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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 for the treatment of the following severe infections when known or thought very likely to be due to bacteria that are susceptible to cefotaxime (see section 5.1): • Bacterial pneumonia • Complicated infections of the kidneys and upper urinary tract • Severe infections of the skin and soft…
Verbatim from this product's MHRA label. Tap a section to expand.
Cefotaxime may be administered by intravenous bolus injection, by intravenous infusion, or by intramuscular injection, after reconstitution of the solution according to the directions given below. 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 sensitivity tests are known. Cefotaxime has synergistic effects with aminoglycosides.
Adults and children over 12 years:
The usual dose in adults is 2 to 6 g daily. The daily dosage should be divided. However, dosage may be varied according to the severity of the infection, sensitivity of causative organisms and condition of the patient. Guidelines for dosage Typical infection in presence (or suspicion) of a sensible micro-organism: 1 g every 12 hours corresponding to a total daily dosage of 2 g intramuscularly or intravenously.
Infection in presence (or suspicion) of sensible or moderately sensible multiple micro- organisms: 1 -2 g every 12 hours corresponding to a total daily dosage of 2 - 4 g. Severe infection by unidentified micro-organisms or for infections that can not be localised: 2-3 g as a single dose every 6 to 8 hours up to a maximum daily dosage of 12 g.
A combination of Cefotaxime and other antibiotics is indicated in severe infections.
Infants and children (1 month to 12 years of age):
The usual dosage for infants and children is < 50kg is 50 - 150 mg/kg/day in 2 to 4 divided doses. In very severe infections up to 200 mg/kg/day in divided doses may be required. In infants and children >50kg the usual dose in adults, without exceeding the maximum daily dose of 12 g should be given.
New born infants and premature infants:
The recommended dosage is 50 mg/kg/day in 2 to 4 divided doses. In case of life-threatening situations it may be necessary to increase the daily dose.
In severe infections 150 – 200 mg/kg/day have been given:
In those situations the following table may serve as a guide, since there are differences in kidney maturation. Age Daily dose of Cefotaxime 0-7 days 50 mg/kg every 12 h 8 days-1 month 50 mg/kg every 8 h Elderly: No dosage adjustment is required, provided that renal and hepatic function are normal.
g. 4) Renal and urinary disorders Decrease in renal function/ Interstititial nephritis increase of creatinine (particularly when co- prescribed with amino- glycosides) General disorders and administratio n site conditions For IM formulati ons: Pain at the injection site Fever Inflammatory reactions at the injection site, including phlebitis/ thrombo- phlebitis For IM formulations (since the solvent contains lidocaine): Systemic reactions to lidocaine 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 or search for MHRA Yellow Card in Google play or Apple App store.
As with other broad-spectrum antibiotics, prolonged use may result in the overgrowth of non-susceptible organisms. Repeated evaluation of the patient's condition is essential.. If super-infection occurs during treatment, specific anti-microbial therapy should be instituted if considered clinically necessary.
* Anaphylactic reactions As with all beta-lactam antibacterial agents, serious and occasionally fatal hypersensitivity reactions have been reported. In case of severe hypersensitivity reactions, treatment with cefotaxime must be discontinued immediately and adequate emergency measures must be initiated.
Before beginning treatment, it should be established whether the patient has a history of severe hypersensitivity reactions to cefotaxime, to other cephalosporins or to any other type of beta-lactam agent. Caution should be used if cefotaxime is given to patients with a history of non-severe hypersensitivity to other beta- lactam agents.
8). Patients should be advised to contact their doctor immediately prior to continuing treatment if skin and/or mucosal reactions occur. 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.
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.
1 • Hypersensitivity to cephalosporins. 4).
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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5 g to 1 g Cefotaxime. For complicated infections consideration should be given to available official guidance. Syphilis should be excluded before initiating the treatment.
Urinary tract infections:
In uncomplicated UTI 1 g every 12 hours.
Bacterial meningitis:
In adults daily doses of 6 to 12 g and in children daily doses of 150 to 200 mg/kg divided in equal doses every 6 to 8 hours are recommended. For the new-born, 50mg/kg of cefotaxime can be given every 12 h to infants 0-7 of age and every 8 h to those 7-28 days of age.
Intraabdominal infections:
Intraabdominal infection should be treated with Cefotaxime in combination with other appropriate antibiotics that are active against anaerobic bacteria.
Duration of therapy:
The duration of therapy with Cefotaxime depends on the clinical condition of the patient and varies according to the course of the disease. 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 days period).
Dosage in renal functional impairment:
In adult patients with a creatinine clearance of ≤ 5 ml/min, the initial dose is similar to the recommended usual dose but the maintenance dose should be halved without change in the frequency of dosing. v. 5 g- 2 g, given at the end of each dialysis session and repeated every 24 hours, is sufficient to treat most infections efficaciously.
Method of administration:
In order to prevent any risk of infection, the preparation of the infusion should be done in close aseptic conditions. Do not delay the infusion after the preparation of the solution. Cefotaxime and aminoglycosides should not be mixed in the same syringe or perfusion fluid.
g. glucose 10%). After preparation the solution should be given as a 20 minute intravenous infusion. g. 9 % sodium chloride or isotonic glucose solution or other compatible fluids for infusions. After preparation, the solution may be given as a 50- 60 minute intravenous infusion.
5g should be dissolved in 2 ml Water for Injections, Cefotaxime 1g should be dissolved in 4 ml Water for Injections, Cefotaxime 2g should dissolved in 10 ml Water for Injections and should be injected over a period of 3-5 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.
0g is dissolved in the 4 ml Water for Injections. The solution should be administered by deep intramuscular injection. 0g may be dissolved in the 4 ml 1 % Lidocaine Hydrochloride (only for adults). Solutions with lidocaine must not be administered intravenously.
If the total daily dose is more than 2 g, the intravenous […]
Medicinal products that inhibit peristalsis should not be given. * Haematological reactions Since Leukopenia, neutropenia and, more rarely, agranulocytosis may develop during treatment with cefotaxime, blood count should be monitored if treatment lasts for longer than 7 days.
In case of neutropenia (< 1400 neutrophils/mm3), treatment should be stopped. Some cases of eosinophilia and thrombocytopenia, rapidly reversible on stropping treatment, have been reported. 8). 2). 5). Renal function must be monitored in these patients, the elderly, and those with pre-existing renal impairment.
g. 8). * 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.
2 % of the WHO recommended maximum daily intake of 2 g sodium for an adult..