CEFOTAXIME 2G POWDER FOR SOLUTION FOR INJECTION OR INFUSION

Active substance: CEFOTAXIME SODIUM

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PACKAGE LEAFLET: INFORMATION FOR THE USER

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 leaflet 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 this leaflet:
1. WHAT CEFOTAXIME IS AND WHAT IT IS
USED FOR
2. BEFORE YOU USE CEFOTAXIME
3. HOW TO USE CEFOTAXIME
4. POSSIBLE SIDE EFFECTS
5. HOW TO STORE CEFOTAXIME
6. FURTHER INFORMATION
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
USED FOR
Cefotaxime is an antibiotic belonging to the
cephalosporin group of antibiotics. It is used
for the treatment of
• Bacterial infections of the chest
(respiratory tract)
• Complicated infections of the kidneys and
upper urinary tract
• Severe infections of the skin and soft tissue
• 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 within)
• 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
of Cefotaxime.
• 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
pharmacist.
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
antibiotics.
• are on a controlled sodium diet.
Newly born babies, infants and children will
receive a dose based on their age and
bodyweight.
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
urine)
• probenecid
• aminoglycoside antibiotics (such as
gentamycin and streptomycin used to treat
infections) other antibiotics (such as
tetracycline, erythromycin and
chloramphenicol)
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
sodium diet.
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 doses.
Children
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
required.
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
given.
Adults:
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
patient.
In severe infections dosage may be increased
up to 12g daily given in 3 or 4 divided doses.

The following information is intended for medical or healthcare professionals only
Cefotaxime Sodium 2g Powder for Solution
for Injection or Infusion
TECHNICAL LEAFLET
Trade name of the medicinal product
Cefotaxime 2g Powder for Solution for Injection or Infusion.
Qualitative and quantitative composition
Each vial contains Cefotaxime sodium.
equivalent to 2g cefotaxime.
Also contains 96mg (4.18mmol) of sodium per vial.
For a full list of excipients, see ‘List of excipients’.
Pharmaceutical form
Powder for solution for injection or infusion.
CLINICAL PARTICULARS
Therapeutic indications
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
section ‘Pharmacodynamic properties’):
• 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 section
‘Pharmacodynamic properties’).
• Complicated infections of the kidneys and upper
urinary tract.
• 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,
Klebsiella spp.)
• 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.
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.
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.
A combination of cefotaxime and other antibiotics in
indicated in severe infections.
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.

Contraindications
• Cefotaxime should not be used in patients with a known
or suspected hypersensitivity to cefotaxime or
cephalosporins.
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
administration).
• 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
clinically necessary.
• 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
this product
- 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.
• 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
strictly recommended.
• Cefotaxime should not be combined with bacteriostatic
antibiotics (e.g. tetracyclines, erythromycin and
chloramphenicol) since an antagonistic effect is possible.
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).

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
infections
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.
Age
Daily dose of Cefotaxime
0-7 days
50 mg/kg every 12 hours
8 days- 1 month
50 mg/kg every 8 hours

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.

Elderly
No dosage adjustment is required, provided that renal and
hepatic function are normal.

Effects on ability to drive and use machines
There have been no reports of the effects of Cefotaxime on
the ability to drive.

Gonorrhoea:
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
initiating treatment.
Urinary tract infections:
In uncomplicated UTI 1 g every 12 hours.
Bacterial meningitis:
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 infections:
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 ≤ 5 ml/min,
the initial dose is similar to the recommended usual dose
should be halved without change in the frequency of
dosing.
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
intravenous infusion.
• 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
Long lasting
IntraIntravenous
venous
Infusion
Injection

Vial
size

Short
Intravenous
Infusion

1g

40-50 ml -

2g

-

Intramuscular
Injection

4 ml
100 ml

4 ml

10 ml

-

Undesirable effects
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
Rare
• Prolonged use may result in overgrowth of nonsusceptible organisms (see section – Special warnings
and precautions for use).
Blood and lymphatic system disorders
Rare
• 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
Rare
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.
Cardiac disorders
Very rare
• A very small number of cases of arrhythmia have
occurred following rapid bolus infusion through a central
venous catheter.
Gastrointestinal disorders
Common
• 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
be initiated.
Hepato-biliary disorders
Rare
• 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
Common
• Hypersensitivity reactions have been reported, these
include cutaneous reactions such as skin rashes,
pruritus, urticaria
• Drug fever
Very rare
• 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
Rare
• There may be a temporary increase in creatinine and
urea in the serum
Very rare
• There have been very rare reports of reversible
interstitial nephritis.
General disorder and administration site conditions
Common
• 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.
Overdose
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.

