Skip to Content

UK Edition. Click here for US version.

CEFOTAXIME 500MG POWDER FOR SOLUTION FOR INJECTION OR INFUSION

Active substance(s): CEFOTAXIME SODIUM / CEFOTAXIME SODIUM / CEFOTAXIME SODIUM

View full screen / Print PDF » Download PDF ⇩

PDF Transcript

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
(G=FR <5ml/ min = serum creatinine approximately 751 miocromol/litre). After
Please refer to the Summary of Product Characteristics for further information 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
WARNING - Cefotaxime diluted in lidocaine must not be administered:
hourly becomes 0.5g eight hourly, 2g eight hourly become 1g eight hourly etc.
• intravenously
• to patients who are allergic to lidocaine
As in all other patients, dosage may require further adjustment according to the
• to infants under • to patients who have heart block (without a
course of the infection and the general condition of the patient.
30 months
pacemaker), or heart failure
Dosage in hepatic impairment: No dosage adjustment is required.
• Posology and method of administration
Intravenous and Intramuscular Administration: Reconstitute cefotaxime
Cefotaxime may be administered intravenously, by bolus injection or by
with Water for Injections PhEur as discussed below in the section entitled
infusion, or by intramuscular injection. The dosage, route and frequency
‘Instructions for use/handling’. Shake well until dissolved and then withdraw
of administration should be determined by the severity of infection, the
the entire contents of the vial into the syringe.
sensitivity of causative organisms and condition of the patient. Therapy may
Intravenous administration (Injection or Infusion): Cefotaxime may be
be initiated before the results of sensitivity tests are known.
administered by intravenous infusion using the fluids stated below in the
Adults:
section entitled ‘Instructions for use/handling’. The prepared infusion may be
The recommended dosage for mild to moderate infections is 1g 12 hourly.
administered over 20-60 minutes.
However, dosage may be varied according to the severity of the infection,
For intermittent I.V. injections, the solution must be injected over a period of
sensitivity of causative organisms and condition of the patient. Therapy may
3 to 5 minutes. During post-marketing surveillance, potentially life-threatening
be initiated before the results of the sensitivity tests are known.
arrhythmia has been reported in very few patients who received rapid
In severe infections dosage may be increased up to 12g daily given in three or intravenous administration of cefotaxime through a central venous catheter.
four divided doses. For infections caused by sensitive Pseudomonas species
Cefotaxime and aminoglycosides should not be mixed in the same syringe or
daily doses of greater than 6g will usually be required.
perfusion fluid.
Children:
• Incompatibilities
The usual dosage range is 100-150mg/kg/day may be required. However, in
Cefotaxime sodium should not be mixed with alkaline solutions such as
very severe infection doses of up to 200mg/kg/day may be required.
sodium bicarbonate injection or solutions containing aminophylline.
Neonates:
Cefotaxime should not be admixed with aminoglycosides. If they are used
The recommended dosage is 50mg/kg/day in two to four divided doses.
concurrently they should be administered in separate sites.
In severe infections 150-200mg/kg/day, in divided doses, have been given.
Cefotaxime should not be mixed with other medicinal products except those
Dosage in renal impairment: Because of extra-renal elimination, it is only
listed below in the section entitled ‘Instructions for use/handling’.
necessary to reduce the dosage of cefotaxime in severe renal failure
106641/5

Artwork No.

862614

18/07/2017

English
Language

Date

IF YOU SIGN THIS PROOF YOU ARE SIGNIFYING
FULL APPROVAL OF DESIGN AND TEXT.

UK
Market

2

9pt (Main Body) / 8pt (Variables)
Min. Point Size

Proof No.

170mm x 320mm
Size

CST

n/a

Profile

Proof By

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 clientʼs brief,
the final responsibility must be taken by our client.

106641/5
Item Code

artwork.leicester@cirrus-artwork.com

Cefotaxime Vial Leaflet
Description

Pharma
Code

FPO

Keyline (non-printing)

