Country: Kanada
Bahasa: Inggeris
Sumber: Health Canada
CEPHALEXIN (CEPHALEXIN MONOHYDRATE)
TEVA CANADA LIMITED
J01DB01
CEFALEXIN
500MG
CAPSULE
CEPHALEXIN (CEPHALEXIN MONOHYDRATE) 500MG
ORAL
50/100/250/500/1000
Prescription
FIRST GENERATION CEPHALOSPORINS
Active ingredient group (AIG) number: 0105911003; AHFS:
APPROVED
2014-07-11
1 PRODUCT MONOGRAPH PR TEVA-CEPHALEXIN 250 mg and 500 mg Cephalexin Capsules, USP PR TEVA-CEPHALEXIN 250 mg and 500 mg Cephalexin Tablets, USP PR TEVA-CEPHALEXIN 125 125 mg/5 mL Cephalexin For Oral Suspension, USP PR TEVA-CEPHALEXIN 250 250 mg/5 mL Cephalexin For Oral Suspension, USP ANTIBIOTIC Teva Canada Limited Date of Revision: 30 Novopharm Court August 12, 2020 Toronto, Ontario Canada M1B 2K9 www.tevacanada.com Control # 237728 2 PRODUCT MONOGRAPH PR TEVA-CEPHALEXIN 250 mg and 500 mg Cephalexin Capsules, USP PR TEVA-CEPHALEXIN 250 mg and 500 mg Cephalexin Tablets, USP PR TEVA-CEPHALEXIN 125 125 mg/5 mL Cephalexin For Oral Suspension, USP PR TEVA-CEPHALEXIN 250 250 mg/5 mL Cephalexin For Oral Suspension, USP THERAPEUTIC CLASSIFICATION Antibiotic ACTION TEVA-CEPHALEXIN is bactericidal against many gram-positive and gram-negative organisms. _In vitro_ tests demonstrate that the cephalosporins are bactericidal through their inhibition of cell- wall synthesis (15) . INDICATIONS TEVA-CEPHALEXIN may be indicated for the treatment of bacterial infections of the respiratory tract (1,12)(l3,l4) , including otitis media (1,2) , genitourinary tract (3) , bone and joints (4,5) , skin and soft tissue (6,7) , when the infection is caused by susceptible organisms. Culture and susceptibility studies should be performed. To reduce the development of drug-resistant bacteria and maintain the effectiveness of TEVA- CEPHALEXIN and other antibacterial drugs, TEVA-CEPHALEXIN should be used only to treat infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. 3 CONTRAINDICATIONS TEVA-CEPHALEXIN (cephalexin) is contraindicated in patients with known allergy to the cephalosporin group of antibiotics. WARNINGS Before therapy with TEVA-CEPHALEXIN (c Baca dokumen lengkap