SUPRAX?
(cefixime) for Oral Suspension, USP 500 mg/5 mL
To reduce the development of drug-resistant bacteria and maintain the effectiveness of Suprax (cefixime) for Oral Suspension and other antibacterial drugs, Suprax should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria.
DRUG DESCRIPTION
Suprax (cefixime) for Oral Suspension is a semisynthetic, cephalosporin antibiotic for oral administration.
After reconstitution each teaspoonful (5 mL) of suspension contains 100 mg of cefixime as the trihydrate. In addition, the suspension contains the following inactive ingredients: strawberry flavor, sodium benzoate, sucrose, colloidal silicon dioxide and xanthan gum.
INDICATIONS
To reduce the development of drug resistant bacteria and maintain the effectiveness of Suprax (cefixime) for Oral Suspension and other antibacterial drugs, Suprax should be used only to treat or prevent 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.
Suprax is indicated in the treatment of the following infections when caused by susceptible strains of the designated microorganisms:
Uncomplicated Urinary Tract Infections caused by Escherichia coli and Proteus mirabilis.
Otitis Media caused by Haemophilus influenzae (beta-lactamase positive and negative strains), Moraxella (Branhamella) catarrhalis, (most of which are beta-lactamase positive) and S. pyogenes*.
Note: For information on otitis media caused by Streptococcus pneumoniae, see CLINICAL STUDIES section.
Pharyngitis and Tonsillitis, caused by S. pyogenes.
Note: Penicillin is the usual drug of choice in the treatment of S. pyogenes infections, including the prophylaxis of rheumatic fever. Suprax is generally effective in the eradication of S. pyogenes from the nasopharynx however, data establishing the efficacy of Suprax in the subsequent prevention of rheumatic fever are not available.
Acute Bronchitis and Acute Exacerbations of Chronic Bronchitis, caused by Streptococcus pneumoniae and Haemophilus influenzae (beta-lactamase positive and negative strains).
Uncomplicated gonorrhea (cervical/urethral), caused by Neisseria gonorrhoeae (penicillinase-and non-penicillinase- producing strains).
Appropriate cultures and susceptibility studies should be performed to determine the causative organism and its susceptibility to cefixime however, therapy may be started while awaiting the results of these studies. Therapy should be adjusted, if necessary, once these results are known.
SIDE EFFECTS
Most of adverse reactions observed in clinical trials were of a mild and transient nature. Five percent (5%) of patients in the U.S. trials discontinued therapy because of drug-related adverse reactions. The most commonly seen adverse reactions in U.S. trials of the tablet formulation were gastrointestinal events, which were reported in 30% of adult patients on either the BID or the QD regimen. Clinically mild gastrointestinal side effects occurred in 20% of all patients, moderate events occurred in 9% of all patients and severe adverse reactions occurred in 2% of all patients. Individual event rates included diarrhea 16%, loose or frequent stools 6%, abdominal pain 3%, nausea 7%, dyspepsia 3%, and flatulence 4%. The incidence of gastrointestinal adverse reactions, including diarrhea and loose stools, in pediatric patients receiving the suspension was comparable to the incidence seen in adult patients receiving tablets.
These symptoms usually responded to symptomatic therapy or ceased when cefixime was discontinued.
