Zocef   Powder for oral suspension

Cefuroxime Axetil 125 mg / 5 ml.

Usage and indications:

 

Zocef 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.

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

 

Dosage and administration:

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

Table 1: Adults and children (≥ 40 kg)

Indication

Dosage

Acute tonsillitis and pharyngitis, acute bacterial sinusitis

250mg twice daily

Acute otitis media

500mg twice daily

Acute exacerbations of chronic bronchitis

500mg twice daily

Cystitis

250mg twice daily

Pyelonephritis

250mg twice daily

Uncomplicated skin and soft tissue infections

250mg twice daily

Lyme disease

500mg twice daily for 14 days (range of 10 to 21 days)

 

Table 2: Children (<40 kg)

Indication

Dosage

Acute tonsillitis and pharyngitis, acute bacterial sinusitis

10mg/kg twice daily to a maximum of 125mg twice daily

Children aged two years or older with otitis media or, where appropriate, with more severe infections

15mg/kg twice daily to a maximum of 250mg twice daily

Cystitis

15mg/kg twice daily to a maximum of 250mg twice daily

Pyelonephritis

15 mg/kg twice daily to a maximum of 250 mg twice daily for 10 to 14 days

Uncomplicated skin and soft tissue infections

15mg/kg twice daily to a maximum of 250mg twice daily

Lyme disease

15mg/kg twice daily to a maximum of 250mg twice daily for 14 days (10 to 21 days)

 

Undesirable effects:

Infections and infestations:

Common: candida overgrowth.

Not known: clostridium difficile overgrowth.

Blood and lymphatic system disorders:

Common: eosinophilia.

Uncommon: positive Coomb's test, thrombocytopenia, leucopenia (sometimes profound).

Not known: hemolytic anemia.

Immune system disorders:

Not known: drug fever, serum sickness, anaphylaxis, Jarisch-Herxheimer reaction.

Nervous system disorders:

Common: headache, dizziness.

Gastrointestinal disorders:

Common: diarrhea, nausea, abdominal pain.

Uncommon: vomiting.

Not known: pseudo-membranous colitis.

Hepatobiliary disorders:

Common: transient increases of hepatic enzyme levels.

Not known: jaundice (predominantly cholestatic), hepatitis.

Skin and subcutaneous tissue disorders:

Uncommon: skin rashes.

Not known: urticaria, pruritus, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis (exanthematic necrolysis) (see Immune system disorders), angioneurotic edema.

Warnings and precautions:

 

Hypersensitivity reactions:

  • Special caution is required to determine any other type of previous hypersensitivity reactions to penicillin or to other beta-lactam medicinal products because patients hypersensitive to these medicines may be hypersensitive to cefuroxime as well (cross- allergy).
  • 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 agents, serious and occasionally fatal hypersensitivity reactions have been reported. 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 agent. Caution should be used if cefuroxime is given to patients with a history of non-severe hypersensitivity to other beta-lactam agents.
  • 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 spirochete 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. Antibacterial agent–associated pseudo-membranous colitis have been reported with nearly all antibacterial agents, including cefuroxime and may range in severity from mild to life threatening. This diagnosis should be considered in patients with diarrhea during or subsequent to the administration of cefuroxime. Discontinuation of therapy with cefuroxime and the administration of specific treatment for Clostridium difficile should be considered. Medicinal products that inhibit peristalsis should not be given.

  • Interference with diagnostic tests:

The development of a positive Coomb's Test associated with the use of cefuroxime may interfere with cross matching of blood.

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.

  • Important information about excipient:

The sucrose content of cefuroxime axetil suspension and granules should be taken into account when treating diabetic patients and appropriate advice provided.

 

Pack: carton box containing a glass bottle of 60ml containing dry powder for oral suspension.

 

 

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