Nitric Oxide is an active pharmaceutical ingredient in the Other Respiratory System Products group (R07AX). The information below is compiled per regulator from the product labels on record, with direct links to the original documents.
GBOfficial regulatory label· revised March 20, 2026[1]
Neophyr, in conjunction with ventilatory support and other appropriate active substances, is indicated: for the treatment of newborn infants ≥ 34 weeks gestation with hypoxic respiratory failure associated with clinical or echocardiographic evidence of pulmonary hypertension, in order to improve oxygenation and to reduce the need for extracorporeal membrane oxygenation.
as part of the treatment of perioperative pulmonary hypertension in adults and newborn infants, infants and toddlers, children and adolescents, ages 0-17 years in conjunction to heart surgery, in order to selectively decrease pulmonary arterial pressure and improve right ventricular function and oxygenation.
How to take
USUnited States· FDA
1 product
Uses
USOfficial regulatory label· revised July 16, 2025[2]
1 INDICATIONS AND USAGE ULSPIRA™ 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.
ULSPIRA 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.
How to take
EUEuropean Union· EMA
1 product
Uses
EUOfficial regulatory label· revised January 29, 2026[3]
INOmax, in conjunction with ventilatory support and other appropriate active substances, is indicated: ▪ for the treatment of newborn infants 34 weeks gestation with hypoxic respiratory failure associated with clinical or echocardiographic evidence of pulmonary hypertension, in order to improve oxygenation and to reduce the need for extracorporeal membrane oxygenation.
▪ as part of the treatment of peri- and post-operative pulmonary hypertension in adults and newborn infants, infants and toddlers, children and adolescents, ages 0-17 years in conjunction to heart surgery, in order to selectively decrease pulmonary arterial pressure and improve right ventricular function and oxygenation.
How to take
CACanada· Health Canada
2 products
2 products on record with this regulator. Detailed label text (uses, dosage, side effects) is being ingested — the original document is linked under Sources [4].
Interaction data compiled from DDInter (academic, CC-BY). Severity classification only - this is not a complete interaction checker and not medical advice.
[1]MHRA (UK) · PL353260003 · revised March 20, 2026
[2]FDA DailyMed · 026e4541-63fa-ae… · revised July 16, 2025 [PDF]
[3]European Medicines Agency · EMEA/H/C/000337 · revised January 29, 2026
[4]Health Canada (DPD) · 02270846 · revised May 13, 2026
[5]OpenFDA adverse-event reports (US), 12 months ending June 4, 2026.
Information on this page is compiled from public regulatory records. Drugvu is not affiliated with any regulator or pharmaceutical manufacturer. This is not medical advice. Always consult a qualified healthcare professional.
GBOfficial regulatory label· revised March 20, 2026[1]
Persistent Pulmonary Hypertension in the Newborn (PPHN) Prescription of nitric oxide should be supervised by a physician experienced in neonatal intensive care. Prescription should be limited to those neonatal units that have received adequate training in the use of a nitric oxide delivery system.
Neophyr should only be delivered according to a neonatologist’s prescription. Neophyr should be used in ventilated newborn infants expected to require support >24 hours. Neophyr should be used only after respiratory support has been optimised.
This includes optimising tidal volume/pressures and lung recruitment (surfactant, high frequency ventilation, and positive end expiratory pressure). Pulmonary hypertension associated with heart surgery Prescription of nitric oxide should be supervised by a physician experienced in cardiothoracic anaesthesia & intensive care.
Prescription should be limited to those cardio-thoracic units that have received adequate training in the use of a nitric oxide delivery system. Neophyr should only be delivered according to an anaesthetist’s or intensive care physician’s prescription.
Posology The posology will be determined in accordance with the medical condition of the patient. Due to the potential risk of NO2 formation, continuous monitoring of NO2 must be performed. Persistent Pulmonary Hypertension in the Newborn (PPH) Newborns > 34 weeks gestation: The maximum recommended dose of Neophyr is 20 ppm and this dose should not be exceeded.
Starting as soon as possible, and in the first 4-24 hours of therapy, the dosage must be reduced gradually to 5 ppm or less, titrating it to the needs of the individual patient, as long as the clinical parameters (oxygenation, arterial pulmonary pressure) are within the desired limits.
60). The treatment can be pursued up to 96 hours or until the oxygen de-saturation is resolved and the patient is ready for gradual withdrawal from Neophyr treatment. The duration of the treatment should be limited to be as short as possible.
