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CEFUROXIME 750MG POWDER FOR SOLUTION FOR INJECTION

Active substance(s): CEFUROXIME / CEFUROXIME SODIUM / CEFUROXIME / CEFUROXIME SODIUM / CEFUROXIME SODIUM STERILE / CEFUROXIME / CEFUROXIME SODIUM / CEFUROXIME SODIUM STERILE

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PACKAGE LEAFLET: INFORMATION FOR THE USER

Cefuroxime 750mg powder for solution for injection.
Cefuroxime 1.5g powder for solution for injection or infusion
(cefuroxime sodium)
Read all of this leaflet carefully before you start taking this medicine.
Keep this leaflet. You may need to read it again.
If you have further questions, ask your doctor or pharmacist.
This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their
symptoms are the same as yours.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell
your doctor or pharmacist.

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

What Cefuroxime is and what it is used for
Before you use Cefuroxime
How to use Cefuroxime
Possible side effects
How to store Cefuroxime
Further informaiton

The name of your medicine is Cefuroxime 750mg Powder
for Injection or Cefuroxime 1.5g Powder for Injection or
Infusion but will be referred to as Cefuroxime or as
Cefuroxime injection throughout this leaflet.
1. WHAT CEFUROXIME IS AND WHAT IT IS USED FOR
Cefuroxime injection is an antibiotic which helps the body
fight infections by destroying certain bacteria that causes
them.
Cefuroxime injection is used to treat many different types
of infections including:
• bronchitis, pneumonia and any other chest infections;
• cystitis and kidney infections;
• pelvic inflammatory diseases;
• gonorrhoea;
• ear, nose and throat infections
• skin, soft tissue, bone and joint infections;
• meningitis.
Your doctor may also give it to you before an operation to
protect you from infection.
2. BEFORE YOU USE CEFUROXIME
Your doctor or nurse will make sure it is safe for you to
have Cefuroxime injection.
Do not take Cefuroxime if you:
• are allergic (hypersensitive) to Cefuroxime or any of
the other ingredients of Cefuroxime listed in section 6.
• have ever had an allergic reaction to antibiotics such
as penicillin or cephalosporins. An allergic reaction
may include a rash, itching, swelling or breathing
difficulties.
Take special care with Cefuroxime and tell your doctor if:
• you have kidney problems or are on dialysis
• you have jaundice (yellowing of the skin and
eyes), low blood protein
• this injection is for a premature baby
• you are on a low sodium diet because Cefuroxime
injection contains significant quantities of sodium
This medicine can alter the results of some blood tests
e.g. blood cross-matching and blood sugar tests for
diabetes. It is important to tell the doctor that you are
taking this medicine if you have to have any of these tests.
Unlike certain cephalosporin antibiotics, Cefuroxime does
not usually cause a false positive result when the urine is
tested for sugar.
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.
Cefuroxime may interfere with
• diuretics (water tablets) e.g. furosemide
• aminoglycoside antibiotics e.g. gentamicin and
neomycin
• other antibiotics e.g. probenacid.

In some cases your doctor will arrange further
monitoring, but this is routine and nothing to worry about.
Using Cefuroxime with food and drink
Cefuroxime injection can be used at any time of the day
without regard to food intake.
Pregnancy and breast-feeding
Ask your doctor or pharmacist for advice before taking
any medicine.
Cefuroxime is not known to harm the unborn child but,
like all medicines, it will only be given to a pregnant
woman if it is really needed. Your doctor will decide this.
Breast-feeding is not recommended whilst taking
Cefuroxime as small amounts of Cefuroxime may enter
the milk. .
Driving and using machines
Cefuroxime is not known to affect the ability to drive or
operate machinery.
Important Information about some of the ingredients of
Cefuroxime injection
Each 750mg vial contains 36.75mg sodium; each 1.5g
vial contains 73.5mg sodium. To be taken into
consideration by patients on a controlled sodium diet.
3. HOW TO USE CEFUROXIME
Your doctor will decide which dose you need. Your doctor
or nurse will inject the Cefuroxime injection into a muscle
or into a vein. In some cases, it may be added to a ‘drip’
intravenous infusion.
Cefuroxime Injection is made up by adding the following
amount of sterile water or other recommended diluting
solution:
Vial size

