Country: Canada
Language: English
Source: Health Canada
CEFIXIME
AURO PHARMA INC
J01DD08
CEFIXIME
400MG
TABLET
CEFIXIME 400MG
ORAL
7/10/20/500
Prescription
THIRD GENERATION CEPHALOSPORINS
Active ingredient group (AIG) number: 0122105003; AHFS:
APPROVED
2014-10-17
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 Read the complete document