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CEFOTAXIME 0.5G POWDER FOR SOLUTION FOR INJECTION

Active substance(s): CEFOTAXIME SODIUM

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PACKAGE LEAFLET: INFORMATION FOR THE USER

Cefotaxime 0.5 g Powder for Solution for Injection
Cefotaxime 1 g Powder for Solution for Injection
Cefotaxime 2 g Powder for Solution for Injection

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Cefotaxime

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor.
• If you get any side effects, talk to your doctor. This includes any possible side effects not listed in this leaflet. See
section 4.

What is in this leaflet:
1. What Cefotaxime is and what it is used for
2. What you need to know before you use Cefotaxime
3. How to use Cefotaxime
4. Possible side effects
5. How to store Cefotaxime
6. Contents of the pack and other Information

1

What Cefotaxime is and what it is used for

The active ingredient in this medicine is cefotaxime.
Cefotaxime is an antibiotic. Cefotaxime belongs to a group of
antibiotics called ‘cephalosporins’.
It is suitable for the treatment of bacterial infections such as:







lung infections (lower respiratory tract),
bladder and kidney infections (urinary tract),
skin infections and infections of the layers (soft tissue)
beneath the skin,
genital tract infections (including gonorrhoea which is a
sexually transmitted disease),
abdominal infections (peritonitis),
brain infections (meningitis).

2

What you need to know before you use
Cefotaxime

DO NOT USE CEFOTAXIME
• if you are allergic (hypersensitive) to cefotaxime or any
other cephalosporin type of antibiotic.
• if you have ever had an severe allergic reaction to
penicillin or other medicines from the penicillin family
(beta-lactam-antibiotics).
If you are not sure, ask your doctor or healthcare professional.

Warnings and precautions
Talk to your doctor before using Cefotaxime if
• you suffer from severe allergies or asthma,
• you develop severe persistent (bloody) diarrhoea. You
may have an inflammation of the large intestine caused by
the use of cefotaxime. In that case, the use of Cefotaxime
must be stopped immediately. Do not take medicines
that reduce bowel movements.
• your treatment lasts for longer than 7 days. In this case
your doctor will order blood sample controls. If your white
blood cell count decreases your doctor will eventually stop
the treatment
• you have kidney problems,
• you are on a low-sodium (low salt) diet.
If any of these apply to you, your doctor may want to change
your treatment or give you special advice.
If given as an injection into the muscle:
Your doctor may consider it necessary to inject this medicine
into a muscle. In this case, the doctor will add lidocaine to the
injection to make it less painful. However, this method of
administering the injection will not be suitable for everyone.
The product information of the chosen lidocain-containing
medicinal product must be regarded.

This medicine can alter the results of some blood and
urine tests If you are having blood tests (such as Coombs’
test) or urinary sugar tests (the Fehling’s type which test for
reducing sugars) tell your doctor you are taking this medicine
as this medicine may cause false positive results.
Your doctor may decide to do tests on your blood if you are
given Cefotaxime for longer than 7 days.

The following information is intended for medical or
healthcare professionals only:
Cefotaxime 0.5 g powder for solution for injection
Cefotaxime 1 g powder for solution for injection
Cefotaxime 2 g powder for solution for injection
Cefotaxime

This is an extract from the Summary of Product
Characteristics to assist in the administration of
Cefotaxime. When determining appropriateness of use in
a particular patient, the prescriber should be familiar with
the SPC.
For slow intravenous injection/infusion and
intramuscular injection.

draft: 970420, 970419
laetus code: 000
mat.no.: 00000000

INCOMPATIBILITIES WITH DILUENTS AND OTHER
MEDICINAL PRODUCTS
• Cefotaxime should not be added with other antibiotics, in
the same syringe or solution for infusion. This concerns
especially aminoglycosides.
• Cefotaxime should not be mixed with solutions containing
sodium bicarbonate.

Other medicines and Cefotaxime
Tell your doctor if you are taking, have recently taken or might
take any other medicines, including medicines you have
obtained without a prescription. This is important because
some medicines should not be taken with Cefotaxime.

Do NOT take Cefotaxime together with these medicines:
• Certain antibiotics – tetracyclines (such as doxycycline
or minocycline), erythromycin, chloramphenicol. They
may not work properly if used with Cefotaxime.
The use of the following medicines is not recommended:
• Any other antibiotics. They may not work properly if used
with Cefotaxime.
• Probenecid (for gout). This can increase the time it takes
for cefotaxime to leave your body.
• Medicines that may affect the way your kidneys work, like
aminoglycoside antibiotics or diuretics (water tablets
such as furosemide).

Pregnancy, breast-feeding and fertility
If you are pregnant or breast-feeding, think you may be
pregnant or are planning to have a baby, ask your doctor for
advice before taking this medicine.
Cefotaxime can pass to a baby in the womb or through breast
milk. If you are pregnant or breast-feeding, your doctor will
decide whether Cefotaxime is right for you.
Driving and using machines
There are no reports that this medicine may affect your ability
to drive or use machines.
However, certain side effects could occur (see section 4),
which may influence your ability to drive or use machines. If
you feel dizzy, do not drive or use any machines.
Cefotaxime contains sodium
Cefotaxime contains 2.09 mmol (equivalent to 48 mg) of
sodium per gram. This should be taken into consideration by
patients on a sodium controlled diet.

