Country: Kanada
Bahasa: Inggeris
Sumber: Health Canada
CEFOXITIN (CEFOXITIN SODIUM)
PFIZER CANADA ULC
J01DC01
CEFOXITIN
1G
POWDER FOR SOLUTION
CEFOXITIN (CEFOXITIN SODIUM) 1G
INTRAMUSCULAR
20ML
Prescription
CEPHAMYCINS
Active ingredient group (AIG) number: 0113134002; AHFS:
CANCELLED POST MARKET
2019-06-28
PRODUCT MONOGRAPH PR CEFOXITIN FOR INJECTION USP 1 g, 2 g cefoxitin per vial Sterile Powder Antibiotic Pfizer Canada ULC 17300 Trans-Canada Highway Kirkland, Québec H9J 2M5 Date of Revision: January 14, 2019 _Manufactured by:_ PFIZER HEALTHCARE INDIA PVT. LTD. Irungattukottai - 602 105, India _ _ _Distributed by: _ APOTEX INC. 150 Signet Drive Toronto, ON, M9L 1T9 Control No: 220679 _Product Monograph – _ _Pr_ _Cefoxitin for Injection USP _ _ _ _Page 2 of 31 _ PRODUCT MONOGRAPH PR CEFOXITIN FOR INJECTION USP 1 g, 2 g cefoxitin per vial Sterile Powder Antibiotic ACTION AND CLINICAL PHARMACOLOGY Cefoxitin is a cephamycin derived from cephamycin C. Evidence from _in vitro _ studies suggests that cefoxitin exerts its bactericidal action through the inhibition of bacterial cell wall synthesis. Studies have indicated that the resistance of cefoxitin to degradation by bacterial beta-lactamases is due to the methoxy group in the 7 α position. After intravenous or intramuscular administration of a 1 g dose, high serum concentrations are attained which rapidly decline to about 2 mcg/mL at 3 hours in persons with normal renal function. The area under the plasma level-time curve is comparable after bolus injection or intravenous infusion over a period of 120 minutes. INDICATIONS AND CLINICAL USE TREATMENT For the treatment of the following infections when due to susceptible organisms: 1- Intra-abdominal infections such as peritonitis and intra-abdominal abscess 2- Gynecological infections such as endometritis and pelvic cellulitis 3- Septicemia 4- Urinary tract infections (including those caused by _Serratia marcescens_ and _Serratia spp_ .) 5- Lower respiratory tract infections 6- Bone and joint infections caused by _Staphylococcus aureus_ 7- Soft tissue infections such as cellulitis, abscesses and wound infections The susceptibility of the causative organism(s) to Cefoxitin for Injection USP should be determined by conducting appropriate culture and susceptibility studies. Therapy may be initiated while awaiting these Baca dokumen lengkap