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Rebound

Abrupt discontinuation of INOmax (nitric oxide) may lead to worsening oxygenation and increasing pulmonary artery pressure.

Methemoglobinemia

Methemoglobinemia 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 (nitric oxide) therapy. In one study,13 of 37 (35%) of neonates treated with INOmax (nitric oxide) 80 ppm had methemoglobin levels exceeding 7%. Following discontinuation or reduction of nitric oxide the methemoglobin levels returned to baseline over a period of hours.

Elevated NO₂ Levels

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 evidence of a carcinogenic effect was apparent, at inhalation expo-sures up to the recommended dose (20 ppm), in rats for 20 hr/day for up to two years. Higher exposures have not been investigated.

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.

Pregnancy: Category C

Animal reproduction studies have not been conducted with INOmax (nitric oxide) . It is not known if INOmax (nitric oxide) can cause fetal harm when administered to a pregnant woman or can affect reproductive capacity. INOmax (nitric oxide) is not intended for adults.

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.

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.

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