Consumer medicine information

Pharmacor Cefuroxime

Cefuroxime

BRAND INFORMATION

Brand name

Pharmacor Cefuroxime

Active ingredient

Cefuroxime

Schedule

S4

 

Consumer medicine information (CMI) leaflet

Please read this leaflet carefully before you start using Pharmacor Cefuroxime.

SUMMARY CMI

PHARMACOR-CEFUROXIME

Consumer Medicine Information (CMI) summary

The full CMI on the next page has more details. If you are worried about using this medicine, speak to your doctor or pharmacist.

1. Why am I using PHARMACOR-CEFUROXIME tablets?

PHARMACOR-CEFUROXIME tablets contains the active ingredient cefuroxime axetil. PHARMACOR-CEFUROXIME tablets is used to treat bacterial infections in your body including infections of ear, nose and throat, lungs or chest, urinary tract, skin and soft tissues. It is also used to treat sexually transmitted infections (urethritis and cervictis).

For more information, see Section 1. Why am I using PHARMACOR-CEFUROXIME tablets? in the full CMI.

2. What should I know before I use PHARMACOR-CEFUROXIME tablets?

Do not use if you have ever had an allergic reaction to PHARMACOR-CEFUROXIME or any of the ingredients listed at the end of the CMI.

Talk to your doctor if you have any other medical conditions, take any other medicines, or are pregnant or plan to become pregnant or are breastfeeding.

For more information, see Section 2. What should I know before I use PHARMACOR-CEFUROXIME tablets? in the full CMI.

3. What if I am taking other medicines?

Some medicines may interfere with PHARMACOR-CEFUROXIME tablets and affect how it works.

A list of these medicines is in Section 3. What if I am taking other medicines? in the full CMI.

4. How do I use PHARMACOR-CEFUROXIME tablets?

  • The usual dose of PHARMACOR-CEFUROXIME is one 250 mg tablet twice a day for 7 to 10 days.
  • Take your complete course of PHARMACOR-CEFUROXIME tablets as directed by your doctor or pharmacist.

More instructions can be found in Section 4. How do I use PHARMACOR-CEFUROXIME tablets? in the full CMI.

5. What should I know while using PHARMACOR-CEFUROXIME tablets?

Things you should do
  • Remind any doctor, dentist or pharmacist you visit that you are using PHARMACOR-CEFUROXIME.
  • Tell your doctor if, for any reason, you have not taken your medicine exactly as directed.
Things you should not do
  • Do not give this medicine to anyone else, even if they have the same condition as you.
  • Do not use PHARMACOR-CEFUROXIME tablets to treat any other complaints unless your doctor tells you to.
Driving or using machines
  • Be careful before you drive or use any machines or tools until you know how PHARMACOR-CEFUROXIME tablets affects you.
Looking after your medicine
  • Store it in a cool (below 25°C), dry place away from moisture, heat or sunlight.

For more information, see Section 5. What should I know while using PHARMACOR-CEFUROXIME tablets? in the full CMI.

6. Are there any side effects?

Common side effects include headache, abdominal pain, dizziness, nausea or vomiting, mild diarrhoea, indigestion or wind, or dry mouth.

Serious side effects include skin rash, a widespread rash with blisters and skin peeling on much of the body surface, persistent diarrhoea, overgrowth of yeast in the body, or allergic reactions.

For more information, including what to do if you have any side effects, see Section 6. Are there any side effects? in the full CMI.



FULL CMI

PHARMACOR-CEFUROXIME

Active ingredient(s): cefuroxime axetil

Consumer Medicine Information (CMI)

This leaflet provides important information about using PHARMACOR-CEFUROXIME tablets. You should also speak to your doctor or pharmacist if you would like further information or if you have any concerns or questions about using PHARMACOR-CEFUROXIME tablets.

Where to find information in this leaflet:

1. Why am I using PHARMACOR-CEFUROXIME tablets?
2. What should I know before I use PHARMACOR-CEFUROXIME tablets?
3. What if I am taking other medicines?
4. How do I use PHARMACOR-CEFUROXIME tablets?
5. What should I know while using PHARMACOR-CEFUROXIME tablets?
6. Are there any side effects?
7. Product details

1. Why am I using PHARMACOR-CEFUROXIME tablets?

PHARMACOR-CEFUROXIME tablets contains the active ingredient cefuroxime axetil. PHARMACOR-CEFUROXIME belongs to a group of medicines called cephalosporin antibiotics.

