INOMAX- nitric oxide gas

국가: 미국

언어: 영어

출처: NLM (National Library of Medicine)

유효 성분:

nitric oxide (UNII: 31C4KY9ESH) (nitric oxide - UNII:31C4KY9ESH)

제공처:

INO THERAPEUTICS LLC

INN (International Name):

nitric oxide

구성:

nitric oxide 0.98 mg in 1 L

관리 경로:

RESPIRATORY (INHALATION)

처방전 유형:

PRESCRIPTION DRUG

치료 징후:

INOmax® 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. INOmax 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.

제품 요약:

INOmax (nitric oxide) is available in the following sizes: Store at 25°C (77°F) with excursions permitted between 15° to 30°C (59° to 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. INOmax MR conditional labeled cylinders (i.e., size 88 aluminum cylinder) may be used at 100 gauss or less. Use of any other cylinders (e.g., size D or 0.4 liter aluminum cylinder) may create a projectile hazard. Occupational Exposure The exposure limit set by the Occupational Safety and Health Administration (OSHA) for nitric oxide is 25 ppm, and for NO2 the limit is 5 ppm. For a list of patents, see https://www.mallinckrodt.com/patents/

승인 상태:

New Drug Application

제품 특성 요약

INOMAX- NITRIC OXIDE GAS
INO THERAPEUTICS LLC
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
INOMAX SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR INOMAX.
INOMAX (NITRIC OXIDE) GAS, FOR INHALATION
INITIAL U.S. APPROVAL: 1999
INDICATIONS AND USAGE
INOmax 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
INOmax (nitric oxide) is a gas available in 800 and 4,880 ppm
concentrations (3).
CONTRAINDICATIONS
Neonates dependent on right-to-left shunting of blood (4).
WARNINGS AND PRECAUTIONS
Rebound: Abrupt discontinuation of INOmax 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, INOmax 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 INO THERAPEUTICS AT
1-877-566-9466
AND HTTP://WWW.INOMAX.COM/ OR FDA AT 1-800-FDA-1088 OR
WWW.FDA.GOV/MEDWATCH.
DRUG INTERACTIONS
Nitric oxide donor compounds may increase the risk of developing
methemoglobinemia (7).
REVISED: 4/2023