Cefuroxime for Injection

New Zealand - English - Medsafe (Medicines Safety Authority)

Buy It Now

Active ingredient:
Cefuroxime sodium 789 mg equivalent to 750 mg cefuroxime;  
Available from:
Mylan New Zealand Ltd
INN (International Name):
Cefuroxime sodium 789 mg (equivalent to 750 mg cefuroxime)
Dosage:
750 mg
Pharmaceutical form:
Powder for injection
Composition:
Active: Cefuroxime sodium 789 mg equivalent to 750 mg cefuroxime  
Units in package:
Vial, glass, Ph Eur Type III or Type II clear glass,
Class:
Prescription
Prescription type:
Prescription
Manufactured by:
Qilu Antibiotics Pharmaceutical Co Ltd
Product summary:
Package - Contents - Shelf Life: Vial, glass, Type II, 10 mL. Closure: bromobutyl rubber stopper, flip-off Al cap. Manufactured at Sinopharm only - 1 dose units - 24 months from date of manufacture stored at or below 25°C 24 hours reconstituted stored at 2° to 8°C (Refrigerate, do not freeze) - Vial, glass, Type I, 15 mL. Closure: bromobutyl rubber stopper, flip-off Al cap. Manufactured at Sinopharm only - 1 dose units - 24 months from date of manufacture stored at or below 25°C 24 hours reconstituted stored at 2° to 8°C (Refrigerate, do not freeze) - Vial, glass, Type II, 10 mL. Closure: chlorobutyl rubber stopper, flipoff Al cap. Manufactured at Reig Jofre only - 1 dose units - 24 months from date of manufacture stored at or below 25°C 24 hours reconstituted stored at 2° to 8°C (Refrigerate, do not freeze) - Vial, glass, Type II, 10 mL. Closure: chlorobutyl rubber stopper, flipoff Al cap. Manufactured at Reig Jofre only - 10 dose units - 24 months from date of manufacture stored at or below 25°C 24 hours reconstituted stored at 2° to 8°C (Refrigerate, do not freeze) - Vial, glass, Type II, 10 mL. Closure: bromobutyl rubber stopper, flip-off Al cap. Manufactured at Sinopharm only - 10 dose units - 24 months from date of manufacture stored at or below 25°C 24 hours reconstituted stored at 2° to 8°C (Refrigerate, do not freeze) - Vial, glass, Type I, 15 mL. Closure: bromobutyl rubber stopper, flip-off Al cap. Manufactured at Sinopharm only - 10 dose units - 24 months from date of manufacture stored at or below 25°C 24 hours reconstituted stored at 2° to 8°C (Refrigerate, do not freeze)
Authorization number:
TT50-6281a
Authorization date:
1998-12-02

Page 1 of 3

NEW ZEALAND CONSUMER MEDICINE INFORMATION

CEFUROXIME FOR INJECTION

Cefuroxime Sodium Injection Powder

250 mg, 750 mg, 1.5 g

What is in this leaflet

This leaflet answers some common

questions about CEFUROXIME

INJECTION.

It does not contain all the available

information. It does not take the

place of talking to your doctor or

pharmacist.

All medicines have risks and

benefits. Your doctor has weighed

the risks of you using

CEFUROXIME INJECTION against

the benefits they expect it will have

for you.

If you have any concerns about

using this medicine, ask your

doctor or pharmacist.

Keep this leaflet with the

medicine. You may need to read it

again.

What CEFUROXIME

INJECTION is used

for

CEFUROXIME INJECTION is an

antibiotic used to treat a wide range

of infections caused by bacteria and

also to prevent infections during

surgery. It can be given to adults

and children.

CEFUROXIME INJECTION

contains the active ingredient

cefuroxime sodium. It belongs to a

group of medicines called

cephalosporin antibiotics which

targets a wide range of common

bacteria. It works by killing the

bacteria causing the infection or

preventing cell growth.