PHARMACOR-CEFUROXIME works by killing bacteria (germs) that cause infections such as infections of:

  • ear, nose and throat
  • lungs or chest
  • urinary tract
  • skin and soft tissues

PHARMACOR-CEFUROXIME is also used to treat sexually transmitted infections (urethritis and cervictis).

PHARMACOR-CEFUROXIME is not addictive.

2. What should I know before I use PHARMACOR-CEFUROXIME tablets?

Warnings

Do not use PHARMACOR CEFUROXIME tablets if:

  • you have ever had an allergic reaction to cefuroxime, penicillin, or any of the ingredients listed at the end of this leaflet.
  • Always check the ingredients to make sure you can use this medicine.
  • the expiry date (EXP) printed on the pack has passed.
  • the packaging is torn or shows signs of tampering.

Check with your doctor if you:

  • are allergic to foods, dyes, preservatives or any other medicines.
  • have had to stop taking another medicine for your infection.
  • test your urine for sugar. PHARMACOR-CEFUROXIME may interfere with some urine tests.
  • have kidney problems.
  • are taking any other medicines, including medicines you buy without a prescription.
  • need a blood test. PHARMACOR-CEFUROXIME can affect the results of a test for blood sugar levels, or a blood screen called the Coombs test.
  • are taking the contraceptive pill. PHARMACOR-CEFUROXIME may reduce how well the contraceptive pill works.

During treatment, you may be at risk of developing certain side effects. It is important you understand these risks and how to monitor for them. See additional information under Section 6. Are there any side effects?

Pregnancy and breastfeeding

Check with your doctor if you are pregnant or intend to become pregnant.

Talk to your doctor if you are breastfeeding or intend to breastfeed.

3. What if I am taking other medicines?

Tell your doctor or pharmacist if you are taking any other medicines, including any medicines, vitamins or supplements that you buy without a prescription from your pharmacy, supermarket or health food shop.

Some medicines may interfere with PHARMACOR-CEFUROXIME tablets and affect how it works. This include:

  • Combined oral contraceptives
  • Ranitidine (histamine-2 blocker)

Check with your doctor or pharmacist if you are not sure about what medicines, vitamins or supplements you are taking and if these affect PHARMACOR-CEFUROXIME tablets.

4. How do I use PHARMACOR-CEFUROXIME tablets?

How much to take

  • Take your complete course of PHARMACOR-CEFUROXIME tablets as directed by your doctor or pharmacist.
    Do not stop just because you feel better, as the medicine may not have killed all the germs and you may start feeling unwell again.
  • The usual dose of PHARMACOR-CEFUROXIME is one 250 mg tablet twice a day for 7 to 10 days. Your doctor may have prescribed a different dosage regimen.

How to take PHARMACOR-CEFUROXIME tablets

  • Swallow the whole tablet with a drink of water.
  • PHARMACOR-CEFUROXIME tablets work better when taken after food.

If you forget to use PHARMACOR-CEFUROXIME tablets

If it is almost time for your next dose, skip the dose you missed and take your next dose when you are meant to. Otherwise, take it as soon as you remember then go back to taking it as you would normally.

Do not take a double dose to make up for the dose you missed.

If you use too much PHARMACOR-CEFUROXIME tablets

If you think that you have used too much PHARMACOR-CEFUROXIME tablets, you may need urgent medical attention.

You should immediately:

  • phone the Poisons Information Centre
    (by calling 13 11 26), or
  • contact your doctor, or
  • go to the Emergency Department at your nearest hospital.

You should do this even if there are no signs of discomfort or poisoning.

5. What should I know while using PHARMACOR-CEFUROXIME tablets?

Things you should do

Tell your doctor if, for any reason, you have not taken your medicine exactly as directed.

Otherwise, your doctor may think that it was not effective and change your treatment unnecessarily.

Remind any doctor or pharmacist you visit that you are taking PHARMACOR-CEFUROXIME tablets.

Things you should not do

  • Do not give this medicine to anyone else, even if they have the same condition as you.
  • Do not use PHARMACOR-CEFUROXIME tablets to treat any other complaints unless your doctor tells you to.

Driving or using machines

Be careful before you drive or use any machines or tools until you know how PHARMACOR-CEFUROXIME tablets affect you.

Looking after your medicine

Follow the instructions in the carton on how to take care of your medicine properly.

