CEFOTAXIME

Cefotaxime may be administered intravenously, by bolus injection or by infusion, or by intramuscular injection. 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.

Adults:

The recommended dosage for mild to moderate infections is 1g 12 hourly. However, dosage may be varied according to the severity of the infection, sensitivity of causative organisms and condition of the patient. Therapy may be initiated before the results of sensitivity tests are known.

In severe infections dosage may be increased up to 12g daily given in three or four divided doses. For infections caused by sensitive Pseudomonas species daily doses of greater than 6g will usually be required.

Children:

The usual dosage range is 100-150mg/kg/day in two to four divided doses. However, in very severe infection doses of up to 200mg/kg/day may be required.

Neonates:

The recommended dosage is 50mg/kg/day in two to four divided doses. In severe infections 150-200mg/kg/day, in divided doses, have been given.

Dosage in renal impairment:

Because of extra-renal elimination, it is only necessary to reduce the dosage of cefotaxime in severe renal failure (GFR <5ml/min = serum creatinine approximately 751 micromol/litre). e. 5g eight hourly, 2g eight hourly becomes 1g eight hourly etc.

As in all other patients, dosage may require further adjustment according to the course of the infection and the general condition of the patient.

Dosage in hepatic impairment:

No dosage adjustment is required. 6 (Instructions for use/handling). Shake well until dissolved and then withdraw the entire contents of the vial into the syringe. 6 (Instructions for use/handling). The prepared infusion may be administered over 20-60 minutes.

V. injections, the solution must be injected over a period of 3 to 5 minutes. 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.

g. 4) Renal and Urinary disorders Decrease in renal function/incre ase of creatinine (particularly when co- prescribed with aminoglycosid es) Interstitial nephritis Candidiasis General disorders and administration site conditions For IM formulatio ns: Pain at the injection site Fever Inflammatory reactions at the injection site, including phlebitis/thro mbophlebitis For IM formulations (since the solvent contains lidocaine): Systemic reactions to lidocaine * postmarketing experience Jarisch-Herxheimer reaction For the treatment of borreliosis, a Jarisch-Herxheimer reaction may develop during the first days of treatment.

The occurrence of one or more of the following symptoms has been reported after several week's treatment of borreliosis: skin rash, itching, fever, leucopenia, increase in liver enzymes, difficulty of breathing, joint discomfort. Hepatobiliary disorders Increase in liver enzymes (ALAT, ASAT, LDH, gamma-GT and/or alkaline phosphatase) and/or bilirubin have been observed.

These laboratory abnormalities may rarely exceed twice the upper limit of the normal range and elicit a pattern of liver injury, usually cholestatic and most often asymptomatic. Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important.

It allows continued monitoring of the benefit/risk balance of the medicinal product. uk/yellowcard.

As with other antibiotics, the use of cefotaxime, especially if prolonged, may result in overgrowth of non susceptible organisms, such as Enterococcus spp, candida, Pseudomonas aeruginosa. Repeated evaluation of the condition of the patient is essential.

If superinfection occurs during treatment with cefotaxime, appropriate measures should be taken and specific anti-microbial therapy should be instituted if considered clinically necessary.

Anaphylactic reactions:

Preliminary enquiry about hypersensitivity to penicillin and other β-Lactam antibiotics is necessary before prescribing cephalosporins since cross allergy occurs in 5–10% of cases. The use of cefotaxime is strictly contra-indicated in subjects with a previous history of immediate-type hypersensitivity to cephalosporins.

Since cross allergy exists between penicillins and cephalosporins, use of the latter should be undertaken with extreme caution in penicillin sensitive subjects. 8). If a hypersensitivity reaction occurs, treatment must be stopped.

Severe skin reactions:

Severe cutaneous adverse reactions (SCARs) including acute generalized exanthematous pustulosis (AGEP), Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), drug reaction with eosinophilia and systemic symptoms (DRESS), which can be life-threatening or fatal, have been reported post-marketing in association with cefotaxime treatment.

At the time of prescription patients should be advised of the signs and symptoms for skin reactions. If signs and symptoms suggestive of these reactions appear, cefotaxime should be withdrawn immediately. If the patient has developed AGEP, SJS, TEN or DRESS with the use of cefotaxime, treatment with cefotaxime must not be restarted and should be permanently discontinued.

Hypersensitivity to cephalosporins. In patients with a history of hypersensitivity to Cefotaxime and/or to any component of Cefotaxime 500mg or 1g Powder for solution for injection or infusion, a penicillin or to any other type of beta-lactam drug.

). For pharmaceutical forms containing lidocaine: • known history of hypersensitivity to lidocaine or other local anaesthetics of the amide type • non-paced heart block • severe heart failure • administration by the intravenous route • infants aged less than 30 months of age.