The duration is variable, but typically, less than 4 days. If there is no response to the inhaled nitric oxide, consult section
This is not medical advice. Consult a qualified healthcare professional.
Side effects & warnings
GBOfficial regulatory label· Adverse reactions· revised March 20, 2026[1]
Summary of safety profile Abrupt discontinuation of the administration of inhaled nitric oxide may cause rebound reaction; decrease in oxygenation and increase in central pressure and subsequent decrease in systemic blood pressure.
Rebound reaction is the most commonly adverse reaction in association with the clinical use of Neophyr. The rebound may be seen early as well as late during therapy. In one clinical study (NINOS), treatment groups were similar with respect to the incidence and severity of intracranial haemorrhage, Grade IV haemorrhage, periventricular leukomalacia, cerebral infarction, seizures requiring anticonvulsant therapy, pulmonary haemorrhage, or gastrointestinal haemorrhage.
Tabulated list of adverse reactions The adverse reactions listed are derived from CINGRI study, review of public domain scientific literature and post marketing safety surveillance (the table below shows adverse reactions that occurred in at least 5 % of patients receiving iNO in the CINRGI study).
Adverse reactions are listed according to MedDRA frequency convention: very common (≥ 1/10), common (≥ 1/100 to <1/10), uncommon (≥ 1/1,000 to <1/100), rare (≥ 1/10,000 to <1/1,000), very rare (<1/10,000), not known (cannot be estimated from the available data).
System organ class Very common Common Not known Blood and lymphatic system disorders Thrombocytopenia - - Metabolism and nutrition disorders Hypokalemia - - Nervous system disorders - Headache* Vascular diorders Hypotension - Pulmonary artery pressure increased** Hypotension** Respiratory, thoracic and mediastinal disorders Atelectasis - - Hepatobiliary disorders Hyperbilirubinemia Investigations Methaemo globin increased, Hypoxemia** * Post-Marketing Safety Surveillance (PMSS) data, symptom experienced by personnel associated to accidental environmental exposure **PMSS data, effects associated with acute withdrawal of the medicinal product, and dose errors associated with the delivery system.
Rapid rebound reactions such as intensified pulmonary vasoconstriction after sudden withdrawal of inhaled nitric oxide therapy has been described, precipitating cardiovascular collapse. Description of selected adverse reactions Inhaled nitric oxide therapy may cause an increase in methaemoglobin.
Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. uk/yellowcard.
GBOfficial regulatory label· Warnings and precautions· revised March 20, 2026[1]
4. Weaning Attempts to wean Neophyr should be made after the ventilator support is substantially decreased or after 96 hours of therapy. When the decision is made to discontinue inhaled nitric oxide therapy, the dose should be reduced to 1 ppm for 30 minutes to one hour.
If there is no change in oxygenation during administration of Neophyr at 1 ppm, the FiO2 should be increased by 10 %, the Neophyr is discontinued, and the neonates monitored closely for signs of hypoxaemia. If oxygenation falls >20 %, Neophyr therapy should be resumed at 5 ppm and discontinuation of Neophyr therapy should be reconsidered after 12 to 24 hours.
Infants who cannot be weaned off Neophyr by 4 days should undergo careful diagnostic work-up for other diseases. Pulmonary hypertension associated with heart surgery Neophyr should be used only after conservative support has been optimised.
Neophyr should be administered under close monitoring of hemodynamics and oxygenation. Newborn infants, infants and toddlers, children and adolescents, ages 0-17 years The starting dose of inhaled nitric oxide is 10 ppm(parts per million) of inhaled gas.
The dose may be increased up to 20 ppm if the lower dose has not provided sufficient clinical effects. The lowest effective dose should be administered and the dose should be weaned down to 5 ppm provided that the pulmonary artery pressure and systemic arterial oxygenation remain adequate at this lower dose.
Clinical data supporting the suggested dose in the age range 12-17 years is limited. Adults The starting dose of inhaled nitric oxide is 20 ppm (parts per million) of inhaled gas. The dose may be increased up to 40 ppm if the lower dose has not provided sufficient clinical effect.
The lowest effective dose should be administered and the dose should be weaned down to 5 ppm provided that the pulmonary artery pressure and systemic arterial oxygenation remain adequate at this lower dose. The effects of inhaled nitric oxide are rapid, decrease in pulmonary artery pressure and improved oxygenation is seen within 5-20 minutes.
In case of insufficient response the dose may be titrated after a minimum of 10 minutes. Consideration should be given to discontinuation of treatment if no beneficial physiological effects are apparent after a 30-minute trial of therapy.
