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CEFOTAXIME 1G POWDER FOR SOLUTION FOR INJECTION OR INFUSION
Active substance(s): CEFOTAXIME SODIUM
PACKAGE LEAFLET: INFORMATION FOR THE USER
The name of your medicine is Cefotaxime 1g
powder for injection or infusion, or
Cefotaxime 2g powder for injection or
infusion but will be referred to as Cefotaxime
or as Cefotaxime Injection in this leaﬂet.
1. WHAT CEFOTAXIME IS AND WHAT IT IS
Cefotaxime is an antibiotic belonging to the
cephalosporin group of antibiotics. It is used
for the treatment of:
• Bacterial infections of the chest
• Complicated infections of the kidneys and
upper urinary tract
• Severe infections of the skin and soft
• Genital infections caused by gonococci
(gonorrhoea -a sexually transmitted
disease), particularly when penicillin has
failed or is unsuitable.
• Intra-abdominal infections such as
peritonitis ( inﬂammation of the
peritoneum, the thin membrane that lines
the abdominal wall and covers the organs
• Acute bacterial meningitis
• Infection of the blood (septicaemia)
2. BEFORE YOU USE CEFOTAXIME
Do not use Cefotaxime if:
• you are allergic (hypersensitive) to
Cefotaxime or any of the other ingredients
• you are allergic (hypersensitive) to any
other cephalosporin type antibiotic
• you have ever had a severe allergic
reaction to any penicillins.
If you feel uncertain, ask your doctor or
Take special care with Cefotaxime
Before treatment with Cefotaxime, make sure
your doctor knows if:
• you have asthma
• you are allergic to lidocaine or you suffer
from heart failure or unpaced heart block
• the solution is to be given to children
under 30 months
• you are having blood tests (such as
Coombs’ Test or urinary sugar tests)
• you have a history of stomach problems
such as colitis
• have ever suffered from kidney problems.
• have allergies, particularly to
cephalosporins, penicillins, or similar
• are on a controlled sodium diet.
Newly born babies, infants and children will
receive a dose based on their age and
Taking 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. This is extremely
important, as using more than one medicine
at the same time can strengthen or weaken
the effect of the medicines.
Cefotaxime may interfere with:
• diuretics (used to increase the ﬂow of
• aminoglycoside antibiotics (such as
gentamycin and streptomycin used to treat
infections) other antibiotics (such as
tetracycline, erythromycin and
In some cases your doctor will arrange
further monitoring, but this is routine and
nothing to worry about.
It is important to tell the doctor that you are
taking this medicine if you require any blood,
urine or diagnostic tests.
The effect of the contraceptive pill may be
decreased during therapy with Cefotaxime.
Additional non-hormonal contraceptive
precautions should therefore be taken during
therapy with Cefotaxime.
Pregnancy and breast-feeding
Before starting treatment, you must tell your
doctor if you are pregnant or if you intend to
become pregnant. Your doctor will then
decide whether you should receive Cefotaxine.
Mothers who wish to breast-feed should
discuss this with their doctor who will then
advise you on what to do.
Ask your doctor or pharmacist for advice
before taking any medicine.
Driving and using machines
Cefotaxine should not affect your ability to
drive or operate machinery.
Important information about some of the
ingredients of Cefotaxime
This medicinal product contains 2.09 mmol
(or 48 mg) sodium per dose. To be taken into
consideration by patients on a controlled
3. HOW TO USE CEFOTAXIME
This medicine will always be administered by
a doctor or nurse because it needs to be
given either as an injection or by a drip. In
adults, Cefotaxime will normally be given
twice daily, however in children and neonates
Cefotaxime is normally given in 2-4 divided
The usual dosage range is 50-150mg/kg/day
in 2 to 4 divided doses. However, in very
severe infections doses of up to
200mg/kg/day in divided doses may be
Young babies (neonates):
The recommended dosage is 50mg/kg/day in
2 to 4 divided doses. In severe infections 150200mg/kg/day, in divided doses, have been
The recommended dosage for mild to
moderate infections is 1g 12 hourly. However,
dosage may be varied according to the
severity of the infection and condition of the
The following information is intended for medical or healthcare professionals only
Cefotaxime Sodium 1g Powder for Solution
for Injection or Infusion
Trade name of the medicinal product
Cefotaxime 1g Powder for Solution for Injection or Infusion.
