Nitric Oxide Gas

Nitric oxide gas is used in term and near-term neonates with hypoxic respiratory failure associated with evidence of pulmonary hypertension.

Nitric oxide gas is available under the following different brand names: INOmax and Genosyl.

Dosage Forms and Strengths

Inhalation Gas

• 100 ppm
• 800 ppm

Dosage Considerations – Should be Given as Follows:

Hypoxic Respiratory Failure

• Indicated in term and near-term neonates with hypoxic respiratory failure associated with evidence of pulmonary hypertension
• Additional studies conducted in premature neonates for the prevention of bronchopulmonary dysplasia have not demonstrated substantial evidence of efficacy
• Term and near-term neonates (greater than 34 weeks’ gestation): 20 ppm, inhaled for up to 14 days
• Decrease dose gradually at end of treatment, do not discontinue abruptly

Side effects of Nitric Oxide Gas may include:

• Low blood pressure (hypotension)
• Withdrawal
• Collapsed lung
• Blood in the urine
• High blood sugar (hyperglycemia)
• Sepsis
• Infection
• Cellulitis
• Stridor

Other side effects of nitric oxide gas include:

• Intracranial hemorrhage, due to platelet aggregation inhibition
• Seizure
• Gastrointestinal hemorrhage due to platelet aggregation inhibition
• Methemoglobinemia
• Acute lung injury, atelectasis, hypoxemia, pulmonary edema, pulmonary hemorrhage, pulmonary toxicity due to nitrogen dioxide formation

Postmarketing side effects of nitric oxide gas reported include:

• Accidental exposure to nitric oxide for inhalation in hospital staff has been associated with chest discomfort, dizziness, dry throat, shortness of breath, and headache

This document does not contain all possible side effects and others may occur. Check with your physician for additional information about side effects.

If your doctor has directed you to use this medication, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider or pharmacist first.

• Nitric oxide gas has no listed severe interactions with other drugs.
• Nitric oxide gas has no listed serious interactions with other drugs.
• Nitric oxide gas has no listed moderate interactions with other drugs.
• Nitric oxide gas has no listed mild interactions with other drugs.

This document does not contain all possible interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share the list with your doctor and pharmacist. Check with your physician if you have health questions or concerns.

Warnings

This medication contains nitric oxide gas. Do not take INOmax or Genosyl if you are allergic to nitric oxide gas or any ingredients contained in this drug.

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center immediately.

Contraindications

• Hypersensitivity
• Neonates dependent on right-to-left shunting of blood

Effects of Drug Abuse

• No information available.

Short-Term Effects

• See "What Are Side Effects Associated with Using Nitric Oxide Gas?"

Long-Term Effects

• See "What Are Side Effects Associated with Using Nitric Oxide Gas?"

Cautions

• Methemoglobinemia and NO2 levels are dose dependent; the most common adverse reaction is hypotension
• Closely monitor PaO2 and methemoglobin levels; measure methemoglobin levels within 4-8 hours after initiation of treatment and then periodically throughout treatment
• Monitor NO2 levels continuously with a suitable nitric oxide delivery system
• If methemoglobin levels are elevated and do not resolve with decreased dose or discontinuation, additional therapy may be warranted (e.g., intravenous/IV vitamin C, IV methylene blue, blood transfusion); hypoxemia from methemoglobinemia may occur
• Wean gradually to avoid rebound pulmonary hypertension syndrome; symptoms include worsening oxygenation, increased pulmonary artery pressure (PAP), systemic hypotension, and decreased cardiac output; reinstate nitric oxide immediately
• Nitrogen dioxide (NO2) forms in gas mixtures containing NO and O2 and may cause airway inflammation and damage to lung tissues; if NO2 exceeds 0.5 ppm, decrease the dose of nitric oxide
• If there is unexpected change in NO2 concentration, or if NO2 concentration reaches 3 ppm when measured in breathing circuit, assess delivery system; may need to adjust dose as appropriate
• Patients with left ventricular dysfunction may experience pulmonary edema when treated with nitric oxide, increased pulmonary capillary wedge pressure, worsening of left ventricular dysfunction, systemic hypotension, bradycardia, and cardiac arrest

Pregnancy and Lactation

Use nitric oxide gas with caution during pregnancy if benefits outweigh risks. Animal studies show risk and human studies are not available or neither animal nor human studies were done.

It is unknown if nitric oxide gas is excreted in breast milk. Consult your doctor.