SUPRAX TABLET

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

CEFIXIME

Available from:

SANOFI-AVENTIS CANADA INC

ATC code:

J01DD08

INN (International Name):

CEFIXIME

Dosage:

200MG

Pharmaceutical form:

TABLET

Composition:

CEFIXIME 200MG

Administration route:

ORAL

Units in package:

100

Prescription type:

Prescription

Therapeutic area:

THIRD GENERATION CEPHALOSPORINS

Product summary:

Active ingredient group (AIG) number: 0122105002; AHFS:

Authorization status:

CANCELLED POST MARKET

Authorization date:

2006-05-05

Summary of Product characteristics

PRODUCT MONOGRAPH
SUPRAX
®
(Cefixime)
200 mg tablets
400 mg tablets
100 mg/5 mL Powder for oral suspension
Antibiotic
sanofi-aventis Canada Inc.
Date of Preparation:
2150 St. Elzear Blvd. West
April 26, 2006
Laval, Quebec H7L 4A8
Submission Control No. 105394
s-a Version 1.0 dated
2
PRODUCT MONOGRAPH
SUPRAX
®
(Cefixime)
THERAPEUTIC CLASSIFICATION
Antibiotic
ACTIONS
SUPRAX (cefixime) exerts its bactericidal effect by attaching to
penicillin-binding proteins 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).
Urinary Tract:
Acute uncomplicated cystitis and urethritis caused by_ E. coli, P.
mirabilis_, and _ Klebsiella_
species.
3
Uncomplicated Gonorrhea
Uncomplicated
gonorrhea
(cervical/urethral
and
rectal)
caused
by
_Neisseria _
_gonorrhoeae_,
i