Qualitative and quantitative composition
Each vial contains Cefotaxime sodium equivalent to 1g
cefotaxime. Also contains 48mg (2.09mmol) of sodium per vial.
For a full list of excipients, see ‘List of excipients’.
White or slightly creamy powder.
Powder for solution for injection or infusion.
Cefotaxime is indicated for the treatment of the following
severe infections when known or thought very likely to be
due to bacteria that are susceptible to cefotaxime (see
• Bacterial pneumonia; cefotaxime is not active against
bacteria that cause atypical pneumonia or against
several other bacterial species that may cause
pneumonia, including P. aeruginosa (see
• Complicated infections of the kidneys and upper
• Severe infections of the skin and soft tissue
• Genital infections caused by gonococci, particularly
when penicillin has failed or is unsuitable
• Intra-abdominal infections (such as peritonitis).
Cefotaxime should be used in combination with an
antibiotic that is active against anaerobes in the
treatment of intra-abdominal infections.
• Acute bacterial meningitis (particularly if due to
H. inﬂuenzae, N. meningitides, S. pneumoniae, E. coli,
• Septicaemia infections originating from the lungs,
urinary tract, or bowel (in case of gram-negative
organisms a combination with another suitable
antibiotic should be considered).
Consideration should be given to ofﬁcial guidance on the
appropriate use of antibacterial agents.
Posology and method of administration
Cefotaxime may be administered by intravenous bolus
injection, by intravenous infusion, by intramuscular
injection after reconstitution of the solution according to the
directions given below. Dosage and mode of administration
should be determined by the severity of the infection,
susceptibility of the causative organism and the patient’s
condition. Therapy may be started before the results of
sensitivity tests are known.
Adults and children over 12 years
The usual dose in adults is for mild to moderate infections
is 2 to 6g daily. However, dosage may be varied according
to the severity of the infection, sensitivity of the causative
organisms and conditions of the patient.
Guidelines for dosage:
Typical infection in presence (or suspicion) of a sensitive
micro-organism: 1g every 12 hours corresponding to a total
daily dosage of 2g intramuscularly or intravenously.
• Cefotaxime should not be used in patients with a known
or suspected hypersensitivity to cefotaxime or
Special warnings and precautions for use
• Special care is indicated in patients who have had an
anaphylactic response to penicillin. Preliminary enquiry
about hypersensitivity to penicillin and other lactam
antibiotics is necessary before prescribing
cephalosporins since cross allergy occurs in 5-10% of
cases. In case of allergic reaction, the treatment should
be stopped immediately.
• Patients with severe renal dysfunction may need dosage
adjustment (see sections 4.2 – Posology and method of
• Cefotaxime should be used with caution in patients with
allergic diathesis and asthma.
• As with other broad-spectrum antibiotics, prolonged
used may result in the overgrowth of non-susceptible
organisms, which may require interruption of treatment.
If super-infection occurs during treatment, speciﬁc antimicrobial therapy should be instituted if considered
• Pseudomembranous colitis has been reported with the
use of broad-spectrum antibiotics. Therefore, it is
important to consider its diagnosis in patients who
develop severe diarrhea during or after antiobiotic use.
The presence of C. difﬁcile toxin should be investigated
and treatment with cefotaxime stopped in cases of
suspected colitis. The diagnosis can be conﬁrmed by
toxin detection and antibiotic therapy (e.g. oral
vancomycin or metronidazole) should be initiated if
considered clinically necessary. The administration of
products which cause foecal stasis should be avoided.