CEFUROXIME INJECTION is used

in adults and children to treat

bacterial infections of the:

lungs or chest (bronchitis,

pneumonia)

ears, nose and throat

(tonsillitis)

urinary tract

soft tissue

bones and joints

(osteomyelitis)

female reproductive organs

brain (meningitis)

abdomen (peritonitis)

blood (septicaemia)

CEFUROXIME INJECTION can

also be used to:

treat gonorrhoea, a sexually

transmitted infection

prevent infections during

various surgeries

Ask your doctor if you have any

questions about why this

medicine has been prescribed for

you.

Your doctor may have prescribed it

for another reason.

This medicine is not addictive.

This medicine is available only with

a doctor’s prescription.

Before you are given

CEFUROXIME

INJECTION

When you must not be

given it

Do not use CEFUROXIME

INJECTION if you have an allergy

to:

any medicine containing

cefuroxime sodium

any penicillins or any other

beta-lactams

any other cephalosporin

antibiotics.

Some of the symptoms of an

allergic reaction may include:

shortness of breath; wheezing or

difficulty breathing; swelling of the

face, lips, tongue or other parts of

the body; rash, itching or hives on

the skin.

Before you start to use it

Tell your doctor if you have

allergies to any other medicines,

foods, preservatives or dyes.

Tell your doctor if you have or

have had any of the following

medical condition:

kidney problems, with extra

caution in the elderly.

Tell your doctor if you are

pregnant or plan to become

pregnant or are breast-feeding.

Your doctor can discuss with you

the risks and benefits involved.

There is no experimental evidence

of birth defects attributable to

CEFUROXIME INJECTION

however; all medicines should be

administered with caution.

CEFUROXIME INJECTION is

passed though breast milk.

If you have not told your doctor

about any of the above, tell

him/her before you start using

CEFUROXIME INJECTION.

Taking other medicines

Tell your doctor or pharmacist if

you are taking any other

medicines, including any that you

get without a prescription from

your pharmacy, supermarket or

health food shop.

Some medicines and

CEFUROXIME INJECTION may

interfere with each other. These

include:

Page 2 of 3

combined oral

contraceptives

water tablets (diuretics),

such as furosemide

aminoglycoside-type

antibiotics

These medicines may be affected

by CEFUROXIME INJECTION or

may affect how well it works. You

may need different amounts of your

medicines, or you may need to take

different medicines.

Your doctor and pharmacist have

more information on medicines to

be careful with or avoid while using

this medicine.

How CEFUROXIME

INJECTION is given

CEFUROXIME INJECTION can be

given in three ways:

as an injection into the

muscle

as an injection into a vein

as a drip (intravenous

infusion)

CEFUROXIME INJECTION must

only be given by a doctor or a

nurse.

Your doctor will decide on the dose

and length of time that you will

receive CEFUROXIME INJECTION.

Use the medicine for as long as the

doctor recommends.

Follow all directions given to you

by your doctor or pharmacist

carefully.

They may differ from the information

contained in this leaflet.

CEFUROXIME INJECTION is

generally given alone although

sometimes your doctor may

prescribe it in combination with

another type of antibiotic called an

aminoglycoside or together with an

antibacterial agent called

metronidazole.

If too much

CEFUROXIME

INJECTION is given

(overdose)

Immediately telephone your

doctor or the National Poisons

Information Centre (0800 POISON

or 0800 764 766) for advice, or go

to Accident and Emergency at

the nearest hospital, if you think

that you or anyone else may have

used too much CEFUROXIME

INJECTION. Do this even if there

are no signs of discomfort or

poisoning. You may need urgent

medical attention.

Symptoms of an overdose may

include convulsions.

While you are using

CEFUROXIME

INJECTION

Things you must do

If you are about to be started on

any new medicine, remind your

doctor and pharmacist that you

are using CEFUROXIME

INJECTION.

Tell any other doctors, dentists,

and pharmacists who treat you

that you are using this medicine.

