Pharmacy Guide
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Pharmacy Guide
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Cefotaxime 500mg, 1g Powder for solution for injection or infusion PL 29831/0030
⚠ This medicine appears to have been discontinued
The electronic medicines compendium (emc) no longer publishes a Summary of Product Characteristics for this product, which usually means it is no longer marketed in the UK. The patient leaflet below is kept for reference, but the product may not be available.
If you were prescribed this medicine, other products containing Cefotaxime sodium may still be available. Do not stop your treatment — ask your pharmacist or GP what to use instead.
What it is and what it is used for
for Cefotaxime belongs to a group of medicines called cephalosporins which are antibiotics. These medicines work by killing bacteria that cause infections. Cefotaxime for injection is used for the treatment of a range of serious bacterial infections including infections of the blood stream (septicaemia), bones (osteomyelitis), the heart valves (endocartitis), the membranes covering the brain (meningitis) and the lining of the abdomen (peritonitis), and to prevent and treat infections following surgical operations.
What you need to know before you take it
cefotaxime for injection Cefotaxime for injection should not be given if:
- You are allergic to cefotaxime or any other cephalosporin
- You have previously had a severe allergic reaction to penicillin or any other beta-lactam antibiotic
- You have ever developed a severe skin rash or skin peeling, blistering and/or mouth sores after taking cefotaxime or other cephalosporins. If any of the above applies to you, you should not be given Cefotaxime for Injection. Information for Health Care Professionals Cefotaxime 500mg powder for solution for injection or infusion Cefotaxime 1g powder for solution for injection or infusion Cefotaxime 2g powder for solution for injection or infusion Dosage and Administration Information Only Please refer to the Summary of Product Characteristics for further information WARNING – Cefotaxime diluted in lidocaine must not be administered:
- intravenously
- to patients who are allergic to
- to infants under lidocaine 30 months
- to patients who have heart block (without a pacemaker), or heart failure
- Posology and method of administration 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,
Take special care with cefotaxime for injection if:
- you have previously had an allergic reaction to penicillin or other antibiotics of this type. Not all people who are allergic to penicillins are also allergic to cephalosporins. Before you are given this medicine your doctor should check whether you have previously had an allergic reaction to such drugs
- you have kidney problems. You will be carefully monitored throughout your treatment
- you are on a low salt diet, your doctor should make sure you are not receiving too much salt by way of cefotaxime injections
- you are being treated for longer than 10 days, your doctor should monitor your blood with blood counts
- you are going to have a blood transfusion, make sure that the doctor who organises your transfusion knows that you are having cefotaxime for injection
- you are diabetic, you may get false positive results with urine glucose tests, such as Clinitest
- you are taking aminoglycosides such as streptomycin and gentamicin. Your kidney function will be carefully monitored. Serious skin reactions including Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS), acute generalized exanthematous pustulosis (AGEP) have been reported in association with cefotaxime treatment. Stop using cefotaxime and seek medical attention immediately if you notice any of the symptoms related to these serious skin reactions described in section 4. You should be kept under observation in case you develop another infection, particularly colitis (infection of the lower bowel), while you are being treated with cefotaxime for injection. Other medicines and cefotaxime Taking other medicines when cefotaxime for injection is being administered can affect how it or the other medicine works. Make sure that your doctor knows what other medicines you are taking. Do not take any other medicines while you are being treated with cefotaxime for injection unless you have told your doctor or pharmacist and asked their advice. This includes medicines you may have bought yourself without a prescription. Please check with your doctor if you are taking any of the following (or any other medication):
- Penicillin antibiotics such as mezlocillin and azlocillin
- Aminoglycoside antibiotics such as streptomycin, neomycin or gentamicin
- Furosemide or other strong diuretics, used to get rid of excess water from the body
- Probenecid, used to prevent gout. If you have any doubts about whether you should be given this medicine, then talk to your doctor. Important information about some of the ingredients of cefotaxime for injection
if you think you are having an allergic reaction to Cefotaxime for injection contains 1.045mmol (or 24mg) cefotaxime for the 500mg vial, 2.09mmol (or 48mg) for the 1g vial
- Feeling sick, being sick, stomach pain and diarrhoea, and 4.18mmol (or 96mg) for the 2g vial of sodium per particularly when it is first given dose. To be taken into consideration by patients on a
- The injection site may be sore controlled sodium diet.
