Cefixime Recall

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To reduce the development of drug resistant bacteria and maintain the effectiveness of cefixime for oral suspension USP and other antibacterial drugs, cefixime for oral suspension USP should be used only to treat infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antimicrobial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.

Cefixime is a cephalosporin antibacterial indicated in the treatment of adults and pediatric patients six months of age or older with the following infections when caused by susceptible isolates of the designated bacteria:

1.1 Uncomplicated Urinary Tract Infections

Uncomplicated Urinary Tract Infections caused by Escherichia coli and Proteus mirabilis.

1.2 Otitis Media

Otitis Media caused by Haemophilus influenzae, Moraxella catarrhalis, and Streptococcus pyogenes. (Efficacy for Streptococcus pyogenes in this organ system was studied in fewer than 10 infections.)

Note: For patients with otitis media caused by Streptococcus pneumoniae, overall response was approximately 10% lower for cefixime than for the comparator. [See CLINICAL STUDIES (14).]

1.3 Pharyngitis and Tonsillitis

Pharyngitis and Tonsillitis caused by Streptococcus pyogenes. (Note: Penicillin is the usual drug of choice in the treatment of Streptococcus pyogenes infections. Cefixime for oral suspension USP is generally effective in the eradication of Streptococcus pyogenes from the nasopharynx; however, data establishing the efficacy of cefixime for oral suspension USP in the subsequent prevention of rheumatic fever is not available.)

1.4 Acute Exacerbations of Chronic Bronchitis

Acute Exacerbations of Chronic Bronchitis caused by Streptococcus pneumoniae and Haemophilus influenzae.

1.5 Uncomplicated Gonorrhea (cervical/urethral)

Uncomplicated Gonorrhea (cervical/urethral) caused by Neisseria gonorrhoeae (penicillinase-and non-penicillinase-producing isolates).


There is currently no drug history available for this drug.

Other Information

Cefixime is a semisynthetic, cephalosporin antibacterial for oral administration. Chemically, it is (6R,7R)-7-[2-(2-Amino-4-thiazolyl)glyoxylamido]-8-oxo-3-vinyl-5-thia-1-azabicyclo [4.2.0] oct-2-­ene-2-carboxylic acid, 72-(Z)-[O-(carboxy methyl) oxime] trihydrate.

Molecular weight = 507.50 as the trihydrate. Chemical Formula is C16H15N5O7S2.3H2O.

The structural formula for cefixime is:

Chemical Structure

  • Inactive ingredients contained in the powder for oral suspension are: colloidal silicon dioxide, strawberry Guarana flavor, sucrose, and xanthan gum.

Cefixime Manufacturers

  • Aurobindo Pharma Limited
    Cefixime Powder, For Suspension [Aurobindo Pharma Limited]
  • Lupin Pharmaceuticals, Inc.
    Cefixime Powder, For Suspension [Lupin Pharmaceuticals, Inc.]

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