Auroxime Tablets

AUROXIME TABLETS is indicated for the treatment of infections caused by susceptible strains of the following organisms in the following infections:

• Pharyngitis and tonsillitis caused by Streptococcus pyogenes.
• Otitis media caused by Streptococcus pneumoniae, Haemophilus influenzae (ampicillin-sensitive and resistant strains), Moraxella (Branhamella) catarrhalis and Streptococcus pyogenes.
• Sinusitis caused by Streptococcus pneumoniae and Haemophilus influenzae.
• Acute and chronic bronchitis caused by Streptococcus pneumoniae, Haemophilus influenzae (ampicillin-sensitive strains) and Haemophilus parainfluenzae (ampicillin-sensitive strains).
• Acute uncomplicated cystitis caused by Escherichia coli and Klebsiella pneumoniae.
• Lyme disease caused by Borrelia burgdorferi.

Posology

Adults:

• Sinusitis and acute or chronic bronchitis: 250 mg twice daily for seven days (Range 5-10 days)
• Acute, uncomplicated cystitis: 125 mg twice daily for seven days (Range 5-10 days)
• Lyme disease: Adults and children over 12 years of age: 500 mg twice daily for 20 days

Special populations

Renal function impairment u2013 a reduced dose may be required (see section 4.4).

Paediatric population

There is no experience with AUROXIME TABLETS in children under 3 months of age.

• 3 months to 2 years of age: 125 mg twice daily
• Over 2 years of age: 250 mg twice daily

Method of administration

AUROXIME TABLETS should be taken half an hour after food for optimum absorption.

• Hypersensitivity to cephalosporin antibiotics or to any components of the formulation (see section 6.1).
• Hypersensitivity to penicillin and other beta-lactam antibiotics.
• Pregnancy and breastfeeding (see section 4.6)

AUROXIME TABLETS should be used with caution in patients with:

• A history of gastrointestinal disease, especially ulcerative colitis, regional enteritis or pseudomembranous colitis.
• Renal function impairment u2013 A reduced dose may be required.
• Porphyria: Safety has not been established.

Hypersensitivity reactions

Special care is indicated in patients who have experienced an allergic reaction to penicillins or other beta-lactam antibiotics because there is a risk of cross-sensitivity. As with all beta-lactam antibacterial medicines, serious and occasionally fatal hypersensitivity reactions have been reported. 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). In case of severe hypersensitivity reactions, treatment with cefuroxime must be discontinued immediately and adequate emergency measures must be initiated.

Before beginning treatment, it should be established whether the patient has a history of severe hypersensitivity reactions to cefuroxime, to other cephalosporins or to any other type of beta-lactam medicine. Caution should be used if cefuroxime is given to patients with a history of non-severe hypersensitivity to other beta-lactam medicines.

Jarisch-Herxheimer reaction

The Jarisch-Herxheimer reaction has been seen following cefuroxime axetil treatment of Lyme disease. It results directly from the bactericidal activity of cefuroxime axetil on the causative bacteria of Lyme disease, the spirochaete Borrelia burgdorferi. Patients should be reassured that this is a common and usually self-limiting consequence of antibiotic treatment of Lyme disease (see section 4.8).

Overgrowth of non-susceptible microorganisms

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 microorganisms (e.g. enterococci and Clostridium difficile), which may require interruption of treatment (see section 4.8).

Antibacterial medicine u2013 associated pseudomembranous colitis have been reported with nearly all antibacterial medicines, including cefuroxime and may range in severity from mild to life threatening. This diagnosis should be considered in patients with diarrhoea during or subsequent to the administration of cefuroxime (see section 4.8). Discontinuation of therapy with cefuroxime and the administration of specific treatment for Clostridium difficile should be considered. Medicines that inhibit peristalsis should not be given (see section 4.8). Pseudomembranous colitis may occur. People who develop abdominal or stomach cramps, abdominal tenderness, severe and watery diarrhea (which may be bloody) and fever, should be investigated for this diagnosis. If the diagnosis of pseudomembranous colitis is suspected, AUROXIME TABLETS should be stopped immediately and appropriate therapy initiated.

Concurrent administration of probenecid increases the area under the mean serum concentration time-curve by 50%. Concomitant use of AUROXIME TABLETS and furosemide should be avoided when possible, due to enhanced nephrotoxicity. The combined use of cephalosporins and aminoglycosides should be undertaken with caution, due to nephrotoxicity. The efficacy of combined oral contraceptives may be decreased by concomitant use with AUROXIME TABLETS.

Interactions with Laboratory Tests:

It is recommended that either glucose oxidase or hexokinase methods be used to determine blood/plasma glucose levels in patients receiving AUROXIME TABLETS. This medicine may give false-negative test results with ferricyanide blood glucose test. AUROXIME TABLETS does not interfere in the alkaline picrate assay for creatinine. A false-positive Coombs reaction may appear in patients who receive large doses of AUROXIME TABLETS.

Pregnancy

Safety and efficacy in pregnancy has not been established (see section 4.3). Studies in animals have shown no harmful effects on pregnancy, embryonal or foetal development, parturition or postnatal development.

Breastfeeding

Safety and efficacy in lactation has not been established (see section 4.3). AUROXIME TABLETS is excreted in human milk in small quantities. Adverse effects at therapeutic doses are not expected, although a risk of diarrhoea and fungus infection of the mucous membranes cannot be excluded. Breastfeeding might have to be discontinued due to these effects. The possibility of sensitisation should be taken into account.

Fertility

There are no data on the effects of cefuroxime axetil on fertility in humans. Reproductive studies in animals have shown no effects on fertility.

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

Tabulated list of adverse reactions

• Frequency not known- cannot be estimated from the available data.

Cephalosporins as a class tend to be absorbed onto the surface of red cells membranes and react with antibodies directed against the medicine to produce a positive Coombs test (which can interfere with crossmatching of blood) and very rarely haemolytic anaemia. Transient rises in serum liver enzymes have been observed which are usually reversible.

Paediatric population

The safety profile for cefuroxime axetil in children is consistent with the profile in adults.

Reporting of 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. Health care providers are requested to report any suspected adverse drug reactions to SAHPRA via the Med Safety APP (Medsafety X SAHPRA) and eReporting platform (who-umc.org) found on SAHPRA website.

(See section 4.8)

Symptoms of overdose: Seizures have been reported.

Treatment of overdose: Treatment is symptomatic and supportive. Serum levels of AUROXIME TABLETS can be reduced by haemodialysis or peritoneal dialysis.