Process Black

Colours Used
Wockhardt UK Limited
Customer

Measure bar should be 150mm at 100% scale

PACKAGE LEAFLET: INFORMATION FOR THE USER
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
Read all of this leaflet carefully before you start to take this
syndrome. Symptoms may include a rash, blistering of the skin,
medicine.
wheals or itching. You must stop treatment immediately and
- Keep this leaflet. You may need to read it again while you are
contact your doctor.
receiving your treatment.
• you are taking aminoglycosides such as streptomycin and
- If you have any further questions, please ask your doctor or nurse.
gentamicin. Your kidney function will be carefully monitored.
- This medicine has been prescribed for you. Do not pass it on to others. You should be kept under observation in case you develop another
It may harm them, even if their symptoms are the same as yours.
infection, particularly colitis (infection of the lower bowel), while you
- If any of the side effects get serious, or if you notice any side effects are being treated with cefotaxime for injection.
not listed in this leaflet, please tell your doctor or pharmacist.
Taking other medicines
The name of your medicine is cefotaxime 500mg, 1g or 2g powder
Taking other medicines when cefotaxime for injection is being
for solution for injection or infusion. In the rest of this leaflet it is
administered can affect how it or the other medicine works. Make
called cefotaxime for injection.
sure that your doctor knows what other medicines you are taking.
Do not take any other medicines while you are being treated
In this leaflet:
with cefotaxime for injection unless you have told your doctor or
1. What cefotaxime for injection is and what it is used for
pharmacist and asked their advice. This includes medicines you may
2. Before you are given cefotaxime for injection
have bought yourself without a prescription.
3. How cefotaxime for injection should be given
4. Possible side effects
Please check with your doctor if you are taking any of the following
5. How to store cefotaxime for injection
(or any other medication):
6. Further information
• Penicillin antibiotics such as mezlocillin and azlocillin
1. WHAT CEFOTAXIME FOR INJECTION IS AND WHAT IT IS USED FOR • Aminoglycoside antibiotics such as streptomycin, neomycin or
gentamicin
Cefotaxime belongs to a group of medicines called cephalosporins
• Furosemide or other strong diuretics, used to get rid of excess
which are antibiotics. These medicines work by killing bacteria that
water from the body
cause infections.
• Probenecid, used to prevent gout
Cefotaxime for injection is used for the treatment of a range of
If you have any doubts about whether you should be given this
serious bacterial infections including infections of the blood stream
medicine, then talk to your doctor.
(septicaemia), bones (osteomyelitis), the heart valves (endocartitis),
Important information about some of the ingredients of
the membranes covering the brain (meningitis) and the lining of the
cefotaxime for injection
abdomen (peritonitis), and to prevent and treat infections following
Cefotaxime for injection contains 1.045mmol (or 24mg) for the
surgical operations.
500mg vial, 2.09mmol (or 48mg) for the 1g vial and 4.18mmol
2. BEFORE YOU ARE GIVEN CEFOTAXIME FOR INJECTION
(or 96mg) for the 2g vial of sodium per dose. To be taken into
Cefotaxime for injection should not be given if:
consideration by patients on a controlled sodium diet.
• You are allergic to cefotaxime or any other cephalosporin.
Pregnancy and breast-feeding
• You have previously had a severe allergic reaction to penicillin or
You should let your doctor or nurse know if you are pregnant or wish
any other beta-lactam antibiotic
to become pregnant or are breast-feeding before this medicine is
If any of the above applies to you, you should not be given
administered.
Cefotaxime for Injection.
Driving and using machines
Take special care with cefotaxime for injection if:
Cefotaxime for injection may cause dizziness. If you are affected you
• you have previously had an allergic reaction to penicillin or other
should not drive or operate machinery.
antibiotics of this type. Not all people who are allergic to penicillins
3. HOW CEFOTAXIME FOR INJECTION SHOULD BE GIVEN
are also allergic to cephalosporins. Before you are given this
Your doctor or nurse will prepare your injection by dissolving the
medicine your doctor should check whether you have previously
cefotaxime powder in a suitable fluid for injection. The mixture is
had an allergic reaction to such drugs.
usually injected intramuscularly (into a muscle) or given intravenously
• you have kidney problems. You will be carefully monitored
(into a vein) either by injection or infusion (drip).
throughout your treatment.
• you are on a low salt diet, your doctor should make sure you are
Cefotaxime which has been dissolved in a solution which contains
not receiving too much salt by way of cefotaxime injections
Lidocaine injection BP, (a local anaesthetic), should not be given
• you are being treated for longer than 10 days, your doctor should
intravenously, or to infants under 30 months, or to patients who are
monitor your blood with blood counts
allergic to Lidocaine injection BP, or who have heart block (without a
• you are going to have a blood transfusion, make sure that the
pacemaker), or heart failure.
doctor who organises your transfusion knows that you are having Adults and the Elderly
cefotaxime for injection
The usual adult (including the elderly) dose by intramuscular or
• you are diabetic, you may get false positive results with urine
intravenous injection is 1g every twelve hours. Lower doses may be
glucose tests, such as Clinitest.
given to patients with severe kidney problems.
• you develop a severe skin reaction such as Stevens-Johnson

