Cefotaxime Sodium for Injection 1g/10ml Finished Medicines with GMP

CEFOTAXIME SODIUM FOR INJECTION 1G/10ML

Indications:

Cefotaxime is indicated in the treatment of the following severe infections when known or thought very likely to be caused by bacteria that are susceptible to cefotaxime :

- Bacterial pneumonia

- Complicated infections of the urinary tract including pyelonephritis

- Severe skin and soft tissue infections

- Genital infections, including gonorrhoea

- Intra-abdominal infections (such as peritonitis)

- Bacterial meningitis

- Endocarditis

- Borreliosis

Treatment of patients with bacteraemia that occurs in association with, or is suspected to be associated with, any of the infections listed above.

Perioperative prophylaxis. For surgical operations with increased risk of infections with anaerobic pathogens, e.g. colorectal surgery, a combination with an appropriate drug with activity against anaerobes is recommended.

Dosage and Administration:

Cefotaxime may be administered by intravenous bolus injection or intravenous infusion or by intramuscular injection after reconstitution of the solution.

Dosage and mode of administration should be determined by the severity of the infection, susceptibility of the causative organism and the patient's condition. Therapy may be started before the result of microbiological tests are known.

Contraindications

Hypersensitivity to the active substance, to other cephalosporins or any of the excipients listed in the product.

Previous, immediate and/or severe hypersensitivity reaction to penicillin or any beta-lactam antibiotic.

For pharmaceutical forms containing lidocaine:

- known history of hypersensitivity to lidocaine or other local anesthetics of the amide type

- non-paced heart block

- severe heart failure

- administration by the intravenous route

- infants aged less than 30 months of age

Drug interactions:

Uricosurics: Probenecid interferes with the renal tubular transfer of cefotaxime, thereby increasing cefotaxime exposure about 2-fold and reducing renal clearance to about half at therapeutic doses. Due to the large therapeutic index of cefotaxime, no dosage adjustment is needed in patients with normal renal function. Dosage adjustment may be needed in patients with renal impairment.

Aminoglycoside antibiotics and diuretics: As with other cephalosporins, cefotaxime may potentiate the nephrotoxic effects of nephrotoxic drugs such as aminoglycosides or potent diuretics (e.g. furosemide). Renal function must be monitored in these patients .

Bacteriostatic antibiotics: Cefotaxime should not be combined with bacteriostatic antibiotics (e.g. tetracyclines, erythromycin and chloramphenicol) because an antagonistic effect is possible.

Interference with Laboratory Tests: As with other cephalosporins, a positive Coombs' test has been seen in some patients treated with cefotaxime. This phenomenon can interfere with the cross-matching of blood.

A false positive reaction to glucose may occur with reducing substances (e.g. Fehling's solution) but not with the use of specific glucose oxidase methods.

Storage instructions:

This medicinal product does not require any special temperature storage conditions.

Keep the vials in the outer carton in order to protect from light.

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