Cefixime

CEFIXIME- cefixime powder, for suspension
NorthStar RxLLC

1. INDICATIONS AND USAGE

1.1 Uncomplicated Urinary Tract Infections

Cefixime for oral suspension is indicated in the treatment of adults and pediatric patients six months of age or older with uncomplicated urinary tract infections caused by susceptible isolates of Escherichia coli and Proteus mirabilis.

1.2 Otitis Media

Cefixime for oral suspension is indicated in the treatment of adults and pediatric patients six months of age or older with otitis media caused by susceptible isolates of 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. [ s ee Clinical Studies ( 14) ].

1.3 Pharyngitis and Tonsillitis

Cefixime for oral suspension is 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 for oral suspension is generally effective in the eradication of Streptococcus pyogenes from the nasopharynx; however, data establishing the efficacy of Cefixime for oral suspension in the subsequent prevention of rheumatic fever is not available.)

1.4 Acute Exacerbations of Chronic Bronchitis

Cefixime for oral suspension is indicated in the treatment of adults and pediatric patients six months of age or older with acute exacerbations of chronic bronchitis caused by susceptible isolates of Streptococcus pneumoniae and Haemophilus influenzae.

1.5 Uncomplicated Gonorrhea (cervical/urethral)

Cefixime for oral suspension is indicated in the treatment of adults and pediatric patients six months of age or older with uncomplicated gonorrhea (cervical/urethral) caused by susceptible isolates of Neisseria gonorrhoeae (penicillinase –and non- penicillinase-producing isolates).

1.6 Usage

To reduce the development of drug resistant bacteria and maintain the effectiveness of Cefixime for oral suspension, USP and other antibacterial drugs, Cefixime for oral suspension, USP 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.

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 Cefixime for oral suspension is available in two different concentrations (100 mg/5 mL, 200 mg/5 mL).

Table 1. Suggested doses for pediatric patients

PEDIATRIC DOSAGE CHART Doses are suggested for each weight range and rounded for ease of administration
Cefixime for Oral Suspension Cefixime Chewable Tablet
100 mg/5 mL 200 mg/5 mL Dose
Patient Weight (kg) Dose/Day (mg) Dose/Day (mL) Dose/Day (mL)
5 to 7.5* 50 2.5
7.6 to 10* 80 4 2
10.1 to 12.5 100 5 2.5 1 tablet of 100 mg
12.6 to 20.5 150 7.5 4 1 tablet of 150 mg
20.6 to 28 200 10 5 1 tablet of 200 mg
28.1 to 33 250 12.5 6 1 tablet of 100 mg and 1 tablet of 150 mg
33.1 to 40 300 15 7.5 2 tablets of 150 mg
40.1 to 45 350 17.5 9 1 tablet of 150 mg and 1 tablet of 200 mg
45.1 or greater 400 20 10 2 tablets of 200 mg

*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.

Children weighing more than 45 kg or older than 12 years should be treated with the recommended adult dose. 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.

2.3 Renal Impairment

Cefixime for oral suspension 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.

Table 2. Doses for Adults with Renal Impairment
Renal Dysfunction Cefixime for Oral Suspension Tablet Chewable Tablet
Creatinine Clearance (mL/min) 100 mg/5 mL 200 mg/5 mL 400 mg 200 mg
Dose/Day (mL) Dose/Day (mL) Dose/Day Dose/Day
60 or greater Normal dose Normal dose Normal dose Normal dose
21 to 59* OR renal hemodialysis* 13 6.5 Not Appropriate Not Appropriate
20 or less OR continuous peritoneal dialysis 8.6 4.4 0.5 tablet 1 tablet

* The preferred concentration of oral suspension to use is 200 mg/5 mL for patients with this renal dysfunction

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