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CEFOTAXIME SODIUM 500 MG INJECTION

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PACKAGE LEAFLET: INFORMATION FOR THE USER
Cefotaxime Sodium 500 mg, 1 g and 2 g Injection
Cefotaxime Sodium
Read all of this leaflet carefully before you start taking
this medicine.
- Keep this leaflet. You may need to read it again.
- If you have any further questions, ask your doctor or
pharmacist.
- This medicine has been prescribed for you. Do not pass
it on to others. It may harm them, even if their symptoms
are the same as yours.
- If any of the side-effects get serious, or if you notice any
side-effects not listed in this leaflet, please tell your doctor
or pharmacist.
In this leaflet:
1. What Cefotaxime Sodium Injection is and what it is used for
2. Before you use Cefotaxime Sodium Injection
3. How to use Cefotaxime Sodium Injection
4. Possible side-effects
5. How to store Cefotaxime Sodium Injection
6. Further information
1. WHAT CEFOTAXIME SODIUM INJECTION IS AND
WHAT IT IS USED FOR
Cefotaxime Sodium Injection contains cefotaxime as the
sodium salt.
Cefotaxime Sodium Injection is used to treat the following
bacterial infections:













respiratory tract, for lung and chest infections, especially
after operations
urinary tract, associated with the kidneys and bladder,
including when there are no symptoms but bacteria are
present in the urine
infections of tissue in the body and on the skin
bones and joints
pelvic inflammatory disease and other gynaecological
infections
blood poisoning (septicaemia)
gonorrhoea (a sexually transmitted disease)
bacterial meningitis.

Cefotaxime may also be given before and, if required,
after an operation to help prevent bacterial infections from
occurring.
2. EFORE YOU USE CEFOTAXIME SODIUM INJECTION
B
Do not use Cefotaxime Sodium Injection if you are:
• allergic (hypersensitive) to cefotaxime or any other
antibiotics, such as penicillin (See section 6, Further
information for details).
If Cefotaxime Sodium Injection is made into a solution
(reconstituted) with lidocaine, do not use:
• if you are allergic (hypersensitive) to lidocaine or other
local anaesthetics of the amide type
• if you suffer from problems with heart rhythm which are
not being managed or controlled (non-paced heart block)
• if you suffer from severe heart failure
• if you are receiving Cefotaxime Sodium Injection
intravenously (directly into your bloodstream)
• if the patient is an infant aged less than 30 months.

Take special care with Cefotaxime Sodium Injection if you:
• suffer from kidney disease
• are being tested for diabetes or undergoing any other
medical tests
• are pregnant, think you may be pregnant, planning a
family or breast-feeding
• are on a low sodium diet
• have a history of allergy e.g. asthma, eczema, hay fever
• are using cefotaxime for a long period of time. Your blood
should be monitored
• experience skin reactions. Contact your doctor immediately
• experience diarrhoea, especially if severe and/or
persistent. Contact your doctor
• experience reduced consciousness or abnormal
movements. Contact your doctor immediately
Using other medicines
Please tell your doctor or pharmacist if you are taking
or have recently taken any other medicines, including
medicines obtained without a prescription.
Take care if you are taking any of the following
medicines:
• probenecid – a drug used to treat gout
• frusemide – a drug to increase the amount of urine you pass
• drugs that are toxic to the kidneys, such as aminoglycoside
antibiotics.
Pregnancy and breast-feeding
Ask your doctor or pharmacist for advice before taking any
medicine.
It is not known if cefotaxime is safe to use during pregnancy.
Cefotaxime passes into breast milk.
Driving and using machines
High doses of cefotaxime may cause impaired
consciousness and abnormal movement. Do not drive or
operate machinery if you experience this type of symptom.
Important information about some of the ingredients of
Cefotaxime Sodium Injection
This medicinal product contains sodium. To be taken into
consideration by patients on a controlled sodium diet.
3. HOW TO USE CEFOTAXIME SODIUM INJECTION
Your doctor or nurse will mix the cefotaxime powder with a
liquid to make a solution and will then inject the cefotaxime
into a vein or muscle. Alternatively, the cefotaxime may be
given by slow injection (infusion) into a vein over 20 to 60
minutes.
Your doctor will decide the most suitable dose according to
your infections and general condition.
You must follow any instructions given to you by your doctor
or nurse. You may still be given Cefotaxime after you start to
feel better.
Adults
Adults will usually receive 1 g every 12 hours for mild to
moderate infections which can be increased to 12 g daily in
three or four divided doses for severe infections.

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INFORMATION FOR THE DOCTOR
Cefotaxime 500 mg, 1 g and 2 g Injection
INFORMATION FOR THE HEALTHCARE PROFESSIONAL

Reconstitution:
From the calculated dose, determine the appropriate number of vials to be used. Add the recommended volume of
reconstitution solution and shake well until the contents of the vial have dissolved completely.
Route of administration

Reconstitution solution

Diluent required

Displacement volume

500 mg
Intravenous or
intramuscular
injection

Water for Injections Ph. Eur.

