References

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

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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. 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.
  6. Kinsella JP. Inhaled nitric oxide in the term newborn. Early Hum Dev. 2008;84(11):709-716.
  7. Kinsella JP, Abman SH. Recent developments in the pathophysiology and treatment of persistent pulmonary hypertension of the newborn. J Pediatr. 1995;126(6):853-864.
  8. INOMAX® [package insert]. Hampton, NJ: Ikaria Holdings; 2010.
  9. 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.
  10. Data on file. Hampton, NJ: Ikaria®; 2010.
  11. Steudel W, Hurford WE, Zapol WM. Inhaled nitric oxide: basic biology and clinical applications. Anesthesiology. 1999;91(4):1090-1121.
  12. 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.
  13. 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.
  14. 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.
  15. 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.

References

 

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*Please note: When you access these resources, you are leaving the INOMAX website. Therefore, INOMAX and Ikaria Holdings Inc. do not endorse the accuracy of the information you may find. We encourage you to talk to your doctor about the accuracy of any information you discover through these Internet resources.

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