TEVA-CEPHALEXIN CAPSULE

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

CEPHALEXIN (CEPHALEXIN MONOHYDRATE)

Available from:

TEVA CANADA LIMITED

ATC code:

J01DB01

INN (International Name):

CEFALEXIN

Dosage:

500MG

Pharmaceutical form:

CAPSULE

Composition:

CEPHALEXIN (CEPHALEXIN MONOHYDRATE) 500MG

Administration route:

ORAL

Units in package:

50/100/250/500/1000

Prescription type:

Prescription

Therapeutic area:

FIRST GENERATION CEPHALOSPORINS

Product summary:

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

Authorization status:

APPROVED

Authorization date:

2014-07-11

Summary of Product characteristics

1
PRODUCT MONOGRAPH
PR
TEVA-CEPHALEXIN
250 mg and 500 mg
Cephalexin Capsules, USP
PR
TEVA-CEPHALEXIN
250 mg and 500 mg
Cephalexin Tablets, USP
PR
TEVA-CEPHALEXIN 125
125 mg/5 mL Cephalexin For Oral Suspension, USP
PR
TEVA-CEPHALEXIN 250
250 mg/5 mL Cephalexin For Oral Suspension, USP
ANTIBIOTIC
Teva Canada Limited
Date of Revision:
30 Novopharm Court
August 12, 2020
Toronto, Ontario
Canada M1B 2K9
www.tevacanada.com
Control # 237728
2
PRODUCT MONOGRAPH
PR
TEVA-CEPHALEXIN
250 mg and 500 mg
Cephalexin Capsules, USP
PR
TEVA-CEPHALEXIN
250 mg and 500 mg
Cephalexin Tablets, USP
PR
TEVA-CEPHALEXIN 125
125 mg/5 mL Cephalexin For Oral Suspension, USP
PR
TEVA-CEPHALEXIN 250
250 mg/5 mL Cephalexin For Oral Suspension, USP
THERAPEUTIC CLASSIFICATION
Antibiotic
ACTION
TEVA-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
TEVA-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)
, 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 TEVA-
CEPHALEXIN and other antibacterial drugs, TEVA-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.
3
CONTRAINDICATIONS
TEVA-CEPHALEXIN (cephalexin) is contraindicated in patients with known
allergy to the
cephalosporin group of antibiotics.
WARNINGS
Before therapy with TEVA-CEPHALEXIN
(c