Nitric oxide (Inhalation)

Nitric oxide is used with a breathing machine (ventilator) and other agents to treat newborn (term and near-term) babies who have respiratory failure due to pulmonary hypertension.

Nitric oxide is a gas that is inhaled through the nose or mouth. It works by relaxing the smooth muscles to widen the blood vessels in the lungs.

This medicine should only be given by or under the direct supervision of a doctor.

It is very important that your baby's doctor check your baby closely while receiving this medicine. This will help the doctor see if the medicine is working properly and decide if your baby should keep receiving it. Blood tests may be needed to check for unwanted effects.

Your baby's doctor also needs to monitor your baby's breathing, oxygen levels, and other vital signs while receiving this medicine.

Stopping this medicine suddenly may increase your baby's risk of having rebound pulmonary hypertension syndrome. Symptoms include: bluish lips or skin, slow heartbeat, lightheadedness, dizziness, fainting, or decreased cardiac output.

This medicine may cause a rare but serious blood problem called methemoglobinemia. Your baby's doctor will measure how much methemoglobin is in your baby's blood while receiving this medicine.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

In deciding to use a medicine, you and your doctor need to think about the risks and benefits. Here are important points to consider for this medicine:

Allergies

Tell your doctor if you have ever had any unusual or allergic reactions to this medicine or any other medicines. Also inform your health care professional about any other allergies, such as to foods, dyes, preservatives, or animals. For over-the-counter products, read the label or package ingredients carefully.

Pediatric

Studies conducted so far have not shown any specific problems that would limit the use of inhaled nitric oxide in newborns with respiratory failure.

Geriatric

Inhaled nitric oxide is not meant for use in older adults.

Breast Feeding

There are no adequate studies in women to determine the risk to infants when using this medication while breastfeeding. Consider the potential benefits and risks before taking this medication while breastfeeding.

Interactions with Medicines

Some medicines should not be used together, while in other cases, two different medicines can be used together even if there is a chance of interaction. If you are receiving this medicine, it is very important for your healthcare professional to know if you are taking any of the medicines listed below. The following interactions are significant but may not include all possible interactions.

Using this medicine with any of the following medicines is not recommended. Your doctor may choose not to treat you with this medication or may change some of the other medicines you take.

• Riociguat

Using this medicine with any of the following medicines may increase the risk of certain side effects, but using both may be the best treatment for you. If both medicines are prescribed, your doctor may adjust the dose or frequency of use for one or both medicines.

• Prilocaine

Interactions with Food/Tobacco/Alcohol

Some medicines should not be used around the time of eating certain foods, as interactions may happen. Using alcohol or tobacco with some medicines may also lead to interactions. Discuss with your healthcare professional about using your medicine with food, alcohol, or tobacco.

Other Medical Problems

Having other medical issues may affect how you can use this medicine. Make sure to tell your doctor if you have any other health problems, especially:

• Heart failure or
• Lung or breathing problems—Use with caution. This may increase the risk for more serious side effects.

• Heart problem (e.g., babies dependent on right-to-left shunt)—This medicine should not be given to patients with this condition.

Along with its necessary effects, a medicine may cause some unwanted effects. Not all of these side effects may happen, but if they do, they may require medical attention.

Check with your doctor or nurse right away if any of the following side effects happen:

More common

• Blurred vision
• confusion
• dizziness, faintness, or lightheadedness when suddenly getting up from lying down or sitting
• sweating
• unusual tiredness or weakness

Incidence not known

• Bluish lips or skin
• chest discomfort
• difficult or labored breathing
• dizziness
• tightness in the chest
• trouble breathing

Get emergency help immediately if any of the following signs of overdose happen:

Symptoms of overdose

• Bluish-colored lips, fingernails, or palms
• dark urine
• fever
• headache
• pale skin
• rapid heart rate
• sore throat
• unusual bleeding or bruising

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Your health care professional may also be able to tell you how to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Incidence not known

• Dry throat

Other side effects not listed may also happen in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

In the U.S.

• Genosyl
• Inomax
• Noxivent

Available Dosage Forms:

• Gas

Therapeutic Class: Stimulant, Respiratory

A nurse or other trained health professional will give your baby this medicine in a hospital. This medicine is inhaled into your baby's lungs through the mouth or nose.

This medicine must be given using the nitric oxide delivery system (eg, Genosyl®, INOmax DS®, INOmax® DS, INOvent®) together with a ventilator (breathing gas administration system).

This medicine is usually given for up to 14 days or until your baby is ready to be weaned from nitric oxide treatment.