• Since haematological abnormalities may develop during
treatment with cefotaxime, blood count should be
monitored if treatment lasts for longer than 7 days. In
case of neutropenia (< 1400 neutrophils/mm3),
treatments should be interrupted.
• Do not mix aminoglycosides and cefotaxime in the same
syringe of liquids for perfusion.
• Fast infusion in a central vein can cause arrhythmia
• The sodium content of cefotaxime (2.09mmol/g) should
be taken into account when prescribing to patients
requiring sodium retention.
• Cefotaxime constituted with lidocaine must never be used:
- by the intravenous route
- in infants under 30 months
- in subjects with a previous history of hypersensitivity to
- in patients who have an unpaced heart block
- in patients with severe heart failure.
Interaction with other medicinal products and other
forms of interaction
With other medicaments:
• Concomitant administration of probenecid leads to an
increase and prolongation of serum concentrations of
cefotaxime by inhibition of renal elimination of cefotaxime.
• The efﬁcacy of oral contraceptives may be decreased
during concomitant use of cefotaxime. Therefore during
therapy with Cefotaxime additional contraceptive
measured should be used.
Infection in the presence (or suspicion) of sensitive or
moderatively sensitive multiple micro-organisms: 1-2g
every 12 hours corresponding to a total daily dosage of 2-4g.
• Concurrent treatment with high doses of cephalosporins
and nephrotoxic drugs such as aminoglycosides or
potent diuretics (e.g. furosemide) may adversely affect
renal function. The monitoring of the renal function if
Severe infection by unidentiﬁed micro-organisms or for
infections that cannot be localized: 2-3g as a single dose
every 6 to 8 hours up to a maximum daily dosage of 12g.
• Cefotaxime should not be combined with bacteriostatic
antibiotics (e.g. tetracyclines, erythromycin and
chloramphenicol) since an antagonistic effect is possible.
A combination of cefotaxime and other antibiotics in
indicated in severe infections.
Other forms of interaction:
• As with other cephalosporins a positive Coombs’ test
has been found in some patients treated with
cefotaxime. This phenomenon can interfere with the
cross-matching of blood.
• A false-positive reaction to glucose may occur with
reducing substances (Benedict’s or Fehling’s solution, or
with Clinitest tablets) but not with the use of speciﬁc
enzyme-based tests (glucose oxidase methods).
Infants and children up to 12 years
The usual dosage for infants and children <50 kg is 50150 mg/kg/day in 2 to 4 divided doses. In very severe
infections up to 200 mg/kg/day in divided doses may be
required. In infants and children >50 kg the usual dose in
adults, without exceeding the maximum daily dose of 12 g
should be given.
Newborn infants and premature infants
The recommended dosage is 50 mg/kg/day in 2 to 4
divided doses. In case of life-threatening situations it may
be necessary to increase the daily dose. In severe
150-200 mg/kg/day have been given: in those situations
the following table may serve as a guide, since there are
differences in kidney maturation.
Daily dose of Cefotaxime
50 mg/kg every 12 hours
8 days- 1 month
50 mg/kg every 8 hours
No dosage adjustment is required, provided that renal and
hepatic function are normal.
For gonorrhoea, a single injection (intramuscularly or
intravenously) of 0.5g to 1 g cefotaxime. For complicated
infections, consideration should be given to available
ofﬁcial guidelines. Syphilis should be excluded before
Urinary tract infections:
In uncomplicated UTI 1 g every 12 hours.
In adults, daily doses of 6 to 12 g and in children daily
doses of 150 to 200 mg/kg divided in equal doses every 6
to 8 hours are recommended. For the new-born, 50 mg/kg
of cefotaxime can be given every 12 hours to infants 0-7
days old and every 8 hours to those 7-28 days old.
Intra-abdominal infection should be treated with Cefotaxime
in combination with other appropriate antibiotics.
