SUPRAX- cefixime powder, for suspension
Lupin Pharmaceuticals, Inc.
1 INDICATIONS AND USAGE
To reduce the development of drug resistant bacteria and maintain the effectiveness of Suprax (cefixime) and other antibacterial drugs, Suprax 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.
Suprax (cefixime) is a cephalosporin antibacterial drug 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. Suprax is generally effective in the eradication of Streptococcus pyogenes from the nasopharynx; however, data establishing the efficacy of Suprax 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).
2 DOSAGE AND ADMINISTRATION
2.1 Adults
The recommended dose of cefixime is 400 mg daily. This may be given as a 400 mg tablet or capsule daily or the 400 mg tablet may be split and given as one half tablet every 12 hours. For the treatment of uncomplicated cervical/urethral gonococcal infections, a single oral dose of 400 mg is recommended. The capsule and tablet may be administered without regard to food.
In the treatment of infections due to Streptococcus pyogenes , a therapeutic dosage of cefixime should be administered for at least 10 days.
2.2 Pediatric Patients (6 months or older)
The recommended dose is 8 mg/kg/day of the suspension. This may be administered as a single daily dose or may be given in two divided doses, as 4 mg/kg every 12 hours.
Note: A suggested dose has been determined for each pediatric weight range. Refer to Table 1. Ensure all orders that specify a dose in milliliters include a concentration, because Suprax for oral suspension is available in three different concentrations (100 mg/5 mL, 200 mg/5 mL, and 500 mg/5 mL).
CONTRAINDICATIONS
Suprax (cefixime) is contraindicated in patients with known allergy to cefixime or other cephalosporins
DESCRIPTION
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 C16 H15 N5 O7 S2 .3H2 O
Microbiology
Mechanism of Action
As with other cephalosporins, the bactericidal action of cefixime results from inhibition of cell wall synthesis. Cefixime is stable in the presence of certain beta-lactamase enzymes. As a result, certain organisms resistant to penicillins and some cephalosporins due to the presence of beta-lactamases may be susceptible to cefixime.