References |
INOMAX® is a vasodilator, which, in conjunction with ventilatory support and other appropriate agents, is indicated for the treatment of term and near-term (>34 weeks gestation) neonates with hypoxic respiratory failure associated with clinical or echocardiographic evidence of pulmonary hypertension, where it improves oxygenation and reduces the need for extracorporeal membrane oxygenation.
INOMAX Important Safety Information (ISI)
INOMAX must not be used in the treatment of neonates known to be dependent on right-to-left shunting of blood
References
- Golombek SG, Young JN. Efficacy of inhaled nitric oxide for hypoxic respiratory failure in term and late preterm infants by baseline severity of illness: a pooled analysis of three clinical trials. Clin Ther. 2010;32(5):939-948.
- Data on file. Hampton, NJ: Ikaria®; 2012.
- INOMAX® [package insert]. Hampton, NJ: Ikaria, Inc.; 2011.
- Davidson D, Barefield ES, Kattwinkel J, et al. Inhaled nitric oxide for the early treatment of persistent pulmonary hypertension of the term newborn: a randomized, double-masked, placebo-controlled, dose-response, multicenter study. Pediatrics. 1998;101(3 pt 1):325-334.
- González A, Fabres J, D’Apremont l, et al. Randomized controlled trial of early compared with delayed use of inhaled nitric oxide in newborns with a moderate respiratory failure and pulmonary hypertension. J Perinatol. 2010;30(6):420-424.
- Williams LJ, Shaffer TH, Greenspan JS. Inhaled nitric oxide therapy in the near-term or term neonate with hypoxic respiratory failure. Neonatal Netw. 2004;23(1):5-13.
- Yoshida K, Kosama K. Biotransformation of nitric oxide. Environ Health Perspect. 1987;73:201-205.
- The Neonatal Inhaled Nitric Oxide Study Group. Inhaled nitric oxide in full-term and nearly full-term infants with hypoxic respiratory failure. N Engl J Med. 1997;336(9):597-604.
- Clark RH, Kueser RJ, Walker MW, et al. Low-dose nitric oxide therapy for persistent pulmonary hypertension of the newborn. N Engl J Med. 2000;342(7):469-474.