Ino Therapeutics

Ino Therapeutics Drugs

• Sorilux
  

  ×

  Sorilux

  

  ---

  2.1 Dosage

  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 (5.2)].

  2.2 Administration

  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 1-877-566-9466/visit inomax.com 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.

  Monitoring

  Measure methemoglobin within 4-8 hours after initiation of treatment with INOmax and periodically throughout treatment [see Warnings and Precautions (5.2)].

  Monitor for PaO2 and inspired NO2 during INOmax administration [see Warnings and Precautions 5.3)].

  Weaning and Discontinuation

  Avoid abrupt discontinuation of INOmax [see Warnings and Precautions (5.1)]. To wean INOmax, downtitrate in several steps, pausing several hours at each step to monitor for hypoxemia.

  Close
  More Info