CAYSTON aztreonam 75 mg for inhalation vial with diluent ampoule

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

aztreonam

Available from:

Gilead Sciences Pty Ltd

INN (International Name):

Aztreonam

Authorization status:

Registered

Patient Information leaflet

CAYSTON CMI v2.0 Page 1 of 5
CONSUMER MEDICINE INFORMATION
CAYSTON
®
Generic Name: aztreonam for inhalation
WHAT IS IN THIS LEAFLET
READ THIS LEAFLET CAREFULLY BEFORE YOU, OR THE PERSON IN YOUR CARE
STARTS TAKING
CAYSTON. Also, read it each time you get your CAYSTON prescription
refilled, in
case something has changed.
This leaflet is only a summary and does not take the place of talking
with your doctor or
pharmacist about your medical condition or your treatment.
Talk to your doctor or pharmacist if you have any questions about
CAYSTON.
Keep this leaflet with the medicine. You may need to read it again.
WHAT IS CAYSTON AND HOW DOES IT WORK?

CAYSTON
is
an
antibiotic,
belonging
to
a
group
of
medicines
called
monobactams.

CAYSTON is used to help people who have Cystic Fibrosis (CF).
CF is a genetic disease that affects a number of organs in the body.
The lungs are
often clogged with thick, sticky mucus that may lead to chronic airway
infections.
CAYSTON is not a cure for this disease.

CAYSTON
is
used
to
fight
lung
infections
caused
by
bacteria
such
as
_Pseudomonas aeruginosa (P. aeruginosa). _

When you inhale CAYSTON with your Altera
TM
Nebulizer System, it will enter
your lungs and contact the _P. aeruginosa _bacteria that are present.
CAYSTON
works by decreasing the number of _P. aeruginosa _bacteria living in
your lungs to
improve your respiratory symptoms and lung function.
WHAT SHOULD I TELL MY DOCTOR BEFORE TAKING CAYSTON?
TELL YOUR DOCTOR IF:

you are allergic to aztreonam or lysine

you are allergic to any antibiotics

you are pregnant or planning on becoming pregnant

you are breast-feeding
Tell your doctor or pharmacist about all of your medical conditions.
CAYSTON CMI v2.0 Page 2 of 5
Tell your doctor or pharmacist about all the medicines you take,
including prescription
and non-prescription medicines and dietary supplements.
DO NOT TAKE CAYSTON IF:

you are allergic to aztreonam or lysine

the expiry date (EXP) on the vial or the ampoule has passed

the solution of

Summary of Product characteristics

CAYSTON Product Information v5.0 Page 1 of 19
PRODUCT INFORMATION
CAYSTON
®
(AZTREONAM FOR INHALATION)
NAME OF THE MEDICINE
CAYSTON
The active substance in CAYSTON is aztreonam.
Aztreonam is a monobactam antibiotic. The monobactams are structurally
different from
beta-lactam antibiotics (e.g., penicillins, cephalosporins,
carbapenems) due to a unique
monocyclic nucleus. This nucleus contains several side chains;
sulfonic acid in the 1-
position activates the nucleus, an aminothiazolyl oxime side chain in
the 3-position
confers specificity for aerobic gram-negative bacteria including
_Pseudomonas spp_
., and a
methyl group in the 4-position enhances beta-lactamase stability.
Aztreonam
is
designated
chemically
as
(Z)-2-[[[(2-amino-4-thiazolyl)[[(2S,-3S)-2-
methyl-4-oxo-1-sulfo-3-azetidinyl]caramoyl]methylene]amino]oxy]-2-methylpropionic
acid. The structural formula is presented below:
N
N
H
S
N
H
2
N
N
O
O
OH
H
3
C
H
3
C
O
O
H
CH
3
SO
3
H
H
Molecular formula: C
13
H
17
N
5
O
8
S
2
.
Molecular weight: 435.435
CAS number: 78110-38-0
DESCRIPTION
CAYSTON is a white to off-white powder. It is soluble in water and
aqueous solutions.
CAYSTON is sterile, hygroscopic, and light sensitive. Once
reconstituted with the
supplied diluent, the pH range is 4.5 to 6.0.
A dose of CAYSTON consists of one vial containing lyophilized
aztreonam (75 mg) and
lysine (46.7 mg) and one ampoule containing diluent (1 mL sterile
saline [0.17% w/v
sodium chloride]). The formulations contain no preservatives.
CAYSTON Product Information v5.0 Page 2 of 19
PHARMACOLOGY
PHARMACOKINETICS
_ _
_Sputum Concentrations _
Aztreonam
concentration
in
individual
patients’
sputum
exhibited
considerable
variability. Ten minutes following a single dose of 75 mg CAYSTON, the
mean sputum
level in 195 patients with cystic fibrosis (CF) was 726 µg/g, which
is approximately 10
times that of the aztreonam MIC
90
for all isolates of
_P. aeruginosa_
observed at baseline
for patients treated with CAYSTON in the Phase 3 placebo-controlled
studies (64 µg/ml).
Mean spu