If you are going to have surgery,

tell the surgeon or anaesthetist

that you are using this medicine.

It may affect other medicines used

during surgery.

If you become pregnant while

using this medicine, tell your

doctor immediately.

If you are about to have any

blood tests, tell your doctor that

you are using this medicine.

It may interfere with the results of

some tests.

Things you must not do

Do not use CEFUROXIME

INJECTION to treat any other

complaints unless your doctor

tells you to.

Do not stop using your medicine

or lower the dosage without

checking with your doctor.

Things to be careful of

Be careful driving or operating

machinery until you know how

CEFUROXIME INJECTION affects

you.

This medicine may cause dizziness

in some people. If you feel dizzy, do

not drive, operate machinery or do

anything else that could be

dangerous.

Side effects

Tell your doctor or pharmacist as

soon as possible if you do not

feel well while you are using

CEFUROXIME INJECTION.

This medicine helps most people

with bacterial infections, but it may

have unwanted side effects in a few

people. All medicines can have side

effects. Sometimes they are

serious, most of the time they are

not. You may need medical

attention if you get some of the side

effects.

Do not be alarmed by the

following lists of side effects.

You may not experience any of

them.

Ask your doctor or pharmacist to

answer any questions you may

have.

Tell your doctor or pharmacist if

you notice any of the following

and they worry you:

white furry, sore tongue and

mouth (oral thrush)

sore, itchy vagina and/or

discharge (vaginal thrush)

swelling and redness along

the vein

swelling, pain or tenderness

at the injection site

nausea, vomiting,

diarrhoea, abdominal pain

tendency to bruise or bleed

easily

The above list includes the more

common side effects that are

usually mild and short-lived.

Page 3 of 3

Tell your doctor as soon as

possible if you notice any of the

following:

signs of an allergic reaction,

such as shortness of

breath, wheezing or

difficulty breathing, swelling

of the face, lips, tongue or

other parts of the body;

rash, itching or hives on the

skin

chills or fever, which may

be accompanied by

shivering

ringing in the ears or

hearing loss

low blood pressure

prolonged or severe

diarrhoea or stomach

cramps

The above list includes serious side

effects that may require medical

attention. Serious side effects are

rare.

After using

CEFUROXIME

INJECTION

Storage

The medicine should be kept in

the packaging until it is time to

use it.

CEFUROXIME INJECTION should

be kept in a cool, dry place where

the temperature stays below 25°C.

CEFUROXIME INJECTION or any

other medicine should not be stored

in the bathroom or near a sink.

Heat and dampness can destroy

some medicines.

CEFUROXIME INJECTION should

be stored where children cannot

reach it.

A locked cupboard at least one-and-

a half metres above the ground is a

good place to store medicines.

Product description

What it looks like

CEFUROXIME INJECTION is a

white to faintly yellow powder to

which water is added to prepare an

off-white suspension for

intramuscular use or a yellow

solution for intravenous

administration. Colour of the

suspension may vary.

CEFUROXIME INJECTION is

supplied in vials which contain 250

mg, 750 mg, or 1.5g of cefuroxime

sodium powder for injection or

infusion.

Not all strengths may be marketed.

Ingredients

CEFUROXIME contains 250 mg,

750 mg, or 1.5 g of cefuroxime

sodium as the active ingredient.

This medicine does not contain

lactose, sucrose, gluten, tartrazine

or any other azo dyes.

If you want to know

more

Should you have any questions

regarding this product, please

contact your pharmacist or doctor.

Who supplies this

medicine

Distributed in New Zealand by:

Mylan New Zealand Ltd,

PO Box 11183,

Ellerslie,

Auckland.

Telephone: (09) 579 2792.

Date of Information

24 February 2017

(Based on datasheet dated

24 February 2017).

Page 1 of 11

NEW ZEALAND DATA SHEET

CEFUROXIME FOR INJECTION

1. Product Name

Cefuroxime for injection, 250mg, 750 mg, 1.5 g, powder for injection.