- Other side effects that some patients have had with Pregnancy and breast-feeding cefotaxime for injection, particularly if given over You should let your doctor or nurse know if you are long periods, include headaches, dizziness, anaemia pregnant or wish to become pregnant or are breastor other changes in the blood (which can cause sore feeding before this medicine is administered. throat and mouth ulcers or a tendency to bleed or Driving and using machines bruise easily), temporary changes in liver function, Cefotaxime for injection may cause dizziness. If you are inflammation of the liver, kidney problems, jaundice, affected you should not drive or operate machinery. painful joints and thrush 3. How cefotaxime for injection should be given
- Treatment with high doses of cefotaxime, particularly in patients with kidney problems, Your doctor or nurse will prepare your injection has been known to cause loss of consciousness, by dissolving the cefotaxime powder in a suitable abnormal movements and convulsions fluid for injection. The mixture is usually injected
- Occasionally, patients have suffered a blood clot in intramuscularly (into a muscle) or given intravenously a vein or irregular heart rhythm after intravenous (into a vein) either by injection or infusion (drip). cefotaxime Cefotaxime which has been dissolved in a solution
- Administration of high doses in patients with kidney which contains Lidocaine injection BP, (a local problems may cause brain disease anaesthetic), should not be given intravenously, or
- Antibiotic treatment can affect the normal bacteria to infants under 30 months, or to patients who are in the gut, causing new infection (colitis). You allergic to Lidocaine injection BP, or who have heart should tell your doctor immediately if you develop block (without a pacemaker), or heart failure. diarrhoea, abdominal cramps or pain, nausea, Adults and the Elderly dehydration, fever or bloody, watery diarrhoea. The usual adult (including the elderly) dose by Do not take any anti-diarrhoea medicines, such as intramuscular or intravenous injection is 1g every loperamide twelve hours. Lower doses may be given to patients
- Occasionally, if you have had an intravenous with severe kidney problems. injection there may be swelling around the area of infection or inflammation of the vein. Children The usual dose for children aged one month to twelve Stop taking cefotaxime and tell your doctor years is 100-150mg per kg body weight daily in two to immediately if you notice any of the following four divided doses. symptoms: The usual dose for infants aged one to four weeks is
- Reddish non-elevated, target-like or circular patches 50mg per kg body weight in two or four divided doses. on the trunk, often with central blisters, skin peeling, Higher doses may be given, particularly in severe ulcers of mouth, throat, nose, genitals and eyes. infections. These serious skin rashes can be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome, Your doctor will decide the dose that is best for you. If toxic epidermal necrolysis) you do not understand, or are in any doubt, ask your
- Widespread rash, high body temperature and doctor or nurse. enlarged lymph nodes (DRESS syndrome or drug If you think you have been given too much or too hypersensitivity syndrome) little cefotaxime for injection
- A red, scaly widespread rash with bumps under Your doctor will decide which dose is best for you. If the skin and blisters accompanied by fever. The you think too much or too little medicine has been symptoms usually appear at the initiation of given to you contact your doctor, nurse, pharmacist or treatment (acute generalised exanthematous nearest hospital. pustulosis).