Store it a cool, dry place where it stays below 25°C. Do not store it:

  • in the bathroom, or
  • in the car or on window sills.

Keep it where young children cannot reach it.

Keep your PHARMACOR-CEFUROXIME in its pack until it is time to take it.

Getting rid of any unwanted medicine

If you no longer need to use this medicine or it is out of date, take it to any pharmacy for safe disposal.

Do not use this medicine after the expiry date.

6. Are there any side effects?

All medicines can have side effects. If you do experience any side effects, most of them are minor and temporary. However, some side effects may need medical attention.

See the information below and, if you need to, ask your doctor or pharmacist if you have any further questions about side effects.

Less serious side effects

Less serious side effectsWhat to do
Gastrointestinal-related
  • abdominal pain
  • nausea or vomiting
  • mild diarrhoea
  • indigestion or wind
  • dry mouth.
Nervous system-related
  • Headache
  • Dizziness
  • muscle spasm
  • encephalopathy (such as reduced ability to think clearly or concentrate, memory loss, drowsiness, seizures, muscle twitches and personality change)
Speak to your doctor if you have any of these less serious side effects and they worry you.

Serious side effects

Serious side effectsWhat to do
Skin-related
  • skin rash, which may blister, and looks like small targets (central dark spots surrounded by a paler area, with a dark ring around the edge) erythema multiforme
  • a widespread rash with blisters and skin peeling on much of the body surface (toxic epidermal necrolysis), particularly around the mouth, nose, eyes and genitals (Stevens-Johnson syndrome)
  • a red rash commonly seen on both sides of buttocks, upper inner thighs, armpits, neck.
Gastrointestinal-related
  • persistent diarrhoea, even if it occurs sometime after you have stopped taking your PHARMACOR-CEFUROXIME
Other
  • an overgrowth of yeast (Candida) in the body which can lead to fungal infections (such as thrush). This side effect is more likely if you take PHARMACOR-CEFUROXIME for a long time.
Tell your doctor immediately if you notice any of these side effects.
Nervous system-related
  • seizure
Allergic reaction-related
  • wheezing
  • swelling of the lips/mouth
  • difficulty in breathing
  • lumpy rash ("hives")
  • fainting
  • hayfever
Stop taking this medicine and call your doctor straight away, or go to the Emergency Department at your nearest hospital if you notice any of these serious side effects.

Tell your doctor or pharmacist if you notice anything else that may be making you feel unwell.

Other side effects not listed here may occur in some people.

Reporting side effects

After you have received medical advice for any side effects you experience, you can report side effects to the Therapeutic Goods Administration online at www.tga.gov.au/reporting-problems. By reporting side effects, you can help provide more information on the safety of this medicine.

Always make sure you speak to your doctor or pharmacist before you decide to stop taking any of your medicines.

7. Product details

This medicine is only available with a doctor's prescription.

What PHARMACOR-CEFUROXIME tablets contain

Active ingredient
(main ingredient)		cefuroxime (as cefuroxime axetil), 250 or 500 mg
Other ingredients
(inactive ingredients)
  • microcrystalline cellulose
  • croscarmellose sodium
  • sodium lauryl sulfate
  • colloidal anhydrous silica
  • calcium stearate
  • calcium carbonate
  • crospovidone
  • OPADRY complete film coating system 03H50807 BLUE

Do not take this medicine if you are allergic to any of these ingredients.

What PHARMACOR-CEFUROXIME tablets look like

PHARMACOR-CEFUROXIME 250 mg tablets: Blue color capsule shaped biconvex film coated tablets with '204' debossed on one side and plain on the other side in 2's, 6's, 10's, 14's, 20's and 50's Al-Al foil blister pack.

PHARMACOR-CEFUROXIME 500 mg tablets: Blue color capsule shaped biconvex film coated tablets with '203' debossed on one side and plain on the other side in 2's, 6's, 10's, 14's, 20's and 50's Al-Al foil blister pack.

Supplier

Your PHARMACOR-CEFUROXIME is supplied by:

Pharmacor Pty Ltd.
CHATSWOOD, NSW, 2067,
Australia.

Where to go for further information

Pharmaceutical companies are not in a position to give people an individual diagnosis or medical advice. Your doctor or pharmacist is the best person to give you advice on the treatment of your condition. You may also be able to find general information about your disease and its treatment from books, for example in public libraries.

This leaflet was prepared on 09/2024.

