Inomax

Last updated on RxList: 7/27/2021
Inomax Side Effects Center

What Is INOmax?

INOmax (nitric oxide) is an inhaled gas that acts as a pulmonary vasodilator used together with a breathing machine (ventilator) to treat respiratory failure in premature babies.

What Are Side Effects of INOmax?

Nitric oxide causes few side effects, but side effects of INOmax may include:

There is also a possibility that the baby will have breathing difficulties and withdrawal symptoms after the treatment with INOmax is stopped.

Dosage for INOmax

The recommended dose of INOmax is 20 ppm. Treatment should be maintained up to 14 days or until the underlying oxygen desaturation has resolved and the neonate is ready to be weaned from INOmax therapy.

What Drugs, Substances, or Supplements Interact with INOmax?

Drug interactions between INOmax and other medications are not expected to occur. Tell your doctor all medications and supplements your baby uses.

INOmax During Pregnancy or Breastfeeding

Nitric oxide is not indicated for use in adults, including pregnant women or nursing mothers. It is unknown if nitric oxide is excreted in human milk. Consult your doctor.

Additional Information

Our INOmax (nitric oxide) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

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.

QUESTION

COPD (chronic obstructive pulmonary disease) is the same as adult-onset asthma. See Answer
Inomax Consumer Information

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.

Read the entire detailed patient monograph for Inomax (Nitric Oxide)

SLIDESHOW

COPD Foods to Boost Your Health - COPD Diet Tips See Slideshow
Inomax Professional Information

SIDE EFFECTS

The following adverse reactions are discussed elsewhere in the label;

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The adverse reaction information from the clinical studies does, however, provide a basis for identifying the adverse events that appear to be related to drug use and for approximating rates.

Controlled studies have included 325 patients on INOmax 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, a result adequate to exclude INOmax mortality being more than 40% worse than placebo.

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

From all controlled studies, at least 6 months of follow-up is available for 278 patients who received INOmax 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, pulmonary 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.

In CINRGI, the only adverse reaction (>2% higher incidence on INOmax than on placebo) was hypotension (14% vs. 11%).

Post-Marketing Experience

Post marketing reports of accidental exposure to nitric oxide for inhalation in hospital staff has been associated with chest discomfort, dizziness, dry throat, dyspnea, and headache.

Read the entire FDA prescribing information for Inomax (Nitric Oxide)

© Inomax Patient Information is supplied by Cerner Multum, Inc. and Inomax Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

Health Solutions From Our Sponsors