Duration of therapy
The duration of therapy with Cefotaxime depends on the
clinical condition of the patient and varies accoriding to the
course of the disease. Administration of Cefotaxime should
be continued until symptoms have subsided or evidence of
bacterial eradication has been obtained. Treatment over at
least 10 days is necessary in infections caused by
Streptococcus pyogenes (parenteral therapy may be
switched to an adequate oral therapy before the end of the
10 day period).
Dosage in renal function impairment
In adult patients with a creatinine clearance of d 5 ml/min,
the initial dose is similar to the recommended usual dose
should be halved without change in the frequency of
Dosage in dialysis or peritoneal dialysis
In patients on haemodialysis and peritoneal dialysis an i.v.
injection of 0.5-2 g, given at the end of each dialysis
session and repeated every 24 hours, is sufﬁcient to treat
most infections efﬁcaciously.
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.
• Intravenous infusion
For short intravenous infusion 1g or Cefotaxime 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
• For long lasting intravenous infusion 2 g Cefotaxime
should be dissolved in 100 ml of Water for Injections or
another suitable ﬂuid, e.g. 0.9% sodium chloride or
isotonic glucose solution or other compatible ﬂuids for
infusions. After preparation, the solution may be given as
a 50-60 minute intravenous infusion.
• Intravenous injection
For intravenous injection Cefotaxime 1 g should be
dissolved in 4 ml Water for Injections, Cefotaxime 2 g
should be dissolved in 10 ml Water for Injections and
should be injected over 3-5 minutes.
• Intramuscular injection
Cefotaxime 1.0 g is dissolved in the 4ml Water for
Injections. The solution should be administered by deep
intramuscular injection. In order to prevent pain from the
injection Cefotaxime 1.0 g may be dissolved in 4 ml %
Lidocaine Hydrochloride (only for adults). Solutions with
lidocaine must not be administered intravenously. If the
total daily dose is more than 2g, then intravenous
administration should be chosen. In the case of severe
infections, intramuscular injection is not recommended.
The following table shows the volume of dilution
Method of Administration
40-50 ml -
Pregnancy and lactation
There are no adequate data to assess possible harmfulness
of cefotaxime during pregnancy. To date, animal
experiments show no indication for adverse effects. Caution
should be exercised when prescribing to pregnant women.
Cefotaxime is excreted in human milk in low
concentrations. Use during lactation can lead in infants to
an effect on the physiological intestinal ﬂora with
diarrhoea, to Saccharomyces colinisation and may also
lead to desensitization. A decision should be made whether
to discontinue nursing or discontinue treatment taking into
account the importance of cefotaxime to the nursing woman.
Effects on ability to drive and use machines
There have been no reports of the effects of Cefotaxime on
the ability to drive.
Very common (>1/10), common (>1/100, <1/10),
uncommon (>1/1000, <1/100), rare (>1/10000, <1/1000),
very rare (<1/10000), not known (cannot be estimated
from the available data).
Infections and infestations
• Prolonged use may result in overgrowth of nonsusceptible organisms (see section 4.4 – Special
warnings and precautions for use).
Blood and lymphatic system disorders
• Granulocytopenia and more rarely agranulocytosis, may
develop during treatment with cefotaxime, particularly if
given over long periods. A few cases of eosinophilia and
neutropenia have been observed, but these were
reversible when treatment was ceased. Rare cases of
haemolytic anaemia have been reported. Rare cases of
thrombocytopenia have been recorded, but these were
rapidly reversible on withdrawal of treatment. It is
therefore recommended that blood count should be
monitored if treatment lasts for longer than 7 days.
Nervous system disorders
Administration of high doses of antibiotic belonging to this
group (particularly in patients with renal insufﬁciency) may
result in encephalopathy, which may result in dizziness,
convulsions and fatigue.