2. Qualitative and Quantitative Composition

Each vial contains 263 mg, 789 mg or 1.578 g of cefuroxime sodium, equivalent to 250 mg, 750

mg or 1.5 g of cefuroxime.

3. Pharmaceutical Form

Cefuroxime is a white to faintly yellow powder to which appropriate amounts of water are added to

prepare an off-white suspension for intramuscular use or a yellow solution for intravenous

administration.

Variations in the intensity of this colour do not indicate any change in either the efficacy or safety of

the product.

4. Clinical Particulars

4.1

Therapeutic indications

Cefuroxime is a bactericidal cephalosporin antibiotic which is resistant to most β-lactamases and is

active against a wide range of Gram-positive and Gram-negative organisms.

It is indicated for the treatment of infections before the infecting organism has been identified or

when caused by sensitive bacteria.

Susceptibility to cefuroxime sodium will vary with geography

and time and local susceptibility data should be consulted where available (see section 5.1).

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, pharyngitis and otitis media.

Urinary

tract

infections

example,

acute

chronic

pyelonephritis,

cystitis

asymptomatic

bacteriuria.

Soft-tissue infections for example, cellulitis, erysipelas 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 including septicaemia, meningitis and peritonitis.

Prophylaxis against infection in abdominal, pelvic, orthopaedic, cardiac, pulmonary, oesophageal and

vascular surgery where there is increased risk from infection.

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), especially for prophylaxis in colonic or gynaecological surgery (see section 6.6).

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Where appropriate cefuroxime sodium is effective when used prior to oral therapy with cefuroxime

axetil in the treatment of pneumonia and acute exacerbations of chronic bronchitis.

4.2

Dose and method of administration

Dose

General recommendations

Many infections respond to 750 mg three times daily by intramuscular or intravenous injection. For

more severe infections the dose should be increased to 1.5 g three times daily given intravenously.

The frequency of administration may be increased to 6-hourly if necessary, giving total daily doses

of 3 to 6 g. Where clinically indicated, some infections respond to 750 mg or 1.5 g twice daily

(intravenously or intramuscularly) followed by oral therapy with cefuroxime axetil.

Special populations

Infants and children

30 to 100 mg/kg/day given as 3 or 4 divided doses. A dose of 60 mg/kg/day is appropriate for most

infections.

Neonates

30 to 100 mg/kg/day given as 2 or 3 divided doses (see section 5.2).

Renal impairment

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.

It is not necessary to reduce the standard dose (750 mg to 1.5 g three times daily) until the

creatinine clearance falls to 20 mL/min or below.

In adults with marked impairment (creatinine clearance 10 to 20 mL/min) 750 mg twice daily is

recommended and with severe impairment (creatinine clearance <10 mL/min) 750 mg once daily is

adequate.

patients

haemodialysis

further

750 mg

dose

should

given

intravenously

intramuscularly at the end of each dialysis. In addition to parenteral use, cefuroxime can be

incorporated into the peritoneal dialysis fluid (usually 250 mg for every 2 litres of dialysis fluid).

For patients in renal failure on continuous arteriovenous haemodialysis or high-flux haemofiltration

in intensive therapy units a suitable dosage is 750 mg twice daily. For low-flux haemofiltration

follow the dosage recommended under Impaired Renal Function.

Gonorrhoea

1.5 g as a single dose (as 2 x 750 mg injections given intramuscularly with different sites, e.g. each

buttock).

Meningitis

Cefuroxime is suitable for sole therapy of bacterial meningitis due to sensitive strains.

3 g given

intravenously every eight hours.

Special populations

Infants and children

150 to 250 mg/kg/day given intravenously in 3 or 4 divided doses.

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Neonates

The dosage should be 100 mg/kg/day given intravenously.