The information provided applies only to: PHARMACOR-CEFUROXIME tablets.

PHARMACOR-CEFUROXIME

AUST R 273228 PHARMACOR-CEFUROXIME cefuroxime 500mg film coated tablet blister pack

AUST R 273229 PHARMACOR-CEFUROXIME cefuroxime 250mg film coated tablet blister pack

This leaflet is subject to copyright.

Published by MIMS November 2024

BRAND INFORMATION

Brand name

Pharmacor Cefuroxime

Active ingredient

Cefuroxime

Schedule

S4

 

1 Name of Medicine

Cefuroxime axetil.

2 Qualitative and Quantitative Composition

Pharmacor Cefuroxime is available in 2 strengths for oral administration containing 250 mg and 500 mg cefuroxime axetil.

Pharmacor Cefuroxime 250 mg.

Each film coated tablet contains 250 mg cefuroxime (as cefuroxime axetil).

Pharmacor Cefuroxime 500 mg.

Each film coated tablet contains 500 mg cefuroxime (as cefuroxime axetil).
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Film coated tablets.

Pharmacor Cefuroxime 250 mg.

Blue color capsule shaped biconvex film coated tablets with '204' debossed on one side and plain on the other side.

Pharmacor Cefuroxime 500 mg.

Blue color capsule shaped biconvex film coated tablets with '203' debossed on one side and plain on the other side.

4 Clinical Particulars

4.1 Therapeutic Indications

Cefuroxime is indicated for the treatment of the following mild to moderately severe infections in adults caused by sensitive bacteria.
Acute upper respiratory infections: otitis media, sinusitis, tonsillitis and pharyngitis.
Acute exacerbations of chronic bronchitis, or acute bronchitis.
Skin and skin structure infections for example, furunculosis, pyoderma and impetigo.
Acute uncomplicated gonococcal urethritis, and cervicitis due to non-penicillinase producing gonococci.

4.2 Dose and Method of Administration

The usual course of therapy with Pharmacor Cefuroxime tablets is 5 to 7 days for treatment of bronchitis, and 7 to 10 days for other infections.
Cefuroxime axetil should be taken after a light meal for optimum absorption.

Adults.

See Table 1.

Renal impairment.

Cefuroxime is primarily excreted by the kidneys. In patients with markedly impaired renal function it is recommended that the dosage of cefuroxime be reduced to compensate for its slower excretion.

4.3 Contraindications

Patients with known hypersensitivity to cephalosporin antibiotics or who have experienced a major allergy to penicillin (anaphylaxis, angioneurotic oedema, urticaria).

4.4 Special Warnings and Precautions for Use

Serious and occasionally fatal hypersensitivity (anaphylactic/ anaphylactoid) reactions have been reported in patients on penicillin/cephalosporin therapy. Although anaphylaxis is more frequent following parenteral therapy, it has occurred in patients on oral penicillins/cephalosporins. These reactions are more likely to occur in individuals with a history of penicillin hypersensitivity and/or a history of sensitivity to multiple allergens. There have been reports of individuals with a history of penicillin/cephalosporin hypersensitivity who have experienced severe reactions when treated with a penicillin/cephalosporins. Past history of a severe allergic reaction to penicillin/cephalosporin is a contraindication to the use of cefuroxime axetil. Before initiating therapy with any penicillin/cephalosporin careful inquiry should be made concerning previous hypersensitivity reactions to penicillins, cephalosporins, or other allergens. There have been reports of hypersensitivity reactions which progressed to Kounis syndrome (acute allergic coronary arteriospasm that can result in myocardial infarction, see Section 4.8 Adverse Effects (Undesirable Effects)). If an allergic reaction occurs, cefuroxime axetil should be discontinued and the appropriate therapy instituted. Serious anaphylactoid reactions require immediate emergency treatment with adrenaline. Oxygen, intravenous steroids, and airway management, including intubation, should also be administered as indicated.
Special care is indicated in patients who have experienced an allergic reaction to penicillins or other beta-lactams.
As with other antibiotics, use of cefuroxime axetil 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), which may require interruption of treatment.
Antibiotic associated pseudomembranous colitis has been reported with many antibiotics including cefuroxime axetil. A toxin produced by Clostridium difficile appears to be the primary cause. The severity of the colitis may range from mild to life threatening. It is important to consider this diagnosis in patients who develop diarrhoea or colitis in association with antibiotic use (this may occur up to several weeks after cessation of antibiotic therapy). If prolonged or significant diarrhoea occurs or the patient experiences abdominal cramps, treatment should be discontinued immediately and the patient investigated further. Mild cases usually respond to drug discontinuation alone although cholestyramine may help by binding the toxin in the colonic lumen. However, in moderate to severe cases appropriate therapy with a suitable oral antibacterial agent effective against Clostridium difficile should be considered. Fluids, electrolytes and protein replacement should be provided when indicated.
Drugs which delay peristalsis e.g. opiates and diphenoxylate with atropine (Lomotil) may prolong and/or worsen the condition and should not be used.