Possible side effects
Reporting of side effects Like many medicines, cefotaxime for injection may If you get any side effects, talk to your doctor, cause side effects in some patients, particularly when pharmacist or nurse. This includes any possible side treatment is first started. You should inform your effects not listed in this leaflet. You can also report side doctor or nurse immediately if you are unwell. effects directly via the Yellow Card Scheme Website: These include: www.mhra.gov.uk/yellowcard or search for MHRA
- Allergic reactions such as rash, itching, fever and, Yellow Card in the Google Play or Apple App Store. very rarely, peeling skin, swelling of the face and By reporting side effects you can help provide more difficulty breathing. Tell your doctor immediately information on the safety of this medicine.
sensitivity of causative organisms and condition of the patient. Therapy may be initiated before the results of the 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 may be required. 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 (G=FR <5ml/ min = serum creatinine approximately 751 miocromol/litre). After an initial loading dose of 1g, daily dose should be halved without change in the frequency or dosing, i.e. 1g twelve hourly becomes 0.5g twelve hourly, 1g eight hourly becomes 0.5g eight hourly, 2g eight hourly become 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.
Intravenous and Intramuscular Administration: Reconstitute cefotaxime with Water for Injections PhEur as discussed below in the section entitled 'Instructions for use/handling'. Shake well until dissolved and then withdraw the entire contents of the vial into the syringe. Intravenous administration (Injection or Infusion): Cefotaxime may be administered by intravenous infusion using the fluids stated below in the section entitled 'Instructions for use/handling'. The prepared infusion may be administered over 20-60 minutes. For intermittent I.V. injections, the solution must be injected over a period of 3 to 5 minutes. During postmarketing surveillance, potentially life-threatening arrhythmia has been reported in very few patients who received rapid intravenous administration of cefotaxime through a central venous catheter. Cefotaxime and aminoglycosides should not be mixed in the same syringe or perfusion fluid.
- Incompatibilities Cefotaxime sodium should not be mixed with alkaline solutions such as sodium bicarbonate injection or solutions containing aminophylline. Cefotaxime should not be admixed with aminoglycosides. If they are used concurrently they should be administered in separate sites. Cefotaxime should not be mixed with other medicinal products except those listed below in in the section entitled 'Instructions for use/handling'.
Customer
Wockhardt UK Limited
Description
Cefotaxime Sol for Injection
- Shelf life and special precautions for storage Unopened: 2 years. Do not store about 25°C. Keep the vials in the outer carton. For the reconstituted solution, chemical and physical in-use stability has been demonstrated for 24 hours at 2-8°C. From a microbiological point of view, once opened, 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 would normally not be longer than 24 hours at 2-8°C, unless reconstitution has taken place in controlled and validated aseptic conditions.
- Instructions for use/handling For single use only. Discard any unused contents. When dissolved in Water for injections PhEur, cefotaxime forms a straw-coloured solution suitable for intravenous and intramuscular injection. Variations in the intensity of colour of the freshly prepared solutions do not indicate a change in potency or safety. Dilution Table: Intravenous Administration Vial size
Diluent* to be added 500mg 2ml 1g 4ml 2g 10ml
106641/7
PRINTING COLOURS Black
TECHNICAL COLOURS Keyline (Non-Printing)
Item Code
106641/7
Tech Black (non-printing)
Profile
n/a
Technical Info (Non-Printing)
Size
320 x 340mm
Min.Point Size
9pt (Leaflet)
DATE
Warning! We cannot accept responsibility for any errors in this proof after approval. Whilst we take extreme care at all times to ensure accuracy to our client's brief, the final responsibility must be taken by our client. IF YOU SIGN THIS PROOF YOU ARE SIGNIFYING FULL APPROVAL OF DESIGN AND TEXT.
Market
UK
Language
English
FPO
Pharma Height
7mm Minimum
Barcode Proof By
EBR
Proof No.
2
Date
02.04.2024
Body Text Fonts: Myriad Pro
Actual Min Point Size 9pt
Approx displacement volume 0.3ml 0.6ml 1.4ml
*Water for injection
16 East Park Road | Leicester | LE5 4QA | UK
APPROVAL SIGNATURE
Approx available volume 2.3ml 4.6ml 11.4ml
How to store it
cefotaxime for injection Keep this medicine out of the sight and reach of children.