Prophylaxis

The usual dose is 1.5 g given intravenously with induction of anaesthesia for abdominal, pelvic and

orthopaedic operations. This may be supplemented with two 750 mg intramuscular doses 8 and 16

hours later.

In cardiac, pulmonary, oesophageal and vascular operations, the usual dose is 1.5 g given

intravenously with induction of anaesthesia, continuing with 750 mg given intramuscularly three

times daily for a further 24 to 48 hours.

In total joint replacement, 1.5 g cefuroxime powder may be mixed dry with each pack of methyl

methacrylate cement polymer before adding the liquid monomer.

Sequential therapy

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.

Duration of both parenteral and oral therapy is determined by the severity of the infection and the

clinical status of the patient.

Pneumonia:

1.5 g

cefuroxime

three

times

daily

twice

daily

(given

intravenously

intramuscularly) for 48 to 72 hours, followed by 500 mg twice daily cefuroxime axetil oral therapy

for 7 to 10 days.

Acute Exacerbations of Chronic Bronchitis: 750 mg cefuroxime three times daily or twice daily

(given intravenously or intramuscularly) for 48 to 72 hours, followed by 500 mg twice daily

cefuroxime axetil oral therapy for 5 to 10 days.

Method of administration

Cefuroxime for Injection – for intravenous (IV) and/or intramuscular (IM) administration.

No more than 750 mg should be injected at one intramuscular site.

For intravenous infusion the solution may be administered directly into the vein or introduced into

the tubing of the giving set if patient is receiving parenteral fluid.

For instructions on preparation of the medicinal product before administration, see section 6.6.

4.3

Contraindications

Cefuroxime is contraindicated in patients who have had previous experience of a major allergy or

anaphylaxis to a cephalosporin or penicillin.

4.4

Special warnings and precautions for use

Cefuroxime should be given with caution to patients who have experienced symptoms of allergy

associated with a cephalosporin or penicillin.

Special care is indicated in patients who have experienced an allergic reaction to penicillins or

other beta-lactams.

Cephalosporin antibiotics at high dosage should be given with caution to patients receiving

concurrent treatment with potent diuretics such as furosemide or aminoglycosides, as renal

impairment has been reported with these combinations. Renal function should be monitored in

these patients, the elderly, and those with pre-existing renal impairment (see section 4.2).

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As with other therapeutic regimens used in the treatment of meningitis, mild-to-moderate hearing

loss has been reported in a few paediatric patients treated with cefuroxime sodium. Persistence of

positive cerebral spinal fluid (CSF) cultures of Haemophilus influenzae at 18 to 36 hours has also

been noted with cefuroxime sodium injection, as well as with other antibiotic therapies; however,

the clinical relevance of this is unknown.

As with other antibiotics, use of cefuroxime may result in the overgrowth of Candida. Prolonged

use may also result in the overgrowth of other non-susceptible organisms (e.g. enterococci and

Clostridium difficile), which may require interruption of treatment.

Pseudomembranous

colitis

delaying

peristalsis

Pseudomembranous

colitis

been

reported with virtually all broad spectrum antibiotics and may range in severity from mild to life-

threatening. It is important to consider this diagnosis in patients who develop diarrhoea in

association with the use of cefuroxime.

Drugs which delay peristalsis may prolong and/or worsen

the condition and should not be used.

If prolonged or significant diarrhoea occurs or the patient

experiences abdominal cramps, treatment should be discontinued immediately and the patient

investigated further.

Prothrombin time – Prolonged prothrombin time may occur in patients receiving protracted

antimicrobial therapy.

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. If there is no

clinical improvement within 72 hours, then the parenteral course of treatment must be continued.

Refer to the relevant prescribing information for cefuroxime axetil before initiating sequential

therapy.

4.5

Interaction with other medicines and other forms of interaction

In common with other antibiotics cefuroxime may affect the gut flora, leading to lower oestrogen

reabsorption and reduced efficacy of combined oral contraceptives.

Cefuroxime does not interfere in enzyme-based tests for glycosuria.

