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Cefixime is indicated for the treatment of the following acute infections when caused by susceptible micro-organisms:
Upper Respiratory Tract Infections (URTI): e.g. otitis media; and other URTI where the causative organism is known or suspected to be resistant to other commonly used antibiotics, or where treatment failure may carry significant risk.
Lower Respiratory Tract Infection: e.g. bronchitis.
Urinary Tract Infections: e.g. cystitis, cystourethritis, uncomplicated pyelonephritis
For oral administration only.
The usual course of treatment is 7 days. This may be continued for up to 14 days if required.
Cefixime is generally well tolerated. Majority of adverse reactions in were mild and self–limiting in nature.
The following adverse reaction (Preferred term# or equivalent) will be considered listed:
Blood and lymphatic system disorders: Eosinophilia, Hypereosinophilia, Agranulocytosis, Leucopenia
Neutropenia, Granulocytopenia, Haemolytic anaemia, Thrombocytopenia, Thrombocytosis.
Gastrointestinal: Abdominal pain, Diarrhoea, Dyspepsia, Nausea, Vomiting, Flatulance.
Diarrhoea has been more commonly associated with higher doses. Some cases of moderate to severe diarrhoea have been reported; this has occasionally warranted cessation of therapy. Cefixime should be discontinued if marked diarrhoea occurs.
Hepatobiliary disorders: Jaundice
Infections and infestations: Pseudomembranous colitis
Nervous system disorders: Dizziness, Headache
Respiratory, thoracic and mediastinal disorders: Dyspnoea
Renal and urinary disorders: Renal failure acute including tubulointerstitial nephritis as an underlying pathological condition.
Immune System disorders, administrative site conditions, skin and subcutaneous tissue disorders: Anaphylactic reaction, Serum sickness-like reaction, Drug rash with eosinophilia and systemic symptoms (DRESS), Pruritus, Rash, Drug Fever, Arthralgia, Erythema multiforme, Stevens-Johnson syndrome, Toxic epidermal necrolysis, Angio-oedema, Urticaria, Pyrexia, Face oedema, Genital pruritus, Vaginitis.
Severe cutaneous adverse reactions: Severe cutaneous adverse reactions such as toxic epidermal necrolysis, Stevens-Johnson syndrome and drug rash with eosinophilia and systemic symptoms (DRESS) have been reported in some patients on cefixime. When severe cutaneous adverse reactions occur, cefixime should be discontinued and appropriate therapy and/or measures should be taken.
Hypersensitivity to penicillins: As with other cephalosporins, cefixime should be given with caution to patients with a history of hypersensitivity to penicillin, as there is some evidence of partial cross-allergenicity between the penicillins and cephalosporins.
Haemolytic anaemia: Drug-induced haemolytic anaemia, including severe cases with a fatal outcome, has been described for cephalosporins (as a class). The recurrence of haemolytic anaemia after re-administration of cephalosporins in a patient with a history of cephalosporin (including cefixime) –associated haemolytic anaemia has also been reported.
Renal failure acute: As with other cephalosporins, cefixime may cause acute renal failure including tubulointerstitial nephritis as an underlying pathological condition. When acute renal failure occurs, cefixime should be discontinued and appropriate therapy and/or measures should be taken.
Store below 30°C and protect from light and moisture.
Keep the medicine out of reach of children.
Alu-Alu blister pack.
Ceficonex-200 is available in an Alu-Alu blister of 10 tablets. Such 10 blisters in a unit carton with package insert.
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