Description
Nitric oxide is used together with a breathing machine (ventilator) and other agents to treat newborn (term and near-term) babies with respiratory failure that is caused by 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 is to be given only by or under the direct supervision of a doctor.
This product is available in the following dosage forms:
- Gas
Before Using
In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. 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 tell your health care 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 demonstrated 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 indicated in geriatric patients.
Breastfeeding
There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.
Drug Interactions
Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are receiving this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of 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 cause an increased 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 change the dose or how often you use one or both of the medicines.
- Prilocaine
Other Interactions
Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. 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 you tell your doctor if you have any other medical problems, especially:
- Heart failure or
- Lung or breathing problems—Use with caution. May increase risk for more serious side effects.
- Heart problem (eg, babies dependent on right-to-left shunt)—Should not be given to patients with this condition.
Proper Use
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 DSIR®, 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.
Precautions
It is very important that your baby's doctor check your baby closely while receiving this medicine. This will allow the doctor to see if the medicine is working properly and to 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 to have rebound pulmonary hypertension syndrome. Symptoms include: bluish lips or skin, slow heartbeat, lightheadedness, dizziness, or 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.
Side Effects
Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor or nurse immediately if any of the following side effects occur:
More common
- Blurred vision
- confusion
- dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
- 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 symptoms of overdose occur:
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. Also, your health care professional may be able to tell you about ways 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 occur 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.
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