Slight

interference

with

copper

reduction

methods

(Benedict’s,

Fehling’s,

Clinitest)

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.

See also section 6.2 and 6.6.

4.6

Fertility, pregnancy and lactation

Pregnancy

There

experimental

evidence

embryopathic

teratogenic

effects

attributable

cefuroxime, but, as with all medicines, it should be administered with caution during the early

months of pregnancy.

Breast-feeding

Cefuroxime is excreted in human milk, and consequently caution should be exercised when

cefuroxime is administered to a nursing mother.

Fertility

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No data available. For pre-clinical fertility data refer to section 5.3.

4.7

Effects on ability to drive and use machines

During treatment with cefuroxime, undesirable effects may occur (e.g. dizziness), which may

influence the ability to drive and use machines. Patients should be cautious when driving or

operating machinery.

4.8

Undesirable effects

Reporting

suspected

adverse

reactions

Reporting

suspected

adverse

reactions

after

authorisation of the medicine is important. It allows continued monitoring of the benefit/risk balance

of the medicine. Healthcare professionals are asked to report any suspected adverse reactions

https://nzphvc.otago.ac.nz/reporting/

Adverse drug reactions are very rare (<1/10,000) and are generally mild and transient in nature.

The frequency categories assigned to the adverse reactions below are estimates, as for most

reactions suitable data for calculating incidence are not available. In addition the incidence of

adverse reactions associated with cefuroxime sodium may vary according to the indication.

Data from clinical trials were used to determine the frequency of very common to rare undesirable

effects.

frequencies

assigned

other

undesirable

effects

(i.e.

those

occurring

<1/10,000) were mainly determined using post-marketing data, and refer to a reporting rate rather

than a true frequency.

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.

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, cutaneous vasculitis.

Vascular disorders

Common: Thrombophlebitis may follow intravenous injection.

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Gastrointestinal disorders

Uncommon: Gastrointestinal disturbance.

Very rare: Pseudomembranous colitis (see section 4.4).

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.

Renal and urinary disorders

Very rare: Elevations in serum creatinine, elevations in blood urea nitrogen and decreased

creatinine clearance (see section 4.4).

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.

4.9

Overdose

Overdosage of cephalosporins can cause cerebral irritation leading to convulsions. Serum levels of

cefuroxime can be reduced by haemodialysis or peritoneal dialysis.

For further advice on management of overdose please contact the National Poisons Information

Centre (0800 POISON or 0800 764 766).

5. Pharmacological Properties

5.1

Pharmacodynamic properties

Pharmacotherapeutic group: antibacterials for systemic use, second generation cephalosporins,

ATC code: J01DC02

Mechanism of action

Cefuroxime is a well characterised and effective antibacterial agent which has bactericidal activity

against a wide range of common pathogens, including β-lactamase producing strains.

Cefuroxime has good stability to bacterial β-lactamase, and consequently is active against many

ampicillin-resistant or amoxicillin-resistant strains.

The bactericidal action of cefuroxime results from inhibition of cell wall synthesis by binding to

essential target proteins.

Pharmacodynamic effects

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The prevalence of acquired resistance is geographically and time dependent and for select species

may be very high. Local information on resistance is desirable, particularly when treating severe

infections.

In vitro susceptibility of micro-organisms to Cefuroxime

Where clinical efficacy of cefuroxime has been demonstrated in clinical trials this is indicated with

an asterisk (*).

Commonly susceptible species

Gram-positive aerobes

Staphylococcus auereus (methicillin susceptible)*

Coagulase negative staphylococcus (methicillin susceptible)

Streptococcus pyogenes*

β-hemolytic streptococci.

Gram-negative aerobes

Haemophilus influenzae, including ampicillin-resistant strains*

Haemophilus parainfluenzae*

Moraxella catarrhalis*

Neisseria gonorrhoeae* including penicillinase and non-penicillinase producing strains

Neisseria meningitidis.

