CEFIXIME 400MG TABLETS

Name of the medicinal product:

Cefixime Tablets 400mg

Qualitative and quantitative composition:

Each tablet contains Cefixime (as Trihydrate) USP equivalent to Anhydrous Cefixime 400mg

Therapeutic indications:

Cefixime is an orally active cephalosporin antibiotic which has marked in vitro bactericidal activity against a wide variety of Gram-positive and Gram-negative organisms.

It 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. Clinical efficacy has been demonstrated in infections caused by commonly occurring pathogens including Streptococcus pneumoniae, Streptococcus pyogenes, Escherichia coli, Proteus mirabilis, Kliebsiella species, Haemophilus influenzae (beta-lactamase positive and negative), Branhamella catarrhalis (beta-lactamase positive and negative) and Enterobacter species. Cefixime is highly stable in the presence of beta-lactamase enzymes. Most strains of enterococci (Streptococcus faecalis, group D Streptococci) and Staphylococci (including coagulase positive and negative strains and methicillin-resistant strains) are resistant to Cefixime. In addition, most strains of Pseudomonas, Bacteriodes fragalis, Listeria monocytogenes and Clostridia are resistant to Cefixime.