Cefixime

Clinical Trials:

Five percent (5%) of patients in the clinical trials discontinued therapy because of drug-related adverse reactions. Thirty-six percent of the pediatric patient population experienced at least one adverse reaction (mild 25%, moderate 9%, severe 2%).

Forty-seven percent of the adult patients experienced at least one adverse reaction (mild 24%, moderate 19%, severe 4%). The most commonly seen adverse reactions in the clinical trials of the tablet formulation were gastrointestinal events, which were reported in 37% of all adult patients treated (mild 21%, moderate 13%, severe 3%).

5%), headache 11%, stool changes 12%, nausea 9%, abdominal pain 5%, dyspepsia 3%, flatulence (3%), dizziness (3%) and vomiting (2%). 9%) versus twice a day (8%). These symptoms usually responded to symptomatic therapy or ceased when cefixime tablets was discontinued.

1): Acute exacerbations of chronic bronchitis Community-acquired Pneumonia Lower urinary tract infections Pyelonephritis In the treatment of: Otitis media Sinusitis Pharyngitis The use of cefixime should be reserved for infections in which the causative organism is known or suspected to be resistant to other commonly used antibacterial agents or when treatment failure with other commonly used antibacterial agents may carry significant risk.

Consideration should be given to official guidance on the appropriate use of antibacterial agents.

5) To reduce the development of drug-resistant bacteria and maintain the effectiveness of cefixime for oral suspension and other antibacterial drugs, cefixime for oral suspension should be used only to treat infections that are proven or strongly suspected to be caused by bacteria.

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 .

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.

) 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) ]. 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.