Shigella spp.

Gram-positive anaerobes

Peptostreptococcus spp.

Propionibacterium spp.

Spirochetes

Borrelia burgdorferi*

Organisms for which acquired resistance may be a problem

Gram-positive aerobes

Streptococcus pneumoniae*

Viridans group streptococcus

Gram-negative aerobes

Bordetella pertussis.

Citrobacter spp. not including C. freundii

Enterobacter spp. not including E. aerogenes and E. cloacae

Escherichia coli*

Klebsiella spp. including K. pneumoniae*

Proteus mirabilis.

Proteus spp. not including P. penneri and P. vulgaris

Providencia spp.

Salmonella spp.

Gram-positive anaerobes

Clostridium spp. not including C. difficile

Gram-negative anaerobes

Bacteroides spp. not including B. fragilis

Fusobacterium spp.

Inherently resistant organisms

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Gram-positive aerobes

Enterococcus spp. including E. faecalis and E. faecium

Listeria monocytogenes.

Gram-negative aerobes

Acinetobacter spp.

Burkholderia cepacia

Campylobacter spp.

Citrobacter freundii

Enterobacter aerogenes

Enterobacter cloacae

Morganella morganii.

Proteus penneri

Proteus vulgaris.

Pseudomonas spp. including P. aeruginosa

Serratia spp.

Stenotrophomonas maltophilia

Gram-positive anaerobes

Clostridium difficile

Gram-negative anaerobes

Bacteroides fragilis.

Others

Chlamydia species

Mycoplasma species

Legionella species.

5.2

Pharmacokinetic properties

Absorption

Peak levels of cefuroxime are achieved within 30 to 45 minutes after intramuscular administration.

Distribution

Protein binding has been variously stated as 33 to 50% depending on the methodology used.

Concentrations of cefuroxime in excess of the minimum inhibitory levels for common pathogens

can be achieved in bone, synovial fluid and aqueous humour. Cefuroxime passes the blood-brain

barrier when the meninges are inflamed.

Biotransformation

Cefuroxime is not metabolised and is excreted by glomerular filtration and tubular secretion

Elimination

The serum half-life after either intramuscular or intravenous injection is approximately 70 minutes.

In the first weeks of life the serum half-life of cefuroxime can be 3 to 5 times that in the adult.

Concurrent administration of probenecid prolongs the excretion of the antibiotic and produces an

elevated peak serum level. There is an almost complete recovery (85-90%) of unchanged

cefuroxime in urine within 24 hours of administration. The major part is excreted in the first six

hours. Serum levels of cefuroxime are reduced by dialysis.

5.3

Preclinical safety data

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Non-clinical data reveal no special hazard for humans based on conventional studies of safety

pharmacology,

repeated

dose

toxicity,

genotoxicity,

carcinogenic

potential

toxicity

reproduction and development.

6. Pharmaceutical Particulars

6.1

List of excipients

None.

6.2

Incompatibilities

Cefuroxime should not be mixed in the syringe with aminoglycoside antibiotics.

The pH of 2.74% w/v Sodium Bicarbonate Injection BP considerably affects the colour of the

solution 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.

6.3

Shelf life

2 years.

After reconstitution, Cefuroxime Mylan should be stored at 2 - 8°C for no longer than 24 hours.

Suspensions of cefuroxime for intramuscular injection and aqueous solutions for direct intravenous

injection retain their potency for five hours if kept below 25

C and for 24 hours if refrigerated.

Some increase in the colour of prepared solutions and suspensions of cefuroxime may occur on

storage.

6.4

Special precautions for storage

Store at or below 25°C and protect from light.

For storage conditions after reconstitution of the medicine, see section 6.3.

6.5

Nature and contents of container

250 mg: Clear 10 ml glass vial with a halobutyl rubber stopper and flip-off aluminium cap.

Pack

size of 1 vial.