- This medicine should not be used after the expiry date (EXP) shown on the vial and carton. The expiry date refers to the last day of that month
- The vials should not be stored above 25°C
- Keep the vial in the outer carton in order to protect from light
- Chemical and physical in-use stability has been demonstrated for 24 hours at 2-8°C. From a microbiological point of view, once opened, 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 would normally not be longer than 24 hours at 2-8°C, unless reconstitution has taken place in controlled and validated aseptic conditions. For single use only. Once reconstituted, any unused portion of solution should be discarded
- Do not use cefotaxime for injection if the solution contains particles or is cloudy. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
Marketing Authorisation Holder and Manufacturer Marketing Authorisation Holder: Wockhardt UK Ltd, Ash Road North, Wrexham, LL13 9UF, UK. Manufacturer: CP Pharmaceuticals Ltd, Ash Road North, Wrexham, LL13 9UF, UK. This leaflet was last revised in 03/2024
6. Contents of the pack and further information What cefotaxime for injection contains Cefotaxime for injection contains the active ingredient cefotaxime as cefotaxime sodium. Each vial contains 500mg, 1g or 2g of cefotaxime. The sodium content per vial is approximately 24mg (1.045mmol), 48mg (2.09mmol) and 96mg (4.18mmol) respectively. What cefotaxime for injection looks like and contents of the pack Cefotaxime for injection is an off white to pale yellow powder, which must be made into a solution before injection. It is available in packs of 1, 10, 25 and 50 vials. X-PIL information To listen to or request a copy of the leaflet in Braille, large print or audio please call, free of charge: 0800 198 5000 (UK only) Please be ready to give the following information: Product name Reference number Cefotaxime 500mg powder for solution for injection or infusion Cefotaxime 1g powder for solution for injection or infusion Cefotaxime 2g powder for solution for injection or infusion
PL 29831/0030 PL 29831/0030 PL 29831/0029
This is a service provided by the Royal National Institute of Blind People. 106641/7 Dilution Table: Intramuscular Administration Vial size
Diluent* to be added 500mg 2ml 1g 4ml 2g 10ml
Approx displacement volume 0.3ml 0.6ml 1.4ml
Approx available volume 2.3ml 4.6ml 11.4ml
*Water for injection or 1% lidocaine Reconstituted solution: Whilst it is preferable to use only freshly prepared solutions for both intravenous and intramuscular injection, cefotaxime is compatible with several commonly used intravenous infusion fluids and will retain satisfactory potency for up to 24 hours refrigerated in the following: Water for Injection Ph Eur Sodium Chloride Intravenous Infusion BP 5% Glucose Intravenous Infusion BP Sodium Chloride and Glucose Intravenous Infusion BP Compound Sodium Lactate Intravenous Infusion BP (Ringer-lactate solution for injection) Intravenous Infusion: 1-2g cefotaxime are dissolved in 40-100ml of infusion fluid. After 24 hours any unused solution should be discarded. Cefotaxime is compatible with 1% lidocaine; however freshly prepared solutions should be used. When using lidocaine as a diluent, intravascular injection must be strictly avoided.
Cefotaxime is compatible with metronidazole infusion (500mg/100ml) and both will maintain potency when refrigerated (2°-8°C) for up to 24 hours. Some increase in colour of prepared solutions may occur on storage. However, provided the recommended storage conditions are observed, this does not indicate change in potency or safety. This leaflet was last revised in 03/2024 The information in this leaflet applies only to Cefotaxime Powder for solution for injection or infusion.
