AURO-CEFIXIME TABLET

Land: Canada

Sprog: engelsk

Kilde: Health Canada

Aktiv bestanddel:

CEFIXIME

Tilgængelig fra:

AURO PHARMA INC

ATC-kode:

J01DD08

INN (International Name):

CEFIXIME

Dosering:

400MG

Lægemiddelform:

TABLET

Sammensætning:

CEFIXIME 400MG

Indgivelsesvej:

ORAL

Enheder i pakken:

7/10/20/500

Recept type:

Prescription

Terapeutisk område:

THIRD GENERATION CEPHALOSPORINS

Produkt oversigt:

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

Autorisation status:

APPROVED

Autorisation dato:

2014-10-17

Produktets egenskaber

Page 1 of 29
PRODUCT MONOGRAPH
PR
AURO-CEFIXIME
CEFIXIME TABLETS 400 MG
MANUFACTURER’S STANDARD
ANTIBIOTIC
AURO PHARMA INC.
DATE OF REVISION:
3700 Steeles Avenue West, Suite # 402 June 10, 2020
Woodbridge, Ontario, L4L 8K8
CANADA
Submission Control No:
239324
Page 2 of 29
PRODUCT MONOGRAPH
PR
AURO-CEFIXIME
Cefixime Tablets
400 mg
Manufacturer’s Standard
THERAPEUTIC CLASSIFICATION
Antibiotic
ACTION AND CLINICAL PHARMACOLOGY
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, cefixime 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
AURO-CEFIXIME (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 29
URINARY TRACT:
Acute uncomplicated cystitis and urethritis caused by
_E. coli_
,
_P. mirabilis_
, and
_Klebsiella_
species.
UNCOMPLICATED GONORRHEA:
Uncomplicated g