Severe cutaneous adverse reactions.

Severe cutaneous adverse reactions (SCAR), such as Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), drug reaction with eosinophilia and systemic symptoms (DRESS), and acute generalised exanthematous pustulosis (AGEP) have been reported in patients taking beta-lactam antibiotics (see Section 4.8 Adverse Effects (Undesirable Effects)).
At the time of prescription patients should be advised of the signs and symptoms and monitored closely for skin reactions. If signs and symptoms suggestive of these reactions appear, cefuroxime should be withdrawn immediately and an alternative treatment considered. If the patient has developed a serious reaction such as SJS, TEN or DRESS with the use of cefuroxime, treatment with cefuroxime must not be restarted in this patient at any time.

Neurotoxicity.

There have been reports of neurotoxicity associated with cephalosporin treatment. Symptoms of neurotoxicity include encephalopathy, seizures and/or myoclonus. Risk factors for developing neurotoxicity with cephalosporin treatment include being elderly, renal impairment, central nervous system disorders and intravenous administration. Withdrawal of the medicine should be considered if there are signs of neurotoxicity.

Use in renal impairment.

Dosage of cefuroxime should not exceed 500 mg per day and should be repeated after dialysis.

Use in the elderly.

The serum half-life of cefuroxime is increased and plasma levels raised in elderly patients with declining renal function. No dosage reduction is necessary in such patients at recommended dosages.

Paediatric use.

No data available.

Effects on laboratory tests.

As a false negative result may occur in the ferricyanide test, it is recommended that either the glucose oxidase or hexokinase methods are used to determine blood/plasma glucose levels in patients receiving cefuroxime axetil. This antibiotic does not interfere in the alkaline picrate assay for creatinine.

4.5 Interactions with Other Medicines and Other Forms of Interactions

Drugs such as ranitidine may result in a lower bioavailability of cefuroxime axetil compared with that of the fasting state.
In common with other antibiotics, cefuroxime axetil may affect the gut flora, leading to lower oestrogen reabsorption and reduced efficacy of combined oral contraceptives.

4.6 Fertility, Pregnancy and Lactation

Effects on fertility.

No data available.
(Category B1)
There is no experimental evidence of embryopathic or teratogenic effects attributable to cefuroxime axetil. However, there is no clinical data on the use of cefuroxime axetil during pregnancy. Therefore it should be administered during pregnancy only if such use is considered essential.
 Cefuroxime is excreted in human milk, and consequently caution should be exercised when cefuroxime axetil is administered to a nursing mother.

4.7 Effects on Ability to Drive and Use Machines

As this medicine may cause dizziness, patients should be warned to be cautious when driving or operating machinery.

4.8 Adverse Effects (Undesirable Effects)

Adverse reactions to cefuroxime axetil have been generally mild and transient in nature. The drug was discontinued in 2.1% of cases, mainly due to diarrhoea/nausea.
The following adverse reactions to cefuroxime axetil have been reported in clinical trials. However, the possibility of the occurrence of other adverse reactions, seen with the cephalosporin class of antibiotics, should be borne in mind.

Cardiac disorders.

Kounis syndrome: unknown.

Gastrointestinal.

Diarrhoea, nausea, vomiting, abdominal discomfort, abdominal pain, flatulence, indigestion, dry mouth, mouth ulcers, pseudomembranous colitis.

Hepatic.

Jaundice (predominantly cholestatic), hepatitis, transient elevations of AST, ALT and LDH.

CNS.

Headache, dizziness, and seizure. Encephalopathy, myoclonus - frequency unknown.

Haemopoietic.

Eosinophilia, positive Coomb's test, increased coagulation time, thrombocytopenia, leukopenia (sometimes profound), haemolytic anaemia.

Hypersensitivity.

