CEPHALEXIN TABLET

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

CEPHALEXIN (CEPHALEXIN MONOHYDRATE)

Available from:

SIVEM PHARMACEUTICALS ULC

ATC code:

J01DB01

INN (International Name):

CEFALEXIN

Dosage:

500MG

Pharmaceutical form:

TABLET

Composition:

CEPHALEXIN (CEPHALEXIN MONOHYDRATE) 500MG

Administration route:

ORAL

Units in package:

15G/50G

Prescription type:

Prescription

Therapeutic area:

FIRST GENERATION CEPHALOSPORINS

Product summary:

Active ingredient group (AIG) number: 0105911003; AHFS:

Authorization status:

APPROVED

Authorization date:

2020-01-16

Summary of Product characteristics

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_Page 1 of 20_
PRODUCT MONOGRAPH
PR
CEPHALEXIN
Cefalexin Tablets, BP
500 mg
ANTIBIOTIC
Sivem Pharmaceuticals ULC
4705 Dobrin Street
Saint-Laurent, Quebec, Canada
H4R 2P7
www.sivem.ca
Date of Revision:
January 28, 2022
Submission
Control: 256488
_CEPHALEXIN Product Monograph _
_Page 2 of 20_
PRODUCT MONOGRAPH
PR
CEPHALEXIN
Cefalexin Tablets, BP
500 mg
THERAPEUTIC CLASSIFICATION
ANTIBIOTIC
ACTION
Cefalexin is bactericidal against many gram-positive and gram-negative
organisms. _ In vitro _tests
demonstrate that the cephalosporins are bactericidal through their
inhibition
of cell-wall_ _
synthesis
(15)
.
INDICATIONS
CEPHALEXIN may be indicated for the treatment of bacterial infections
of the respiratory tract
(1,12)(l3,l4)
, including
otitis media
(1,2)
, genitourinary tract
(3)
, bones and joints
(4,5)
, skin and soft
tissue
(6,7)
when the infection is caused by susceptible organisms. Culture and
susceptibility
studies should be performed.
To reduce the development of drug-resistant bacteria and maintain the
effectiveness of Cefalexin
and other antibacterial drugs, CEPHALEXIN should be used only to treat
infections that are
proven or strongly suspected to be caused by susceptible bacteria.
When culture and
susceptibility
information are available, they should be considered in selecting or
modifying
antibacterial therapy. In the absence of such data, local epidemiology
and susceptibility
patterns
may contribute to the empiric selection of therapy.
CONTRAINDICATIONS
CEPHALEXIN is contraindicated in patients with known allergy to the
cephalosporin group of
antibiotics.
WARNINGS
Before therapy with CEPHALEXIN is instituted,
careful inquiry should be made concerning
previous hypersensitivity
reactions to cephalosporins,
penicillins
or other drugs.
_CEPHALEXIN Product Monograph _
_Page 3 of 20_
CEPHALEXIN should be given only with caution to penicillin-sensitive
patients. There is some
evidence of cross-allergenicity
between the penicillins
and the cephalosporins. Patients have
been reported to have had severe re