CEFUROXIME FOR INJECTION USP POWDER FOR SOLUTION

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

CEFUROXIME (CEFUROXIME SODIUM)

Available from:

PHARMACEUTICAL PARTNERS OF CANADA INC

ATC code:

J01DC02

INN (International Name):

CEFUROXIME

Dosage:

1.5G

Pharmaceutical form:

POWDER FOR SOLUTION

Composition:

CEFUROXIME (CEFUROXIME SODIUM) 1.5G

Administration route:

INTRAVENOUS

Units in package:

16ML

Prescription type:

Prescription

Therapeutic area:

SECOND GENERATION CEPHALOSPORINS

Product summary:

Active ingredient group (AIG) number: 0122448007; AHFS:

Authorization status:

CANCELLED POST MARKET

Authorization date:

2008-02-15

Summary of Product characteristics

PRODUCT MONOGRAPH
PR
CEFUROXIME FOR INJECTION USP
750 mg, 1.5 g, and 7.5 g cefuroxime
ANTIBIOTIC
Pharmaceutical Partners of Canada Inc.
Date of Preparation:
45 Vogell Road, Suite 200
February 6, 2008
Richmond Hill, ON L4B 3P6
Control No.: 119563
Page 2 of 46
CEFUROXIME FOR INJECTION USP
750 mg, 1.5 g, and 7.5 g cefuroxime
THERAPEUTIC CLASSIFICATION
Antibiotic
ACTION AND CLINICAL PHARMACOLOGY
_In vitro _ studies demonstrate that the bactericidal action of
cefuroxime results from
inhibition
of
bacterial
cell
wall
synthesis
by
inhibiting
the
transpeptidase
and
carboxypeptidase enzymes.
INDICATIONS AND CLINICAL USES
TREATMENT
Cefuroxime for Injection USP is indicated for the treatment of
patients with infections
caused by susceptible strains of the designated organisms in the
following diseases:
LOWER RESPIRATORY TRACT INFECTIONS
Pneumonia caused by _Streptococcus pneumoniae_, _Haemophilus
influenzae_ including
ampicillin-resistant
strains,
_Klebsiella_
species,
_Staphylococcus _
_aureus _
including
ampicillin-resistant (but not methicillin-resistant) strains,
_Streptococcus pyogenes_, and
_Escherichia coli_.
Page 3 of 46
URINARY TRACT INFECTIONS
Caused by _Escherichia coli _and _Klebsiella _species.
SOFT TISSUE INFECTIONS
Caused by _ Staphylococcus aureus _ including ampicillin-resistant
(but not methicillin-
resistant) strains, _Streptococcus pyogenes_, _Escherichia coli_,
_Klebsiella _species.
MENINGITIS
Caused by _ Staphylococcus aureus _ including ampicillin-resistant
(but not methicillin-
resistant) strains, _Streptococcus pneumoniae_, _Haemophilus
influenzae_, and _Neisseria _
_meningitidis_.
GONORRHOEA
Caused by _Neisseria gonorrhoea _including ampicillin-resistant
strains.
BONE AND JOINT INFECTIONS
Caused
by
_Staphylococcus _
_aureus _
(penicillinase
and
non-penicillinase
producing
strains).
Specimens for bacteriologic culture should be obtained prior to
therapy in order to
identify the causative organisms and to determine their susceptibility
to cefuroxime.
Therapy may be instituted before results of suscep