• A very small number of cases of arrhythmia have
occurred following rapid bolus infusion through a central
• Commonly, patients receiving cefotaxime experience
gastrointestinal disturbance such as candidasis, nausea,
vomitingm abdominal pain, diarrhea. If severe and
persistent diarrhea occurs, pseudomenbranous colitis
should be considered. In cases or suspicion of
pseudomenranous colitis, treatment with cefotaxime
should be discontinued and appropriate therapy should
• Moderate and transient increase in bilirubin, liver
transaminase and other enzymes has been observed
rarely (ALT, AST, LDH, GGT, alkaline phosphatase).
Skin and cutaneous tissue disorders
• Hypersensitivity reactions have been reported, these
include cutaneous reactions such as skin rashes,
• Drug fever
• Erythema multiforme exsudativum,
• Stevens-Johnson syndrome
• Toxic epidermal necrolysis
• Anaphylactic shock (see section 4.9 Overdose)
In patients with allergic diathesis, hypersensitivity reactions
after administration of Cefotaxime are more likely to occur.
During therapy of infections with spirochetes, a
Herxheimer-like reaction may occur.
This may result in fever, shivering, headache and joint pain.
Renal and urinary disorders
• There may be a temporary increase in creatinine and
urea in the serum
• There have been very rare reports of reversible
General disorder and administration site conditions
• Transient and local pain may be experienced at the site
of injection. This is more likely to occur with higher
doses. Phlebitis has been reported in patients receiving
intravenous cefotaxime. However, this has rarely been a
cause for discontinuation of treatment.
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of
the medicinal product is important. It allows continued
monitoring of the benefit/risk balance of the medicinal product.
Healthcare professionals are asked to report any suspected
adverse reactions via the Yellow Card Scheme at:
In this OHDæHW:
1. WHAT CEFOTAXIME IS AND WHAT IT IS
2. BEFORE YOU USE CEFOTAXIME
3. HOW TO USE CEFOTAXIME
4. POSSIBLE SIDE EFFECTS
5. HOW TO STORE CEFOTAXIME
6. FURTHER INFORMATION
Cefotaxime 1g Powder for Solution for Injection or Infusion
Cefotaxime 2g Powder for Solution for Injection or Infusion
Cefotaxime (as Cefotaxime sodium)
Read all of this OHDæHW carefully before you start using this medicine.
• Keep this leaﬂet. You may need to read it again.
• If you have further questions, please ask your doctor or your 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 gets serious, or if you notice any side effects not listed in this
leaﬂet, please tell your doctor or pharmacist.
In severe infections dosage may be increased
up to 12g daily given in 3 or 4 divided doses.
Dosage in Gonorrhoea:
A single injection of Cefotaxime may be
administered intramuscularly or
intravenously. It can also be given by
intravenous infusion over 20 minutes.
If you use more Cefotaxime than you
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 you forget to use Cefotaxime:
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 you
may have missed a dose then talk to your
nurse or doctor. It is important that the
course of treatment your doctor has
prescribed is taken. You may start to feel
better but it is important not to stop taking
this medicine, until the doctor advises,
otherwise your condition may get worse
If you have any further questions on the use
of this product, ask your doctor or
Very rare side effects
• Your heart may ﬂutter.
• Dark discoloration of urine, bloody or
cloudy urine or any change in your urine
output (This may be due to a condition
called interstitial nephritis)
• Fever, thrush, a furry tongue, headache,
joint pain, move abnormally or involuntary
muscle contractions, breathing difﬁculties
and feel tired.
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 Yellow Card
Scheme at: 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 out of the reach and sight of children.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Cefotaxime can cause side
effects although not everybody gets them.
Do not use Cefotaxime after the expiry date
which is stated on the label after EXP. The
expiry date refers to the last day of that month.
Contact your doctor or nearest hospital
emergency department immediately if you
experience swelling of the face and/or throat
when given Cefotaxime, since this may be
due to a serious allergic reaction.