750mg
1.5g

Intramuscular
injection
(suspension)

Intravenous
injection
(solution)

Intravenous
infusion
(solution)

3 ml

6 ml

-

-

15 ml

-

On reconstitution, product must be mixed vigorously for
at least 90 seconds prior to withdrawing into the syringe;
and if not given immediately, again just prior to
administration.
Usual doses
Adults: Most adults need 750mg three or four times a day
but for more severe infections this may be increased to
1.5g three or four times a day. If you have kidney trouble,
you may be given the lower dose just once or twice a day.
• Your doctor may give you 1.5g of Cefuroxime
injection before surgery to protect you from
infection. You may get further doses of 750mg
of Cefuroxime injection after the operation.
• If you have a joint replacement operation, Cefuroxime
may be mixed in the cement which is used.
Infants and children: Most need 60mg for each kilogram
of their body weight each day. This will be divided into
three or four doses.
Newborn babies: Most need 30 to 100mg for each
kilogram of their body weight each day. This will be
divided into three or four doses.

• If you or a child is being treated for meningitis,
larger doses of Cefuroxime injection may be needed.
For the treatment of gonorrhoea:
• 1.5g should be given as a single dose. This may be
given as 2 x 750mg injections into different sites e.g.
each buttock.
For the treatment of pneumonia:
• A twice daily dose of 1.5g injection should be given
for 48-72 hours, followed by a twice daily dose of
500mg cefuroxime axetil oral therapy for 7 days.
For the treatment of acute exacerbations of chronic
bronchitis:
• A twice daily dose of 750mg injection should be given
for 48-72 hours, followed by a twice daily dose of
500mg cefuroxime axetil oral therapy for 5-7 days.
If you take more Cefuroxime 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 take Cefuroxime:
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, Cefuroxime can cause side effects,
although not everybody gets them.
Some people may be allergic to antibiotics; if any of the
following rare side effects occur soon after having your
injection, tell your doctor immediately:
• Loss of consciousness
• Sudden wheeziness and chest tightness or
breathing difficulties
• Swelling of the eyelids, face or lips
• Severe skin rashes that can peel or blister
• Fever
Other side effects are classified according to the following
frequencies:
- Very common (in more than 1 in 10 patients)
- Common (in more than 1 in 100 but less than
1 in 10 patients)
- Uncommon (in more than 1 in 1000 but in less
than 1 in 100 patients)
- Rare (in more than 1 in 10,000 but less than
1 in 1000 patients)
- Very rare (in less than 1 in 10,000 patients including
reports of isolated cases)
Common:
• Changes in liver enzymes
• Inflammation or pain at the site of injection
Uncommon:
• Diarrhoea which contains blood or mucous
Rare:
• Thrush infections
• Easy bruising (thrombocytopenia)
• Changes in how the liver and kidneys function
Very rare:
• Headache, joint pain, generally feeling unwell
(Pseudomembranous colitis)
• Inflammation of the kidneys