This is not medical advice. Consult a qualified healthcare professional.
Who should not take it
GBOfficial regulatory label· Contraindications· revised March 20, 2026[1]
Newborns with known dependency to right-left blood shunt or newborns with significant left-right shunt. - Patients with congenital or acquired deficiency of methaemoglobin reductase (MetHb reductase) or glucose 6 phosphate dehydrogenase (G6PD).
1.
This is not medical advice. Consult a qualified healthcare professional.
USOfficial regulatory label· revised July 16, 2025[2]
1 Dosage Term and near-term neonates with hypoxic respiratory failure The recommended dose of ULSPIRA is 20 ppm. Maintain treatment up to 14 days or until the underlying oxygen desaturation has resolved and the neonate is ready to be weaned from ULSPIRA therapy.
2)] . 2 Administration Nitric Oxide Delivery Systems ULSPIRA must be administered using a calibrated FDA-cleared Nitric Oxide Delivery System (NODS). There are various FDA-cleared NODS; refer to the NODS labeling to determine which NODS to use with this drug product and for needed information on training and technical support for users of this drug product with the NODS.
Do not use ULSPIRA with Inomax DSIR Plus and DSIR Plus MRI NODS. Do not use ULSPIRA in the MRI suite. Keep available a backup battery power supply and an independent reserve nitric oxide delivery system to address power and system failures .
2)]. 3)] . 1)]. To wean ULSPIRA, downtitrate in several steps, pausing several hours at each step to monitor for hypoxemia. 1). 1).
This is not medical advice. Consult a qualified healthcare professional.
Most-reported reactions to the US regulator (12 mo to June 4, 2026): 420 reports total. [5]
Device Malfunction 75
Underdose 67
Product Use Issue 49
Device Issue 37
Drug Ineffective 37
Death 34
Condition Aggravated 28
Oxygen Saturation Decreased 25
Respiratory Failure 23
Multiple Organ Dysfunction Syndrome 16
Off Label Use 16
Product Use In Unapproved Indication 16
Side effects & warnings
USOfficial regulatory label· Adverse reactions· revised July 16, 2025[2]
1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
The adverse reaction information from the clinical studies does, however, provide a basis for identifying the adverse events that appear to be related to drug use and for approximating rates. Controlled studies have included 325 patients on nitric oxide doses of 5 to 80 ppm and 251 patients on placebo.
Total mortality in the pooled trials was 11% on placebo and 9% on nitric oxide, a result adequate to exclude nitric oxide mortality being more than 40% worse than placebo. In both the NINOS and CINRGI studies, the duration of hospitalization was similar in nitric oxide and placebo-treated groups.
From all controlled studies, at least 6 months of follow-up is available for 278 patients who received nitric oxide and 212 patients who received placebo. Among these patients, there was no evidence of an adverse effect of treatment on the need for rehospitalization, special medical services, pulmonary disease, or neurological sequelae.
In the NINOS study, treatment groups were similar with respect to the incidence and severity of intracranial hemorrhage, Grade IV hemorrhage, periventricular leukomalacia, cerebral infarction, seizures requiring anticonvulsant therapy, pulmonary hemorrhage, or gastrointestinal hemorrhage.
In CINRGI, the only adverse reaction (>2% higher incidence on nitric oxide than on placebo) was hypotension (14% vs. 11%). 2 Post-Marketing Experience Post marketing reports of accidental exposure to nitric oxide for inhalation in hospital staff has been associated with chest discomfort, dizziness, dry throat, dyspnea, and headache.
The most common adverse reaction is hypotension. (6). gov/medwatch.
USOfficial regulatory label· Warnings and precautions· revised July 16, 2025[2]
2)]. , Rebound Pulmonary Hypertension Syndrome. Signs and symptoms of Rebound Pulmonary Hypertension Syndrome include hypoxemia, systemic hypotension, bradycardia, and decreased cardiac output. If Rebound Pulmonary Hypertension occurs, reinstate ULSPIRA therapy immediately.
2 Hypoxemia from Methemoglobinemia Nitric oxide combines with hemoglobin to form methemoglobin, which does not transport oxygen. Methemoglobin levels increase with the dose of ULSPIRA; it can take 8 hours or more before steady-state methemoglobin levels are attained.
Monitor methemoglobin and adjust the dose of ULSPIRA to optimize oxygenation. If methemoglobin levels do not resolve with decrease in dose or discontinuation of ULSPIRA, additional therapy may be warranted to treat methemoglobinemia [see Overdosage (10)].