Always keep this medicine in the closed
original pack, in order to protect from light.
Do not store above 25˚C.
The following side effects may occur in some
patients during treatment:
Very common: affects more than 1 user in 10
Common: affects 1 to 10 users in 100
Uncommon: affects 1 to 10 users in 1000
Rare: affects 1 to 10 users in 10000
Very rare: affects less than 1 user in 10000
Not known: frequency cannot be estimated
from the available data
Common side effects
• Abdominal pain, diarrhoea, nausea (feeling
sick) and vomiting (being sick), candidiasis.
You may develop severe and persistent
diarrhoea, during or after treatment,
especially if you notice blood or mucous
(manifestations of pseudomembranous
• Skin rash, itching, hives (urticaria), allergic
reactions and swelling of the neck, face or
Injection site problems:
• Pain, redness and swelling.
• Drug fever
Rare side effects
• Changes in the amount of blood cells. This
may cause sore throat and mouth ulcers. If
your treatment is more than 7 days your
doctor should monitor your blood counts.
Cefotaxime may also lead to increased risk
of infection. Your doctor may carry out
blood tests to identify the speciﬁc problem
with your blood.
Nervous system problems:
• Patients with kidney problems may
experience dizziness, convulsions and
fatigue when taking high doses of
Symptoms of intoxication
Cefotaxime has a wide margin of safety. Cases of acute
intoxication with cefotaxime have not been published.
Symptoms of overdose may largely correspond to the
proﬁle of side effects.
In cases of overdosage (particularly in renal insufﬁciency)
there is a risk of reversible encephalopathy.
Therapy of intoxication
There is no speciﬁc antidote for overdose. Serum levels of
cefotaxime can be reduced by haemodialysis or peritoneal
Therapy of hypersensitivity reactions
Anaphylactic shock requires immediate countermeasures.
Upon ﬁrst signs of hypersensitivity reactions (e.g.
cutaneous reactions such as skin rashes or urticaria,
headache, nausea, restlessness) the administration of
Cefotaxime should be discontinued. In cases of severe
reactions or anaphylactic reactions, emergency treatment
should be initiated, such as administration of epinephrine
and / or glucocorticoids.
According to the clinical severity additional therapeutic
measures may be required (e.g. artiﬁcial breathing,
application of histamine-receptor antagonists). In cases of
circulatory collapse, resuscitation must be initiated
according to the current guidelines.
• moderate and transient increase in liver
enzymes (increase in bilirubin, liver
transaminase and rarely increase in
• Temporary increase in kidney function
parameters(serum creatinine, urea)
ATC Code: J01D A10
Pharmacotherapeutic group: Beta-lactam antibiotics,
Cefotaxime is a third generation broad spectrum
bactericidal cephalosporin antibiotic. The bactericidal
properties are due to the inhibitory effect of cefotaxime on
bacterial cell wall synthesis.
According to the EUCAST (European Committee on
Antimicrobial Susceptibility Testing) Clinical MIC
breakpoints (v 2.0, dated 25-05-2009) the following
breakpoints have been identiﬁed for cefotaxime:
Pseudomonas Acinetobacter Staphylococcus 3
Enterococcus Streptococcus A, B, C, G
Susceptible (<) /Resistant (> )
1. Non-species related breakpoints have been
determined mainly on the basis of Pk/Pd data and are
independent of MIC distributions of speciﬁc species.
They are for use only for species not mentioned in the
table or footnotes.
2. The cephalosporin breakpoints for Enterobacteriaceae
will detect reduced susceptibility mediated by most
clinically important beta-lactamases in
Enterobacteriaceae. Occasional ESBL-producing strains
will be reported susceptible. For purposes of infection
control, epidemiology and surveillance, laboratories may
wish to use speciﬁc tests to screen for and conﬁrm
3. Susceptibility of staphylococci to cephalosporins is
inferred from the methicillin susceptibility.
