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 should not be used in the treatment of neonates known to be dependent on right-to-left shunting of blood
References
1. Angus DC, Clermont G, Watson RS, Linde-Zwirble WT, Clark RH, Roberts MS. Cost-effectiveness of inhaled nitric oxide in the treatment of neonatal respiratory failure in the United States. Pediatrics. 2003;112(6 Pt 1):1351-1360.
2. Angus DC, Linde-Zwirble WT, Clermont G, Griffin MF, Clark RH. Epidemiology of neonatal respiratory failure in the United States: projections from California and New York. Am J Respir Crit Care Med. 2001;164(7):1154-1160.
3. Eriksen V, Nielsen LH, Klokker M, Greisen G. Follow-up of 5- to 11-year-old children treated for persistent pulmonary hypertension of the newborn. Acta Paediatr. 2009;98(2):304-309.
4. Lipkin PH, Davidson D, Spivak L, Straube R, Rhines J, Chang CT. Neurodevelopmental and medical outcomes of persistent pulmonary hypertension in term newborns treated with nitric oxide. J Pediatr. 2002:140(3):306-310.
5. 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;336:597-604.
6. 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;342:469-474.
7. INOMAX® [package insert]. Clinton, NJ: Ikaria Holdings; 2009.
8. 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;101:325-334.
9. Data on file. Clinton, NJ: Ikaria®; 2009.
10. Miller MJ et al. Respiratory disorders in preterm and term infants. In: Martin RJ, Fanaroff AA, Walsh MC. Fanaroff and Martin’s Neonatal-Perinatal Medicine: Diseases of the Fetus and Infant. Vol 2. 8th ed. Philadelphia, PA: Mosby Elsevier; 2006:1122-1146.
11. Kinsella JP. Early Hum Dev. 2008;84:709-716.
12. Kinsella JP, Abman SH. J Pediatr. 1995;126:853-864.