Intravenous
infusion

Water for Injections Ph. Eur.
Sodium Chloride Injection BP
5% Dextrose Injection BP
Dextrose and Sodium Chloride
Injection BP
Sodium lactate Injection BP

1g

2g

500 mg

1g

2g

2 ml

4 ml

10 ml

0.45 ml

0.9 ml

1.8 ml

40-100 ml for 1-2 g of
Cefotaxime Sodium Injection

Children
The dose for children and babies depends on their body
weight.
If cefotaxime is used to help prevent bacterial infection
during your operation, it should be stopped within 24 hours.
If you receive more Cefotaxime Sodium Injection than
you should
If you receive too much cefotaxime, your blood will be
passed through an artificial kidney (dialysis). This will
remove cefotaxime from your blood.
4. POSSIBLE SIDE-EFFECTS
Like all medicines, Cefotaxime Sodium Injection can cause
side-effects, although not everybody gets them.
If you experience any of the following side-effects, contact
your doctor immediately.
• On very rare occasions, skin rashes, swelling of the
face, neck, tongue and fever can lead to a severe allergic
reaction. Severe allergic reactions can cause breathing
difficulties including severe wheezing or shortness of breath
• Irregular heart rhythms may be experienced suggesting
circulation problems
• Diarrhoea can develop into severe forms which require
special treatment
• If you are being treated for Lyme Disease you may
experience a specific reaction involving skin rash, itching,
fever, breathing difficulties or joint discomfort.
When the medicine is given over 10 days, problems
may arise with your blood cells, therefore your doctor
may monitor your blood during treatment. High doses
of cefotaxime may affect your kidney function. If you
already have kidney disease these high doses, in certain
circumstances, can lead to brain damage, reduced levels
of consciousness, movement difficulties, involuntary
movements, headache, and dizziness.
It is possible to have pain and redness at the site of the
injection.
The following side-effects have been linked to this
treatment:
• skin rashes
• blisters
• fever
• infections by yeast and fungi such as thrush
• changes to your heart rhythm
• breathing difficulties
• diarrhoea
• feeling sick
• being sick
• abdominal pain
• bowel problems
• liver problems, sometimes with yellowing of the skin or eyes
• kidney problems, especially if you are taking a high dose
at the same time as some other medicines.

5. HOW TO STORE CEFOTAXIME SODIUM INJECTION
Keep out of reach and sight of children.
Do not use Cefotaxime Sodium Injection after the expiry
date which is stated on the vial and carton after EXP. The
expiry date refers to the last day of that month. Store the
unopened vial below 25°C. Keep container in the outer
carton.
Once the powder has been dissolved; the solution should be
used immediately or stored at 2-8°C and discarded after 24
hours.
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
protect the environment.
6. FURTHER INFORMATION
The active substance in Cefotaxime Sodium Injection is
cefotaxime as the sodium salt. The total sodium (salt)
content is approximately 24, 48 or 96 mg respectively.
What Cefotaxime Sodium Injection looks like and the
contents of the pack
Cefotaxime Sodium Injection is a white to slightly yellow
powder. It is supplied in 500 mg, 1 g or 2 g vials with 1, 5,
10, 25 or 50 vials in a carton.
PL 39655/0007 - Cefotaxime Sodium 500 mg injection
PL 39655/0008 - Cefotaxime Sodium 1 g Injection
PL 39655/0009 - Cefotaxime Sodium 2 g Injection
Marketing Authorisation Holder :
Stravencon Ltd, Landmark House,
17 Hanover Square,
Mayfair,
London,
W1S 1HU,
UK.
Manufacturer:
IPG Pharma Ltd,
Atrium Court,
The Ring,
Bracknell,
RG12 1BW.
This leaflet was last revised in June 2014
A055/UK/C

These side-effects go away when the treatment is stopped.
If any of the side-effects get serious or if you notice any
side-effects not listed in this leaflet, please tell your doctor or
pharmacist.

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Prepared injections should be used immediately.
Prepared infusion to be administered over 20-60 minutes.
Cefotaxime Sodium Injection is for single patient use only, discard any unused solution.
Cefotaxime and aminoglycosides should not be mixed in the same syringe or perfusion fluid.
Reconstitute with:
Water for Injections Ph. Eur.
Sodium Chloride Injection BP
5% Dextrose Injection BP
Dextrose and Sodium Chloride Injection BP
Sodium lactate Injection BP
Metronidazole Infusion (500 mg/100 ml)
1% lidocaine/lignocaine (freshly prepared)
The compatibility of cefotaxime in other infusion fluids should be checked before use.
The reconstituted solution should be clear, do not use the solution if particles are present.

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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.

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