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Controlled studies have included 325 patients on INOmax (nitric oxide) doses of 5 to 80 ppm and 251 patients on placebo. Total mortality in the pooled trials was 11% on placebo and 9% on INOmax (nitric oxide) , a result adequate to exclude INOmax (nitric oxide) mortality being more than 40% worse than placebo.

In both the NINOS and CINRGI studies,the duration of hospitalization was similar in INOmax (nitric oxide) and placebo-treated groups.

From all controlled studies, at least 6 months of follow-up is available for 278 patients who received INOmax (nitric oxide) and 212 patients who received placebo. Among these patients, there was no evidence of an adverse effect of treatment on the need for rehospitalization,special medical services, pul-monary disease, or neurological sequelae.

In the NINOS study, treatment groups were similar with respect to the incidence and severity of intracranial hemorrhage, Grade IV hemorrhage, periventricular leukomalacia, cerebral infarction, seizures requiring anticonvulsant therapy, pulmonary hemorrhage, or gastrointestinal hemorrhage.

The table below shows adverse events with an incidence of at least 5% on INOmax (nitric oxide) in the CINRGI study, and that were more common on INOmax (nitric oxide) than on placebo.

ADVERSE EVENTS IN THE CINRGI TRIAL

No formal drug-interaction studies have been performed, and a clinically significant interaction with other medications used in the treatment of hypoxic respiratory failure cannot be excluded based on the available data. INOmax (nitric oxide) has been administered with tolazoline, dopamine, dobuta-mine, steroids, surfactant, and high-frequency ventilation. Although there are no study data to evaluate the possibility, nitric oxide donor compounds, including sodium nitroprusside and nitroglycerin, may have an additive effect with INOmax (nitric oxide) on the risk of developing methemoglobine-mia. An association between prilocaine and an increased risk of methe-moglobinemia,particularly in infants,has specifically been described in a literature case report. This risk is present whether the drugs are administered as oral, parenteral, or topical formulations.

Last reviewed on RxList: 7/29/2008
This monograph has been modified to include the generic and brand name in many instances.