Skip to Content

UK Edition. Click here for US version.

CEFUROXIME 250MG POWDER FOR INJECTION

Active substance(s): CEFUROXIME SODIUM

View full screen / Print PDF » Download PDF ⇩
Transcript
PACKAGE LEAFLET: INFORMATION FOR THE USER

Cefuroxime 250mg Powder for Injection
Cefuroxime 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 any further questions, 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 your pharmacist.
In this leaflet:
1. What Cefuroxime Injection is and what it is used for
2. Before you are given Cefuroxime Injection
3. How Cefuroxime Injection is given
4. Possible side effects
5. How to store Cefuroxime Injection
6. Further information

Taking other medicines:
Tell your doctor if you are taking any of the following medicines as they
may interact with Cefuroxime Injection:
• probenecid, which is a medicine used to treat “gout”
• “water tablets” (to help you go to the toilet) such as furosemide
• an aminoglycoside-type antibiotic or any other antibiotics.
Please tell your doctor or pharmacist if you are taking or have recently
taken, any other medicines including medicines obtained without a
prescription.
Pregnancy and breast-feeding:
If you are pregnant, likely to become pregnant or are breast-feeding, you
must tell your doctor before you are given this medicine.

1. WHAT CEFUROXIME INJECTION IS AND WHAT IT IS USED FOR
Your medicine contains the active substance Cefuroxime, which is one of
a group of medicines called antibiotics. These are used to kill the bacteria
or ‘germs’ that cause infections.
Your doctor has decided to give you Cefuroxime Injection because you
have an infection, or to protect you from infection before an operation.

2. BEFORE YOU ARE GIVEN CEFUROXIME INJECTION
Do not take Cefuroxime Injection:
• If you are allergic (hypersensitive) to cefuroxime or other similar
antibiotics (called “cephalosporins”)
• If you have had a severe allergic reaction to penicillin or other similar
antibiotics (called “beta-lactams”)
• If you had an immediate allergic reaction when given penicillin or similar
antibiotics.
If you are unsure about any of these, ask your doctor.
Take special care with Cefuroxime Injection if you have been told that
your kidneys are not working as well as they should be. Talk to your doctor
if this applies to you.
If you have previously had an allergic reaction to penicillin or other similar
antibiotics, you should tell your doctor. It may be alright for you to be given
this medicine.
If the allergic reaction was severe or immediate, you should not take this
medicine.

Driving and using machines
This medicine has no known effects on the ability to drive or use machines.
Important information about some of the ingredients of Cefuroxime
Injection:
This medicine contains approximately 2.2 mmol (51mg) of sodium per
gram. This should be taken into consideration by patients on a controlled
sodium diet.

3. HOW CEFUROXIME INJECTION IS GIVEN
Cefuroxime Injection will usually be given by a doctor or nurse, either
directly into a vein or into a muscle. In some cases, it may be added to an
intravenous infusion (‘drip’).
The correct dose will be decided by your doctor and depends on the type
of infection and your weight and age.
Adults:
The usual adult dose is 750mg three times a day. The duration of treatment
depends on the type of infection. Larger or more frequent doses are
sometimes needed for more severe infections.
For example, to treat gonorrhoea the usual dose is 1.5 grams (1.5g) as a
single injection or as two separate 750mg injections.
To treat meningitis, the usual adult dose is 3 grams (3g) every 8 hours.
To prevent infections following an operation, the usual dose is 1.5 grams
(1.5g) given at the same time as the anaesthetic. After the operation, your
doctor or nurse may give you 750mg injections at regular intervals for up
to 48 hours depending on the type of operation.

INFORMATION FOR THE HEALTHCARE PROFESSIONAL
The following information is intended for medical or healthcare professionals only.
Instructions for use and handling:

Incompatibilities

This medicinal product is for single use only. Discard any unused contents.

Solutions containing cefuroxime should not be mixed with or added to
solutions containing other agents other than those listed opposite.

Intramuscular use
Add 1ml water for injections to Cefuroxime 250mg powder for injection.
Shake gently to produce an opaque suspension (final volume 1.1ml).
Intravenous use
Dissolve in water for injections using at least 2ml to produce a clear
solution (final volume 2.1ml).
Reconstituted solutions may be diluted with:
10% dextrose
0.9% sodium chloride injection
M/6 sodium lactate injection
Ringer’s injection
Lactated Ringer’s injection

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 powder for injection. However, if required, for
patients receiving sodium bicarbonate injection by infusion, the cefuroxime
powder for injection may be introduced into the tube of the giving set.
Cefuroxime powder for injection should not be mixed in the syringe with
aminoglycoside antibiotics.
Posology and method of administration

These solutions may be given directly into the vein or introduced into the
tubing of the giving set if the patient is receiving parenteral fluids.
Storing Cefuroxime Injection:
Keep vials in outer carton to protect from light.
Reconstituted solution: Chemical and physical stability has been
demonstrated for 24 hours at 2°C – 8°C and for 8 hours at 25°C. From a
microbiological point of view, the product should be used immediately.
If not used immediately, in-use storage times and conditions are the
responsibility of the user and would normally be no longer than 24 hours
at 2-8°C unless reconstitution has taken place in controlled and validated
aseptic conditions.

Usually cefuroxime is effective when administered alone, but when
appropriate it may be used in combination with metronidazole or an
aminoglycoside.
General Dosage
Adults: Many infections will respond to 750mg three times daily by
intramuscular or intravenous injection. For more severe infections,
this dose should be increased to 1.5g three times daily intravenously.
The frequency of dosage may be increased to six-hourly injections
(intramuscular or intravenous) giving total daily doses of 3g to 6g.
Infants and Children: Doses of 30 to 100mg/kg/day given as three or
four divided doses. A dose of 60 mg/kg/day will be appropriate for most
infections.

