País: Estados Unidos
Idioma: inglés
Fuente: NLM (National Library of Medicine)
NITRIC OXIDE (UNII: 31C4KY9ESH) (NITRIC OXIDE - UNII:31C4KY9ESH)
VERO BIOTECH, INC.
RESPIRATORY (INHALATION)
PRESCRIPTION DRUG
GENOSYL ® is 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. GENOSYL is contraindicated in neonates dependent on right-to-left shunting of blood. The safety and efficacy of nitric oxide for inhalation has been demonstrated in term and near-term neonates with hypoxic respiratory failure associated with evidence of pulmonary hypertension [see Clinical Studies (14.1)] . Additional studies conducted in premature neonates for the prevention of bronchopulmonary dysplasia have not demonstrated substantial evidence of efficacy [see Clinical Studies (14.3)] . No information about its effectiveness in other age populations is available. Nitric oxide is not indicated for use in the adult population.
GENOSYL Delivery System cassettes produce at least 216 liters of 800 ppm nitric oxide gas (at standard temperature and pressure, STP) (NDC 72385-001-01). Store at 20°C to 25°C (68°F to 77°F) with excursions permitted between 15°C –30°C (59°F –86°F) [see USP Controlled Room Temperature]. The GENOSYL Delivery System must be used with antioxidant cartridges not older than 12 months from the manufacturing date. Occupational Exposure The exposure limit set by the Occupational Safety and Health Administration (OSHA) for nitric oxide is 25 ppm, and for NO 2 the limit is 5ppm.
New Drug Application
GENOSYL- NITRIC OXIDE GAS VERO BIOTECH, INC. ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE GENOSYL SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR GENOSYL.GENOSYL (NITRIC OXIDE), FOR INHALATION USE INITIAL U.S. APPROVAL: 1999 INDICATIONS AND USAGE GENOSYL 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 ( 1). 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). DOSAGE FORMS AND STRENGTHS GENOSYL (nitric oxide) is a gas, available at concentrations up to 800 ppm. (3) CONTRAINDICATIONS Neonates dependent on right-to-left shunting of blood ( 4). WARNINGS AND PRECAUTIONS Rebound Pulmonary Hypertension: Abrupt discontinuation of GENOSYL 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 Levels: Monitor NO levels ( 5.3). Heart Failure: In patients with pre-existing left ventricular dysfunction, GENOSYL 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 VERO BIOTECH AT 1-877-337-4118 AND HTTP://WWW.VERO-BIOTECH.COM/ OR FDA AT 1-800-FDA-1088 ORWWW.FDA.GOV/MEDWATCH. DRUG INTERACTIONS Nitric oxide donor compounds may increase the risk of developing me Leer el documento completo