3 Airway Injury from Nitrogen Dioxide Nitrogen dioxide (NO2) forms in gas mixtures containing NO and O2. Nitrogen dioxide may cause airway inflammation and damage to lung tissues. If there is an unexpected change in NO2 concentration, or if the NO2 concentration reaches 3 ppm when measured in the breathing circuit, then the delivery system should be assessed in accordance with the Nitric Oxide Delivery System O&M Manual troubleshooting section, and the NO2 analyzer should be recalibrated.
The dose of ULSPIRA and/or FiO2 should be adjusted as appropriate. 4 Worsening Heart Failure Patients with left ventricular dysfunction treated with ULSPIRA may experience pulmonary edema, increased pulmonary capillary wedge pressure, worsening of left ventricular dysfunction, systemic hypotension, bradycardia and cardiac arrest.
Discontinue ULSPIRA gas while providing symptomatic care. 1). 2). 3). 4).
This is not medical advice. Consult a qualified healthcare professional.
Who should not take it
USOfficial regulatory label· Contraindications· revised July 16, 2025[2]
4 CONTRAINDICATIONS ULSPIRA is contraindicated in neonates dependent on right-to-left shunting of blood. Neonates dependent on right-to-left shunting of blood (4).
This is not medical advice. Consult a qualified healthcare professional.
EUOfficial regulatory label· revised January 29, 2026[3]
Persistent Pulmonary Hypertension in the Newborn (PPHN) Prescription of nitric oxide should be supervised by a physician experienced in neonatal intensive care. Prescription should be limited to those neonatal units that have received adequate training in the use of a nitric oxide delivery system.
INOmax should only be delivered according to a neonatologist’s prescription. INOmax should be used in ventilated newborn infants expected to require support >24 hours. INOmax should be used only after respiratory support has been optimised.
This includes optimising tidal volume/pressures and lung recruitment (surfactant, high frequency ventilation, and positive end expiratory pressure). Pulmonary hypertension associated with heart surgery Prescription of nitric oxide should be supervised by a physician experienced in cardiothoracic anaesthesia & intensive care.
Prescription should be limited to those cardio-thoracic units that have received adequate training in the use of a nitric oxide delivery system. INOmax should only be delivered according to an anaesthetist’s or intensive care physician’s prescription.
43 Page 2/56 3 Persistent Pulmonary Hypertension in the Newborn (PPHN) The maximum recommended dose of INOmax is 20 ppm and this dose should not be exceeded. In the pivotal clinical trials, the starting dose was 20 ppm. Starting as soon as possible and within 4-24 hours of therapy, the dose should be weaned to 5 ppm provided that arterial oxygenation is adequate at this lower dose.
60. Treatment can be maintained up to 96 hours or until the underlying oxygen desaturation has resolved and the neonate is ready to be weaned from INOmax therapy. The duration of therapy is variable, but typically less than four days.
In cases of failure to respond to inhaled nitric oxide, see section
This is not medical advice. Consult a qualified healthcare professional.
Side effects & warnings
EUOfficial regulatory label· Adverse reactions· revised January 29, 2026[3]
Summary of safety profile Abrupt discontinuation of the administration of inhaled nitric oxide may cause rebound reaction; decrease in oxygenation and increase in central pressure and subsequent decrease in systemic blood pressure.
Rebound reaction is the most commonly adverse reaction in association with the clinical use of INOmax. The rebound may be seen early as well as late during therapy. In one clinical study (NINOS), treatment groups were similar with respect to the incidence and severity of intracranial haemorrhage, Grade IV haemorrhage, periventricular leukomalacia, cerebral infarction, seizures requiring anticonvulsant therapy, pulmonary haemorrhage, or gastrointestinal haemorrhage.
Tabulated list of adverse reactions The table below presents adverse reactions (ADRs) that have been reported with the use of INOmax from either the CINRGI trial of 212 neonates or post marketing experience in neonates (<1 months of age)).
43 Page 7/56 8 System organ class Very common Common Uncommon Rare Very rare Not known Blood and lymphatic system disorders Thrombo- cytopeniaa - Methaemoglobi naemiaa - - - Cardiac disorders - - - - - Bradycardiab (following abrupt discontinuation of therapy) Vascular disorders - Hypotensiona,b, d - - - - Respiratory, thoracic and mediastinal disorders - Atelectasisa - - - Hypoxiab,d Dyspnoeac Chest Discomfortc Dry throatc Nervous system disorders - - - - - Headachec Dizzinessc a: Identified from the clinical trial b: Identified from Post Marketing experience c: Identified from Post-Marketing experience, experienced by healthcare personnel following accidental exposure d: Post Marketing Safety Surveillance (PMSS) data, effects associated with acute withdrawal of the medicinal product, and /or delivery system failures.
