Cefotaxime
Indications
Cefotaxime is indicated for the treatment
of the following infections either before the infecting organism has
been identified or when caused by bacteria of established sensitivity:
Septicaemia Respiratory Tract Infections such as acute or chronic
bronchitis, bacterial pneumonia, infected bronchiectasis, lung abscess
and postoperative chest infections Urinary Tract Infections such as
acute and chronic pyelonephritis, cystitis and asymptomatic bacteriuria
Soft-tissue Infection such as cellulitis, peritonitis and wound
infections Bone and Joint Infections such as osteomyelitis, septic
arthritis Obstetric and gynaecological infections: such as pelvic
inflammatory disease Gonorrhoea particularly when penicillin has failed
or is unsuitable Other Bacterial Infections: meningitis and other
sensitive infections suitable for parenteral antibiotic therapy
Prophylaxis: The administration of Cefotaxime prophylactically may
reduce the incidence of certain post operative infections in patients
undergoing surgical procedures that are classified as contaminated or
potentially contaminated or in clean operation where infection would
have serious effects.
Pharmacology
Cefotaxime binds to 1 or more of the
penicillin binding proteins (PBPs) which inhibit the final
transpeptidation step of peptidoglycan synthesis in bacterial cell wall,
thus inhibiting biosynthesis and arresting cell wall assembly resulting
in bacterial cell death. Cefotaxime is a broad spectrum bactericidal
3rd generation parenteral cephalosporin antibiotic. Cefotaxime is
exceptionally active against gram-negative organisms sensitive or
resistant to first or second generation cephalosporins. It is similar to
other cephalosporins in activity against gram-positive bacteria.
Dosage & Administration
Adults: The recommended
dosage for mild to moderate infections is 1 gm every 12 hourly. However,
dosage may be varied according to the severity of infection,
sensitivity of causative organisms and condition of the patient. In
severe infections dosage may be increased up to 12 gm daily given in 3
or 4 divided doses. For infections caused by sensitive Pseudomonas spp.
daily doses of greater than 6 gm will usually be required
Children: The usual dosage range is 100-150 mg/kg/day in 2 to 4 divided doses. However, in very severe infections doses of up to 200 mg/kg/day may be required.
Neonates: The recommended dosage is 50 mg/kg/day in 2 to 4 divided doses. In severe infections 150-200 mg/kg/day, in divided doses, have been given.
Dosage in gonorrhoea: 500 mg as a single dose.
Children: The usual dosage range is 100-150 mg/kg/day in 2 to 4 divided doses. However, in very severe infections doses of up to 200 mg/kg/day may be required.
Neonates: The recommended dosage is 50 mg/kg/day in 2 to 4 divided doses. In severe infections 150-200 mg/kg/day, in divided doses, have been given.
Dosage in gonorrhoea: 500 mg as a single dose.
Interaction
Increased nephrotoxicity has been reported
following concomitant administration of cephalosporins and
aminoglycoside antibiotics.
Contraindications
Cefotaxime is contraindicated in patients
who have shown hypersensitivity to cefotaxime or the cephalosporin group
of antibiotics.
Side Effects
Adverse reactions to Cefotaxime have
occurred relatively infrequently and have generally been mild and
transient. Effects reported include candidiasis, rashes, fever,
transient rises in liver transaminase and/or alkaline phosphatase and
diarrhoea. As with all cephalosporins, pseudomembranous colitis may
rarely occur during treatment. If this occurs the drug should be stopped
and specific treatment instituted.As with other cephalosporins, changes
in renal function have been rarely observed with high doses of
Cefotaxime. Administration of high doses of cephalosporins particularly
in patients with renal insufficiency may result in encephalopathy.
Hypersensitivity reactions have been reported, these include skin
rashes, drug fever and very rarely anaphylaxis.
Pregnancy & Lactation
Although studies in animals have not shown
any adverse effect on the developing foetus, the safety of Cefotaxime in
human pregnancy has not been established. Consequently, Cefotaxime
should not be administered during pregnancy especially during first
trimester, without carefully weighing the expected benefit against
possible risks. Cefotaxime is excreted in the milk.
Precautions & Warnings
Cefotaxime should be prescribed with
caution in individuals with a history of gastrointestinal disease,
particularly colitis. Because high and prolonged antibiotic
concentrations can occur from usual doses in patients with transient or
persistent reduction of urinary output because of renal insufficiency,
the total daily dosage should be reduced when Cefotaxime is administered
to such patients. Continued dosage should be determined by degree of
renal impairment, severity of infection, and susceptibility of the
causative organism. There is no clinical evidence supporting the
necessity of changing the dosage of Cefotaxime in patients with even
profound renal dysfunction.
Use in Special Populations
Dosage in renal impairment:
Because of extra-renal elimination, it is only necessary to reduce the
dosage of Cefotaxime in severe renal failure (GFR<5 ml/min = serum
creatinine approximately 751 micromol/litre). After an initial loading
dose of 1 gm, daily dose should be halved without change in the
frequency of dosing. In all other patients, dosage may require further
adjustment according to the course of infection and the general
condition of the patient.
Therapeutic Class
Third generation Cephalosporins
Storage Conditions
Store below 25°C, protected from light and
moisture. Use reconstituted solution immediately. Reconstituted solution
is stable for up to 24 h if stored between 2° to 8°C.
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