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
should:
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
again.
If you have any further questions on the use
of this product, ask your doctor or
pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Cefotaxime can cause side
effects although not everybody gets them.
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.
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
Stomach problems:
• Abdominal pain, diarrhoea, nausea
(feeling sick) and vomiting (being sick),
candidiasis. You may develop severe and
persistent diarrhea, during or after
treatment, especially if you notice blood or
mucous (manifestations of
pseudomembranous colitis)
Skin problems:
• Skin rash, itching, hives (urticaria), allergic
reactions and swelling of the neck, face or
throat.
Injection site problems:
• Pain, redness and swelling.
Other problems:
• Drug fever
Rare side effects
Blood problems:
• 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
Cefotaxime.
Liver problems:
• moderate and transient increase in liver
enzymes (increase in bilirubin, liver
transaminase and rarely increase in
ALT,AST,LDH,GGT)
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
dialysis.
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
hypersensitivity
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.
PHARMACOLOGICAL PROPERTIES
Pharmacodynamic properties
ATC Code: J01D A10
Pharmacotherapeutic group: Beta-lactam antibiotics,
cephalosporins
General properties
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.
Breakpoints
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:
Susceptible (<) /Resistant (> )
Enterobacteriaceae 2
Pseudomonas Acinetobacter Staphylococcus 3
Enterococcus Streptococcus A, B, C, G
Streptococcus pneumoniae
Other streptococci
Haemophilus influenzae
Moraxella Catarrhalis
Neisseria gonorrhoeae
Neisseria Meningitidis
Gram-positive, anaerobes
Gram-negative, anaerobes
Non-species related
breakpoints 1
S

1/2

Note 3
Note 4
0.5/2
0.5/0.5
0.12/0.12
1/2
0.12/0.12
0.12/0.12
1/2

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
ESBL-production.
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
benzylpenicillin.
-- = Susceptibility testing not recommended as the
species is a poor target for therapy with the drug
Susceptibility
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.
Species
Susceptible
Gram-positive aerobes
Staphylococcus aureus
(Methicillin-susceptible)*
Group A Streptococci (including Streptococcus
pyogenes)*
Group B Streptococci
‚-hemolytic Streptococci (Group C,F, G)
Streptococcus pneumoniae*$
Viridans Group Streptococci
Gram negative aerobes
Citrobacter spp.*
Escherichia coli*
Haemophilus influenzae*
Haemophilus parainfluenzae*
Klebsiella spp. *
Moraxella catarrhalis*
Neisseria gonorrhoeae*
Neisseria meningitides*
Proteus spp. *
Providencia spp.*
Yersinia enterocolitica
Anaerobes
Clostridium spp. (not Clostridium difficile)
Peptostreptococcus spp.
Propionibacterium spp.
Others
Borrelia spp.
Resistant
Gram-positive aerobes
Enterococcus spp.
Enterococcus faecalis
Enterococcus faecium
Listeria spp.
Staphylococcus aureus (MRSA)
Staphylococcus epidermidis (MRSE)
Gram-negative aerobes
Acinetobacter spp.
Citrobacter spp.
Enterobacter spp.
Morganella morganii
Pseudomonas spp.
Serratia spp.
Xanthomonas maltophilia
Anaerobes
Bacteroides spp.
Clostridium difficile
Others
Clamydiae
Mycoplasma spp.
Legionella pneumophilia
*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%
Methicillin-(oxacillin) resistant staphylococci (MRSA) are
resistant to all currently available b-lactam antiobiotics,
including cefotaxime.
Penicillin-resistant Streptococcus pneumoniae show a
variable degree of cross-resistance to cephalosporins such
as cefotaxime

Kidney problems:
• Temporary increase in kidney function
parameters(serum creatinine, urea)
Very rare side effects
Heart problems
• Your heart may flutter.
Kidney problems
• 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)
Other
• Fever, thrush, a furry tongue, headache,
joint pain, move abnormally or involuntary
muscle contractions, breathing difficulties
and feel tired.
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.
5. HOW TO STORE CEFOTAXIME
Keep out of the reach and sight of children.
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.
Always keep this medicine in the closed
original pack, in order to protect from light.
Do not store above 25˚C.
Once reconstituted, this medicine should be
used immediately.
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 Cefotaxime
sodium equivalent to 2 g of Cefotaxime.
There are no other ingredients.
What Cefotaxime looks like and contents of
the pack
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
Manufacturer
Manufacturer:
Laboratorio Reig Jofre, S.A.
Gran Capitán, 10 - 08970 Sant Joan Despí,
Barcelona, Spain
For any information about this medicinal
product, please contact the local representative
of the Marketing Authorisation Holder.
This leaflet was last revised May 2012

Pharmacokinetic properties
Absorption
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 g
dose.
Distribution
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
breast milk.
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.
Biotransformation
Cefotaxime is partly metabolized in human beings.
Approximately 15-25% of a parenteral dose is metabolized
to the O-desacetylcefotaxime metabolite, which also has
antibiotic properties.
Elimination
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
bacteria.
PHARMACEUTICAL PARTICULARS
List of excipients
None.
Incompatibilities
This medicinal product must not be mixed with other
medicinal products except those mentioned in section
‘Special precautions for disposal and other handling’.
Shelf life
Vial before opening: 2 years.
Vial after first opening: The product should be used
immediately.
After reconstitution: The product should be used
immediately.
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 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
safety.
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
Injection).
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 discolouration 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 25174/0007

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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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