LUPIN-CEPHALEXIN TABLET

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

CEPHALEXIN (CEPHALEXIN MONOHYDRATE)

Available from:

LUPIN PHARMA CANADA LIMITED

ATC code:

J01DB01

INN (International Name):

CEFALEXIN

Dosage:

500MG

Pharmaceutical form:

TABLET

Composition:

CEPHALEXIN (CEPHALEXIN MONOHYDRATE) 500MG

Administration route:

ORAL

Units in package:

100/500

Prescription type:

Prescription

Therapeutic area:

FIRST GENERATION CEPHALOSPORINS

Product summary:

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

Authorization status:

APPROVED

Authorization date:

2017-12-29

Summary of Product characteristics

1
PRODUCT MONOGRAPH
PR
LUPIN-CEPHALEXIN
250 mg and 500 mg
Cephalexin Tablets, Manufacturer Standard
ANTIBIOTIC
Date of Revision:
Lupin Pharma Canada Ltd.
September 20, 2019
1001 De Maisonneuve Est, Suite 304
Montréal, Quebec
H2L 4P9
Control # 227424
2
PRODUCT MONOGRAPH
PR
LUPIN-CEPHALEXIN
250 mg and 500 mg
Cephalexin Tablets, Manufacturer Standard
THERAPEUTIC CLASSIFICATION
Antibiotic
ACTION
LUPIN-CEPHALEXIN
(cephalexin)
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 AND CLINICAL USES
LUPIN-CEPHALEXIN (cephalexin) may be indicated for the treatment of
bacterial infections of
the respiratory tract
(1,12)(13,14)
, including otitis media
(1,2)
, genitourinary tract
(3)
, bone 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
LUPIN-CEPHALEXIN and other antibacterial drugs, LUPIN-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
LUPIN-CEPHALEXIN (cephalexin) is contraindicated in patients with
known allergy to the
cephalosporin group of antibiotics.
WARNINGS
Before therapy with LUPIN-CEPHALEXIN (cephalexin) is instituted,
careful inquiry should be
made concerning previous hypersensitivity reactions to cephalosporins,
penicillins or other
drugs.
LUPIN-CEPHALEXIN should be given only with caution to
penicillin-sensitive patients. There
3
is some evidence of cross-allergenicity between the penicillins and
the cephalos