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.
• 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)
Table 2: Children (<40 kg)
Infections and infestations:
Common: candida overgrowth.
Not known: clostridium difficile overgrowth.
Blood and lymphatic system disorders:
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.
Common: diarrhea, nausea, abdominal pain.
Not known: pseudo-membranous colitis.
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:
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.
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.
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.
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.