Inomax (Inhalation)

Nitric oxide is used along 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 helps by relaxing the smooth muscles to widen the blood vessels in the lungs.

This medicine is to be given only 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 continue to receive 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 developing 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, the risks of taking the medicine must be weighed against the benefits it will provide. This is a decision you and your doctor will make together. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also inform your healthcare professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies performed to date have not shown pediatric-specific problems that would limit the usefulness of inhaled nitric oxide in newborn babies with respiratory failure.

Geriatric

Use of inhaled nitric oxide is not recommended in geriatric patients.

Breast Feeding

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

Interactions with Medicines

Although some medicines should not be used together at all, in other cases, two different medicines may be used together even if an interaction could happen. In such cases, your doctor may want to adjust the dose, or other precautions may be necessary. When you are receiving this medicine, it is especially important that your healthcare professional knows if you are taking any of the medicines listed below. The following interactions have been selected based on their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or 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 drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may adjust the dose or how often you use one or both of the medicines.

• Prilocaine

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also lead to interactions. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure to inform your doctor if you have any other medical issues, especially:

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

• Heart problem (e.g., babies dependent on right-to-left shunt)—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 occur, but if they do, they might need 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 standing up quickly 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 you experience any of the following signs of overdose:

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 have ways to help prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue, are bothersome, or if you have 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, talk to your healthcare professional.

Call your doctor for medical advice about side effects. You can 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.