750 mg: Clear 10 ml or 15 ml glass vial with a halobutyl rubber stopper and flip-off aluminium cap.

Pack size of 1 or 10 vials.

1.5 g: Clear 10 ml or 15 ml glass vial with a halobutyl

rubber stopper and flip-off aluminium cap.

Pack size of 1 vial.

Not all pack types and sizes may be marketed.

6.6

Special precautions for disposal and other handling

Preparation of a Suspension for Intramuscular Injection

Add 1 mL Water for Injections to 250 mg Cefuroxime for Injection or 3 mL Water for Injections to

750 mg Cefuroxime for Injection. Shake gently to produce an opaque suspension.

Preparation of a Solution for Intravenous Injection

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250 mg & 750 mg Vials

For reconstitution of the powder dissolve Cefuroxime for Injection in Water for Injections using at

least 2 mL for 250 mg and at least 6 mL for 750 mg.

1.5 g Vial

For reconstitution of the powder

Draw up at least 15 mL of water for injections into a suitable syringe (20 mL).

Transfer 10 mL into the 1.5 g vial and reconstitute the contents of the vial.

Then draw up the dissolved contents of the vial into the same syringe.

Preparation of a Solution for Intravenous Infusion

1.5 g Vial

For intravenous infusions of less than 30 minutes, the contents of the 1.5 g vial may be dissolved

in a 50 mL vial or bag of Water for Injection as follows:

For reconstitution of the powder

Draw up at least 10 mL of water for injections from the 50 mL vial or bag using a suitable

syringe.

Transfer the 10 mL into the 1.5 g vial and reconstitute the content of the vial.

Then transfer the dissolved contents of the vial into the 50 mL vial or bag.

Compatibilities

1.5 g cefuroxime constituted with 15 mL Water for Injections may be added to metronidazole

injection (500 mg/100 mL) and both retain their activity for up to 24 hours below 25

1.5 g cefuroxime is compatible with azlocillin 1 g (in 15 mL) or 5 g (in 50 mL) for up to 24 hours at

C, or 6 hours below 25

Cefuroxime (5 mg/mL) in 5%w/v or 10%w/v Xylitol Injection may be stored for up to 24 hours at

Cefuroxime is compatible with aqueous solutions containing up to 1% lignocaine hydrochloride.

Cefuroxime is compatible with the following more commonly used intravenous infusion fluids. It will

retain potency for up to 24 hours at room temperature in:

Sodium Chloride Injection BP 0.9% w/v.

5% Dextrose Injection BP.

0.18% w/v Sodium Chloride plus 4% Dextrose Injection BP.

5% Dextrose and 0.9% Sodium Chloride Injection.

5% Dextrose and 0.45% Sodium Chloride Injection.

5% Dextrose and 0.225% Sodium Chloride Injection.

10% Dextrose Injection.

10% Invert Sugar in Water for Injection.

Ringer’s Injection USP.

Lactated Ringer’s Injection USP.

M/6 Sodium Lactate Injection.

Compound Sodium Lactate Injection BP (Hartmann’s Solution).

The stability of cefuroxime in Sodium Chloride Injection BP 0.9% w/v and in 5% Dextrose Injection

is not affected by the presence of hydrocortisone sodium phosphate.

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Cefuroxime has also been found compatible for 24 hours at room temperature when admixed in

intravenous infusion with:

Heparin (10 and 50 units/mL) in 0.9% Sodium Chloride Injection;

Potassium Chloride (10 and 40 mEqL) in 0.9% Sodium Chloride Injection.

unused

medicine

waste

material

should

disposed

accordance

with

local

requirements.

7. Medicines Schedule

Prescription Medicine

8. Sponsor Details

Mylan New Zealand Ltd

PO Box 11183

Ellerslie

AUCKLAND

Telephone 09-579-2792

9. Date of First Approval

11 November 1999

10. Date of Revision of the Text

24 February 2017 Revise to SmPC format, pack size addition.

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