Nitric Oxide — Active Pharmaceutical Ingredient

Nitric Oxide is an active pharmaceutical ingredient found in 4 FDA-approved drug products. Forms: GAS. Routes: INHALATION.

This content is for informational purposes only. Always consult a healthcare professional.

Nitric Oxide (4 brand names, 1 dosage form, 1 route)

Available dosage forms: GAS.

Routes of administration: INHALATION.

Brand Names

  • GENOSYL
  • INOMAX
  • NOXIVENT
  • ULSPIRA

Indications and Usage

Noxivent ™ is a vasodilator indicated to improve oxygenation and reduce the need for extracorporeal membrane oxygenation in term and near-term (>34 weeks gestation) neonates with hypoxic respiratory failure associated with clinical or echocardiographic evidence of pulmonary hypertension in conjunction with ventilatory support and other appropriate agents.

Dosage and Administration

The recommended dose is 20 ppm, maintained for up to 14 days or until the underlying oxygen desaturation has resolved ( 2.1). Doses greater than 20 ppm are not recommended ( 2.1, 5.2) Administration: • Avoid abrupt discontinuation ( 2.2, 5.1).

Contraindications

Neonates dependent on right-to-left shunting of blood ( 4).

Warnings and Precautions

Rebound: Abrupt discontinuation of Noxivent™ may lead to worsening oxygenation and increasing pulmonary artery pressure ( 5.1). Methemoglobinemia: Methemoglobin increases with the dose of nitric oxide; following discontinuation or reduction of nitric oxide, methemoglobin levels return to baseline over a period of hours ( 5.2). Elevated NO 2Levels: Monitor NO 2levels ( 5.3). Heart Failure: In patients with pre-existing left ventricular dysfunction, Noxivent™ may increase pulmonary capillary wedge pressure leading to pulmonary edema ( 5.4).

Adverse Reactions

The most common adverse reaction is hypotension. ( 6). To report SUSPECTED ADVERSE REACTIONS, contact contact Vero Biotech at 1-833-669-8368 and http://www.vero-biotech.com/ or FDA at 1-800-FDA-1088 or or www.fda.gov/medwatch.

Drug Interactions

Nitric oxide donor compounds may increase the risk of developing methemoglobinemia ( 7).

Overdosage

Overdosage with Noxivent™ is manifest by elevations in methemoglobin and pulmonary toxicities associated with inspired NO 2. Elevated NO 2 may cause acute lung injury. Elevations in methemoglobin reduce the oxygen delivery capacity of the circulation. In clinical studies, NO 2 levels >3 ppm or methemoglobin levels >7% were treated by reducing the dose of, or discontinuing, nitric oxide. Methemoglobinemia that does not resolve after reduction or discontinuation of therapy can be treated with intravenous vitamin C, intravenous methylene blue, or blood transfusion, based upon the clinical situation.

⚠ Caution
Medical Disclaimer: This information is for educational purposes only. Always consult a healthcare professional before taking any medication.