…………………………………………………… 11 STABILITY AND STORAGE RECOMMENDATIONS…............................................. 15 AVAILABILITY OF DOSAGE FORMS………………………………………………... 16 PHARMACEUTICAL INFORMATION………………………………………………… 17 MICROBIOLOGY………………………………………………………………………...
18 PHARMACOLOGY……………………………………………………………………… 21 TOXICOLOGY…………………………………………………………………………… 29 REFERENCES……………………………………………………………………………. 5 g, 1 g, 2 g) β-lactam Antibiotic ACTION AND CLINICAL PHARMACOLOGY CEFOTAXIME SODIUM FOR INJECTION BP (cefotaxime sodium) is a semi-synthetic, 2- aminothiazolyl cephalosporin antibiotic for parenteral use.
In vitro studies indicate that the antibacterial action of cefotaxime sodium results from inhibition of cell wall synthesis. It is stable against the action of most β-lactamases. INDICATIONS AND CLINICAL USE Treatment CEFOTAXIME SODIUM FOR INJECTION BP (cefotaxime sodium) may be indicated for the treatment of infections caused by susceptible strains of the designated micro-organisms in the diseases listed below.
g. S. faecalis), Staphylococcus aureus (penicillinase and non-penicillinase producing), Escherichia coli, Hemophilus influenzae, (including ampicillin resistant strains) and unspecified Klebsiella species.
Urinary Tract Infections:
Caused by Escherichia coli, unspecified Klebsiella species (including K. pneumoniae), Proteus mirabilis, indole positive Proteus, Serratia marcescens and Staphylococcus epidermidis. Also, uncomplicated gonorrhea caused by N. gonorrhoeae including penicillin resistant strains.
Bacteremia/Septicemia:
Caused by Escherichia coli, unspecified Klebsiella strains and Serratia marcescens.
Skin Infections:
Caused by Staphylococcus aureus (penicillinase and non-penicillinase producing), S. epidermidis, group A streptococci, Escherichia coli, Proteus mirabilis and indole positive Proteus.
Intra-abdominal Infections:
Caused by Escherichia coli, and unspecified Klebsiella species.
Gynecological Infections:
Including pelvic inflammatory disease, endometritis and pelvic cellulitis caused by E. coli, group A streptococci and Staphylococcus epidermidis; anaerobic bacteria including unspecified Peptococcus and Peptostreptococcus strains and some strains of Bacteroides fragilis.
In several cases, although clinical cures were achieved, bacteriological follow-up was not available. 4 CEFOTAXIME SODIUM FOR INJECTION BP, like other cephalosporins, has no activity against Chlamydia trachomatis. Therefore, when cephalosporins are used in the treatment of patients with pelvic inflammatory disease and C.
trachomatis is one of the suspected pathogens, appropriate anti-chlamydial coverage should be added.
Central Nervous System Infections:
Meningitis and ventriculitis caused by Haemophilus influenzae, Neisseria meningitidis, Streptococcus pneumoniae, Klebsiella pneumoniae and Escherichia coli. CEFOTAXIME SODIUM FOR INJECTION BP is not active against Listeria monocytogenes.
Clinical experience with cefotaxime sodium in anaerobic infections is limited. Cefotaxime sodium has been used with some success in wound and intra-abdominal infections against some strains of unidentified Bacteroides and anaerobic cocci.
Cefotaxime sodium has been shown to be active against some strains of Pseudomonas. In the treatment of infections encountered in immunosuppressed and granulocytopenic patients, results of therapy with cefotaxime sodium have not been impressive.
e. Streptococcus faecalis. Specimens for bacteriologic culture should be obtained prior to therapy in order to isolate and identify the causative organisms and to determine their susceptibilities to CEFOTAXIME SODIUM FOR INJECTION BP.
Therapy may be instituted before results of susceptibility studies are known; antibiotic treatment should be re-evaluated once these results become available. g. abdominal or vaginal hysterectomy, gastrointestinal and genitourinary tract surgery) that may be classified as contaminated or potentially contaminated.
In patients undergoing caesarian section who are considered to be at increased risk of infection, intraoperative (after clamping the umbilical cord) and postoperative use of CEFOTAXIME SODIUM FOR INJECTION BP may also reduce the incidence of certain postoperative infections.
Effective use for elective surgery depends on the time of administration (see DOSAGE AND ADMINISTRATION section). g. neomycin) is recommended. If there are signs of infection, specimens for culture should be obtained for identification of the causative organism so that appropriate therapy may be instituted.
To reduce the development of drug-resistant bacteria and maintain the effectiveness of 5 CEFOTAXIME SODIUM FOR INJECTION BP and other antibacterial drugs, CEFOTAXIME SODIUM FOR INJECTION BP 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.
CONTRAINDICATIONS CEFOTAXIME SODIUM FOR INJECTION BP (cefotaxime sodium) is contraindicated in patients who have shown hypersensitivity to […]