Laboratory tests have shown that Cefuroxime can also
cause changes in the blood, such as a decrease in blood
haemoglobin concentrations (may result in anaemia),
decreases in white blood cell counts (with an increased
risk of infection), decreases in the very tiny blood cells
called platelets (resulting in bruising and prolonged
bleeding) and increases in the numbers of a type of white
blood cells (eosinophils).
Like other medicines used to treat meningitis, Cefuroxime
may take some time in clearing up the infection. As a
result of this, hearing loss caused by meningitis has
occurred in a few patients after using cefuroxime.
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 CEFUROXIME
Keep out of the reach and sight of children.
The un-opened dry powder should be stored below 30˚C.
Store in the original package.
From a microbiological point of view, the reconstituted
solution should be used immediately. If not used
immediately, the reconstituted solution should be stored
at 2-8˚C for no longer than 24 hours.
Do not use Cefuroxime after the expiry date which is
stated on the label and carton after EXP.
The expiry refers to the last day of that month.
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 INFORMAITON
What Cefuroxime injection contains
Cefuroxime injection contains the active ingredient
Cefuroxime Sodium. There are no other ingredients.
What Cefuroxime looks like and contents of the pack
Cefuroxime 750 mg powder for injection is a white or
off-white powder which forms:
• an off-white, opaque suspension for intramuscular use
when reconstituted with 3ml of Water for Injections.
• a yellowish, clear solution for intravenous use when
reconstituted with 6ml of Water for Injections.
Cefuroxime 1.5 g powder for injection or infusion is a
white or off-white powder which forms:
• a yellowish, clear solution for intravenous injection
when reconstituted with 15 ml of Water for Injections.
• a yellowish, clear solution for intravenous infusion
when reconstituted with 50 ml of Water for Injections.
Cefuroxime 750 mg powder for injection is available in
10 ml vials in packs of 1, 5, 10 or 100 vials.
Cefuroxime 1.5 g powder for injection or infusion is
available in 20 and 100 ml vials in packs of 1, 10 or 20
vials.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Laboratorio Reig Jofre, S.A.
Gran Capitán, 10
08970 Sant Joan Despí,
Barcelona, Spain
This leaflet was last revised in October 2015.

TECHNICAL LEAFLET

Infants and Children: 200 to 240mg/kg/day i.v. in three or four divided doses.
This dosage may be reduced to 100mg/kg/day i.v. after three days or when
clinical improvement occurs.

‘The following information is for medical or healthcare
professional only’

Neonates: The initial dosage should be 100mg/kg/day i.v. A reduction to
50mg/kg/day i.v. may be made when clinically indicated.

NAME OF THE MEDICINAL PRODUCT
Cefuroxime 750mg powder for solution for injection.

Adults: 3g i.v. every eight hours. Data are not yet sufficient to recommend a
dose for intrathecal administration.

QUALITATIVE AND QUANTITATIVE COMPOSITION
Vials contain 750mg cefuroxime (as sodium salt).
For full list of excipients, ‘List of excipients’.
PHARMACEUTICAL FORM
Powder for solution for injection
White or off-white powder.
CLINICAL PARTICULARS
Therapeutic indications
Cefuroxime is a bactericidal cephalosporin antibiotic which is resistant to most
beta-lactamases and is active against a wide range of Gram-positive and Gramnegative organisms. It is indicated for the treatment of infections before the
infecting organism has been identified or when caused by sensitive bacteria. In
addition, it is an effective prophylactic against post-operative infection in a
variety of operations. Usually Cefuroxime will be effective alone, but when
