1. INDICATIONS AND USAGE
Cefixime for oral suspension, USP is a cephalosporin antibacterial drug indicated in the treatment of adults and pediatric patients six months and older with the following infections:
Uncomplicated Urinary Tract Infections (
1.1)
Otitis Media (
1.2)
Pharyngitis and Tonsillitis (
1.3)
Acute Exacerbations of Chronic Bronchitis (
1.4)
Uncomplicated Gonorrhea (cervical/urethral)(
1.5)
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 bacteria.(
1.6)
1.1 Uncomplicated Urinary Tract Infections
Cefixime for oral suspension is indicated in the treatment of adults and pediatric patients six months of age or older with uncomplicated urinary tract infections caused by susceptible isolates of
Escherichia coli and
Proteus mirabilis.
1.2 Otitis Media
Cefixime for oral suspension is indicated in the treatment of adults and pediatric patients six months of age or older with otitis media caused by susceptible isolates of
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. [
s
ee Clinical Studies (
14)
].
1.3 Pharyngitis and Tonsillitis
Cefixime for oral suspension is indicated in the treatment of adults and pediatric patients six months of age or older with pharyngitis and tonsillitis caused by susceptible isolates of
Streptococcus pyogenes. (Note: Penicillin is the usual drug of choice in the treatment of
Streptococcus
pyogenes infections. Cefixime for oral suspension is generally effective in the eradication of
Streptococcus pyogenes from the nasopharynx; however, data establishing the efficacy of Cefixime for oral suspension in the subsequent prevention of rheumatic fever is not available.)
1.4 Acute Exacerbations of Chronic Bronchitis
Cefixime for oral suspension is indicated in the treatment of adults and pediatric patients six months of age or older with acute exacerbations of chronic bronchitis caused bysusceptible isolates of
Streptococcus pneumoniae and
Haemophilus influenzae.
1.5 Uncomplicated Gonorrhea (cervical/urethral)
Cefixime for oral suspension is indicated in the treatment of adults and pediatric patients six months of age or older with uncomplicated gonorrhea (cervical/urethral) caused by susceptible isolates of
Neisseria gonorrhoeae (penicillinase and non- penicillinase-producing isolates).
1.6 Usage
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.