abrupt discontinuation of GENOSYL [see Warnings and Precautions (5.1)]. To wean GENOSYL, down titrate in several steps, pausing several hours at each step to monitor for hypoxemia.
More about Genosyl (nitric oxide)
- Side Effects
- During Pregnancy or Breastfeeding
- Drug Interactions
- Drug class: miscellaneous respiratory agents
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Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.