No information available.

Abrupt discontinuation of INOmax may lead to worsening oxygenation and increasing pulmonary artery pressure.

Methemogloginemia increases with the dose of nitric oxide. In the clinical trials, maximum methemoglobin levels usually were reached approximately 8 hours after initiation of inhalation, although methemoglobin levels have peaked as late as 40 hours following initiation of INOmax therapy. In one study, 13 of 37 (35%) of neonates treated with INOmax 80 ppm had methhemoglobin levels exceeding 7%. Following discontinuation or reduction of nitric oxide the methemoglobin levels returned to baseline over a period of hours.

In one study, NO2 levels were <0.5 ppm when neonates were treated with placebo, 5 ppm, and 20 ppm nitric oxide over the first 48 hours. The 80 ppm group had a mean peak NO2 level of 2.6 ppm.

Carcinogenesis, Mutagenesis, Impairment of Fertility

No long-term studies in animals to evaluate the carcinogenic potential of nitric oxide have been performed. Nitric oxide has demonstrated genotoxicity in Salmonella (Ames Test), human lymphocytes, and after in vivo exposure in rats. There are no animal or human studies to evaluate nitric oxide for effects on fertility or harm to the developing fetus.

Pregnancy

Category C

Animal reproduction studies have not been conducted with INOmax. It is not known if INOmax can cause fetal harm when administered to a pregnant women or can effect reproductive capacity. INOmax is not intended for adults.

Pediatric Use

Nitric oxide for inhalation has been studied in a neonatal population (up to 14 days of age). No information about its effectiveness in other age populations is available.

Nursing Mothers

Nitric oxide is not indicated for use in the adult population, including nursing mothers. It is not known whether nitric oxide is excreted in human milk.

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