appropriate it may be used in combination with an aminoglycoside antibiotic,
or in conjunction with metronidazole, orally or by suppository or injection, (see
Pharmaceutical precautions).
In situations where mixed aerobic and anaerobic infections are encountered or
suspected (e.g. peritonitis, aspiration pneumonia, abscesses in the lung, pelvis
and brain), or are likely to occur (e.g. in association with colorectal or
gynaecological surgery) it is appropriate to administer Cefuroxime in
combination with metronidazole.
Most of these infections will respond to an i.v. regimen of Cefuroxime (750mg)
plus metronidazole injection (500mg/100ml) administered eight-hourly. In
more severe or well established mixed infections, an i.v. regimen of
Cefuroxime (1.5g) plus metronidazole injection (500mg/100ml) eight-hourly
may be indicated. For the prophylaxis of infection in surgery (e.g. colorectal
and gynaecological) a single dose of 1.5g Cefuroxime plus metronidazole
injection (500mg/100ml) is appropriate.
Alternatively this may be followed by two 750mg doses of Cefuroxime plus
metronidazole.
Indications include:
Respiratory tract infections for example, acute and chronic bronchitis, infected
bronchiectasis, bacterial pneumonia, lung abscess and post operative chest
infections.
Ear, nose and throat infections for example, sinusitis, tonsillitis and
pharyngitis.
Urinary tract infections for example acute and chronic pyelonephritis, cystitis
and asymptomatic bacteriuria.
Soft-tissue infections for example cellulitis, erysipelas, peritonitis and wound
infections.
Bone and joint infections for example, osteomyelitis and septic arthritis.
Obstetric and gynaecological infections pelvic inflammatory diseases.
Gonorrhoea particularly when penicillin is unsuitable.
Other infections such as meningitis.
Prophylaxis against infection in abdominal, pelvic, orthopaedic, cardiac,
pulmonary, oesophageal and vascular surgery where there is increased risk
from infection.
This permits the use of sequential therapy with the same antibiotic, when a
change from parenteral to oral therapy is clinically indicated.
Where appropriate Cefuroxime is effective when used prior to oral therapy with
cefuroxime axetil in the treatment of pneumonia and acute exacerbations of
chronic bronchitis.
Posology and method of administration
Route and method of administration
Cefuroxime 750mg may be administered by intravenous or intramuscular
injection. For instructions on dilution of the product before administration, see
‘Special precautions for disposal and other handling’.
Normal dosage
Adults:
Many infections will respond to 750mg t.i.d. by i.m. or i.v. injection. For more
severe infections, this dose should be increased to 1.5g t.i.d. i.v. The frequency
of i.m. or i.v. injection can be increased to six-hourly if necessary, giving total
doses of 3g to 6g daily.
Where clinically indicated, adults with pneumonia and acute exacerbations of
chronic bronchitis have been shown to respond to 750mg or 1.5g b.d.,
followed by oral therapy with cefuroxime axetil (see Sequential therapy).
Infants and Children:
Doses of 30 to 100mg/kg/day given as three or four divided doses. A dose of
60mg/kg/day will be appropriate for most infections.
Neonates:
Doses of 30 to 100mg/kg/day given as two or three divided doses. In the first
weeks of life the serum half-life of cefuroxime can be three to five times that in
adults.
Elderly:
See dosage in adults.
Other Recommendations
Gonorrhoea:
1.5g should be given as a single dose. This may be given as 2 x 750mg
injections into different sites (e.g. each buttock).
Meningitis:
Cefuroxime is suitable for sole therapy of bacterial meningitis due to sensitive
strains. The following dosages are recommended.

