INFUCEF 250 Tablet

Use in pregnancy:

There are not sufficient data on the use of cefuroxime axetil during pregnancy to assess its possible harmfulness. So far, anima tests have not yielded evidence of harmfulness. Cefuroxime crosses the placenta. Cefuroxime axetil should not be used during pregnancy unless considered essential by the physician.

Use during lactation:

Cefuroxime is excreted to a small degree in human milk; breast-feeding should be avoided in women using cefuroxime axetil.

If after administration of cefuroxime axetil sensitivity reactions occur, the use should be discontinued immediately and an appropriate treatment should be established.

Special care is indicated in patients who have experienced an allergic reaction to penicillins or other beta-lactams.

As with other broad spectrum antibiotics, prolonged use of cefuroxime axetil may result in the overgrowth of non-susceptible organisms (e.g. candida, enterococci and clostridium difficile, which may require interruption of treatment.

In patients who develop severe diarrhoea during or after use of cefuroxime axetil, the risk of life threatening pseudomembranous colitis should be taken into account. The use of cefuroxime axetil should be discontinued and the appropriate treatment established. The use of preparations inhibiting the intestinal peristaltism is contra-indicated.

A 20-day treatment of Lyme disease may cause the frequency of developing diarrhoea to increase.

Long term use of cefuroxime axetil may lead to an excess of pathogens resistant lo cefuroxime axetil. It is of high importance that the patient is can fully checked. If a superinfection occurs during treatment appropriate measures should be taken. The use of cefuroxime axetil is not recommended in patients with severe intestinal tract disorders accompanied by vomiting and diarrhoea, since in these situations a sufficient absorption can not be guaranteed. Administration of a parenteral formulation of cefuroxime should be considered.

The Jarisch-Herxheimer reaction has been reported following cefuroxime axetil treatment of Lyme disease. The reaction results directly from the bactericidal activity of cefuroxime axetil on the spirochaete Borrelia burgdorferi. Patients should be informed of this common and usually self-limited reaction being a consequence of antibiotic treatment of Lyme disease.

Simultaneous use of medicines enhancing the pH of the stomach is not recommended.

There is no clinical experience with the use of cefuroxime axetil in children under the age of 3 months. With respect to the treatment of early Lyme disease there is only clinical experience with children from the age of 12 and with adults.

Special care should be taken with phenylketonuric patients because of the aspartame containing coating.

Either the glucose oxidase or the hexokinase methods are recommended to determine the blood and plasma glucose levels in patients receiving cefuroxime axetil. Cefuroxime does not interfere in the alkaline picrate assay for creatinine.

During the treatment with cefuroxime sodium, some children have experienced slight to moderate hearing loss.

Interaction with other medicinal products and other forms of interaction Simultaneous use of medicines enhancing the pH of the stomach decreases the bioavailability of cefuroxime axetil. It is recommended to avoid this combination.

Since bacteriostatic drugs may interfere with the bactericidal action of cephalosporins, it is advisable to avoid giving tetracyclines, macrolides or chloramphenicol in conjunction with cefuroxime axetil.

The concomitant administration of probenicid can produce higher and sustained concentrations of cefuroxime in the serum and in the bile.

Cefuroxime may interfere with the determination of glucose in urine with copper containing reagentia (Benedict-or Fehling solution, Clinitest). For the determination of blood and plasma sugar levels in patients receiving cefuroxime axetil, the glucose oxidase or hexokinase method is recommended.

The use of cefuroxime axetil may be accompanied by a false positive Coombs lest. This may interfere with the performance of cross matching tests with blood. Cephalosporin antibiotics at high dosage should be given with caution to patients receiving potent diuretics, aminoglycosides, or amphotericin as these combinations increases the risk of nephrotoxicity.

- Diarrhoea, nausea and vomiting

- Immune system disorders

- Skin and subcutaneous tissue disorders

- Renal and urinary disorders

- Nervous system disorders

- Increased levels of creatinine and urea in serum, especially in patients with impaired renal function.

Hypersensitivity to cefuroxime, other cephalosporins or to any of the excipients.

Previous immediate and/or severe hypersensitivity reaction to a penicillin or to any other type of beta-lactam medicinal products.

Therapeutic Indications

Cefuroxime axetil is indicated for the treatment of mild to moderately severe infections caused by micro-organisms susceptible to cefuroxime, such as:

• Upper respiratory tract infections: acute oti1is media, sinusitis, tonsillitis and pharyngitis

• Acute bronchitis, acute exacerbations of chronic bronchitis

• Lower uncomplicated urinary tract infections: cystitis

• Skin and soft tissue infections: furunculosis, pyoderma and impetigo

• Treatment of early stage Lyme disease (stadium I) and subsequent prevention of late complications in adults and children above 12 years of age.

Consideration should be given to official guidance on the appropriate use of antibacterial agents.

Posology and method of administration

Cefuroxime axetil tablets are coated to mask their taste: they should not be chewed.

The usual duration of therapy is 7 days (ranging from 5 to 10days). In case of pharyngotonsillitis caused by Streptococcus pyogenes a therapy duration of at least 10 days is indicated. The duration of treatment of early Lyme disease should be 20 days. In order to achieve optimum absorption cefuroxime axetil table is should be taken shortly after meals. The dosage depends on the severity of the infection. For severe infections parenteral forms of cefuroxime are recommended. Where appropriate cefuroxime axetil is effective when used following initial parenteral cefuroxime sodium in the treatment of pneumonia and acute exacerbations of chronic bronchitis.

Dosage schedule for tablets:

+Adults and children over 12 years of age:

* Upper respiratory tract infections: 250-500mg twice daily.

* Lower respiratory tract infections: 500mg twice daily.

* Lower uncomplicated urinary tract infections: 125-250mg twice daily

* Skin and soft tissue infections: 250-500mg twice daily

* Early Lyme disease: 500mg twice daily during 20 days

+Children from 5 to 12 years of age:

* Above-mentioned indications, if relevant for this group of children: 125-250mg twice daily

* Acute otitis media: 250mg twice daily

Children under 5 years of age:

Cefuroxime axetil tablets are not suitable for use in children under the age of 5. For patients in this age group it is advised to use an oral suspension. There is no experience in children under 3 months of age.

Dosage regimen in renal impairment, in dialysis patients and elderly:

No special precautions are necessary in patients with renal impairment, or in elderly patients if the daily dosage does not exceed 1 gram. In patients with renal impairment and creatinine clearance below 20ml/min cefuroxime axetil tablets should be dosed carefully. Patients undergoing haemodialysis will require a supplementary dose of cefuroxime at the end of each dialysis treatment.