Rash, pruritus, urticaria.
Patients with a history of delayed hypersensitivity to penicillin (but not a cephalosporin) experienced delayed hypersensitivity reaction to cefuroxime axetil in 2.9% cases.
As with other cephalosporins, rare cases of severe hypersensitivity reactions, including Stevens-Johnson syndrome, erythema multiforme, toxic epidermal necrosis, drug fever, serum sickness-like reaction and anaphylaxis have been reported with cefuroxime axetil.

Infections and infestations.

Candida overgrowth.

Skin and other subcutaneous tissue disorders.

Severe cutaneous adverse reactions, including Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), drug reaction with eosinophilia and systemic symptoms (DRESS), and acute generalised exanthematous pustulosis (AGEP), and symmetrical drug-related intertriginous and flexural exanthema (SDRIFE) (baboon syndrome) have been reported in beta-lactam antibiotics.

Others.

Vaginitis.

Cephalosporin-class adverse reactions.

Several cephalosporins have been implicated in triggering seizures, particularly in patients with renal impairment when the dosage was not reduced (see Section 4.2 Dose and Method of Administration). If seizures associated with drug therapy occur, the drug should be discontinued. Anticonvulsant therapy can be given if clinically indicated.

Reporting suspected adverse effects.

Reporting suspected adverse reactions after registration 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 at www.tga.gov.au/reporting-problems.

4.9 Overdose

Overdosage of cephalosporins can cause cerebral irritation leading to convulsions.
Serum levels of cefuroxime can be reduced by haemodialysis.
For information on the management of overdose, contact the Poisons Information Centre on 13 11 26 (Australia).

5 Pharmacological Properties

5.1 Pharmacodynamic Properties

Mechanism of action.

Cefuroxime axetil is a semisynthetic cephalosporin. It is a prodrug which owes its in vivo bactericidal activity to the release of the active compound cefuroxime.
Cefuroxime has bactericidal activity against a wide range of common pathogens, including beta-lactamase producing strains. The bactericidal action of cefuroxime results from inhibition of cell wall synthesis by binding to essential target proteins. Cefuroxime has good stability to bacterial beta-lactamases.

Clinical trials.

Cefuroxime has been shown to be usually active against the following organisms in vitro and in clinical studies:

Aerobes gram-negative.

Escherichia coli, Haemophilus influenzae (including ampicillin-resistant strains), Haemophilus parainfluenzae, Neisseria gonorrhoeae (non-penicillinase producing strains).

Aerobes gram-positive.

Staphylococcus aureus and Staphylococcus epidermidis (including penicillinase producing strains but excluding methicillin resistant strains), Streptococcus pyogenes (and other beta-haemolytic streptococci), Streptococcus pneumoniae, Streptococcus Group B (Streptococcus agalactiae).
The following organisms are not susceptible to cefuroxime: Clostridium difficile, Pseudomonas spp, Campylobacter spp, Acinetobacter calcoaceticus, Listeria monocytogenes, methicillin resistant strains of Staphylococcus aureus and Staphylococcus epidermidis, Legionella spp, Proteus vulgaris, Morganella morganii, Serratia spp, Bacteroides fragilis, most strains of Enterococcus faecalis, Citrobacter spp, Enterobacter spp.

Susceptibility tests.

Diffusion techniques.

Quantitative methods that require measurement of zone diameters give the most precise estimate of antibiotic susceptibility. One such standard procedure that has been recommended for use with disks to test susceptibility of organisms to cefuroxime uses the 30 microgram cefuroxime disk. Interpretation involves the correlation of the diameters obtained in the disk test with the minimum inhibitory concentration (MIC) for cefuroxime.
Reports from the laboratory giving results of the standard single-disk susceptibility test with a 30 microgram cefuroxime disk should be interpreted according to the following criteria (see Table 2).
A report of "Susceptible" indicates that the pathogen is likely to be inhibited by generally achievable blood levels. A report of "Moderately Susceptible" suggests that the organism would be susceptible if high dosage is used or if the infection is confined to tissues and fluids in which high antibiotic levels are attained. A report of "Resistant" indicates that achievable concentrations of the antibiotic are unlikely to be inhibitory and other therapy should be selected.
Standardized procedures require the use of laboratory control organisms. The 30 microgram cefuroxime disk should give the following zone diameters (see Table 3).

Dilution techniques.

