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INOmax is a brand name for Nitric Oxide. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: 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…
Verbatim from this product's EMA label. Tap a section to expand.
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
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.
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.
1. Neonates known to be dependent on right-to-left, or significant left-to-right, shunting of blood.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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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.
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.
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 […]