Antibiotic

Cefixime

400 mg 10 ct.

Cefixime Tablets are indicated for the use of treating a variety of bacterial infections such as Pharyngitis, Tonsilitis, Chronic Bronchitis, Gonorrhea and Urinary Tract Infections.

NDC:
64980-0430-01
Manufacturer:
Rising Pharma
BG

INDICATIONS & USAGE

Uncomplicated Urinary Tract Infections

Cefixime tablets are indicated in the treatment of adults and pediatric patients weighing more than 45 kg or older than 12 years with uncomplicated urinary tract infections caused by susceptible isolates of Escherichia coli and Proteus mirabilis.

Pharyngitis and Tonsillitis

Cefixime tablets are 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. (Note: Penicillin is the usual drug of choice in the treatment of Streptococcus pyogenes infections. Cefixime tablets are generally effective in the eradication of Streptococcus pyogenes from the nasopharynx; however, data establishing the efficacy of cefixime tablets in the subsequent prevention of rheumatic fever is not available.)

Acute Exacerbations of Chronic Bronchitis

Cefixime tablets are indicated in the treatment of adults and pediatric patients weighing more than 45 kg or older than 12 years with acute exacerbations of chronic bronchitis caused by susceptible isolates of Streptococcus pneumoniae and Haemophilus influenzae.

Uncomplicated Gonorrhea (cervical/urethral)

Cefixime tablets are indicated in the treatment of adults and pediatric patients weighing more than 45 kg or older than 12 years with uncomplicated gonorrhea (cervical/urethral) caused by susceptible isolates of Neisseria gonorrhoeae (penicillinase-and non-penicillinase-producing isolates).

Usage

To reduce the development of drug resistant bacteria and maintain the effectiveness of cefixime tablets and other antibacterial drugs, cefixime tablets 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.

DOSAGE AND ADMINISTRATION

Adults

The recommended dose of cefixime is 400 mg daily. This may be given as a 400 mg tablet 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 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.

Pediatric Patients (weighing more than 45 kg or older than 12 years)

Children weighing more than 45 kg or older than 12 years should be treated with the recommended adult dose. 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 should not be substituted for the chewable tablets or suspension in the treatment of otitis media.

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

Renal Impairment

Cefixime 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. Refer to Table 2 for dose adjustments for adults with renal impairment. Neither hemodialysis nor peritoneal dialysis removes significant amounts of drug from the body.

CONTRAINDICATIONS

Cefixime is contraindicated in patients with known allergy to cefixime or other cephalosporins.

Full Prescribing Information: DailyMed

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