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.

What is in this leaflet?

Please read this leaflet carefully before you take PHARMACOR CEFUROXIME tablets.

This leaflet answers some common questions about PHARMACOR CEFUROXIME. It does not contain all of 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 expected benefits of you taking PHARMACOR CEFUROXIME against the risks this medicine could have for you.

If you have any concerns about taking this medicine, ask your doctor orpharmacist.

Keep this leaflet with the medicine. You may need to read it again.

What PHARMACOR CEFUROXIME is used for

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

  • 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 belongs to a group of medicines called cephalosporin antibiotics.

PHARMACOR CEFUROXIME is not addictive.

Before you take PHARMACOR CEFUROXIME tablets

Do not take if

You must not take PHARMACOR CEFUROXIME tablets if:

  • you have ever had an allergic reaction to cefuroxime, penicillin or any of the ingredients listed toward the end of this leaflet. (See Ingredients)
  • the expiry date (EXP) printed on the pack has passed.
  • the packaging is torn or shows signs of tampering.

Tell your doctor if:

You must tell your doctor if:

  • you are allergic to foods, dyes, preservatives or any other medicines.
  • you have had to stop taking another medicine for your infection.
  • you test your urine for sugar. PHARMACOR CEFUROXIME tablets may interfere with some urine tests.
  • you have kidney problems.
  • you are pregnant, think you may be pregnant or are breastfeeding.
  • you are taking any other medicines, including medicines you buy without a prescription.
  • you 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.
  • you are taking the contraceptive pill. PHARMACOR CEFUROXIME may reduce how well the ceontraceptive pill works.

How to use PHARMACOR CEFUROXIME

Take your complete course of tablets as your doctor has prescribed. 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.

How much to take

Take PHARMACOR CEFUROXIME tablets as directed by your doctor or pharmacist. The usual dose of PHARMACOR CEFUROXIME is one 250 mg tablet twice a day. Your doctor may have prescribed a different dosage.

How to take it

The tablet should be swallowed whole with a drink of water.

PHARMACOR CEFUROXIME tablets work better when taken after food.

How long to take it

PHARMACOR CEFUROXIME tablets should be taken for 7 to 10 days. Your doctor may prescribe a different duration of treatment.

If you take too much (Overdose)

Immediately telephone your doctor or Poisons Information Centre (telephone 131126) for advice, or go to Accident and Emergency at the nearest hospital, if you think you or anyone else may have taken too much PHARMACOR CEFUROXIME, even if there are no signs of discomfort or poisoning. You may need urgent medical attention.

If you are not sure what to do, contact your doctor or pharmacist.

While you are taking PHARMACOR CEFUROXIME tablets

Things you must 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.

If you forget to take it

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 that you missed.

Things you must not do

Do not give this medicine to anyone else, even if their symptoms seem similar to yours.

Do not use PHARMACOR CEFUROXIME tablets to treat any other complaints unless your doctor tells you to.

Be careful driving or operating machinery until you know how PHARMACOR CEFUROXIME affects you.

Side effects

Check with your doctor as soon as possible if you think you are having any side effects or allergic reactions due to PHARMACOR CEFUROXIME tablets, even if the problem is not listed below.

Like other medicines, PHARMACOR CEFUROXIME tablets can cause some side-effects. If they occur, they are most likely to be minor and temporary. However, some may be serious and need medical attention.

The most commonly reported side-effects are:

  • headache,
  • abdominal pain,
  • dizziness,
  • nausea or vomiting,
  • mild diarrhoea,
  • indigestion or wind,
  • dry mouth.

Tell your doctor immediately if you notice any of the following:

  • 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)
  • 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.
  • persistent diarrhoea, even if it occurs sometime after you have stopped taking your PHARMACOR CEFUROXIME.

If you think you are having an allergic reaction to PHARMACOR CEFUROXIME tablets, STOP TAKING THE TABLETS AND TELL YOUR DOCTOR IMMEDIATELY or go to the casualty department at your nearest hospital.

Symptoms usually include some or all of the following:

  • wheezing
  • swelling of the lips/mouth
  • difficulty in breathing
  • lumpy rash ("hives")
  • fainting
  • hayfever

This is not a complete list of all possible side-effects. Others may occur in some people and there may be some side-effects not yet known.

Do not be alarmed by this list of possible side-effects. You may not experience any of them.

After using it

Storage

Keep this medicine where children cannot reach it, such as in a locked cupboard.

Keep PHARMACOR CEFUROXIME tablets in a cool, dry place where it stays below 25 degrees C. Do not leave in a car, on a window sill or in a bathroom.

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

Return any unused or expired medicine to your pharmacist.

Product description

What PHARMACOR CEFUROXIME tablets looks like.

PHARMACOR CEFUROXIME tablets 250 mg: 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 tablets 500 mg: 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.

Ingredients

PHARMACOR CEFUROXIME tablets contain 250/500 mg of the active ingredient cefuroxime (as axetil). PHARMACOR CEFUROXIME also contains the following inactive ingredients: microcrystalline cellulose, croscarmellose sodium, sodium lauryl sulfate, colloidal anhydrous silica, calcium stearate, calcium carbonate, crospovidone and OPADRY complete film coating system 03H50807 BLUE

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 March 2020

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

PHARMACOR CEFUROXIME 250 mg tablets: AUST R 273229

PHARMACOR CEFUROXIME 500 mg tablets: AUST R 273228

This leaflet is subject to copyright.

Published by MIMS May 2020

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

Dosage.

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

Precautions.

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.

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.

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) 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 http://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 Poison Information Centre on 131126 (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