CLAFORAN SUMMARY
Sterile CLAFORAN® (cefotaxime sodium) is a semi-synthetic, broad spectrum cephalosporin antibiotic for parenteral administration. It is the sodium salt of 7-[2-(2-amino-4-thiazolyl) glyoxylamido]-3-(hydroxymethyl)-8-oxo-5-thia-1-azabicyclo [4.2.0] oct-2-ene-2-carboxylate 72(Z)-(o-methyloxime), acetate (ester). CLAFORAN contains approximately 50.5 mg (2.2 mEq) of sodium per gram of cefotaxime activity. Solutions of CLAFORAN range from very pale yellow to light amber depending on the concentration and the diluent used. The pH of the injectable solutions usually ranges from 5.0 to 7.5. The CAS Registry Number is 64485-93-4.
CLAFORAN is indicated for the treatment of patients with serious infections caused by susceptible strains of the designated microorganisms in the diseases listed below.
- Lower respiratory tract infections, including pneumonia, caused by
Streptococcus pneumoniae
(formerly
Diplococcus pneumoniae),
Streptococcus pyogenes * (Group A streptococci) and other streptococci (excluding enterococci, e.g., Enterococcus faecalis),
Staphylococcus aureus
(penicillinase and non-penicillinase producing), Escherichia coli,
Klebsiella
species,
Haemophilus influenzae
(including ampicillin resistant strains), Haemophilus parainfluenzae, Proteus mirabilis,
Serratia marcescens *,
Enterobacter
species, indole positive
Proteus
and
Pseudomonas
species (including
P. aeruginosa).
- Genitourinary infections. Urinary tract infections caused by
Enterococcus
species,
Staphylococcus epidermidis,
Staphylococcus aureus *, (penicillinase and non-penicillinase producing), Citrobacter
species,
Enterobacter
species,
Escherichia coli,
Klebsiella
species,
Proteus mirabilis,
Proteus vulgaris *,
Providencia stuartii,
Morganella morganii *,
Providencia rettgeri *,
Serratia marcescens
and
Pseudomonas
species (including
P. aeruginosa). Also, uncomplicated gonorrhea (cervical/ urethral and rectal) caused by
Neisseria gonorrhoeae, including penicillinase producing strains.
- Gynecologic infections, including pelvic inflammatory disease, endometritis and pelvic cellulitis caused by
Staphylococcus epidermidis,
Streptococcus
species,
Enterococcus
species,
Enterobacter
species *,
Klebsiella
species *,
Escherichia coli,
Proteus mirabilis,
Bacteroides
species (including
Bacteroides fragilis *),
Clostridium
species, and anaerobic cocci (including
Peptostreptococcus
species and
Peptococcus
species) and
Fusobacterium
species (including
F. nucleatum *).
CLAFORAN, 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 antichlamydial coverage should be added. - Bacteremia/Septicemia caused by
Escherichia coli,
Klebsiella
species, and
Serratia marcescens,
Staphylococcus aureus
and
Streptococcus
species (including
S. pneumonia).
- Skin and skin structure infections caused by
Staphylococcus aureus
(penicillinase and non-penicillinase producing), Staphylococcus epidermidis,
Streptococcus pyogenes
(Group A streptococci) and other streptococci,
Enterococcus
species,
Acinetobacter
species *,
Escherichia coli,
Citrobacter
species (including
C. freundii *),
Enterobacter
species,
Klebsiella
species,
Proteus mirabilis,
Proteus vulgaris *,
Morganella morganii,
Providencia rettgeri *,
Pseudomonas
species,
Serratia marcescens,
Bacteroides
species, and anaerobic cocci (including
Peptostreptococcus * species and
Peptococcus
species).
- Intra-abdominal infections including peritonitis caused by
Streptococcus
species *,
Escherichia coli,
Klebsiella
species,
Bacteroides
species, and anaerobic cocci (including
Peptostreptococcus * species and
Peptococcus * species)
Proteus mirabilis *, and
Clostridium
species *.
- Bone and/or joint infections caused by
Staphylococcus aureus
(penicillinase and non-penicillinase producing strains), Streptococcus
species (including
S. pyogenes *),
Pseudomonas
species (including
P. aeruginosa *), and
Proteus mirabilis *.
- Central nervous system infections, e.g., meningitis and ventriculitis, caused by
Neisseria meningitidis,
Haemophilus influenzae,
Streptococcus pneumoniae,
Klebsiella pneumoniae * and
Escherichia coli *.
(*) Efficacy for this organism, in this organ system, has been studied in fewer than 10 infections.
To reduce the development of drug-resistant bacteria and maintain the effectiveness of CLAFORAN and other antibacterial drugs, CLAFORAN 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 antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.
|