Rapid rebound reactions such as intensified pulmonary vasoconstriction and hypoxia after sudden withdrawal of inhaled nitric oxide therapy has been described, precipitating cardiovascular collapse. Description of selected adverse reactions Inhaled nitric oxide therapy may cause an increase in methaemoglobin.
Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V.
EUOfficial regulatory label· Warnings and precautions· revised January 29, 2026[3]
4. Weaning Attempts to wean INOmax should be made after the ventilator support is substantially decreased or after 96 hours of therapy. When the decision is made to discontinue inhaled nitric oxide therapy, the dose should be reduced to 1 ppm for 30 minutes to one hour.
If there is no change in oxygenation during administration of INOmax at 1 ppm, the FiO2 should be increased by 10 %, the INOmax is discontinued, and the neonates monitored closely for signs of hypoxaemia. If oxygenation falls >20 %, INOmax therapy should be resumed at 5 ppm and discontinuation of INOmax therapy should be reconsidered after 12 to 24 hours.
Infants who cannot be weaned off INOmax by 4 days should undergo careful diagnostic work-up for other diseases. Pulmonary hypertension associated with heart surgery INOmax should be used only after conservative support has been optimised.
In clinical trials INOmax has been given in addition to other standard treatment regimes in the peri-operative setting, including inotropic and vasoactive medicinal products. INOmax should be administered under close monitoring of haemodynamics and oxygenation.
Newborn infants, infants and toddlers, children and adolescents, ages 0-17 years The starting dose of inhaled nitric oxide is 10 ppm(part per million) of inhaled gas. The dose may be increased up to 20 ppm if the lower dose has not provided sufficient clinical effects.
The lowest effective dose should be administered and the dose should be weaned down to 5 ppm provided that the pulmonary artery pressure and systemic arterial oxygenation remain adequate at this lower dose. Clinical data supporting the suggested dose in the age range 12-17 years is limited.
Adults The starting dose of inhaled nitric oxide is 20 ppm (part per million) of inhaled gas. The dose may be increased up to 40 ppm if the lower dose has not provided sufficient clinical effects. The lowest effective dose should be administered and the dose should be weaned down to 5 ppm provided that the pulmonary artery pressure and systemic arterial oxygenation remain adequate at this lower dose.
The effects of inhaled nitric oxide are rapid, decrease in pulmonary artery pressure and improved oxygenation is seen within 5-20 minutes. In case of insufficient response the dose may be titrated after a minimum of 10 minutes. Consideration should be given to discontinuation of treatment if no beneficial physiological effects are apparent after a 30-minute trial of therapy.
This is not medical advice. Consult a qualified healthcare professional.
Who should not take it
EUOfficial regulatory label· Contraindications· revised January 29, 2026[3]
1. Neonates known to be dependent on right-to-left, or significant left-to-right, shunting of blood.
This is not medical advice. Consult a qualified healthcare professional.
Treatment may be initiated at any time point in the perioperative course to lower pulmonary pressure. In clinical studies treatment was often initiated before separation from Cardio Pulmonary Bypass. Inhaled NO has been given for time periods up to 7 days in the perioperative setting, but common treatment times are 24 -48 hours.
Weaning Attempts to wean Neophyr should be commenced as soon as the hemodynamics have stabilised in conjunction to weaning from ventilator and inotropic support. The withdrawal of inhaled nitric oxide therapy should be performed in a stepwise manner.
The dose should be incrementally reduced to 1 ppm for 30 minutes with close observation of systemic and central pressure, and then turned off. Weaning should be attempted at least every 12 hours when the patient is stable on a low dose of Neophyr.
Too rapid weaning from inhaled nitric oxide therapy carries the risk of a re-bound increase in pulmonary artery pressure with subsequent circulatory instability.
Additional information on special populations:
No relevant information for dosage adjustment recommendation on special populations, such as renal/hepatic impairment or geriatric, has been found. Therefore caution is recommended in these populations. The safety and efficacy of inhaled nitric oxide in premature infants less than 34 weeks of gestation has not yet been established, no recommendation or posology can be made.
