CEFOTAXIME SODIUM FOR INJECTION, BP POWDER FOR SOLUTION

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

CEFOTAXIME SODIUM

Available from:

STERIMAX INC

ATC code:

J01DD01

INN (International Name):

CEFOTAXIME

Dosage:

2G

Pharmaceutical form:

POWDER FOR SOLUTION

Composition:

CEFOTAXIME SODIUM 2G

Administration route:

INTRAMUSCULAR

Units in package:

10

Prescription type:

Prescription

Therapeutic area:

THIRD GENERATION CEPHALOSPORINS

Product summary:

Active ingredient group (AIG) number: 0152507002; AHFS:

Authorization status:

APPROVED

Authorization date:

2014-11-07

Summary of Product characteristics

PRODUCT MONOGRAPH
PR
CEFOTAXIME SODIUM FOR INJECTION, BP
Sterile Cefotaxime (as Cefotaxime sodium), 500 mg, 1 g, 2 g
β-lactam Antibiotic
SteriMax Inc.
DATE OF REVISION:
2770 Portland Drive
March 17, 2020
Oakville, ON L6H 6R4
Control No.: 233966
2
PRODUCT MONOGRAPH
PR
CEFOTAXIME SODIUM FOR INJECTION, BP
Sterile Cefotaxime (as Cefotaxime sodium), 500 mg, 1 g, 2 g
β-lactam Antibiotic
ACTION AND CLINICAL PHARMACOLOGY
Cefotaxime sodium for Injection, BP (cefotaxime sodium) is a
semi-synthetic, 2-aminothiazolyl
cephalosporin antibiotic for parenteral use.
_In vitro _
studies indicate that the antibacterial action of
cefotaxime sodium results from inhibition of cell wall synthesis. It
is stable against the action of
most β-lactamases.
INDICATIONS AND CLINICAL USE
TREATMENT
Cefotaxime sodium for Injection, BP (cefotaxime sodium) may be
indicated for the treatment of
infections caused by susceptible strains of the designated
micro-organisms in the diseases listed
below.
LOWER RESPIRATORY TRACT INFECTIONS:
Pneumonia and lung abscess caused by
_Streptococcus pneumoniae _
(formerly
_Diplococcus _
_pneumoniae_
), other streptococci (excluding enterococci, e.g.
_S. faecalis_
),
_Staphylococcus aureus _
(penicillinase and non-penicillinase producing),
_Escherichia coli_
,
_Hemophilus influenzae_
,
(including ampicillin resistant strains) and unspecified
_Klebsiella _
species.
URINARY TRACT INFECTIONS:
Caused by
_Escherichia coli_
, unspecified
_Klebsiella _
species (including
_K. pneumoniae_
),
_Proteus _
_mirabilis_
, indole positive
_Proteus_
,
_Serratia marcescens _
and
_Staphylococcus epidermidis_
. Also,
uncomplicated gonorrhea caused by
_N. gonorrhoeae _
including penicillin resistant strains.
BACTEREMIA/SEPTICEMIA:
Caused by
_Escherichia coli_
, unspecified
_Klebsiella _
strains and
_Serratia marcescens_
.
SKIN INFECTIONS:
Caused by
_Staphylococcus aureus _
(penicillinase and non-penicillinase producing),
_S. epidermidis_
, group A streptococci,
_Escherichia coli_
,
_Proteus mirabilis _
and indole positive
_Proteus_
.