Indicatios:

Cefuroxime axetil is indicated for the treatment of the infections listed below in adults and children from the age of 3 months.

- Acute streptococcal tonsillitis and pharyngitis.

- Acute bacterial sinusitis.

- Acute otitis media.

- Acute exacerbations of chronic bronchitis.

- Cystitis

- Pyelonephritis.

- Uncomplicated skin and soft tissue infections.

- Treatment of early Lyme disease.

Dosage and administration：

Posology

The usual course of therapy is seven days (may range from five to ten days).

Table 1. Adults and children (≥40 kg)

Table 2. Children (<40 kg)

There is no experience of using Cefuroxime axetil in children under the age of 3 months.

Contraindications:

Hypersensitivity to the active substance or to any of the excipients

Patients with known hypersensitivity to cephalosporin antibiotics.

History of severe hypersensitivity (e.g. anaphylactic reaction) to any other type of betalactam antibacterial agent (penicillins, monobactams and carbapenems).

Precautions:   

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.   In case of severe hypersensitivity reactions, treatment with cefuroxime must be discontinued immediately and adequate emergency measures must be initiated.

Severe cutaneous adverse reactions (SCAR), such as Stevens Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), drug reaction with eosinophilia and systemic symptoms (DRESS), erythema multiforme (EM) and acute generalised exanthematous pustulosis (AGEP), which can be life-threatening or fatal, have been reported in patients receiving cefuroxime.

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.

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.

Drug interactions:

Drugs which reduce gastric acidity may result in a lower bioavailability of cefuroxime axetil compared with that of the fasting state and tend to cancel the effect of enhanced absorption after food.

Cefuroxime is excreted by glomerular filtration and tubular secretion. Concomitant use of probenecid is not recommended. Concurrent administration of probenecid significantly increases the peak concentration, area under the serum concentration time curve and elimination half-life of cefuroxime.

Concomitant use with oral anticoagulants may give rise to increased INR.

Storage:

Store in the original packaging in order to protect from moisture

This medicinal product does not require any special temperature storage conditions