4. The susceptibility of streptococcus groups A, B, C
and G can be inferred from their susceptibility to
-- = Susceptibility testing not recommended as the
species is a poor target for therapy with the drug
Once reconstituted, this medicine should be
This medicine is for single use only: discard
any remaining solution immediately after use.
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 contains
The active ingredient is Cefotaxime Sodium.
Cefotaxime 1g powder for solution for
injection or infusion contains Cefotaxime
sodium equivalent to 1 g of Cefotaxime.
Cefotaxime 2g powder for solution for
injection or infusion contains 2 g of
Cefotaxime sodium Ph. Eur., equivalent to 2 g
of Cefotaxime base.
There are no other ingredients.
What Cefotaxime looks like and contents of
Cefotaxime is a white or slightly creamy
powder which forms a straw-coloured
solution on reconstitution.
Cefotaxime 1g powder for injection or
infusion is available in packs of 10 or 50 vials.
Cefotaxime 2g powder for injection or
infusion is available in packs of 10 vials.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and
Laboratorio Reig Jofre, S.A.
Gran Capitán, 10 - 08970 Sant Joan Despí,
For any information about this medicinal
product, please contact the local representative
of the Marketing Authorisation Holder.
This leaflet was last revised May 2015
Methicillin-(oxacillin) resistant staphylococci (MRSA) are
resistant to all currently available b-lactam antiobiotics,
Penicillin-resistant Streptococcus pneumoniae show a
variable degree of cross-resistance to cephalosporins such
Cefotaxime is for parenteral application. Mean peak
concentrations 5 minutes after intravenous injection are
about 81-102 mg/l following a 1 g dose cefotaxime and
about 167-214 mg/l 8 minutes after a 2 g dose.
Intramuscular injection produces mean peak plasma
concentrations of 20 mg/l within 30 minutes following a 1
Cefotaxime gives good penetration into different
compartments. Therapeutic drug levels exceeding the
minimum inhibitory levels for common pathogens can
rapidly be achieved. Cerebrospinal ﬂuid concentrations are
low when the meninges are not inﬂamed but cefotaxime
usually passes the blood-brain barrier in levels above the
MIC of the sensitive pathogens when the meninges are
inﬂamed (3-30 μg/ml). Cefotaxime concentrations (0.2-5.4
μg/ml), inhibitory for most Gram-negative bacteria, are
attained in purulent sputum, bronchial secretions and
pleural ﬂuid after doses of 1 or 2 g. Concentrations likely to
be effective against most sensitive organisms are similarly
attained in female reproductive organs, otitis media
effusions, prostatic tissue, interstitial ﬂuid, peritoneal ﬂuid
and gall bladder wall, after therapeutic doses. High
concentrations of cefotaxime and O-desacetyl-cefotaxime
are attained in bile. Cefotaxime passes the placenta and
attains high concentrations in foetal ﬂuid and tisues (up to
6 mg/kg). Small amounts of cefotaxime diffuses into the
Protein binding for cefotaxime is approximately 25-40%.
The apparent distribution volume for cefotaxime is 21-37 l
after 1g intravenous infusion over 30 minutes.
Cefotaxime is partly metabolized in human beings.
Approximately 15-25% of a parenteral dose is metabolized
to the O-desacetylcefotaxime metabolite, which also has
The main route of excretion of cefotaxime and Odesacetylcefotaxime is the kidney. Only a small amount
(2%) of cefotaxime is excreted in the bile. In the urine
collected within 6 hours 40-60% of the administered dose
of cefotaxime is recovered as unchanged cefotaxime and
20% is found as O-desacetlycefotaxime. After
administration of radioactive labeled cefotaxime more than
80& can be recovered in the urine, 50-60% of this fraction
is unchanged cefotaxime and the rest contains metabolites.
The total clearance of cefotaxime is 240-390 ml/min and
the renal clearance is 130-150 ml/min.