106641/7
Customer
Wockhardt UK Limited
Description
Cefotaxime Sol for Injection
Item Code
106641/7
Profile
n/a
Size
320 x 340mm
Min.Point Size
9pt (Leaflet)
PRINTING COLOURS
16 East Park Road | Leicester | LE5 4QA | UK
APPROVAL SIGNATURE
DATE
Warning! We cannot accept responsibility for any errors in this proof after approval. Whilst we take extreme care at all times to ensure accuracy to our client's brief, the final responsibility must be taken by our client. IF YOU SIGN THIS PROOF YOU ARE SIGNIFYING FULL APPROVAL OF DESIGN AND TEXT.
Market
UK
Language
English
FPO
Pharma Height
7mm Minimum
Barcode Proof By
EBR
Proof No.
2
Date
02.04.2024
Body Text Fonts: Myriad Pro
Actual Min Point Size 9pt
Black
TECHNICAL COLOURS Keyline (Non-Printing)
Frequently asked questions about Cefotaxime 500mg, 1g Powder for solution for injection or infusion PL 29831/0030
How do I take Cefotaxime 500mg, 1g Powder for solution for injection or infusion PL 29831/0030?
Cefotaxime 500mg, 1g Powder for solution for injection or infusion PL 29831/0030 comes as injection containing 500mg / 1g. Always follow the dose your doctor or pharmacist has given you, and read the leaflet that comes with the medicine.
What is the active substance in Cefotaxime 500mg, 1g Powder for solution for injection or infusion PL 29831/0030?
The active substance in Cefotaxime 500mg, 1g Powder for solution for injection or infusion PL 29831/0030 is cefotaxime sodium.
Where does this information come from?
This leaflet reproduces the patient information leaflet approved for Cefotaxime 500mg, 1g Powder for solution for injection or infusion PL 29831/0030, as published on the electronic medicines compendium (emc). The version printed inside your medicine’s packaging is the one that applies to you.
Can I get Cefotaxime 500mg, 1g Powder for solution for injection or infusion PL 29831/0030 without a prescription?
Whether a medicine is available over the counter or on prescription only depends on its licence. Check the leaflet, or ask your pharmacist — they can tell you straight away.
About this leaflet
The text above reproduces the patient information leaflet approved for this medicine, restructured for easier reading.
- Source: electronic medicines compendium (emc), Datapharm
- Active substance: cefotaxime sodium
- Official document: view the original leaflet on emc →
⚕For healthcare professionals — Summary of Product Characteristics (SmPC)Full SmPC: dosage, interactions, contraindications, warnings+
4.1. Therapeutic indications
1. Cefotaxime is indicated in the treatment of serious infections, either before the infecting organism has been identified or when caused by bacteria of established sensitivity, including osteomyelitis, septicaemia, bacterial endocarditis, meningitis, and peritonitis.and other serious bacterial infections suitable for parenteral antibiotic therapy. 2. Cefotaxime may be used for pre-operative prophylaxis in patients undergoing surgical procedures, that may be classified as contaminated or potentially so.
4.2. Posology and method of administration
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). After an initial loading dose of 1g, daily dose should be halved without change in the frequency of dosing, i.e. 1g twelve hourly becomes 0.5g twelve hourly, 1g eight hourly becomes 0.5g 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.Intravenous and Intramuscular Administration: Reconstitute cefotaxime with Water for Injections PhEur as directed in Section 6.6 (Instructions for use/handling). Shake well until dissolved and then withdraw the entire contents of the vial into the syringe.Intravenous administration (Injection or Infusion): Cefotaxime may be administered by intravenous infusion using the fluids stated in Section 6.6 (Instructions for use/handling). The prepared infusion may be administered over 20-60 minutes.For intermittent I.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.Cefotaxime and aminoglycosides should not be mixed in the same syringe or perfusion fluid.
4.3. Contraindications
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.Allergic cross reactions can exist between penicillins and cephalosporins (see section 44.).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.
