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CEFOTAXIME is a brand name for Cefotaxime. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: 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 (see section 4.4 and 5.1): • Bacterial pneumonia • Complicated infections of the urinary tract including pyelonephritis • Severe skin and soft tissue…
Verbatim from this product's MHRA label. Tap a section to expand.
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. Adults and adolescents over 12 years Adults and adolescents usually receive 2 to 6 g cefotaxime daily. The daily dose should be divided in two single doses every 12 hours.
• Common infections in presence (or suspicion) of sensitive bacteria: 1 g every 12 hours. • Infections in presence (or suspicion) of several sensitive or moderately sensitive bacteria: 1-2 g every 12 hours. • Severe infections or for infections that cannot be localised: 2-3 g as a single dose every 6 to 8 hours (maximum daily dose: 12 g).
A combination of cefotaxime and other antibiotics is indicated in severe infections. Term newborn (0-28 days), infants and children up to 12 years of age Depending on the severity of the infection: 50-100-150 mg/kg/day, 12-6 hourly.
In life-threatening situations the daily dose may be raised to 200 mg/kg/day under careful attention of the renal function, especially in the newborn period 0-7 days due to not fully matured kidney function. Premature infants The recommended dosage is 50 mg/kg/day divided into 2 to 4 doses (every 12 to 6 hours).
This maximum dose should not be exceeded due to the not yet fully matured kidneys. Elderly No dosage adjustment is required, provided that the function of the kidneys and the liver is normal. 5- 1 g cefotaxime. For complicated infections, consideration should be given to available official guidelines.
Syphilis should be excluded before initiating treatment.
Bacterial meningitis Adults:
Daily dose of 9-12 g cefotaxime divided into equal doses every 6-8 hours (3 g 3-4 times daily). Children: 150-200 mg/kg/day divided into equal doses every 6-8 hours. Newborns: 0-7 days: 50 mg/kg every 12 hours, 7-28 days: 50 mg/kg every 8 hours.
Perioperative prophylaxis 1 - 2 g as single dose as close to start of surgery as possible. In those cases where the operation time exceeds 90 minute an additional dose of prophylactic antibiotic should be given. Intra-abdominal infections Intra-abdominal infections should be treated with cefotaxime in combination with other antibiotics with coverage for anaerobic bacteria.
4), haemolytic anaemia Immune system disorders Jarisch-Herxheimer reactions Anaphylactic reactions, angiooedema, bronchospasm, anaphylactic shock. g. 4) Renal and urinary disorders Decrease in renal function / increase of creatinine (particularly when co- prescribed with aminoglycosides) Interstitial nephritis General disorders and administration site conditions For IM formulations: Pain at the injection site Fever, inflammatory reactions at the injection site, including phlebitis / thrombophlebitis 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. Repeated evaluation of the patient's condition is essential. If superinfection occurs during therapy, appropriate measures should be taken.
8). If a hypersensitivity reaction occurs, treatment must be stopped. 3). • 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.
In children, the presentation of a rash can be mistaken for the underlying infection or an alternative infectious process, and physicians should consider the possibility of a reaction to cefotaxime in children that develop symptoms of rash and fever during therapy with cefotaxime.
g. pseudomembranous colitis) Diarrhea, particularly if severe and/or persistent, occurring during treatment or in the initial weeks following treatment, may be symptomatic of Clostridium difficile associated disease (CDAD). CDAD may range in severity from mild to life threatening, the most severe form of which is pseudo-membranous colitis.
The diagnosis of this rare but possibly fatal condition can be confirmed by endoscopy and/or histology. It is important to consider this diagnosis in patients who present with diarrhoea during or subsequent to the administration of cefotaxime.
1. • Previous, immediate and/or severe hypersensitivity reaction to penicillin or any beta- lactam antibiotic.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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Dosage in renal function impairment In adult patients with a creatinine clearance of ≤5 ml/min, the initial dose equal to the recommended usual dose but the maintenance dose should be reduced by half without change in the frequency of dosing.
Blood tests to determine the required dose may be carried out. 5-2 g, given at the end of each dialysis session and repeated every 24 hours, is sufficient to treat most infections efficaciously. Duration of therapy The duration of therapy with cefotaxime depends on the clinical condition of the patient and varies according to the bacteriological progress.
Administration of cefotaxime should be continued until symptoms have subsided or evidence of bacterial eradication has been obtained. Treatment over at least 10 days is necessary in infections caused by Streptococcus pyogenes (parenteral therapy may be switched to an adequate oral therapy before the end of the 10 day period).
Method of administration Intravenous infusion In order to avoid any risk of infection, the reconstitution of the solution for infusion should be done in close aseptic conditions. Do not postpone the infusion after the reconstitution of the solution.
For short intravenous infusion:
Following reconstitution, the solution should be administered over 20 minutes.
For long lasting intravenous infusion:
Following reconstitution, the solution should be administered over 50-60 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. gonorrhoea). It is not indicated in severe infections and should undergo a risk-benefit assessment. It is recommended that no more than 4 ml are injected unilaterally. If the daily dose exceeds 2 g cefotaxime or if cefotaxime is injected more frequently than twice per day, the intravenous route is recommended.
In case of severe infections, intramuscular injection is not recommended. The solution should be administered by deep intramuscular injection. Solutions with lidocaine must not be administered intravenously. Cefotaxime reconstituted with lidocaine should not be administrated to children in the first year of age.
The product information of the chosen lidocain containing medicinal product must be regarded. 6. Cefotaxime and aminoglycosides should not be mixed in the same syringe or perfusion fluid.
If a diagnosis of pseudomembranous colitis is suspected, cefotaxime should be stopped immediately and appropriate specific antibiotic therapy should be started without delay. Clostridium difficile associated disease can be favoured by faecal stasis.
Medicinal products that inhibit peristalsis should not be given. • Haematological reactions Leucopenia, neutropenia and, more rarely, agranulocytosis may develop during treatment with cefotaxime, particularly if given over long periods.
For treatment courses lasting longer than 7-10 days, the blood white cell count should be monitored and treatment stopped in the event of neutropenia. Some cases of eosinophilia and thrombocytopenia, rapidly reversible on stopping treatment, have been reported.
Cases of haemolytic anemia have also been reported. 2). 5). Renal function must be monitored in these patients, the elderly, and those with pre-existing renal impairment. g. 8). Patients should be advised to contact their doctor immediately prior to continuing treatment if such reactions occur.
• The use of cefotaxime for treatment of endocarditis should be restricted to patients known to have penicillin allergy (not type 1). Cefotaxime should be used in combination with other appropriate antibacterial agents, considering its limited antibacterial spectrum.
• Precautions for administration 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.
2). • Effects on Laboratory Tests As with other cephalosporins a positive Coombs' test has been found in some patients treated with cefotaxime. This phenomenon can interfere with the cross- matching of blood. Urinary glucose testing with non-specific reducing agents may yield false-positive results.
This phenomenon is not seen when a glucose-oxydase specific method is used. 4% of the WHO recommended maximum daily intake of 2g sodium for an adult. To be taken into consideration by patients on a controlled sodium diet.