Prophylaxis:
The usual dose is 1.5g i.v. with induction of anaethesia for abdominal, pelvic
and orthopaedic operations, but may be supplemented with two 750mg i.m.
doses eight and sixteen hours later. In cardiac, pulmonary, oesophageal and
vascular operations, the usual dose is 1.5g i.v. with induction of anaesthesia
continuing with 750mg i.m. t.d.s. for a further 24 to 48 hours.
In total joint replacement, 1.5g cefuroxime powder may be mixed dry with each
pack of methyl methacrylate cement polymer before adding the liquid
monomer.
Sequential therapy:
Pneumonia:
1.5g b.d. (i.v. or i.m.) for 48-72 hours, followed by 500mg b.d. cefuroxime
axetil oral therapy for 7 days.
Acute exacerbations of chronic bronchitis:
750mg b.d. (i.v. or i.m.) for 48-72 hours, followed by 500mg b.d. cefuroxime
axetil oral therapy for 5-7 days.
Duration of both parenteral and oral therapy is determined by the severity of
the infection and the clinical status of the patient.
Dosage in impaired renal function
Cefuroxime is excreted by the kidneys. Therefore, as with all such antibiotics,
in patients with markedly impaired renal function it is recommended that the
dosage of Cefuroxime should be reduced to compensate for its slower
excretion. However, it is not necessary to reduce the dose until the creatinine
clearance falls below 20ml/min. In adults with marked impairment (creatinine
clearance 10-20ml/min) 750mg b.d. is recommended and with severe
impairment (creatinine clearance <10ml/min) 750mg once daily is adequate.
For patients on haemodialysis a further 750mg dose should be given at the end
of each dialysis. When continuous peritoneal dialysis is being used, a suitable
dosage is usually 750mg twice daily.
For patients in renal failure on continuous arteriovenous haemodialysis or highflux haemofiltration in intensive therapy units a suitable dosage is 750mg twice
daily. For low-flux haemofiltration follow the dosage recommended under
impaired renal function.
Cefuroxime is also available as the axetil ester for oral administration. This
permits parenteral therapy with cefuroxime to be followed by oral therapy in
situations where a change from parenteral to oral is clinically indicated.
Contraindications
Hypersensitivity to cefuroxime or to any of the cephalosporins. Previous
immediate and/or severe hypersensitivity reaction to a penicillin or to any other
type of beta-lactam drug.
Special warnings and precautions for use
Special care is indicated in patients who have experienced an allergic reaction
to penicillins or beta-lactams.
There may be some variation on the results of biochemical tests of renal
function, but these do not appear to be of clinical importance. As a precaution,
renal function should be monitored if this is already impaired.
Delayed sterilisation of the CSF in patients with Haemophilus influenzae
meningitis may result in an adverse outcome such as deafness and /or
neurological sequelae. Persistence of positive CSF cultures of H. influenzae at
18-36 hours has been noted in some patients treated with cefuroxime sodium
injection and, as with other therapeutic regimens used in the treatment of
meningitis, hearing loss has been reported in some children.
With a sequential therapy regime the timing of change to oral therapy is
determined by severity of the infection, clinical status of the patient and
susceptibility of the pathogens involved. The change to oral therapy should
only be made once there is a clear clinical improvement. If there has been no
clinical improvement after 72 hours of parenteral treatment, then the patient's
treatment should be reviewed. Please refer to the relevant prescribing
information for cefuroxime axetil before initiating sequential therapy.
This medicinal product contains 36.75 mg sodium per dose. To be taken into
consideration by patients on a controlled sodium diet.
Interaction with other medicinal products and other forms of interaction
Cephalosporin antibiotics at high dosage should be given with caution to
patients receiving concurrent treatment with potent diuretics such as
furosemide and aminoglycosides, as these combinations are suspected of
adversely affecting renal function. Clinical experience with Cefuroxime has
shown that this is not likely to be a problem at the recommended dose levels.
Cefuroxime does not interfere in enzyme-based tests for glycosuria. Slight
interference with copper reduction methods (Benedict's, Fehling's, Clinitest)
may be observed. However, this should not lead to false-positive results, as
may be experienced with some other cephalosporins.
It is recommended that either the glucose oxidase or hexokinase methods are
used to determine blood/plasma glucose levels in patients receiving
Cefuroxime. This antibiotic does not interfere in the alkaline picrate assay for
creatinine.
Pregnancy and lactation
There is no experimental evidence of embryopathic or teratogenic effects
attributable to Cefuroxime but, as with all drugs, it should be administered with
caution during the early months of pregnancy.
Cefuroxime is excreted in human milk, and consequently caution should be
exercised when Cefuroxime is administered to a nursing mother.
Effects on ability to drive and use machines
None reported.
Undesirable effects
The following convention has been used for the classification of frequency:
Very common
>1/10
Common
>1/100 and <1/10
Uncommon
>1/1000 and <1/100
Rare
>1/10,000 and <1/1000
Very rare
<1/10,000.

