SYSTEM FOR USE IN ADMINISTERING INHALED NITRIC OXIDE GAS
Disclosed are systems for use in administering inhaled nitric oxide gas as a therapeutic treatment, where the systems reduce the risk of inducing an increase in pulmonary capillary wedge pressure leading to pulmonary edema in neonatal patients who have hypoxic respiratory failure and are candidates for inhaled nitric oxide treatment, the system comprising a source of pharmaceutically acceptable nitric oxide gas for inhalation, a delivery device suitable for delivering nitric oxide gas from the source to a term or near-term neonate patient, and instructions for use in operating the system.
1 . A system for use in administering inhaled nitric oxide gas, which system reduces the risk of inducing an increase in pulmonary capillary wedge pressure (PCWP) leading to pulmonary edema in neonatal patients who have hypoxic respiratory failure and are candidates for inhaled nitric oxide treatment, the system comprising:
a source of pharmaceutically acceptable nitric oxide gas for inhalation;
a delivery device suitable for delivering nitric oxide gas from the source to a term or near-term neonate patient; and
instructions for use in operating the system, the instructions comprising: (i) a description of using the system to deliver 20 ppm inhaled nitric oxide gas to treat hypoxic respiratory failure in a term or near-term neonate; (ii) a contraindication for neonates who are dependent on right to left shunting of blood; and (iii) a warning that a patient with pre-existing left ventricular dysfunction may experience increased PCWP leading to pulmonary edema when treated with inhaled nitric oxide gas, wherein the warning:
is effective to reduce use of inhaled nitric oxide gas to treat neonate patients who have hypoxic respiratory failure and pre-existing left ventricular dysfunction but who are not dependent on right to left shunting of blood, and
thereby reduces the risk of occurrence of increased PCWP leading to pulmonary edema in neonates who have hypoxic respiratory failure.
2 . The system of claim 1 , wherein the warning reduces the risk of occurrence of increased PCWP leading to pulmonary edema resulting from treatment with 20 ppm nitric oxide during use of the system in neonates who have hypoxic respiratory failure.
3 . The system of claim 1 , wherein the source of pharmaceutically acceptable nitric oxide gas for inhalation is a compressed gas supplied in a cylinder.
4 . The system of claim 1 , wherein the source of pharmaceutically acceptable nitric oxide gas for inhalation is a mixture of nitric oxide gas and nitrogen gas.
5 . The system of claim 1 , wherein the warning also says that patients with pre-existing left ventricular dysfunction may experience other adverse events, besides increased PCWP leading to pulmonary edema, upon treatment with inhaled nitric oxide gas.
6 . A system for use in administering inhaled nitric oxide gas, which system reduces the risk of inducing an increase in PCWP leading to pulmonary edema in neonatal patients who have hypoxic respiratory failure and are candidates for inhaled nitric oxide treatment, the system comprising:
a source of pharmaceutically acceptable nitric oxide gas for inhalation;
a delivery device suitable for delivering nitric oxide gas from the source to a term or near-term neonate patient; and
instructions for use in operating the system, the instructions comprising (i) a description of using the system to deliver 20 ppm inhaled nitric oxide gas to treat hypoxic respiratory failure in a term or near-term neonate; and (ii) a warning that a patient with pre-existing left ventricular dysfunction may experience increased PCWP leading to pulmonary edema when treated with inhaled nitric oxide gas, wherein the warning:
is effective to reduce use of inhaled nitric oxide gas to treat neonate patients who have hypoxic respiratory failure and pre-existing left ventricular dysfunction but who are not dependent on right to left shunting of blood, and
thereby reduces the risk of occurrence of increased PCWP leading to pulmonary edema in neonates that have hypoxic respiratory failure.
7 . The system of claim 6 , wherein the warning reduces the risk of occurrence of increased PCWP leading to pulmonary edema resulting from treatment with 20 ppm nitric oxide during use of the system in neonates who have hypoxic respiratory failure.
8 . The system of claim 6 , wherein the source of pharmaceutically acceptable nitric oxide gas for inhalation is a compressed gas supplied in a cylinder.
9 . The system of claim 6 , wherein the source of pharmaceutically acceptable nitric oxide gas for inhalation is a mixture of nitric oxide gas and nitrogen gas.
10 . The system of claim 6 , wherein the warning also says that patients with pre-existing left ventricular dysfunction may experience other adverse events, besides increased PCWP leading to pulmonary edema, upon treatment with inhaled nitric oxide gas.
11 . A system for use in administering inhaled nitric oxide gas, which system reduces the risk of inducing increased PCWP leading to pulmonary edema in neonatal patients who have hypoxic respiratory failure and are candidates for inhaled nitric oxide treatment, the system comprising:
a source of pharmaceutically acceptable nitric oxide gas for inhalation; and
instructions for administering nitric oxide gas from the source to treat hypoxic respiratory failure in a term or near-term neonate at a dosage of 20 ppm nitric oxide gas, the instructions comprising a warning that a patient with pre-existing left ventricular dysfunction may experience increased PCWP leading to pulmonary edema when treated with inhaled nitric oxide gas, wherein the warning:
is effective to reduce use of inhaled nitric oxide gas to treat neonate patients who have hypoxic respiratory failure and pre-existing left ventricular dysfunction but who are not dependent on right to left shunting of blood, and
thereby reduces the risk of occurrence of increased PCWP leading to pulmonary edema in neonates that have hypoxic respiratory failure.
12 . The system of claim 11 , wherein the warning reduces the risk of occurrence of increased PCWP leading to pulmonary edema resulting from treatment with 20 ppm nitric oxide during use of the system in neonates who have hypoxic respiratory failure.
13 . The system of claim 11 , wherein the source of pharmaceutically acceptable nitric oxide gas for inhalation is a compressed gas supplied in a cylinder.
14 . The system of claim 11 , wherein the source of pharmaceutically acceptable nitric oxide gas for inhalation is a mixture of nitric oxide gas and nitrogen gas.
15 . The system of claim 11 , wherein the warning also says that patients with pre-existing left ventricular dysfunction may experience other adverse events, besides increased PCWP leading to pulmonary edema, upon treatment with inhaled nitric oxide gas.