Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2017 Publisher: Villerton Invest SA, Rue Edward Steichen 14, 2540 Luxembourg
Consideration should be given to official guidance on the appropriate use of antibacterial agents.
Cefotaxime sodium is indicated for the treatment of the following severe infections when known or thought very likely to be due to organisms that are susceptible to cefotaxime.
Peri-operative prophylaxis in surgical procedures such as colorectal, gastrointestinal, prostatic, urogenital and gynaecological surgery in patients who have a definite risk of post-operative infections. Cefotaxime should be used in combination with another antibiotic that can provide anaerobic cover in the treatment of intra-abdominal infections. Cefotaxime should be used in combination with an aminoglycoside in the treatment of infections caused by Pseudomonas.
Protection is best insured by achieving adequate local tissue concentrations at the time contamination is likely to occur.
Administration should usually be stopped within 24 hours since continuing use of any antibiotic in the majority of surgical procedures does not reduce the incidence of subsequent infection.
Cefotaxime sodium may be administered intravenously, by bolus injection or infusion, or intramuscularly. The dosage, route and frequency of administration should be determined by the severity of infection, the sensitivity of causative organisms and condition of the patient. Therapy may be initiated before the results of sensitivity tests are known.
The clinician should consult published protocols for information on dosage regimens in specific conditions such as gonorrhoea, Pseudomonas infections and CNS infections.
Dosage and type of administration depend on the severity of the infection, the sensitivity of the bacterium and the condition of the patient.
The duration of the treatment depends on the course of the disease. As a general rule Cefotaxime is administered for a further 3 to 4 days after improvement/regression of the symptoms.
Adults and children over 12 years in general receive 1 g Cefotaxime every 12 hours. In severe cases, the daily dose can be increased up to 12 g. Daily doses up to 6 g can be divided into at least two individual administrations at 12 hourly intervals. Higher daily doses must be divided into at least 3 to 4 individual administrations at 8 or 6 hour intervals respectively.
The following table may serve as a guide to dosages:
| Type of Infection | Single Dose Cefotaxime | Dose Interval | Daily Dose Cefotaxime |
|---|---|---|---|
| Typical infections, in which sensitivity is demonstrated and bacterium is proven or suspected | 1 g | 12 h | 2 g |
| Infections, in which various bacteria with high to medium sensitivity are demonstrated or suspected | 2 g | 12 h | 4 g |
| Unclear bacterial illness which cannot be localised and where the patient is critically ill | 2–3 g | 8 h | 6 g |
| up to 6 h | up to 8 g | ||
| up to 6 h | up to 12 g |
For the treatment of gonorrhoea in adults, 1 vial of Cefotaxime Sodium for Injection 500mg administered as a single administration.
In most cases due to less sensitive infective bacteria, an increase may be necessary, i.e. 1 g Cefotaxime. Examination for syphilis needs to be carried out before commencing therapy.
For peri-operative infection prophylaxis the administration of a single dose of 1 to 2 g Cefotaxime 30 to 60 minutes prior to the operation is recommended. Another antibiotic to cover anaerobic organisms is necessary. A repeat dose is required if the duration of the operation exceeds 90 minutes.
Lyme borrelisosis: A daily dose of 6 g Cefotaxime (14 to 21 days duration). The daily dose was generally administered divided into 3 parts (2 g Cefotaxime 3 times daily).
Infants and children up to 12 years receive 50 to 100 mg Cefotaxime according to the severity of the infection (up to 150 mg) per kilogram of body weight per day, divided into equal doses, administered at 12 (up to 6) hour intervals. In individual cases – particularly in life threatening situations – it may be necessary to increase the daily dose to 200 mg Cefotaxime per kilogram of body weight.
In neonates and infants doses of 50 mg Cefotaxime per kilogram of body weight per day should not be exceeded in view of not fully matured kidney clearance.
In case of life-threatening situations it may be necessary to increase the daily dose.
In those situations the following table is recommended.
| Age | Daily Dose of Cefotaxime |
|---|---|
| 0–7 days | 50 mg/kg every 12 hours IV |
| 7 days–1 month | 50 mg/kg every 8 hours IV |
| >1 month | 75 mg/kg every 8 hours IV |
It is not necessary to differentiate between premature and normal-gestational age infants.
With patients with a creatinine clearance of 20ml/minute or less, the maintenance dose is reduced to half the normal dose. With patients with a creatinine clearance of 5 ml/minute or less, a reduction of the maintenance dose to 1 g Cefotaxime (divided into 2 individual administrations at 12 hour intervals), seems to be appropriate. The stated recommendations are based on experiences with adults.
