CEFOXITIN FOR INJECTION POWDER FOR SOLUTION

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

CEFOXITIN (CEFOXITIN SODIUM)

Available from:

TEVA CANADA LIMITED

ATC code:

J01DC01

INN (International Name):

CEFOXITIN

Dosage:

1G

Pharmaceutical form:

POWDER FOR SOLUTION

Composition:

CEFOXITIN (CEFOXITIN SODIUM) 1G

Administration route:

INTRAMUSCULAR

Units in package:

10ML

Prescription type:

Prescription

Therapeutic area:

CEPHAMYCINS

Product summary:

Active ingredient group (AIG) number: 0113134002; AHFS:

Authorization status:

APPROVED

Authorization date:

1999-09-14

Summary of Product characteristics

PRODUCT MONOGRAPH
CEFOXITIN FOR INJECTION
USP
1 g, 2 g and 10 g vials
ANTIBIOTIC
Teva Canada Limited
Date of Revision:
30 Novopharm Court November 16, 2023
Toronto, Ontario
Canada
M1B 2K9
Control #:259940
PRODUCT MONOGRAPH
CEFOXITIN FOR INJECTION
1 g, 2 g and 10 g vials
THERAPEUTIC CLASSIFICATION
Antibiotic
ACTION AND CLINICAL PHARMACOLOGY
Cefoxitin is a cephamycin derived from cephamycin C. Evidence from _in
vitro_ studies suggests
that Cefoxitin exerts its bactericidal action through the inhibition
of bacterial cell wall synthesis.
Studies
have
indicated
that
the
resistance
of
Cefoxitin
to
degradation
by
bacterial
beta-
lactamases is due to the methoxy group in the 7α position.
After intravenous or intramuscular administration of a 1 g dose, high
serum concentrations are
attained which rapidly decline to about 2 µg/mL at 3 hours in persons
with normal renal
function. The area under the plasma level-time curve is comparable
after bolus injection or
intravenous infusion over a period of 120 minutes.
INDICATIONS AND CLINICAL USE
TREATMENT
For the treatment of the following infections when due to susceptible
organisms:
1 -
Intra-abdominal infections such as peritonitis and intra-abdominal
abscess
2 -
Gynecological infections such as endometritis and pelvic cellulitis
3 -
Septicemia
4 -
Urinary tract infections (including those caused by _Serratia
marcescens_ and _Serratia spp_.)
5 -
Lower respiratory tract infections
6 -
Bone and joint infections caused by _Staphylococcus aureus_
7 -
Soft tissue infections such as cellulitis, abscesses and wound
infections
The susceptibility of the causative organism(s) to Cefoxitin for
Injection should be determined
by conducting appropriate culture and susceptibility studies. Therapy
may be initiated while
awaiting these test results. Adjustments in treatment may be required
once these results become
available.
Organisms particularly appropriate for therapy with Cefoxitin for
Injection are:
GRAM POSITIVE
Staphylococci: penicillinase producing and non-producing
Streptococci excl