3

How to use Cefotaxime

Always use this medicine exactly as your doctor or
pharmacist has told you. Check with your doctor or
pharmacist if you are not sure.

Cefotaxime is normally given by a doctor or nurse.
It is given:
• by slow injection (for 3-5 minutes) or through a drip (for
20-60 minutes) into one of your veins (intravenous) or
• by deep injection into a large muscle of the buttock
(intramuscular).

The dose of Cefotaxime is determined by your doctor
depending on your age, your weight and the severity of the
infection and on how well your liver and kidneys are working.
Your doctor will explain this to you.

The recommended dose is:
Adults and children over 12 years who weigh more than 50 kg:
• 2-6 g daily. The daily dose should be divided.
• In severe infections the dose may go up to 12 g daily.
Continued on the next page >>

INSTRUCTIONS FOR USE, HANDLING AND DISPOSAL
Aseptic techniques should be used to reconstitute the
solution. The reconstituted solution should be administered
immediately.
Cefotaxime is compatible with several commonly used
intravenous infusion fluids:
• Water for Injection
• 0.9 % Sodium Chloride solution
• 5 % Glucose solution
• 5 % Glucose/0.9 % Sodium Chloride solution
• Ringer-lactate solution
• 5 % Metronidazole solution
• Dextran 40 in 0.9 % Sodium Chloride solution
• Dextran 40 in 5 % Glucose solution

The compatibility of cefotaxime in other infusion fluids should
be checked before use.
Following reconstitution the solution should be clear and pale
yellowish to brown-yellowish. Do not use if any particulate
matter is visible. Withdraw only one dose.
Any unused solution should be discarded.
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Continued on the next page >>

Infants and children (1 month to 12 years of age) who weigh
less than 50 kg:
• 50–150 mg for each kg of body weight per day in two to
four divided doses.
• In severe infections the dose may go up to 200 mg for
each kg of body weight per day in divided doses.

Infants (younger than four weeks old):
• 50 mg per kg body weight daily in two to four divided doses.
• In severe infections the dose may go up to 150-200 mg for
each kg of body weight per day.
The elderly:
The usual dosage for adults does not need to be adjusted if
the kidney function and liver function are good.

Special dosage information:
• Gonorrhoea: a single injection of 0.5 - 1 g is required.
• Uncomplicated bladder or kidney infections: the dose is
1 g twice daily
• Brain infections: in adults the dose is 6-12 g daily, in
children 150-200 mg for each kg of body weight per day
and in newborns 50 mg for each kg of body weight per day.
• Abdominal infections: Cefotaxime may be used in
combination with other antibiotics.
In special cases Cefotaxime may be injected directly into a
large muscle. In this case Cefotaxime powder for solution for
injection may be dissolved in a medicine called lidocaine
which is intended to make the injection less painful.

If you use more Cefotaxime than you should
As you will be given Cefotaxime by a doctor or nurse, you are
unlikely to be given the wrong dose. However, if you
experience bad side effects or think you have been given too
much, tell your doctor immediately.
If you forget to use Cefotaxime
If you think you have not been given a dose of Cefotaxime,
tell your doctor immediately.

If you have any further questions on the use of this medicine,
ask your doctor or nurse.

4

Possible side effects

Like all medicines, this medicine can cause side effects,
although not everybody gets them.

You must contact your doctor immediately if you notice
any of the following:

Uncommon: may affect up to 1 in 100 people
• increased tendency to bleed or bruise more easily caused
by a fall in the number of blood platelets (thrombocytopenia),
fever, sore throat or mouth ulcers due to infections caused
by a low level of white blood cells (leucopenia) or high
level of a specific type of white blood cells (eosinophilia).

Not known: frequency cannot be estimated from the
available data
• Inflammation of the bowels, called colitis (or
antibiotic-associated colitis), causing severe long-lasting
watery or bloody diarrhoea with stomach cramps and fever
• Serious blood problems, including changes in the numbers
of some white blood cells (which may cause frequent
infections, fever, severe chills, sore throat, or mouth ulcers)
• Damage to red blood cells (causing tiredness, being short
of breath or looking pale)
• Severe allergic reactions with symptoms such as swelling
of the lips, tongue, face and neck, sudden difficulty in
breathing, speaking and swallowing;
• Headache, dizziness, convulsions (fits) (these may be
symptoms of a brain disorder called encephalopathy)
• Changes in heart beat (rhythm or rate), after a very quick
injection into a vein
• Yellow skin and eyes, loss of appetite, light-coloured urine
caused by inflammation of the liver.
• Skin rash, which may blister, and looks like small targets
(central dark spot surrounded by a paler area, with a dark
ring around the edge).
• A widespread rash with blisters and peeling skin. (These
may be signs of Stevens-Johnson syndrome or toxic
epidermal necrolysis).
• Increased or reduced urine output, or traces of blood in
your urine, sometimes with swollen limbs and / or flank
pain caused by kidney problems
• For intramuscular injection: combination with lidocaine can
cause systemic reactions