Infections and infestations
Rare: Candida overgrowth from prolonged use.
Blood and lymphatic system disorders
Common: Neutropenia, eosinophilia.
Uncommon: Leukopenia, decreased haemoglobin concentration, positive
Coomb’s test.
Rare: Thrombocytopenia.
Very rare: Haemolytic anaemia.
Cephalosporins as a class tend to be absorbed onto the surface of red cell
membranes and react with antibodies directed against the drug to produce a
positive Coomb’s Test (which can interfere with cross matching of blood) and
very rarely haemolytic anaemia.
Immune system disorders
Hypersensitivity reactions including
Uncommon: Skin rash, urticaria and pruritus.
Rare: Drug fever.
Very rare: Interstitial nephritis, anaphylaxis.
See also Skin and subcutaneous tissue disorders and Renal and urinary
disorders.
Gastrointestinal disorders
Uncommon: Gastrointestinal disturbance.
Very rare: Pseudomembranous colitis.
Hepatobiliary disorders
Common: Transient rise in liver enzymes.
Uncommon: Transient rise in bilirubin.
Transient rises in serum liver enzymes or bilirubin occur, particularly in
patients with pre-existing liver disease, but there is no evidence of harm to the
liver.
Skin and subcutaneous tissue disorders
Very rare: Erythema multiforme, toxic epidermal necrolysis and Stevens
Johnson Syndrome.
See also Immune system disorders.
Renal and urinary disorders
Very rare: Elevations in serum creatinine, elevations in blood urea nitrogen and
decreased creatinine clearance (See Special Warnings and Precautions for
use).
See also Immune system disorders.
General disorders and administration site conditions
Common: Injection site reactions which may include pain and thrombophlebitis.
Pain at the intramuscular injection site is more likely at higher doses. However
it is unlikely to be 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:
http://www.mhra.gov.uk/yellowcard.
Overdose
Overdosage of cephalosporins can cause cerebral irritation leading to
convulsions. Serum levels of cefuroxime can be reduced by haemodialysis or
peritoneal dialysis.
PHARMACOLOGICAL PROPERTIES
Pharmacodynamic properties
Pharmacotherapeutic group: cephalosporins and related substances, ATC-Code:
J01D A06
Mode of action
Cefuroxime axetil owes its in vivo bactericidal activity to the parent compound
cefuroxime. All cephalosporins (ß-lactam antibiotics) inhibit cell wall production
and are selective inhibitors of peptidoglycan synthesis. The initial step in drug
action consists of binding of the drug to cell receptors, called Penicillin-Binding
Proteins. After a ß-lactam antibiotic has bound to these receptors, the
transpeptidation reaction is inhibited and peptidoglycan synthesis is blocked.
Bacterial lysis is the end result.
Mechanism of resistance
Bacterial resistance to cefuroxime may be due to one or more of the following
mechanisms:
• hydrolysis by beta-lactamases. Cefuroxime may be efficiently hydrolysed
by certain of the extended-spectrum beta-lactamases (ESBLs) and by the
chromosomally-encoded (AmpC) enzyme that may be induced or stably
derepressed in certain aerobic gram-negative bacterial species
• reduced affinity of penicillin-binding proteins for cefuroxime
• outer membrane impermeability, which restricts access of cefuroxime to
penicillin binding proteins in gram-negative organisms
• drug efflux pumps
Methicillin-resistant staphylococci (MRS) are resistant to all currently available
ß-lactam antibiotics including cefuroxime.
Penicillin-resistant Streptococcus pneumoniae are cross-resistant to
cephalosporins such as cefuroxime through alteration of penicillin binding
proteins.
Beta-lactamase negative, ampicillin resistant (BLNAR) strains of H. influenzae
should be considered resistant to cefuroxime despite apparent in vitro
susceptibility.
Strains of Enterobacteriaceae, in particular Klebsiella spp. and Escherichia coli
that produce ESBLs (extended spectrum ß-lactamase) may be clinically
resistant to therapy with cephalosporins despite apparent in vitro susceptibility
and should be considered as resistant.
Breakpoints:
According to the NCCLS (National Committee on Clinical Laboratory Standards)
in 2001 the following breakpoints have been defined for cefuroxime:
Enterobacteriaceae: ≤ 4 μg/ml susceptible, ≥ 32 μg/ml resistant
Staphylococcus spp.: ≤ 4 μg/ml susceptible, ≥ 32 μg/ml resistant
Haemophilus spp.: ≤ 4 μg/ml susceptible; ≥ 16 μg/ml resistant
Streptococcus pneumoniae: ≤ 1 μg/ml susceptible, ≥ 4 μg/ml resistant
Streptococcus spp. other than S.pneumoniae: Streptococcal isolates
susceptible to penicillin (MIC90 ≤ 0.12 μg/ml) may be considered susceptible
to cefuroxime.
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. As necessary, expert advice should be sought
when the local prevalence of resistance is such that the utility of the agent in at
least some types of infections is questionable.