Method of administration For inhalation use. Modalities of administration of Neophyr can modify the toxicity profile of the drug. Administration recommendations have to be followed. Nitric oxide is normally administered by inhalation in patients via mechanical ventilation after it has been diluted with a mix of oxygen/air using a nitric oxide administration device that has been approved for clinical use as per the European Community standards (CE marked).
Direct endotracheal administration without dilution is contra-indicated due to the risk of local lesion of the mucous membrane when it comes into contact with the gas. NO must correctly mix with other gases in the ventilator circuit.
It is advisable to ensure the least amount of contact time possible between the nitric oxide and the oxygen in the inspiratory circuit in order to limit the risk of the formation of toxic oxidation derivatives in the inhaled gas. The administration system should supply a constant concentration of inhaled Neophyr, notwithstanding the ventilation equipment and ventilation modality utilised.
In order to avoid errors in the dosage, the concentration of Neophyr inhaled must be continually regulated in the inhalation branch of the circuit close to the patient, and near the tip of the endotracheal tube. The concentration of nitrogen dioxide (NO2) and FiO2 must also be regulated in the same place using a calibrated and EC-approved monitoring apparatus.
The concentration of NO2 in the inhaled mix must be as low as possible. If the concentration of NO2 exceeds 1 ppm, the dose of Neophyr and/or FiO2 must be reduced, having ruled out any possible malfunction in the administration system.
05: the fraction of inhaled oxygen must not vary more than 5% ). If an unexpected change in the concentration of Neophyr is produced, refer to the instruction for use of the administration device. The pressure of the Neophyr gas cylinder must be monitored in order to allow the gas cylinder to be changed without interruptions or changes to the treatment.
There must also be a reserve supply of gas cylinders to allow changes at the […]
Treatment may be initiated at any time point in the peri-operative course to lower pulmonary pressure. In clinical studies treatment was often initiated before separation from Cardio Pulmonary Bypass. Inhaled NO has been given for time periods up to 7 days in the peri-operative setting, but common treatment times are 24 -48 hours.
Weaning Attempts to wean INOmax should be commenced as soon as the haemodynamics have stabilised in conjunction to weaning from ventilator and inotropic support. 43 Page 3/56 4 therapy should be performed in a stepwise manner. The dose should be incrementally reduced to 1 ppm for 30 minutes with close observation of systemic and central pressure, and then turned off.
Weaning should be attempted at least every 12 hours when the patient is stable on a low dose of INOmax. Too rapid weaning from inhaled nitric oxide therapy carries the risk of a re-bound increase in pulmonary artery pressure with subsequent circulatory instability.
Paediatric population The safety and efficacy of INOmax in premature infants less than 34 weeks of gestation has not yet been established. 1 but no recommendation or posology can be made. Method of administration For endotracheopulmonary use.
Nitric oxide is delivered to the patient via mechanical ventilation after dilution with an oxygen/air mixture using an approved (CE-marked) nitric oxide delivery system. Before initiation of therapy, during set-up, secure that the device setting is in agreement with the cylinder gas concentration.
The delivery system must provide a constant inhaled INOmax concentration irrespective of the ventilator. With a continuous flow neonatal ventilator, this may be achieved by infusing a low flow of INOmax into the inspiratory limb of the ventilator circuit.
Intermittent flow neonatal ventilation may be associated with spikes in nitric oxide concentration. The nitric oxide delivery system for intermittent flow ventilation should be adequate to avoid spikes in nitric oxide concentration.
The inspired INOmax concentration must be measured continuously in the inspiratory limb of the circuit near the patient. The nitrogen dioxide (NO2) concentration and FiO2 must also be measured at the same site using calibrated and approved (CE-marked) monitoring equipment.
05). The INOmax gas cylinder pressure must be displayed to allow timely gas cylinder replacement without inadvertent loss of therapy and backup gas cylinders must be available to provide timely replacement. INOmax therapy must be available for manual ventilation such as suctioning, patient transport, and resuscitation.
In the event of a system failure or a wall-outlet power failure, a backup battery power supply and reserve nitric oxide delivery system should be available. The power supply for the monitoring equipment should be independent of the delivery device function.
The upper limit of exposure (mean exposure) to nitric oxide for personnel defined by worker's legislation is 25 ppm for 8 hours (30 mg/m3) in most countries and the corresponding limit for NO2 is 2-3 ppm (4-6 mg/m3). Training in administration The key elements that need to be covered in training hospital personnel are as follows.
Correct set-up and connections - Connections to the gas cylinder and to the ventilator patient breathing circuit […]