4.4. Special warnings and precautions for use
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. Serious, including fatal hypersensitivity reactions have been reported in patients receiving cefotaxime (see sections 4.3 and 4.8). 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. 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. Patients with renal insufficiency: The dosage should be modified according to the creatinine clearance calculated (see section 4.2). Patients with severe renal dysfunction should be placed on the dosage schedule recommended under “Posology and Method of Administration”.Caution should be exercised if cefotaxime is administered together with aminoglycosides, probenecid or other nephrotoxic drugs (see section 4.5). Renal function must be monitored in these patients, the elderly, and those with pre-existing renal impairment.Haematological reactions: Leukopenia, 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 anaemia have also been reported (see section 4.8).Sodium intake: The sodium content of cefotaxime (2.09mmol/g) should be taken into account when prescribing to patients requiring sodium restriction.Clostridium difficile associated disease (e.g. pseudomembranous colitis): Cefotaxime may predispose patients to pseudomembranous colitis. Although any antibiotic may predispose to pseudomembranous colitis, the risk is higher with broad spectrum drugs, such as cephalosporins. This side effect, which may occur more frequently in patients receiving higher doses for prolonged periods, should be considered as potentially serious. Diarrhoea, 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 antibody 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.Neurotoxicity: High doses of beta-lactam antibiotics, including cefotaxime, particularly in patients with renal insufficiency, may result in encephalopathy (e.g. impairment of consciousness, abnormal movements and convulsions) (see section 4.8).Patients should be advised to contact their doctor immediately prior to continuing treatment if such reactions occur.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. The recommended time for injection or infusion should be followed (see section 4.2).See section 4.3 for contraindications for formulations containing lidocaine.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.
4.5. Interaction with other medicinal products and other forms of interaction
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 (see section 4.4).Uricosurics: Probenecid interferes with 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 (see sections 4.4 and 4.2). Interference with Laboratory Tests:
A false positive Coombs test may be seen during treatment with cephalosporins. This phenomenon may occur during treatment with cefotaxime and can interfere with blood cross-matching.A false positive reaction to urinary glucose may occur with copper reduction methods (Benedict's, Fehling's or Clinitest) but not with the use of specific glucose oxidase methods.There is a potential for mezlocillin and azlocillin to reduce the clearance of cefotaxime.
4.6. Pregnancy and lactation
Pregnancy: The safety of cefotaxime has not been established in human pregnancy. Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity. There are, however, no adequate and well controlled studies in pregnant women.Cefotaxime crosses the placental barrier. Therefore, cefotaxime should not be used during pregnancy unless the anticipated benefit outweighs any potential risks.Lactation: Cefotaxime passes into human breast milk in small amounts and is usually compatible with breast feeding, but careful monitoring of the infant is recommended. Effects on the physiological intestinal flora of the breast-fed infant leading to diarrhoea, colonisation by yeast-like fungi, and sensitisation of the infant cannot be excluded.Therefore, a decision must be made whether to discontinue breast-feeding or to discontinue therapy taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman.
4.7. Effects on ability to drive and use machines
Cefotaxime has been associated with dizziness, which may affect the ability to drive or operate machinery.There is no evidence that cefotaxime directly impairs the ability to drive or to operate machines. High doses of cefotaxime, particularly in patients with renal insufficiency, may cause encephalopathy (e.g. impairment of consciousness, abnormal movements and convulsions) (see section 4.8). Patients should be advised not to drive or operate machinery if any such symptoms occur.
