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CEFOTAXIME 1G POWDER FOR SOLUTION FOR INJECTION/INFUSION

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PACKAGE LEAFLET: INFORMATION FOR THE USER

Cefotaxime 500mg, 1g and 2g
Powder for Solution for Injection/Infusion
Cefotaxime Sodium
Read all of this leaflet before you start
taking this medicine:
• Keep this leaflet as you may wish to read it again.
• If you have any further questions, ask your doctor or
pharmacist.
• If any of the side effects get serious or you notice any side
effects not listed in this leaflet please tell your doctor or
pharmacist.
In the rest of this leaflet your medicine is called Cefotaxime.

In this leaflet
1.
2.
3.
4.
5.
6.

What Cefotaxime is and what it is used for
Before you are given Cefotaxime
How Cefotaxime is given
Possible side effects
How Cefotaxime is stored
Further information

1. What Cefotaxime is and what it is used for
Cefotaxime is available in vials containing 500mg, 1g and 2g of
cefotaxime sodium as a powder. There are no other ingredients. The
powder is then mixed with liquid, normally water, to make a solution
which is ready for use as an injection, or an infusion (“drip”).
Cefotaxime is one of a group of medicines called antibiotics, which
kill bacteria that cause infections in your body.
Cefotaxime is used to treat various bacterial infections including
those of:
• the chest (respiratory tract infections)
• the bladder and urethra (the tube which carries urine from
the bladder)
• the blood (septicaemia)
• the skin and tissues
• the bone and joints
• the genital tract in women; including infections which occur,
pre, post and during pregnancy.

Take special care with Cefotaxime
If you can answer yes to any of the following questions, talk to your
doctor before taking this medicine:
• do you have any kidney problems? If so, you should discuss
this with your doctor, as he may wish to reduce the dose.
• are you on a sodium controlled diet?
• have you ever had colitis (inflammation of the bowel)?
• have you ever had a serious blistering of your skin after having
Cefotaxime?
• have you ever had a blood reaction after having Cefotaxime?
The liquid used to make up the infusion (“drip”) solution may also
contain other ingredients prescribed by your doctor. You should ask
the person giving you the drip what it contains in case you may be
allergic to any of these ingredients.
Cefotaxime may interfere with certain laboratory tests. If you need
to have any diagnostic, urine or blood tests whilst taking this
medicine, please ensure the doctor or nurse knows that you are
taking Cefotaxime.
If your doctor suspects you are suffering from bacterial meningitis,
you will be urgently transferred to hospital. Before being transferred
to hospital for further treatment, you may be given a single injection
of Cefotaxime.
Please tell your doctor if any one of the above warnings applies to
you, or has applied to you in the past.
Taking other medicines
You should make sure you have told your doctor or pharmacist
about any other medicines that you are taking; including any you
have bought without a prescription.

This medicine can also be used to treat:
• gonorrhoea (a type of sexually transmitted disease)
• meningitis

If you can answer yes to any of the following questions, talk to your
doctor before taking this medicine:
• are you taking any aminoglycoside antibiotics (such as
amikacin, gentamicin, streptomycin, tobramycin)?
• are you taking any diuretics (such as furosemide) to treat high
blood pressure?
• are you taking probenecid (used to treat gout)?
• are you taking any medicines used to thin the blood (such as
warfarin)?
• are you taking the contraceptive pill?

Cefotaxime may also be given before and after operations to stop
infections from happening.

Pregnancy and breast-feeding
Talk to your doctor before you are given this medicine.

2. Before you are given Cefotaxime
You must not be given this medicine if you have ever suffered a
severe reaction to cephalosporin antibiotics, or any other antibiotics,
particularly penicillins.
The liquid used to make up the injection solution may contain other
ingredients such as lidocaine, a local anaesthetic. If you can answer
yes to any of the following questions, talk to your doctor before taking this medicine:
• are you allergic to lidocaine or other similar local anaesthetics?
• if this medicine is for your child, is your child younger than 30
months?
• do you suffer from either severe heart failure or an unpaced heart block?

Cefotaxime should not be taken during pregnancy, especially during
the first three months, or when breast-feeding unless the benefits
outweigh the risks to the mother and baby.
Driving and using machines
At the recommended dose Cefotaxime is not expected to cause you
to be drowsy or less alert. However, at higher doses some people
experience drowsiness, abnormal movements and fits which may
affect their ability to drive and use machines

3. How Cefotaxime is given
• Cefotaxime is available in a range of strengths; 500mg, 1g and 2g.
• You may be prescribed one or more of these strengths in order to
achieve the correct dosage to treat your illness.

