Nitric Oxide

Nitric oxide causes few side effects, but your baby may have noisy breathing, blood in the urine, or possibly a collapsed lung. There is also a possibility that the baby will have breathing difficulties after the nitric oxide treatment is stopped.

Some of these problems may require further treatment by health care professionals. Your baby will remain under constant supervision during treatment with nitric oxide.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Nitric oxide is inhaled into the baby's lungs through the mouth or nose.

Your baby may also be using a breathing tube connected to a ventilator (a machine that moves air in and out of the lungs to help your baby breathe easier and get enough oxygen).

Nitric oxide is usually given for up to 14 days. You baby may need to be weaned off this medication slowly, using less and less before treatment is stopped completely.

Your baby's breathing, blood pressure, oxygen levels, and other vital signs will be watched closely during treatment with nitric oxide. This will help your doctor determine how long to continue treatment with nitric oxide. Your child may also need blood tests.

Since nitric oxide is given in a controlled medical setting by a healthcare professional, an overdose is not likely to occur. However, an overdose of nitric oxide is not expected to produce life-threatening symptoms.

Since nitric oxide is given as needed by a healthcare professional, it is not likely that your baby will miss a dose.

INOmax (nitric oxide gas) is a drug administered by inhalation. Nitric oxide, the active substance in INOmax, is a pulmonary vasodilator. INOmax is a gaseous blend of nitric oxide and nitrogen (0.08% and 99.92%, respectively for 800 ppm). INOmax is supplied in aluminum cylinders as a compressed gas under high pressure (2000 pounds per square inch gauge [psig]).

The structural formula of nitric oxide (NO) is shown below:

Included as part of the PRECAUTIONS section.

Your doctor or pharmacist can provide more information about nitric oxide.

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

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Vasodilating agent.1

Absorption

Bioavailability

Absorbed systemically following inhalation.a

Distribution

Extent

Rapidly distributes into the pulmonary system; combines with hemoglobin in the pulmonary capillary bed to produce methemoglobin and nitrate which distribute into the systemic circulation.a

Elimination

Metabolism

Rapidly metabolized to methemoglobin and nitrate following inhalation.1 6 8 9 10

Elimination Route

Excreted principally in urine as nitrate.a

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