Céfépime 0,5g, 1g, 2g

Qualitative and quantitative composition

  • Céfépime 0,5g :
    Each vial contains 0.5g cefepime (in the form of 594.6mg cefepime dihydrochloride monohydrate).
  • Céfépime 1g :
    Each vial contains 1g of cefepime (in the form of 1189.2 mg cefepime dihydrochloride monohydrate).
  • Céfépime 2g :
    Each vial contains 2g cefepime (in the form of 2378.5 mg cefepime dihydrochloride monohydrate).
  • List of excipients: see SPC.

Pharmaceutical form and presentations

  • Powder for solution for intravenous administration, 0.5g vial;
  • Powder for solution for intravenous administration, 1g vial;
  • Powder for solution for intravenous administration, 2g vial.

Clinical data

  • Pharmacotherapeutic class

    Beta-lactam antibiotic, fourth-generation cephalosporin.

  • Therapeutic indications

    Cefepime is only used in infections requiring hospitalization (e.g. severe pneumonia, intra-abdominal infection, wound infection) and in nosocomial infections. (See CBIP)

  • Contraindications

    IgE-mediated hypersensitivity to penicillin.

  • Administration and precautions for use

    This medicinal product is administered intravenously.
    As with all beta-lactam antibacterial agents, serious and sometimes fatal hypersensitivity reactions have been reported. Before initiating treatment with Cefepime, careful consideration should be given to whether the patient has previously experienced hypersensitivity reactions to cefepime, beta-lactam antibiotics or other drugs.

  • Drug and non-drug interactions

    • Renal function should be carefully monitored if cefepime is used in combination with potentially nephrotoxic drugs, such as aminoglycosides and potent diuretics.
    • Cephalosporins may potentiate the action of coumarin anticoagulants.
    • Concomitant treatment with bacteriostatic antibiotics may alter the action of beta-lactam antibiotics.

  • Undesirable effects

    Confers CBIP.

  • Pregnancy and breastfeeding

    Pregnancy:

    Reproduction studies in mice, rats and rabbits have not indicated any harm to the foetus. However, there are no adequate and well-controlled studies in pregnant women. As animal reproduction studies do not always predict human response, this medicine should only be used during pregnancy if clearly needed.

    Breastfeeding:

    Cefepime is excreted in very low concentrations in breast milk. Therapeutic doses of cefepime should be used with caution in nursing mothers, and the infant should be closely monitored.

  • Surdosage

    In cases of severe overdosage, particularly in patients with renal failure, hemodialysis may help eliminate cefepime from the body. Peritoneal dialysis confers no benefit. Accidental overdosage has occurred when high doses were administered to patients with renal dysfunction. Symptoms of overdosage include encephalopathy (altered consciousness, including confusion, hallucinations, stupor and coma), myoclonic seizures and neuromuscular excitability.

Pharmaceutical information

  • Shelf life and storage precautions

    The shelf life of the bottle before opening is 3 years. Store at a temperature not exceeding 25°C. Keep the vials in the outer packaging in a dark place.

  • Special precautions for handling and disposal

    Parenteral solutions should be inspected for particulate matter prior to administration. The solution may change colour during storage (from colourless to amber yellow), without affecting the efficacy of the product.
    Any unused medicine or waste must be disposed of in accordance with current regulations.

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