Use a standardized dilution method (broth, agar, microdilution) or equivalent with cefuroxime powder. The MIC values obtained should be interpreted according to the following criteria (see Table 4).
As with standard diffusion techniques, dilution methods require the use of laboratory control organisms. Standard cefuroxime powder should provide the following MIC values (see Table 5).
Susceptibility to cefuroxime axetil will vary with geography and time and local susceptibility data should be consulted where available.

5.2 Pharmacokinetic Properties

Absorption.

After oral administration cefuroxime axetil is absorbed from the gastrointestinal tract and rapidly hydrolysed in the body to release cefuroxime into the circulation. Approximately 60% of an administered dose is absorbed. Optimum absorption occurs when it is administered after a light meal. Absorption is not decreased by drugs which affect gastrointestinal motility e.g. loperamide, diphenoxylate or castor oil. However, absorption is decreased by concurrent administration of drugs such as ranitidine.

Distribution.

The mean peak serum level of cefuroxime following a 250 mg dose in normal healthy adults, after food, was 4.1 mg/L and occurred two to three hours after dosing. Serum levels were significantly higher in the elderly, apparently due to slower excretion. Unhydrolysed drug has not been detected in the serum but 1-2% of the administered dose is excreted in the urine in a form which indicates that small amounts of the intact ester are absorbed into circulation. The mean serum half-life of cefuroxime is approximately 1.2 hours. Protein binding has been variously stated as 33-50% depending on the methodology used.

Metabolism.

Cefuroxime is not metabolised to any significant extent.

Excretion.

Excretion occurs mainly through the kidney both by glomerular filtration and tubular secretion. Approximately 49% of an administered dose, after food, is recovered in the urine in 24 hours; urinary recovery is significantly reduced if the drug is taken on an empty stomach. After a 250 mg dose urinary concentrations at 0-6 and 6-12 hours were 227 microgram/mL (range 92-515) and 35.3 microgram/mL (range 7.6-102) respectively.
Concurrent administration of probenecid prolongs the terminal half-life of cefuroxime. Serum levels of cefuroxime are reduced by haemodialysis.

5.3 Preclinical Safety Data

Preclinical safety data were either not assessed or not identified as part of the registration of this medicine.

Genotoxicity.

No data available.

Carcinogenicity.

No data available.

6 Pharmaceutical Particulars

6.1 List of Excipients

Each Pharmacor Cefuroxime tablets contain microcrystalline cellulose, croscarmellose sodium, sodium lauryl sulfate, colloidal anhydrous silica, calcium stearate, calcium carbonate, crospovidone and Opadry complete film coating system 03H50807 Blue.

6.2 Incompatibilities

Incompatibilities were either not assessed or not identified as part of the registration of this medicine.

6.3 Shelf Life

3 years.

6.4 Special Precautions for Storage

Store below 25°C.

6.5 Nature and Contents of Container

Pharmacor Cefuroxime 250 mg tablets are packed in Alu-Alu Blister packs in pack size* of 2, 6, 10, 14, 20 and 50 tablets.
Pharmacor Cefuroxime 500 mg tablets are packed in Alu-Alu Blister packs in pack size* of 2, 6, 10, 14, 20 and 50 tablets.
* Not all pack sizes may be marketed.

6.6 Special Precautions for Disposal

In Australia, any unused medicine or waste material should be disposed of in accordance to local requirements.

6.7 Physicochemical Properties

Cefuroxime axetil is the 1-(acetyloxy) ethyl ester of cefuroxime. It is a white or almost white powder, soluble in acetone, in ethyl acetate and in methanol, slightly soluble in ethanol (96 percent) and insoluble in water.

Chemical structure.


Molecular formula: C20H22N4O10S.
Molecular weight of 510.48.

CAS number.

CAS registry number: 64544-07-6.
pH (5% w/v aqueous solution): About 5.3.
PKa: 2.5.
Log P: log Kow = 0.891.
Cefuroxime axetil is in the amorphous form.
It is a mixture of the 2 diastereoisomers of (1RS)-1-(acetyloxy)ethyl (6R,7R)-3-[(carbamoyloxy)methyl]-7-[[(Z)-2-(furan-2-yl)-2(methoxyimino) acetyl]amino]-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylate.
1 Hansch, C., Leo, A., D. Hoekman. Exploring QSAR - Hydrophobic, Electronic, and Steric Constants. Washington, DC: American Chemical Society., 1995., p. 167.

7 Medicine Schedule (Poisons Standard)

Schedule 4 - Prescription Only Medicine.

Summary Table of Changes