·Drug Category : Antibiotics

WONTAXIME Inj.1g
(Cefotaxime sodium)

■ COMPOSITION
Each vial contains 1g of Cefotaxime sodium as activity

■ INDICATIONS
Cefotaxime is susceptible the following organisms ;
Staphylococcus, Streptococcus, Neisseria, Haemophilus influenzae, Escherichia coli, Citrobacter,
Salmonella, Klebsiella, Enterobacter, Serratia, Proteus, yersinia enterocolitis, Clostridium, bacteroides,
Pseudomonas aeruginosa, Streptococcus faecalis
Cefotaxime is indicated for the treatment of the following infections ;
Lower respiratory tract infections : pneumonia and lung abscess Uncomplicated gonorrhea
Urinary tract infections Bacteremia/septicemia Intra-abdominal infections
Skin infections :
Gynecological infections : including pelvic inflammatory disease, endometritis and pelvic cellulitis
CNS infections : meningitis and ventriculitis Prophylactic use : the administration of cefotaxime
perioperatively (preoperatively, intraoperatively and postoperatively) may reduce the incidence of
certain infections in patients undergoing elective surgical procedures (e.g. abdominal or vaginal
hysterectomy, gastrointestinal and genitourinary tract surgery)that may be classified as contaminated
or potentially contaminated.

■ DOSAGE
Cefotaxime may be administered i.v. or i.m. after reconstitution.
1. ADULTS & CHILDREN OVER 12 YEARS OLD : Dosage and route of administration should be
determined by susceptibility of the causative organisms, severity of the infection and condition
of the patient.
Type of infection Daily Dose (g) Frequency and Route Uncomplicated Gonorrhea 11g i.m. (single dose)
Uncomplicated infections 21g every 12 hours i.m. or i.v.
Moderately severe to severe 3-61 to 2 g every 8 hours i.m. or i.v. infections
Very severe infections 6-82g every 6 to 8 hours i.v. (e.g. septicemia, CNS)
Life-threatening infections up to 122g every 4 hours i.v.
2. INFANTS & CHILDREN UNDER 12 YEARS OLD : The recommended dose is 50 to 100mg/kg/day
i.v. in 2 to 4 divided doses.
In life-threatening infections up to 150 to 200mg/kg/day, in divided doses, may be required.
3. IMMATURE INFANTS : The dose should not exceed 50mg/kg/day.
4. PATIENTS WITH IMPAIRED RENAL FUNCTION : In patients with estimated creatinine clearance of
less than 5 mL/min, the maintenance dose must be halved. The initial dose may be determined
by susceptibility of the causative organisms and severity of the infection.

■ CONTRAINDICATIONS
In patients who have shown hypersensitivity to cefotaxime sodium, the cephalosporin or the
penicillin groups of antibiotics.

■ PRECAUTIONS
Cefotaxime should be prescribed with caution in individuals with a history of lower gastrointestinal
disease, particularly colitis.

■ ADVERSE EFFECTS
The most frequent adverse reactions with frequency of occurrence are :
Hypersensitivity : rash, pruritus, fever.
Local : injection site inflammation with i.v. administration. Pain, induration and tenderness after i.m.
injection.
Gastrointestinal : colitis ; diarrhea, nausea and vomiting. Symptoms of pseudomembranous colitis
can appear during or after cefotaxime treatment.
Hematologic System : neutropenia, transient leukopenia, eosinophilia, thrombocytopenia and
agranulocytosis have been reported. Some individuals have developed positive direct Coombs' test
during treatment with cefotaxime and other cephalosporin antibiotics. Rare cases of hemolytic
anemia have been reported.
Genitourinary System : moniliasis, vaginitis.
CNS : headache
Liver : transient elevations in AST (SGOT), ALT (SGPT), serum LDH, and serum alkaline phosphatase
levels have been reported.
Kidney : increased serum creatinine and BUN have occasionally been observed.
■ INTERACTIONS
Cephalosporin antibiotics at high dosage should be given with caution to patients receiving
aminoglycoside antibiotics or potent diuretics such as furosemide as these combinations are
thought to have an adverse effect on renal function. However, at the recommended doses,
enhancement of nephrotoxicity is unlikely to be a problem with cefotaxime.

■ PREGNANCY
Although studies in animals have not shown an adverse effect on the developing fetus, the safety
of cefotaxime in human pregnancy has not been established. Consequently, cefotaxime should not
be administered during pregnancy especially during the first trimester, without carefully weighing
the expected benefits against the possible risks.

■ LACTATION
Cefotaxime is excreted in human milk in low concentrations. Caution should be exercised when the
drug is administered to nursing mothers.

■ INTERFERENCE WITH LABORATORY TESTS

A positive Coombs' test may be seen during treatment with cephalosporins. This phenomenon
may occur during treatment with cefotaxime. A false-positive reaction to glucose may occur with
reducing substances but not with the use of specific glucose oxidase methods.

■ OVERDOSAGE
In the case of overdosage and particularly in renal insufficiency, there is a risk of reversible
encephalopathy. Serum levels of cefotaxime may be reduced by peritoneal dialysis or haemodialysis.

■ INCOMPATIBILITIES
Solutions of cefotaxime must not be admixed with aminoglycoside solutions. If cefotaxime and
aminoglycosides are to be administered to the same patient, they must be administered separately
and not as a mixed injection.

■ PHARMACEUTICAL PRECAUTIONS
Parenteral drug products should be inspected visually for particulate matter and discoloration prior
to administration. The dry powder in vials should be stored away from heat (below 25℃) and
protected from light. It is preferable to use only freshly prepared solutions for both intravenous
and intramuscular injection. After 24 hours any unused solution should be discarded. Some increase
in color of prepared solutions may occur on storage. However, provided the recommended storage
conditions are observed, this does not indicate change in potency or safety.

■ STORAGE : Hermetic container at room temperature

■ SHELF LIFE : 2 years

■ PACKS : Box of 10 vials, 50vials

This drug is manufactured in accordance with Korea Good Manufacturing Practice (KGMP) as
recommended by WHO.