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.

* Efficacy for this organism in this organ system was studied in fewer than 10 infections.

Adults: Once Suprax is reconstituted, the recommended dose of the suspension is 400 mg daily. For the treatment of uncomplicated cervical/urethral gonococcal infections, a single oral dose of 400 mg is recommended.

Children: 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.

Children weighing more than 50 kg or older than 12 years should be treated with the recommended adult dose.

Otitis media should be treated with the suspension. Clinical studies of otitis media were conducted with the suspension, and the suspension results in higher peak blood levels than the tablet when administered at the same dose. Therefore, the tablet should not be substituted for the suspension in the treatment of otitis media. (See CLINICAL PHARMACOLOGY.)

Efficacy and safety in infants aged less than six months have not been established.

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

Renal Impairment

Suprax may be administered in the presence of impaired renal function. Normal dose and schedule may be employed in patients with creatinine clearances of 60 mL/min or greater. Patients whose clearance is between 21 and 60 mL/min or patients who are on renal hemodialysis may be given 75% of the standard dosage at the standard dosing interval (i.e., 300 mg daily). Patients whose clearance is < 20 mL/min, or patients who are on continuous ambulatory peritoneal dialysis may be given half the standard dosage at the standard dosing interval (i.e., 200 mg daily). Neither hemodialysis nor peritoneal dialysis remove significant amounts of drug from the body.

Reconstitution Directions For Oral Suspension

After reconstitution the suspension may be kept for 14 days either at room temperature, or under refrigeration, without significant loss of potency. Keep tightly closed. Shake well before using. Discard unused portion after 14 days.

Suprax® (cefixime) for Oral Suspension is an off-white to pale yellow colored powder. After reconstituted as directed, each 5 mL of reconstituted suspension contains 100 mg of cefixime as the trihydrate. Suprax is supplied as follows:

NDC 68180-202-03 - 50 mL Bottle
NDC 68180-202-02 - 75 mL Bottle
NDC 68180-202-01 - 100 mL Bottle

Prior to reconstitution: Store drug powder at 20 - 25°C (68 - 77°F) [See USP Controlled Room Temperature].

After reconstitution: Store at room temperature or under refrigeration.

Keep tightly closed.

**Clinitest® and Clinistix® are registered trademarks of Ames Division, Miles Laboratories, Inc. Tes-Tape® is a registered trademark of Eli Lilly and Company.

Manufactured for: Lupin Pharmaceuticals, Inc. 111 South Calvert Street Baltimore, Maryland 21202. United States. Manufactured by: Lupin Limited Mumbai 400 098, INDIA. Revised: August 2005. FDA Rev date: 2/3/2004

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