Mecefix B.E 75- Cefixim is indicated for the treatment of infections
COMPOSITION: Each sachet (1.5g) contains: Cefixime................ 75 mg
DOSAGE FORM: Granule
PAKAGING: Box of 20 sachets
INDICATIONS • Cefixime is indicated for the treatment of the following infections when caused by susceptible micro - organism. • Upper respiratory tract infections: Bacterial pharyngitis, tonsillitis, otitis media, sinusitis. • Lower respiratory tract infections: Acute bronchitis and acute exacerbations of chronic bronchitis. • Uncomplicated urinary tract infections: Acute cystidis. • Uncomplicated gonorrhoea.
DOSAGE AND ADMINISTRATIONS Adults and children over 12 years • The recommended dosage is 200 - 400mg daily given either as a single dose or in two divided doses. • For upper respiratory tract infections and uncomplicated urinary tract infections: 200mg once daily. • In lower respiratory tract infections: 400mg daily is recommended. • For sinusitis: the therapeutic dosage must be administered for 10 to 14 days. • Treatment of uncomplicated Gonorrhoea: The recommended dosage is 400mg as a single oral dose.
Infants and childrens below 12 years of age • The recommended dosage is 8mg/kg daily given either as a single dose or in two divided doses. • In patients with more serious symptoms or unadequate effect, the dosage may increase to 6mg/kg, twice daily.
CONTRA - INDICATIONS Cefixime is contra - indicated in patients with known allergy to the Cephalosporin group of antibiotics.
PRECATIONS • Precaution with patient has had previous hypersensitivity reactions to Cephalosporin, Penicillins. Rate of cross hypersensitivity among Beta - lactam antibiotics has been clearly documented and may occur in up to 10% of patients with a history of Penicillin allergy. • The possibility of the emergence of resistant organisms which might result in overgrowth should be kept in mind, particularly during prolonged treatment. • Cefixime should be prescribed with caution in individual with a history of gastrointestinal disease, particularly colitis.
USE IN PREGNANCY AND LACTATION Pregnancy: Safe use in human pregnancy has not been established, only use real neccesarily. Lactation: It is not known whether cefixime is excreted in human breast milk, only use real neccesarily.
SIDE - EFFECTS • Gastrointestinal: Diarrhoea, abdominal pain, dyspepsia, nausea and vomiting. Several cases of documented pseudomembraneous colitis were identified during the studies. The onset of pseudomembranous colitis symptoms may occur during or after therapy. • Hypersensitivity reactions: Skin rash, urticaria, drug fever, and pruritus. Erythema multiforme, Stevens - Johnson syndrome, and serum sickness-like reactions have been reported. • Hepatic: Transient elevation in SGPT, SGOT and alkaline phosphatase. • Renal: Transient elevations in BUN or Creatinine. • Central nervous system: Headaches or dizziness. • Hemic and Lymphatic systems: Transient thrombocytopenia, leukopenia, and eosinophilia. Prolongation in prothrombin time was seen rarely. • Other: Genital pruritus, vaginitis, candidiasis.
INTERACTIONS • Elevated carbamazepine levels have been reported when Cefixime is administered concomitantly. • A false - positive direct Coombs test has been reported during treatment with other cephalosporin antibiotics; therefore, it should be recognized that a positive Coombs test may be due to the drug. • Anticoagulants: Prolongation in clotting time was reported when using Cefixime with anticoagulants (Warfarin).