Since Cefotaxime is to a large extent eliminated by haemodialysis, an additional dose should be administered to patients who are dialysed, after the dialysis procedure.
No dosage adjustments are needed in patients with normal function.
Since Cefotaxime is available as the sodium salt, the sodium content per dose should be taken into account within the framework of the overall therapy and with special balance checks.
Basis for calculation: 1 g Cefotaxime (equivalent to 1.04 g Cefotaxime sodium) should be calculated as 48 mg sodium equivalent to 2.1 mmol sodium.
For IV, Cefotaxime Sodium for Injection 500mg is dissolved in at least 2 ml water for injections, Cefotaxime Sodium for Injection 1 g in at least 4 ml and subsequently injected directly into the vein over 3 to 5 minutes or after clamping of the infusion tube into the distal end of the tube.
During post-marketing surveillance, potentially life-threatening arrhythmia has been reported in a very few patients who received rapid intravenous administration of cefotaxime through a central venous catheter.
For brief infusion 2g of Cefotaxime Sodium for Injection is dissolved in 100 ml of isotonic sodium chloride or glucose solution and subsequently IV infused over 50 to 60 minutes. Another compatible infusion solution can also be used for the solution.
For intramuscular injection. Cefotaxime Sodium for Injection 500mg is dissolved in 2 ml and Cefotaxime Sodium for Injection 1 g in 4 ml water for injections respectively. Afterwards the injection should take place deep into the gluteal muscle. Pain with the IM injection can be avoided by dissolving Cefotaxime Sodium for Injection 500mg in 2ml or Cefotaxime Sodium for Injection 1 g in 4 ml 1% lidocaine solution. An intravascular injection is to be avoided in this case, since with intravascular administration lidocaine may lead to unrest, tachycardia, disturbances of cardiac conduction as well as vomiting and cramp. Cefotaxime reconstituted with lidocaine should not be administered to infants under 30 months.
It is recommended that no more than 4 ml be injected unilaterally. If the daily dose exceeds 2 g Cefotaxime or if Cefotaxime is injected more frequently than twice per day, the IV route is recommended.
Combination therapy of Cefotaxime with aminoglycosides is indicated without availability of an antibiogram in the case of severe, life-threatening infections. Kidney function must be watched in such combination usage. Cefotaxime and aminoglycosides should not be mixed in the same syringe or infusion fluid.
In cases of infections with Pseudomonas aeruginosa combination with other antibiotics effective against Pseudomonas can also be indicated.
For infection prophylaxis (peri-operative prophylaxis in surgical procedures such as colorectal, gastro-intestinal, prostatic, urogenital, obstetric and gynaecological surgery) in patients with weakened defence mechanisms, combination can also be indicated with other suitable antibiotics.
Intoxication in the strictest sense, is not known in man. Symptoms of overdose may largely correspond to the profile of side effects. With certain risk patterns and with the administration of very high doses, there is a risk of reversible encephalopathy, central nervous system excitation conditions, myoclonia and cramp, as have been described for other beta lactams. The risk of the appearance of these undesirable effects is increased in patients with severely restricted kidney function, epilepsy and meningitis.
In case of overdose, cefotaxime must be discontinued and supportive treatment initiated, which includes measures to accelerate elimination and symptomatic treatment of adverse reactions e.g. convulsions.
Drug initiated cramps can be treated with diazepam or phenobarbital, but not with phenytoin. With anaphylactic reactions the usual emergency measures must be commenced, preferably with the first indications.
No specific antidote exists. Plasma levels of cefotaxime can be reduced by haemodialysis or peritoneal dialysis
Product as packaged for sale: 3 years.
Following reconstitution: 24 hours.
Product as packaged for sale: Do not store above 25°C. Keep container in the outer carton.
Following reconstitution: 2°C-8°C.
500 mg and 1 g presentations in 10 ml glass vials closed with rubber stoppers and sealed with aluminium caps.
Packaged singly or in cartons of 10, 25 or 50.
Following reconstitution: Cefotaxime sodium is compatible with the following diluents:
Water for Injections
Sodium Chloride 0.9%
Dextrose 5 and 10%
Ringer’s Solution
Ringer-Lactate Solution
Lignocaine 1% (only freshly prepared solutions should be used)
Chemical and physical in-use stability has been demonstrated for 24 hours at 2°C-8°C. However, from a microbiological point of view, the product should be used immediately. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and should not exceed 24 hours at 2°C-8°C.
After 24 hours any unused solution should be discarded.
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