SUPRAX TABLET

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

CEFIXIME

Available from:

ODAN LABORATORIES LTD

ATC code:

J01DD08

INN (International Name):

CEFIXIME

Dosage:

400MG

Pharmaceutical form:

TABLET

Composition:

CEFIXIME 400MG

Administration route:

ORAL

Units in package:

7/10

Prescription type:

Prescription

Therapeutic area:

THIRD GENERATION CEPHALOSPORINS

Product summary:

Active ingredient group (AIG) number: 0122105003; AHFS:

Authorization status:

APPROVED

Authorization date:

2006-05-04

Summary of Product characteristics

PRODUCT MONOGRAPH
PR
SUPRAX
®
CEFIXIME TABLETS, MFR. STD., 400 MG_ _
CEFIXIME FOR ORAL SUSPENSION, MFR. STD., 100 MG/5 ML
_ _
_ _
ANTIBIOTIC
ODAN LABORATORIES LTD.
325 Stillview Ave.,
Pointe-Claire, Québec
H9R 2Y6
Date of Revision:
March 17, 2020
Submission Control No. : 233967
www.odanlab.com
_Page 2 of 30 _
PRODUCT MONOGRAPH
PR
SUPRAX
®
Cefixime tablets, Mfr. Std., 400 mg
Cefixime for oral suspension, Mfr. Std., 100 mg/5 mL
THERAPEUTIC CLASSIFICATION
Antibiotic
ACTION AND CLINICAL PHARMACOLOGY
SUPRAX (cefixime) exerts its bactericidal effect by attaching to
penicillin-binding proteins
(PBP) and inhibiting peptidoglycan synthesis, thus causing damage to
the bacterial cell wall.
Following oral dosing, SUPRAX attains peak serum levels in
approximately 4 hours. The
half-life is about 3 to 4 hours and is not dose dependent. Cefixime is
excreted by renal and
biliary mechanisms. About 50% of the absorbed dose is excreted
unchanged in the urine within
24 hours. There is no evidence of metabolism of cefixime
_in vivo_
.
INDICATIONS AND USAGE
SUPRAX (cefixime) is indicated in the treatment of the following
infections caused by
susceptible strains of the designated microorganisms:
UPPER RESPIRATORY TRACT:
Pharyngitis and tonsillitis caused by
_S. pyogenes_
.
MIDDLE EAR:
Otitis media caused by
_S. pneumoniae, H. influenzae _
(beta-lactamase positive and negative
strains),
_M. catarrhalis_
(former
_B. catarrhalis_
) (beta-lactamase positive and negative strains)
and
_S. pyogenes_
.
PARANASAL SINUSES
:
Sinusitis caused by
_S. pneumoniae, H. influenzae_
(beta-lactamase positive and negative strains),
and
_M. catarrhalis_
(former
_B. catarrhalis_
) (beta-lactamase positive and negative strains).
LOWER RESPIRATORY TRACT:
Acute
bronchitis
caused
by
_S. pneumoniae, _
_M. _
_catarrhalis_
(former
_B. _
_catarrhalis_
)
_ _
(beta-lactamase positive and negative strains) and
_ H. influenzae _
(beta-lactamase positive and
negative strains).
_Page 3 of 30 _
URINARY TRACT:
Acute uncomplicated cystitis and urethritis caused by
_ E. col