Cefotaxime is indicated for the treatment of a wide range of infections, either before the causative organism is identified or when caused by susceptible bacteria. These include septicemia; respiratory tract infections such as acute or chronic bronchitis, bacterial pneumonia, infected bronchiectasis, lung abscess, and postoperative chest infections; urinary tract infections including acute and chronic pyelonephritis, cystitis, and asymptomatic bacteriuria; soft tissue infections such as cellulitis, peritonitis, and wound infections; bone and joint infections including osteomyelitis and septic arthritis; obstetric and gynecological infections such as pelvic inflammatory disease and gonorrhea (especially when penicillin is ineffective or unsuitable); and other bacterial infections including meningitis and infections appropriate for parenteral antibiotic therapy.

Prophylaxis: Cefotaxime may also be used prophylactically to reduce the risk of postoperative infections in patients undergoing surgical procedures classified as contaminated, potentially contaminated, or certain clean surgeries where infection could lead to serious complications.

Cefotaxime acts by binding to one or more penicillin-binding proteins (PBPs), thereby inhibiting the final transpeptidation step of bacterial cell wall synthesis. This leads to disruption of cell wall formation and ultimately bacterial cell death. It is a broad-spectrum, bactericidal, third-generation parenteral cephalosporin antibiotic. Cefotaxime is particularly effective against gram-negative organisms, including those resistant to first- or second-generation cephalosporins, while maintaining activity against gram-positive bacteria similar to other cephalosporins.

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.

Concurrent use of cephalosporins with aminoglycoside antibiotics has been associated with an increased risk of nephrotoxicity.

Cefotaxime is contraindicated in patients with known hypersensitivity to cefotaxime or other cephalosporin antibiotics.

Adverse effects with cefotaxime are relatively uncommon and generally mild and transient. Reported effects include candidiasis, skin rashes, fever, transient elevation of liver enzymes (transaminases and/or alkaline phosphatase), and diarrhea. Rarely, pseudomembranous colitis may occur during treatment, requiring discontinuation of the drug and appropriate management. Changes in renal function have been reported, particularly with high doses, especially in patients with renal impairment, which may lead to encephalopathy. Hypersensitivity reactions such as rash, drug fever, and very rarely anaphylaxis may also occur.

Although animal studies have not demonstrated harm to the fetus, the safety of cefotaxime in human pregnancy has not been fully established. Therefore, it should not be used during pregnancy, especially in the first trimester, unless the potential benefit outweighs the possible risk. Cefotaxime is excreted in breast milk.

Cefotaxime should be used with caution in patients with a history of gastrointestinal disease, particularly colitis. In patients with impaired renal function, accumulation of the drug may occur due to reduced urinary excretion, and dose adjustment may be necessary. Dosage should be individualized based on the severity of infection, degree of renal impairment, and susceptibility of the causative organism. There is no strong clinical evidence supporting routine dosage modification even in severe renal dysfunction, but careful monitoring is recommended.

Dosage in renal impairment: Due to partial elimination outside the kidneys, dosage reduction is generally required only in severe renal failure (GFR <5 mL/min; serum creatinine approximately 751 micromol/L). After an initial loading dose of 1 g, subsequent doses may be reduced without changing dosing frequency. In other cases, dosage adjustment should be based on infection severity and patient condition.

Third generation Cephalosporins

Store below 25°C, protected from light and moisture. Use the reconstituted solution immediately. If necessary, it may be stored for up to 24 hours at 2°–8°C.