Other possible side effects:

Very common: may affect more than 1 in 10 people
• Intramuscular injection may be painful

Uncommon: may affect up to 1 in 100 people
• People being treated for infections with bacteria called
spirochetes often show symptoms like fever and shivering
which are described as ‘Herxheimer reaction’ and indicate
the effectiveness of the therapy.
• Changes in the results of blood tests that check how the
liver and kidneys are working
• Fever
• Allergic reactions such as skin rash (nettle rash), itchy skin
• Painful swelling and inflammation where the injection is
given into a vein
• Soft stools or diarrhoea
Not known: frequency cannot be estimated from the
available data
• Feeling sick (nausea) and being sick (vomiting)
• Pain in your stomach (abdomen)

Your doctor may want to perform tests during your treatment
to measure any changes.

Reporting of side effects
If you get any side effects, talk to your doctor or nurse. This
includes any possible side effects not listed in this leaflet. You
can also report side effects directly via the Yellow Card
Scheme (www.mhra.gov.uk/yellowcard). By reporting side
effects you can help provide more information on the safety of
this medicine.

5

How to store Cefotaxime

Keep this medicine out of the sight and reach of children.

Do not use Cefotaxime after the expiry date which is stated
on the carton and label after EXP. The expiry date refers to
the last day of that month.

Powder:
Do not store above 25°C. Keep container in the outer carton
in order to protect from light.
For storage conditions of the reconstituted/diluted medicinal
product, see the area of the package leaflet headed ‘The
following information is intended for medical or healthcare
professionals only’.
Do not throw away any medicines via wastewater or
household waste. Ask your pharmacist how to throw away
medicines you no longer use. These measures will help
protect the environment.

6

Contents of the pack and other
information

What Cefotaxime contains
• Active substance:
The active substance is cefotaxime (as sodium salt).
Cefotaxime contains [0.5 g / 1 g / 2 g] cefotaxime.
• Other ingredients:
The medicinal product contains no other ingredients than
the active substances.

What Cefotaxime looks like and contents of the pack
Cefotaxime is a powder for solution for injection or infusion
packaged in glass bottles. The bottles are packed in carton
boxes. Each box contains Cefotaxime glass bottles.
Content
1 vial per carton, 1 vial per carton in pack of 5 cartons, 1 vial
per carton in pack of 10 cartons, 1 carton of 10 vials, 1 carton
of 25 vials, 1 carton of 50 vials, 1 carton of 100 vials
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Sandoz Ltd, Frimley Business Park, Frimley, Camberley
Surrey, GU16 7SR, UK.
This leaflet was last revised in 05/2014.

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Method of administration:
In order to prevent any risk of infection, the preparation of the
infusion should be done in close aseptic conditions. Do not
delay the infusion after the preparation of the solution.
Cefotaxime and aminoglycosides should not be mixed in the
same syringe or perfusion fluid.


draft: 970420, 970419
laetus code: 000
mat.no.: 00000000



Intravenous infusion
For short intravenous infusion Cefotaxime 1 g/2 g should
be dissolved in 40-50 ml Water for Injections or in another
compatible fluid (e.g. glucose 10%). After preparation the
solution should be given as a 20 minute intravenous infusion.
For long lasting intravenous infusion Cefotaxime 2 g
should be dissolved in 100 ml of a suitable fluid e.g. 0.9%
sodium chloride or isotonic glucose solution or other
compatible fluids for infusions. After preparation the solution
should be given as a 50-60 minute intravenous infusion.

Intravenous injection
Cefotaxime 0.5 g/1 g/2 g should be dissolved in 2 ml/4 ml/
10 ml Water for Injections and should be injected over a
period of 3-5 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.



Intramuscular injection
Cefotaxime 0.5 g/1 g should be dissolved in 2 ml/4 ml
Water for Injections. The solution should be administered
by deep intramuscular injection. In order to prevent pain
from injection Cefotaxime 0.5 g/1 g may be dissolved in
2 ml/4 ml 1 % Lidocaine Hydrochloride (only for adults).
Solutions with lidocaine must not be administered
intravenously. If the total daily dose is more than 2 g, the
intravenous administration should be chosen. In the case
of severe infections, intramuscular injection is not
recommended. The product information of the chosen
lidocain-containing medicinal product must be regarded.

The following table shows the volume of dilution for each vial size
H

Vial
size

0.5 g
1g
2g

Method of administration

Short
Long lasting Intravenous Intramuscuintravenous intravenous
injection
lar injection
Infusion
infusion
-

-

2 ml

2 ml

40-50 ml

100 ml

10 ml

-

40-50 ml

-

4 ml

4 ml

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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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