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 In December 1999, INO Therapeutics received U.S. Food and Drug Administration (FDA) approval for its first product, INOmax® (nitric oxide) for inhalation. INOmax was the first and only pharmaceutical vasodilator approved for the treatment of persistant pulmonary hypertension in the newborn, and INOmax is the only brand of nitric oxide approved for human use in the U.S. INOmax, used in conjunction with ventilatory support and other appropriate agents, is indicated for the treatment of term and near-term (>34 weeks) neonates with hypoxic respiratory failure (HRF) associated with clinical or echocardiographic evidence of pulmonary hypertension (high blood pressure in the lungs). In babies with HRF, blood vessels in the lungs constrict, making it difficult for the heart to pump blood through the lungs for oxygenation. INOmax is a pulmonary vasodilator, which relaxes the blood vessels of the lungs in newborns whose heart and lungs could not otherwise carry enough oxygenated blood to the body tissues. INOmax improves oxygenation and reduces the need for extracorporeal membrane oxygenation (ECMO), a highly invasive procedure in which an infant's blood is oxygenated by connecting the baby to a heart-lung machine. INOmax should not be used in the treatment of neonates known to be dependent on right-to-left shunting of blood. Abrupt discontinuation of INOmax may lead to a worsening condition. Methemoglobinemia is a dose-dependent side effect of inhaled nitric oxide therapy. Nitrogen dioxide (NO2) forms rapidly in gas mixtures containing nitric oxide and oxygen thus may cause airway inflammation and damage. Methemoglobin, NO2, and FiO2 should be monitored during nitric oxide administration For more information on INOmax, including important safety information and complete Prescribing Information, please visit INOmax.com. |
