SUPRAX

SUPRAX- cefixime tablet
SUPRAX- cefixime capsule
SUPRAX- cefixime tablet, chewable
SUPRAX- cefixime powder, for suspension
LUPIN LIMITED

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).

Table 1. Suggested doses for pediatric patients
*
The preferred concentrations of oral suspension to use are 100 mg/5 mL or 200 mg/5 mL for pediatric patients in these weight ranges.
PEDIATRIC DOSAGE CHART Doses are suggested for each weight range and rounded for ease of administration
Suprax ( cefixime ) for Oral Suspension Suprax ( cefixime ) Chewable Tablet
100 mg / 5 mL 200 mg / 5 mL 500 mg / 5 mL
Patient Weight ( kg ) Dose / Day ( mg ) Dose / Day ( mL ) Dose / Day ( mL ) Dose / Day ( mL ) Dose
5 to 7.5* 50 2.5
7.6 to 10* 80 4 2
10.1 to 12.5 100 5 2.5 1 1 tablet of 100 mg
12.6 to 20.5 150 7.5 4 1.5 1 tablet of 150 mg
20.6 to 28 200 10 5 2 1 tablet of 200 mg
28.1 to 33 250 12.5 6 2.5 1 tablet of 100 mg and 1 tablet of 150 mg
33.1 to 40 300 15 7.5 3 2 tablets of 150 mg
40.1to 45 350 17.5 9 3.5 1 tablet of 150 mg and 1 tablet of 200 mg
45.1 or greater 400 20 10 4 2 tablets of 200 mg

Children weighing more than 45 kg or older than 12 years should be treated with the recommended adult dose. Suprax (cefixime) Chewable Tablets must be chewed or crushed before swallowing.

Otitis media should be treated with the chewable tablets or suspension. Clinical trials of otitis media were conducted with the chewable tablets or suspension, and the chewable tablets or suspension results in higher peak blood levels than the tablet when administered at the same dose.

Therefore, the tablet or capsule should not be substituted for the chewable tablets or suspension in the treatment of otitis media [see CLINICAL PHARMACOLOGY (12.3)].

In the treatment of infections due to Streptococcus pyogenes , a therapeutic dosage of cefixime should be administered for at least 10 days.

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