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Inomax

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Inomax

Inomax Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

INOmax (nitric oxide) is used together with a breathing machine (ventilator) to treat respiratory failure in premature babies. It is an inhaled gas that acts as a pulmonary vasodilator. Nitric oxide causes few side effects, but side effects may include 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 treatment is stopped.

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

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.

What is Patient Information in Detail?

Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.

Inomax in Detail - Patient Information: Side Effects

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.

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) »

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Inomax FDA Prescribing Information: Side Effects
(Adverse Reactions)

SIDE EFFECTS

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.

Clinical Trials Experience

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 gaastrointestinal hemorrhage.

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

Post-Marketing Experience

Accidental Exposure

Based upon post-marketing experience, 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) »

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Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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