ACSI092F00

FRONT

Children:
For infants and children, the dose is based on how much they weigh and
is usually between 30mg to 100mg per kilogram daily divided into three
or four separate doses. For newborn children the dose is the same as for
infants and children, but is divided into 2 or 3 doses.
To treat meningitis, the usual dose is between 200mg to 240mg per
kilogram daily divided into three or four separate doses. This may be
reduced to 100mg per kilogram daily when your child shows signs of
improvement.
For newborn children, the usual dose is 100mg per kilogram daily which
may be reduced to 50mg per kilogram daily when your child shows signs
of improvement.
Patients with kidney problems:
For patients with kidney problems, the usual dose is 750mg given once
or twice daily.

4. POSSIBLE SIDE EFFECTS
Like all medicines, Cefuroxime Injection can cause side effects, although
not everybody gets them.
As with other antibiotics, some people find they have an allergy to it.
Tell your doctor immediately if any of the following symptoms occur:
• Sudden wheeziness and tightness of chest
• Swelling of eyelids, face or lips
• Skin lumps or “hives” (nettle rash)
• Severe skin rashes with itching
Antibiotic treatment can affect the normal bacteria in the gut, causing new
infection (colitis). You should tell your doctor immediately if you develop
diarrhoea.
The following side effects may occur in some patients treated with
Cefuroxime injection. Tell your doctor if any become troublesome:
Common side effects (probably affecting more than 1 in 100 patients)
• Reduction in number of white blood • Increased liver enzymes
cells which makes infections more likely • Pain, redness and swelling
• Increase in number of white blood cells at the injection site
Uncommon side effects (probably affecting less than 1 in 100 patients)
• Reduced haemoglobin concentration
• Itching
• False positive blood tests
• Loose stools or diarrhoea
• Rash with small, raised, red areas of skin • Skin and whites of the eyes
(which may be itchy and/or scaly)
turn yellow

Rare side effects (probably affecting less than 1 in 1,000 patients)
• Fewer red blood cells which can make • Serious allergic reaction
which causes difficulty in
the skin pale and cause weakness or
breathing or dizziness
breathlessness
• Fever
• Reduction in blood platelets which
• Yeast infections e.g. thrush
increases risk of bruising or bleeding

Neonates: Doses of 30 to 100mg/kg/day given as two of 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
Gonorrhoea:
1.5g should be given as a single dose or as two 750mg injections into
different sites e.g. each buttock.
Meningitis:
Cefuroxime powder for injection is suitable for sole therapy of bacterial
meningitis due to sensitive strains.
The following dosages are
recommended.
Infants and children: 200 to 240mg/kg/day intravenously in three or four
divided doses. This dosage may be reduced to 100mg/kg/day after three
days or when clinical improvement occurs.

Very rare side effects (probably affecting less than 1 in 10,000 patients)
• Reduction in red blood cells which can • Problems with kidney
function
make the skin pale or yellow and cause
• Serious illness with
weakness or breathlessness
blistering of the skin,
• Diarrhoea containing blood (which may
mouth, eyes and genitals
be a sign of a condition called
pseudomembranous colitis)
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 INJECTION
Keep out of the reach and sight of children.
Do not use Cefuroxime Injection after the expiry date which is printed on
the label and carton.
Keep vials in outer carton to protect from light.
Your doctor, pharmacist or nurse will know how to store Cefuroxime
Injection properly.

6. FURTHER INFORMATION
What Cefuroxime Injection contains
• The active substance is Cefuroxime 250mg
• Your medicine contains no other ingredients
What Cefuroxime Injection looks like and contents of the pack:
Cefuroxime Injection is a white powder in a glass vial.
Each vial contains 250mg of Cefuroxime.
Each carton contains 1, 5, 10, 20 or 50 vials. Not all pack sizes may be
marketed.
Marketing Authorisation Holder:
Villerton Invest SA
40, Avenue Monterey
L-2163 Luxembourg
Manufacturer:
Facta Farmaceutici SpA, 64100 Teramo, Italy
This leaflet was last revised in January 2015.

L08GBCEFU2504

Dosage in impaired renal function
As cefuroxime is excreted by the kidneys, the dosage should be reduced
to allow for slower excretion in patients with impaired renal function, once
creatinine clearance falls below 20ml/min, as follows:
Marked impairment (creatinine clearance 10 – 20ml/min): 750mg twice
daily.
Severe impairment (creatinine clearance <10ml/min): 750mg once daily.
For patients on haemodialysis, a further 750mg dose should be given at
the end of each dialysis.
Continuous peritoneal dialysis: 750mg twice daily.
Renal failure on continuous arteriovenous haemodialysis or high-flux
haemofiltration in intensive therapy units: 750mg twice daily.
Low-flux haemofiltration: as for impaired renal function.

Neonates: The initial dose should be 100mg/kg/day intravenously. This
may be reduced to 50mg/kg/day when clinically indicated.
Adults: 3g intravenously every eight hours. No data are currently available
to recommend a dose for intrathecal administration.
Prophylaxis:
The usual dose is 1.5g intravenously with induction of anaesthesia. For
abdominal, pelvic and orthopaedic operations this may be followed
with two 750mg doses 8 and 16 hours later. For cardiac pulmonary,
oesophageal and vascular operations, this may be supplemented with
750mg intramuscularly three times a day 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.

BACK

L08GBCEFU2504

ACSI092F00

Expand view ⇕

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.

Hide