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)