Commonly susceptible species
Aerobes, Gram positive:
Staphylococcus aureus (methicillin-susceptible)
Coagulase-negative staphylococci (methicillin-susceptible)
Streptococcus agalactiae
Streptococcus pneumoniae
Streptococcus pyogenes
Aerobes, Gram negative:
Escherichia coli
Haemophilus influenzae
Klebsiella species
Moraxella catarrhalis
Proteus mirabilis
Proteus rettgeri
Anaerobes,
Peptococcus species
Peptostreptococcus species
Other organisms:
Borrelia burgdorferi.
Species for which resistance may be a problem
Acinetobacter species
Citrobacter species
Enterobacter species
Morganella morganii
Resistant
Bacteroides fragilis
Clostridium difficile
Enterococci
Listeria monocytogenes
Proteus vulgaris
Pseudomonas species
Serratia species
Pharmacokinetic properties
Peak levels of cefuroxime are achieved within 30 to 45 minutes after
intramuscular administration. The serum half-life after either intramuscular or
intravenous injection is approximately 70 minutes. Concurrent administration
of probenecid prolongs the excretion of the antibiotic and produces an elevated
peak serum level. There is almost complete recovery of unchanged cefuroxime
in the urine within 24 hours of administration, the major part being eliminated
in the first six hours. Approximately 50% is excreted through the renal tubules
and approximately 50% by glomerular filtration. Concentrations of cefuroxime
in excess of the minimum inhibitory levels for common pathogens can be
achieved in bone, synovial fluid and aqueous humor. Cefuroxime passes the
blood-brain barrier when the meninges are inflamed.
Preclinical safety data
No additional data of relevance.
PHARMACEUTICAL PARTICULARS
List of excipients: None.
Incompatibilities
Cefuroxime is compatible with most commonly used intravenous fluids and
electrolyte solutions.
The pH of 2.74% w/v sodium bicarbonate injection BP considerably affects the
colour of solutions and therefore this solution is not recommended for the
dilution of Cefuroxime. However, if required, for patients receiving sodium
bicarbonate injection by infusion the Cefuroxime may be introduced into the
tube of the giving set.
Cefuroxime should not be mixed in the syringe with aminoglycoside antibiotics.
Shelf life
Un-opened dry powder: 3 years
Reconstituted solution: 24 hours stored in the conditions recommended in
‘Special precautions for storage’.
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 8˚C, unless reconstitution/dilution (etc) has taken place in controlled
and validated aseptic conditions.
Special precautions for use
Up-opened dry powder: Store below 30˚C. Store in the original package.
Reconstituted solution:The reconstituted solution should be stored at 2-8˚C for
no longer than 24 hours.
Refer to ‘Shelf life’ for the storage of sterile products that have been opened,
diluted or reconstituted.
Nature and contents of container
A type II transparent, colourless glass vial, with a bromobutyl stopper and a
blue aluminum and polypropylene flip off cap with adhesive labels.
Cefuroxime 750mg Powder for Injection is available in 10ml vials in packs of 1,
5, 10 or 100 vials. Not all pack sizes may be marketed.
Special precautions for disposal and other handling
Cefuroxime 750mg when dissolved in Water for Injections forms an off-white,
opaque suspension for intramuscular use or a yellowish, clear solution for
intravenous administration.
Intramuscular injection
750mg of Cefuroxime should be dissolved in 3ml of Water for Injections.
Shake gently to produce an opaque suspension.
Intravenous injection
750mg of Cefuroxime should be dissolved in 6ml of Water for Injections.
Shake gently to produce a clear solution. This solution may be given directly
into the vein or introduced into the tubing of the giving set if the patient is
receiving parenteral fluids.
On reconstitution, product must be mixed vigorously for at least 90 seconds
prior to withdrawing into the syringe; and if not given immediately, again just
prior to administration.
Any unused product or waste material should be disposed of in accordance
with local requirements.
MARKETING AUTHORISATION HOLDER
Laboratorios Reig Jofre, S.A.
Gran Capitán, 10
08970 Sant Joan Despí, Barcelona (Spain)
MARKETING AUTHORISATION NUMBER
PL 25174/0008

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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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