AZACTAM FOR INJECTION 1 gvial

Country: Singapore

Language: English

Source: HSA (Health Sciences Authority)

Active ingredient:

AZTREONAM

Available from:

BRISTOL-MYERS SQUIBB (SINGAPORE) PTE. LTD.

ATC code:

J01DF01

Dosage:

1 g/vial

Pharmaceutical form:

INJECTION, POWDER, FOR SOLUTION

Composition:

AZTREONAM 1 g/vial

Administration route:

INTRAVENOUS, INTRAMUSCULAR

Prescription type:

Prescription Only

Manufactured by:

CATALENT ANAGNI S.R.L.

Authorization status:

ACTIVE

Authorization date:

1988-04-29

Patient Information leaflet

1 

AZACTAM
*

(AZTREONAM) 

DESCRIPTION 
AZACTAM is a totally synthetic bactericidal antibiotic classified as
a monobactam. It 
has activity against a wide spectrum of gram-negative aerobic
pathogens. 
The monobactams, having a unique
monocyclic beta-lactam nucleus, are structurally 
different from other beta-lactam antibiotics (e.g.,
penicillins, cephalosporins, 
cephamycins, carbapenems). The sulfonic acid substituent in the
1-position of the ring 
activates the beta-lactam moiety; an aminothiazolyl oxime side
chain in the 3-position 
and a methyl group in the 4-position confer the specific
antibacterial spectrum and beta-
lactamase stability. 
Aztreonam is designated
chemically as (Z)-2-[[[(2-amino-4-thiazolyl)[[(2S,-3S)-2-
methyl-4-oxo-1-sulfo-3-azetidinyl]carbamoyl]methylene]amino]oxy]-2-methylpropionic 
acid. The structural formula is: 

C
13
H
17
N
5
O
8
S
2
   MW 435.42 CAS-78110-38-0 

CLINICAL PHARMACOLOGY 
_Adult Pharmacokinetics _
Single 30 minute intravenous infusions of 500 mg, 1 g and 2 g doses
of AZACTAM  in 
healthy subjects produced peak serum levels of 54, 90, and 204
µg/mL, respectively, 
immediately after administration; at eight hours, serum levels were
1, 3, and 6 µg/mL, 
respectively (Figure 1). Single 3-minute intravenous injections
of the same doses resulted 
2 
in serum levels of 58, 125 and 242 µg/mL at five minutes following
completion of 
injection. 
Serum concentrations of aztreonam in healthy subjects following
completion of single 
intramuscular injections of 500 mg and 1 g doses are depicted
in Figure 1; maximum 
serum concentrations occur at about one hour. After
identical single intravenous or 
intramuscular doses of AZACTAM, the serum concentrations of
aztreonam are 
comparable at one hour (1.5 hours from start of intravenous
infusion) with similar slopes 
of serum concentrations thereafter. 

The serum levels of aztreonam following single 500 mg, or 1 g
(intramuscular or 
intrav

Summary of Product characteristics

C
13
H
17
N
5
O
8
S
2
MW 435.42 CAS-78110-38-0
AZACTAM
*
(AZTREONAM)
DESCRIPTION
AZACTAM is a totally synthetic bactericidal antibiotic classified as a
monobactam. It has
activity against a wide spectrum of gram-negative aerobic pathogens.
The monobactams, having a unique monocyclic beta-lactam nucleus, are
structurally
different from other beta-lactam antibiotics (e.g., penicillins,
cephalosporins, cephamycins,
carbapenems). The sulfonic acid substituent in the 1-position of the
ring activates the beta-
lactam moiety; an aminothiazolyl oxime side chain in the 3-position
and a methyl group in
the 4-position confer the specific antibacterial spectrum and
beta-lactamase stability.
Aztreonam is designated chemically as
(Z)-2-[[[(2-amino-4-thiazolyl)[[(2S,-3S)-2-methyl-
4-oxo-1-sulfo-3-azetidinyl]carbamoyl]methylene]amino]oxy]-2-methylpropionic
acid.
The structural formula is:
CLINICAL PHARMACOLOGY
_Adult Pharmacokinetics _
Single 30 minute intravenous infusions of 500 mg, 1 g and 2 g doses of
AZACTAM in
healthy subjects produced peak serum levels of 54, 90, and 204 µg/mL,
respectively,
immediately after administration; at eight hours, serum levels were 1,
3, and 6 µg/mL,
respectively (Figure 1). Single 3-minute intravenous injections of the
same doses resulted
1
Approved
2.0
v
in serum levels of 58, 125 and 242 µg/mL at five minutes following
completion of
injection.
Serum concentrations of aztreonam in healthy subjects following
completion of single
intramuscular injections of 500 mg and 1 g doses are depicted in
Figure 1; maximum
serum concentrations occur at about one hour. After identical single
intravenous or
intramuscular
doses
of
AZACTAM,
the
serum
concentrations
of
aztreonam
are
comparable at one hour (1.5 hours from start of intravenous infusion)
with similar slopes
of serum concentrations thereafter.
The
serum
levels
of
aztreonam
following
single
500
mg,
or
1
g
(intramuscular
or
intravenous) or 2 g (intravenous) doses of AZACTAM exceed the MIC
90
for
_Neisseria _
sp.,
_H. influenza _
and most genera of