国家: 美国
语言: 英文
来源: NLM (National Library of Medicine)
cefotetan disodium (UNII: 0GXP746VXB) (cefotetan - UNII:48SPP0PA9Q)
AstraZeneca Pharmaceuticals, LP
cefotetan disodium
INJECTION, SOLUTION
1 g in 50 mL
INTRAVENOUS
PRESCRIPTION DRUG
To reduce the development of drug-resistant bacteria and maintain the effectiveness of CEFOTAN and other antibacterial drugs, CEFOTAN should be used only to treat or prevent 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 antimicrobial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. CEFOTAN is indicated for the therapeutic treatment of the following infections when caused by susceptible strains of the designated organisms: Cefotetan, like other cephalosporins, has no activity against Chlamydia trachomatis . Therefore, when cephalosporins are used in the treatment of pelvic inflammatory disease, and C. trachomatis is one of the suspected pathogens, appropriate antichlamydial coverage should be added. *Efficacy for this organism in this organ system was studied in fewer tha
CEFOTAN (cefotetan disodium for injection) is a dry, white to pale yellow powder supplied in vials containing cefotetan disodium equivalent to 1 g and 2 g cefotetan activity for intravenous and intramuscular administration. The vials should not be stored at temperatures above 22°C (72°F) and should be protected from light. 1 g ADD-Vantage Vial (NDC 0310-0376-31) 2 g ADD-Vantage Vial (NDC 0310-0377-32) 1 g Vial (NDC 0310-0376-10) 2 g Vial (NDC 0310-0377-20) 1 g Piggyback Vial (NDC 0310-0376-11) 2 g Piggyback Vial (NDC 0310-0377-21) CEFOTAN is also available as a 10 g pharmacy bulk package. 10 g in 100 mL Vial (NDC 0310-0375-10) CEFOTAN (cefotetan injection) is supplied as a frozen, iso-osmotic, premixed solution in single dose Galaxy® plastic containers (PL 2040) as follows: 1 g in 50 mL plastic container (NDC 0310-0378-51) 2 g in 50 mL plastic container (NDC 0310-0379-51) Store containers at or below -20°C/-4°F. [See DIRECTIONS FOR USE OF CEFOTAN (cefotetan injection) IN GALAXY® PLASTIC CONTAINER (PL 2040)].
CEFOTAN- CEFOTETAN DISODIUM INJECTION, SOLUTION CEFOTAN- CEFOTETAN DISODIUM INJECTION, POWDER, FOR SOLUTION ASTRAZENECA PHARMACEUTICALS, LP ---------- CEFOTAN® CEFOTETAN DISODIUM FOR INJECTION FOR INTRAVENOUS OR INTRAMUSCULAR USE CEFOTAN® CEFOTETAN INJECTION FOR INTRAVENOUS USE ONLY IN GALAXY® PLASTIC CONTAINER (PL 2040) To reduce the development of drug-resistant bacteria and maintain the effectiveness of CEFOTAN and other antibacterial drugs, CEFOTAN should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria. DESCRIPTION CEFOTAN (cefotetan disodium for injection) and CEFOTAN (cefotetan injection) in Galaxy * plastic container (PL 2040) as cefotetan disodium are sterile, semisynthetic, broad-spectrum, beta-lactamase resistant, cephalosporin (cephamycin) antibiotics for parenteral administration. It is the disodium salt of [6R-(6α,7α)]-7-[[[4-(2-amino-1-carboxy-2-oxoethylidene)-1,3-dithietan-2-yl]carbonyl]amino]-7- methoxy-3-[[(1-methyl-1_H_-tetrazol-5-yl)thio]methyl]-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2- carboxylic acid. Its molecular formula is C H N Na O S with a molecular weight of 619.57. STRUCTURAL FORMULA CEFOTAN (cefotetan disodium for injection) is supplied in vials containing 80 mg (3.5 mEq) of sodium per gram of cefotetan activity. It is a white to pale yellow powder which is very soluble in water. Reconstituted solutions of CEFOTAN (cefotetan disodium for injection) are intended for intravenous and intramuscular administration. The solution varies from colorless to yellow depending on the concentration. The pH of freshly reconstituted solutions is usually between 4.5 to 6.5. CEFOTAN in the ADD-Vantage Vial† is intended for intravenous use only after dilution with the appropriate volume of ADD-Vantage diluent solution. CEFOTAN is available in two vial strengths. Each CEFOTAN 1 g vial contains cefotetan disodium equivalent to 1 g cefotetan activity. Each CEFOTAN 2 g vial contains cefotetan disodium equivalent to 2 g cefotetan activity. 阅读完整的文件