• 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 Diluent* to
size
be added
500mg
2ml
1g
4ml
2g
10ml

Approx available
volume
2.3ml
4.6ml
11.4ml

Approx displacement
volume
0.3ml
0.6ml
1.4ml

*Water for injection
Dilution Table: Intramuscular Administration
Vial Diluent* to
size
be added
500mg
2ml
1g
4ml
2g
10ml

Approx available
volume
2.3ml
4.6ml
11.4ml

*Water for injection or 1% lidocaine

3

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 08/2017
The information in this leaflet applies only to Cefotaxime Powder for
solution for injection or infusion.
7

Approx displacement
volume
0.3ml
0.6ml
1.4ml
106641/5

862614
Artwork No.

English
Language

18/07/2017

UK
Market

Date

IF YOU SIGN THIS PROOF YOU ARE SIGNIFYING
FULL APPROVAL OF DESIGN AND TEXT.

9pt (Main Body) / 8pt (Variables)
Min. Point Size

2

170mm x 320mm
Size

Proof No.

n/a

Profile

CST

106641/5
Item Code

Proof By

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 clientʼs brief,
the final responsibility must be taken by our client.

Cefotaxime Vial Leaflet
Description

Pharma
Code

FPO

Keyline (non-printing)

Process Black

Colours Used
Wockhardt UK Limited

artwork.leicester@cirrus-artwork.com

This is a service provided by the Royal National Institute of Blind People.
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 08/2017

Customer

Website: www.hpra.ie
E-mail: medsafety@hpra.ie
By reporting side effects you can help provide more information on
the safety of this medicine.
5. HOW TO STORE 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.
6. 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
PL 29831/0030
injection or infusion
Cefotaxime 1g powder for solution for
PL 29831/0030
injection or infusion
Cefotaxime 2g powder for solution for
PL 29831/0029
injection or infusion

Measure bar should be 150mm at 100% scale

Children
The usual dose for children aged one month to twelve years is
100-150mg per kg body weight daily in two to four divided doses.
The usual dose for infants aged one to four weeks is 50mg per kg
body weight in two or four divided doses.
Higher doses may be given, particularly in severe infections.
Your doctor will decide the dose that is best for you. If you do not
understand, or are in any doubt, ask your doctor or nurse.
If you think you have been given too much or too little
cefotaxime for injection
Your doctor will decide which dose is best for you. If you think too
much or too little medicine has been given to you contact your doctor,
nurse, pharmacist or nearest hospital.
4. POSSIBLE SIDE EFFECTS
Like many medicines, cefotaxime for injection may cause side effects
in some patients, particularly when treatment is first started. You
should inform your doctor or nurse immediately if you are unwell.
These include:
• Allergic reactions such as rash, itching, fever and, very rarely,
peeling skin, swelling of the face and difficulty breathing. Tell your
doctor immediately if you think you are having an allergic reaction
to cefotaxime.
• Feeling sick, being sick, stomach pain and diarrhoea, particularly
when it is first given.
• The injection site may be sore.
• Other side effects that some patients have had with cefotaxime for
injection, particularly if given over long periods, include headaches,
dizziness, anaemia or other changes in the blood (which can cause
sore throat and mouth ulcers or a tendency to bleed or bruise
easily), temporary changes in liver function, inflammation of the
liver, kidney problems, jaundice, painful joints and thrush.
• Treatment with high doses of cefotaxime, particularly in
patients with kidney problems, has been known to cause loss of
consciousness, abnormal movements and convulsions.
• Occasionally, patients have suffered a blood clot in a vein or
irregular heart rhythm after intravenous cefotaxime.
• Administration of high doses in patients with kidney problems may
cause brain disease.
• Antibiotic treatment can affect the normal bacteria in the gut,
causing new infection (colitis). You should tell your doctor
immediately if you develop diarrhoea, abdominal cramps or pain,
nausea, dehydration, fever or bloody, watery diarrhoea. Do not
take any anti-diarrhoea medicines, such as loperamide.
• Occasionally, if you have had an intravenous injection there may be
swelling around the area of infection or inflammation of the vein.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse.
This includes any possible side effects not listed in this leaflet. You
can also report side effects directly via the national reporting systems
listed below.
United Kingdom
Yellow Card Scheme
www.mhra.gov.uk/yellowcard
Ireland
HPRA Pharmacovigilance
Earlsfort Terrace
IRL - Dublin 2
Tel: +353 1 6764971
Fax: +353 1 6762517

Expand Transcript

Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

Hide