INOmax

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

Nitric oxide

Patient Information leaflet

INOMAX
® 
Nitric oxide gas for inhalation

CONSUMER MEDICINE INFORMATION 

INOmax


_Version- 31 March 2011_

1 
WHAT IS IN THIS LEAFLET? 

This leaflet answers some 
common questions about 
INOMAX® It does not 
contain all the available 
information.  It does not take 
the place of talking to your 
specialist, doctor or 
pharmacist. 

All medicines have risks and 
benefits.  Your doctor has 
weighed up the risks of using 
INOmax® against the 
benefits it is expected to 
have for your baby. 

IF YOU HAVE ANY QUESTIONS 
ABOUT USING THIS MEDICINE, 
ASK YOUR DOCTOR OR 
PHARMACIST. 

KEEP THIS LEAFLET.  You may 
need to read it again. 

WHAT DOSAGE FORM 
DOES INOMAX® COME 
IN? 

INOmax® is a medicinal 
product that is in the form of 
a gas and is packaged in gas 
cylinders in a concentration 
of 800 parts per million 
(ppm). 

WHAT DOES INOMAX® 
CONTAIN? 

MEDICINAL INGREDIENT IS: 
Nitric oxide 

NON-MEDICINAL INGREDIENTS 
ARE:  
Nitrogen is the only inactive 
ingredient.  Nitrogen is a 
major component of the air 
we breathe. 

WHAT IS INOMAX® 
USED FOR? 
Babies who have been born 
near or at term and who have 
been diagnosed with a 
condition called hypoxic 
respiratory failure may be 
given INOmax®. 

A baby with hypoxic 
respiratory failure has less 
blood flow through the 
lungs, and low amounts of 
oxygen in the blood. Some 
medical conditions, such as 
pulmonary hypertension 
(high blood pressure in the 
lung), meconium aspiration 
(faecal material that blocks 
the lungs) and infection, may 
cause hypoxic respiratory 
failure. 

Before your baby’s doctor 
prescribes INOmax®, other 
types of therapy may be 
given to try to improve your 
baby’s condition.  If these 
other therapies do not 
improve your baby’s 
condition, INOmax® may be 
given. 

INOmax® is a 
‘PRESCRIPTION ONLY 
MEDICINE’.  It is to be 
given only to the

Summary of Product characteristics

INOMAX
® 
PRODUCT INFORMATION 

INOmax® Product Information / Version:  18 July 2011 SRN 
1/12 

PRODUCT INFORMATION 

NAME OF THE DRUG 

INOmax® (nitric oxide for inhalation) 

Pharmacotherapeutic class: Pulmonary vasodilator 

DESCRIPTION 

INOMAX® (nitric oxide) is a
drug administered by inhalation.  Nitric oxide, the active
substance in 
INOmax®, is a pulmonary vasodilator.  INOmax® is a gaseous blend
of nitric oxide and nitrogen (0.08% 
and 99.92%, respectively for 800 ppm).  INOmax® is supplied
in aluminium cylinders as a compressed gas 
under high pressure (13, 789.51 kPa gauge). 

Structural formula, including relative and absolute
stereochemistry: 
N O
..
.
..
..

Molecular formula: 
NO 

Chemical Abstracts Service (CAS) registry number: 
[10102-43-9] 

PHARMACOLOGY 

MECHANISM OF ACTION 
Nitric oxide is a compound produced by many cells of the
body.   It relaxes vascular smooth muscle by 
binding to the haeme moiety of cytosolic guanylate cyclase,
activating guanylate cyclase and increasing 
intracellular levels of cyclic guanosine 3’,5’-monophosphate,
which then leads to vasodilation. When 
inhaled, nitric oxide produces pulmonary vasodilation.  

PHARMACODYNAMICS 
EFFECTS ON PULMONARY VASCULAR TONE
IN PPHN:  Persistent pulmonary hypertension of the newborn 
(PPHN) occurs as a primary developmental defect or as a
condition secondary to other diseases such as 
meconium aspiration syndrome (MAS), pneumonia, sepsis,
hyaline membrane disease, congenital 
diaphragmatic hernia (CDH), and
pulmonary hypoplasia.  In these states, pulmonary vascular
resistance 
(PVR) is high,
which results in hypoxaemia secondary to right-to-left shunting
of blood through the patent 
ductus arteriosus and foramen ovale.  In neonates with PPHN,
INOmax® improves oxygenation (as 
indicated by significant increases in PaO2).  

INOmax®