Negara: Kanada
Bahasa: Inggris
Sumber: Health Canada
CEFIXIME
ODAN LABORATORIES LTD
J01DD08
CEFIXIME
400MG
TABLET
CEFIXIME 400MG
ORAL
7/10
Prescription
THIRD GENERATION CEPHALOSPORINS
Active ingredient group (AIG) number: 0122105003; AHFS:
APPROVED
2006-05-04
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 Baca dokumen lengkapnya