The serum half-lives of cefotaxime and Odesacetylcafotaxime are normally about 50-80 and 90
minutes respectively. In the elderly, the serum half-life of
cefotaxime is 120-150 min.
In patients with impaired renal function (creatinine
clearance 3-10ml/min) the serum half-life of cefotaxime
can be increased to 2.5-3.6 hours.
In neonates, the pharmacokinetics are inﬂuenced by
gestation and chronological age, the half-life being
prolonged in premature and low birth weight neonates of
the same age.
Preclinical safety data
Preclinical data reveal no special hazard for humans based
on conventional studies of safety pharmacology, repeat
dose toxicity, genotoxicity, and toxicity to reproduction.
Cefotaxime passes through the placenta. After intravenous
administration of 1 g cefotaxime during the birth values of
14 μg/ml were measures in the umbilical cord serum in the
ﬁrst 90 minutes after application, which dropped to
approximately 2.5 μg/ml by the end of the second hour
after application. In the amniotic ﬂuid, the highest
concentration of 6.9 μg/ml was measured after 3-4 hours.
This value exceeds the MIC for most gram-negative
The prevalence of resistance may vary geographically and
with time for selected species and local information on
resistance is desirable particularly when treating severe
infections. This information gives only an approximate
guidance on the probabilities whether micro-organisms will
be susceptible to cefotaxime or not.
Group A Streptococci (including Streptococcus
Group B Streptococci
‚-hemolytic Streptococci (Group C,F, G)
Viridans Group Streptococci
Gram negative aerobes
Klebsiella spp. *
Proteus spp. *
Clostridium spp. (not Clostridium difﬁcile)
Staphylococcus aureus (MRSA)
Staphylococcus epidermidis (MRSE)
*Clinical efﬁcacy has been demonstrated for susceptible
isolates in approved clinical indications.
$ Frequency of resistance ranges in EU is >10%
(extreme values); Streptococcus pneumoniae show a
variable degree of resistance - 12.7%
List of excipients
This medicinal product must not be mixed with other
medicinal products except those mentioned in ‘Special
precautions for disposal and other handling’.
Vial before opening: 2 years.
Vial after ﬁrst opening: The product should be used
After reconstitution: The product should be used
From a microbiological point of view, 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 to 8ºC, unless reconstitution has taken place in
controlled and validated aseptic conditions.
Special precautions for use
Unopened: Do not store above 25ºC. Keep the vial in the
outer carton in order to protect from light.
For storage conditions of the reconstituted medicinal
product, see ‘Shelf life’.
Nature and contents of container
Type II transparent glass vial, with a bromobutyl stopper
and a ﬂip off aluminum and polypropylene cap.
Packs of 10 or 50 vials.
Special precautions for disposal
Cefotaxime is supplied as a white to slightly creamy
powder, which when dissolved in Water for Injections Ph.
Eur. forms a straw-coloured solution suitable for IV or IM
injection. Variations in the intensity of colour of the freshly
prepared solution do not indicate a change in potency or
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:
- Water for Injections Ph. Eur.
- Sodium Chloride Injection BP.
- 5% Dextrose Injection BP.
- Dextrose and Sodium Chloride Injection BP.
- Compound Sodium Lactate Injection BP (Ringer-lactate
Any unused solution should be discarded.
Cefotaxime is also compatible with 1% lignocaine, however
freshly prepared solutions should be used.
Cefotaxime is also compatible with metronidazole infusion
(500mg/100ml). 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 medicinal product is for single use only; Discard any
contents remaining in the vial immediately after use.
The reconstituted solution is to be inspected visually for
particulate matter and discoloration prior to administration.
The solution should only be used if the solution is clear and
free from particles.
MARKETING AUTHORISATION HOLDER
Laboratorio Reig Jofre, S.A.
Gran Capitán, 10
08970 Sant Joan Despí, Barcelona, Spain
MARKETING AUTHORISATION NUMBER
PL 25174 / 0006