powder for solution for injection in vials No. 1

Instructions Normative documents


1 vial contains 1000 mg of a cefotaxime (in sodium salt form).


Dosage form

powder for solution for injection


Pharmacological group

Antibacterial medications for systemic use. Other β-lactam antibiotics. Cephalosporins of III generation. Cefotaxime. ATC code J01D D01.


Pharmacological properties

The bactericidal activity of cefotaxime (cefotaxime for injection) sodium results from inhibition of cell wall synthesis. Cefotaxime (cefotaxime for injection) sodium has in vitro activity against a wide range of gram-positive and gram-negative organisms. Cefotaxime (cefotaxime for injection) sodium has a high degree of stability in the presence of β-lactamases, both penicillinases and cephalosporinases, of gram-negative and gram-positive bacteria. Cefotaxime (cefotaxime for injection) sodium has been shown to be active against most strains of the following microorganisms both in vitro and in clinical infections as described in the INDICATIONS AND USAGE section.

Aerobes, Gram-positive:
Enterococcus spp.
Staphylococcus aureus*, including β-lactamase-positive and negative strains
Staphylococcus epidermidis
Streptococcus pneumoniae
Streptococcus pyogenes (Group A beta-hemolytic streptococci)
Streptococcus spp.
*Staphylococci which are resistant to methicillin/oxacillin must be considered resistant to cefotaxime (cefotaxime for injection) sodium.

Aerobes, Gram-negative:
Acinetobacter spp.
Citrobacter spp.
Enterobacter spp.
Escherichia coli
Haemophilus influenzae (including ampicillin-resistant strains)
Haemophilus parainfluenzae
Klebsiella spp. (including Klebsiella pneumoniae)
Morganella morganii
Neisseria meningitidis
Proteus mirabilis
Proteus vulgaris
Providencia rettgeri
Providencia stuartii
Serratia marcescens

NOTE: Many strains of the above organisms that are multiply resistant to other antibiotics, e.g. penicillins, cephalosporins, and aminoglycosides, are susceptible to cefotaxime (cefotaxime for injection) sodium. Cefotaxime (cefotaxime for injection) sodium is active against some strains of Pseudomonas aeruginosa.

Bacteroides spp., including some strains of Bacteroides fragilis
Clostridium spp. (Note: Most strains of Clostridium difficile are resistant.)
Fusobacterium spp. (including Fusobacterium nucleatum).
Peptococcus spp.
Peptostreptococcus spp.

Cefotaxime (cefotaxime for injection) sodium also demonstrates in vitro activity against the following microorganisms but the clinical significance is unknown. Cefotaxime (cefotaxime for injection) sodium exhibits in vitro minimal inhibitory concentrations (MIC’s) of 8 µg/mL or less against most ( ≥ 90%) strains of the following microorganisms; however, the safety and effectiveness of cefotaxime (cefotaxime for injection) sodium in treating clinical infections due to these microorganisms have not been established in adequate and well-controlled clinical trials:

Aerobes, Gram-negative:
Providencia spp.
Salmonella spp. (including Salmonella typhi)
Shigella spp.

Cefotaxime (cefotaxime for injection) sodium is highly stable in vitro to four of the five major classes of β-lactamases described by Richmond et al.1, including type IIIa (TEM) which is produced by many gram-negative bacteria. The drug is also stable to β-lactamase (penicillinase) produced by staphylococci. In addition, cefotaxime (cefotaxime for injection) sodium shows high affinity for penicillin-binding proteins in the cell wall, including PBP: Ib and III.

Cefotaxime (cefotaxime for injection) sodium and aminoglycosides have been shown to be synergistic in vitro against some strains of Pseudomonas aeruginosa but the clinical significance is unknown.



Infections caused by susceptible microorganisms:

– upper respiratory tract infections (tonsillitis, otitis media);
– respiratory tract infections (bronchitis, pneumonia, pleurisy, abscesses);
– infections of the genitourinary system;
– septicemia, bacteremia;
– intra-abdominal infections (including peritonitis);
– skin and soft tissue infections;
– bones and joints infections;
– meningitis (with the exception of listeriosis) and other CNS infections;
– prevention of infections after surgeries on the digestive tract, urological and obstetric-gynecological operations.



Cefotaxime (cefotaxime for injection) is generally well tolerated. The most common adverse reactions have been local reactions following IV injection. Other adverse reactions have been encountered infrequently.

The most frequent adverse reactions (greater than 1%) are:
Local (4.3%)— Injection site inflammation with IV administration.

Hypersensitivity (2.4%)—Rash, pruritus, fever, eosinophilia and less frequently urticaria and anaphylaxis.

Gastrointestinal (1.4%)—Colitis, diarrhea, nausea, and vomiting.

Symptoms of pseudomembranous colitis can appear during or after antibiotic treatment.

Nausea and vomiting have been reported rarely.

Less frequent adverse reactions (less than 1%) are:
Cardiovascular System—Potentially life-threatening arrhythmias following rapid (less than 60 seconds) bolus administration via central venous catheter have been observed.

Hematologic System—Neutropenia, transient leukopenia, eosinophilia, thrombocytopenia and agranulocytosis have been reported. Some individuals have developed positive direct Coombs Tests during treatment with cefotaxime (cefotaxime for injection) and other cephalosporin antibiotics. Rare cases of hemolytic anemia have been reported.

Genitourinary System—Moniliasis, vaginitis.

Central Nervous System—Headache, encephalopathy.

Liver—Transient elevations in SGOT, SGPT, serum LDH, and serum alkaline phosphatase levels have been reported.

Kidney—As with some other cephalosporins, interstitial nephritis and transient elevations of BUN and creatinine have been occasionally observed with cefotaxime (cefotaxime for injection) .

Cutaneous—As with other cephalosporins, isolated cases of erythema multiforme, Stevens-Johnson syndrome, and toxic epidermal necrolysis have been reported.


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