4.8. Undesirable effects
System organ class
Very common
(≥ 1/10)
Common
(≥ 1/100 to <1/10)
Uncommon
(≥ 1/1,000 to <1/100)
Rare
(≥ 1/10,000 to <1/1,000)
Very rare
(<1/10,000)
Not known
(cannot be estimated from available data)*
Infections and infestations
Superinfection (see section 4.4)
Blood and the lymphatic system disorders
Leukopenia
Eosinophilia
Thrombocytopenia
Neutropenia
Granulocytopenia
Agranulocytosis (see section 4.4)
Haemolytic anaemia
Immune system disorders
Jarisch-Herxheimer reaction
Anaphylactic reactions
Angioedema
Bronchospasm
Anaphylactic shock
Nervous system disorders
Convulsions (see section 4.4)
Headache
Dizziness
Encephalopathy (e.g. impairment of consciousness, abnormal movements) (see section 4.4)
Cardiac disorders
Arrhythmia following rapid bolus infusion through central venous catheter
Gastrointestinal disorders
Diarrhoea
Nausea
Vomiting
Abdominal pain
Pseudomembranous colitis (see section 4.4)
Hepato-biliary disorders
Increase in liver enzymes (ALAT, ASAT, LDH, gamma-GT and/or alkaline phosphatise) and/or bilirubin
Hepatitis* (sometimes with jaundice)
Skin and subcutaneous disorders
Rash
Pruritus
Urticaria
Drug fever
Erythema multiforme
Stevens-Johnson syndrome
Toxic epidermal necrolysis (see section 4.4)
Drug reaction with eosinophilia and systemic symptoms (DRESS) ( see section 4.4)
Renal and Urinary disorders
Decrease in renal function/increase of creatinine (particularly when co-prescribed with aminoglycosides)
Interstitial nephritis
Candidiasis
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. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at www.mhra.gov.uk/yellowcard.
4.9. Overdose
Symptoms of overdose may largely correspond to the profile of side effects.There is a risk of reversible encephalopathy in cases of administration of high doses of β–lactam antibiotics including cefotaxime.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).No specific antidote exists. Serum levels of cefotaxime may be reduced by peritoneal dialysis or haemodialysis.
🇷🇴 Known in Romania as
Medicines sold in Romania with the same active substance: Cunoscut în România ca
- CEFOTAXIMA SWYSSI 1 g prescriptionCEFOTAXIMUM · injection / infusion
- CEFOTAXIMA ATB 1 g prescriptionCEFOTAXIMUM · injection / infusion
- CEFOTAXIM MIP 1 g prescriptionCEFOTAXIMUM · injection / infusion
- CEFOTAXIM MIP 2 g prescriptionCEFOTAXIMUM · injection / infusion
- CEFOTAX 500 mg prescriptionCEFOTAXIMUM · injection / infusion
- CEFOTAX 1 g prescriptionCEFOTAXIMUM · injection / infusion
Same active substance. The strength, the form and whether you need a prescription can differ. Always ask a pharmacist before you switch. Romanian medicines in the UK →
🇵🇱 Known in Poland as
Medicines sold in Poland with the same active substance: W Polsce znany jako
- BiotaksymCefotaximum · injection / infusion
- TarcefoksymCefotaximum · injection / infusion
- Cefotaxim-MIP 2 gCefotaximum · injection / infusion
- Cefotaxim-MIP 1 gCefotaximum · injection / infusion
- Cefotaxime Dali PharmaCefotaximum · injection / infusion
Same active substance. The strength, the form and whether you need a prescription can differ. Always ask a pharmacist before you switch. Polish medicines in the UK →
💬 Ask about this leaflet
Ask anything about Cefotaxime 500mg, 1g Powder for solution for injection or infusion PL 29831/0030. The assistant answers only from this leaflet — if the leaflet does not cover it, it will say so. It does not give medical advice.
Answers come from the patient leaflet published on the electronic medicines compendium (emc). They are not medical advice. Ask a pharmacist or your GP if you are unsure. For urgent help call NHS 111, or 999 in an emergency.
Medicines containing Cefotaxime sodium
- Cefotaxime 1 g Powder for solution for injection vial
- Cefotaxime 1 g powder for solution for injection/infusion
- Cefotaxime 1g powder for solution for injection/infusion vials
- Cefotaxime 2 g Powder for solution for injection vial
- Cefotaxime 500mg powder for solution for injection/infusion vials
- Cefotaxime, 2 g, powder for solution for injection/infusion