NOXIVENT 102 gas

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

NITRIC OXIDE (UNII: 31C4KY9ESH) (NITRIC OXIDE - UNII:31C4KY9ESH)

Available from:

Linde Gas & Equipment Inc

Administration route:

RESPIRATORY (INHALATION)

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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

Product summary:

Noxivent™ (nitric oxide) is available in the following sizes: Store at 25°C (77°F) with excursions permitted between 15-30°C (59-86°F) [see USP Controlled Room Temperature]. All regulations concerning handling of pressure vessels must be followed. Protect the cylinders from shocks, falls, oxidizing and flammable materials, moisture, and sources of heat or ignition. 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 5 ppm. Distributed by Linde Gas & Equipment 10 Riverview Drive Danbury, CT 06810-6268 © 2021 Linde Inc MDI-7003 (Rev.01)

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

NOXIVENT 102- NOXIVENT 102 GAS
LINDE GAS & EQUIPMENT INC
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
NOXIVENT™ SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION
FOR
NOXIVENT™.
NOXIVENT™ (NITRIC OXIDE) GAS, FOR INHALATION INITIAL U.S. APPROVAL:
1999
RECENT MAJOR CHANGES
Dosage and Administration (2.2) 10/2015
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:
• Use only with a NOxBOXi® operated by trained personnel ( 2.2)
• Avoid abrupt discontinuation ( 2.2, 5.1).
DOSAGE FORMS AND STRENGTHS
Noxivent™ (nitric oxide) is a gas available in 100 ppm and 800 ppm
concentrations ( 3).
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
Levels: Monitor NO
levels ( 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 LINDE, INC. AT 1-800-
772-9247 AND HTTP://WWW.L