The dose you will receive will depend on the nature of your
treatment, your age and your medical condition. A doctor or nurse
will usually give you this medicine. The medicine will be given to you
either as an injection in a vein or underneath the skin or as a slow
injection via a drip into a vein.
If you have the impression that the effect of Cefotaxime is too strong
or too weak, talk to your doctor or pharmacist.
Unless otherwise prescribed by your doctor, the usual dose is as
follows:
Adults over 18 years of age and the elderly
Your doctor will usually give you the following:
• Mild to moderate infections: the usual dose is 1g given twice
a day. However, the dosage may be varied depending on the
severity or type of your infection or your condition.
• Severe infections: the dose may be increased up to 12g
divided over 3 – 4 times a day.
• Gonorrhoea: a single dose of 500mg may be given as an
injection.
Children
Your doctor will usually give your child the following:
• Mild to moderate infections: the usual dose is 100-150mg per
kilogram of bodyweight divided over 2 – 4 times a day.
• Severe infections: the dose may be increased up to 200mg per
kilogram of bodyweight divided over 2 – 4 times a day.
Newborn babies
Your doctor will usually give your baby the following:
• Mild to moderate infections: the usual dose is 50mg per
kilogram of bodyweight divided over 2 – 4 times a day.
• Severe infections: the dose may be increased up to 150 - 200mg
per kilogram of bodyweight divided over 2 – 4 times a day.
People with kidney disease
Your doctor may give you a lower dose. You may need to have blood
tests to check that you are getting the dose you need.

• thrush
• headache
• blood problems. The signs include feeling tired, bruising easily,
being short of breath and nose bleeds. If you take the medicine for
more than 10 days, your doctor may ask you to take a blood test,
but this is just routine and nothing to worry about
• changes in the numbers of white cells in your blood. The signs
include a sudden high temperature (fever), shivering and a
sore throat
• skin rash or swelling, or other allergic reactions such as itching
• kidney problems such as pains in the kidney area
• inflammation of the kidney which can cause swollen ankles or
high blood pressure
• injury to the liver making you feel tired or unwell
• liver problems shown in a blood test
• a new infection
• dizziness
• pain or burning feeling along the vein where your injection has
been given
The following side effects have been reported for similar types of
antibiotic medicines, although they have not been reported
specifically for cefotaxime:
• restlessness, nervousness or sleep disturbances
• confusion, dizziness or hallucinations
• stiffness in the muscles
Symptoms that have occurred after several weeks of treatment for
Lyme’s Disease:
The following symptoms have been reported during treatment for
Lyme’s Disease. These may be side effects or may actually be
symptoms of the actual disease:
• skin rash or itching
• fever
• difficulty in breathing
• discomfort in the joints
• changes in blood cell count associated with increased
susceptibility to infections
• changes to liver enzymes in the blood

If you are given too much Cefotaxime
It is most unlikely that you will be given too much medicine by the
nurse or doctor. Your doctor and nurse will be monitoring your
progress, and checking the medicine that you are given. Always ask if
you are not sure why you are getting a dose of medicine.

If any of the side effects discussed above get serious, or if you
notice any other side effects not mentioned in this leaflet, please
inform your doctor or pharmacist.

If a dose of Cefotaxime is forgotten
Your doctor or nurse have instructions when to give you your
medicine. It is most unlikely that you will not be given the medicine
as it has been prescribed. If you think that a dose has been missed
then talk to your nurse or doctor.

Your doctor or pharmacist is responsible for storing your medicine.
They are also responsible for disposing of any unused medicine
correctly.

4. Possible side effects
Like all medicines, Cefotaxime may sometimes cause side effects, as
well as the effects that are needed. Some side effects are mild and go
away when you stop taking this medicine, whilst others can be more
serious.
If you have any of the following side effects you must call a doctor
urgently:
• severe allergic reactions (with lip/ tongue swelling, wheezing,
fever or shock)
• abnormal movement, sudden, involuntary muscle contractions or
loss of consciousness –these are symptoms of a serious condition
called encephalopathy
• severe diarrhoea – this could be a symptom of a condition
called pseudomembranous colitis which needs immediate
treatment
• severe blistering of the skin, mouth, eyes or genitals (symptoms
of serious illnesses such as Stevens-Johnson syndrome, erythema
multiforme or toxic epidermal necrosis)
• heart flutter – this could be a sign that you are suffering from a
heart condition called arrhythmia
Other less serious side effects may occur on taking this medicine.
The following side effects have been reported:
• diarrhoea, loss of appetite, feeling sick, being sick or stomach pains
• if your medicine is given as an injection some people find it slightly
painful where the injection has been given. It may also cause your
veins to swell following intravenous injection

5. How Cefotaxime is stored






keep out of the reach and sight of children
do not use after the expiry date printed on the carton and label
store below 25°C and protect from light
can be stored in a fridge for up to 24 hours, once reconstituted

6. Further information
What Cefotaxime contains
The active substance is cefotaxime sodium. There are no other
ingredients in your medicine.
Each glass vial will contain either 500mg, 1g or 2g of Cefotaxime
powder.
What Cefotaxime looks like
• Cefotaxime 500mg Powder for Solution for Injection/Infusion is a
white or slightly yellow powder in glass vials. This is supplied in a
carton
• Cefotaxime 1g Powder for Solution for Injection/Infusion is a white
or slightly yellow powder in glass vials. This is supplied in a carton
• Cefotaxime 2g Powder for Solution for Injection/Infusion is a white
or slightly yellow powder in glass vials. This is supplied in a carton
Marketing Authorisation Holder and Manufacturer:
Lupin (Europe) Ltd, Victoria Court, Bexton Road, Knutsford,
WA16 0PF, UK
Date of preparation: August 2011

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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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