CEFIXIME

CEFIXIME — cefixime powder, for suspension
CEFIXIME — cefixime capsule
Lupin Pharmaceuticals, Inc.

1 INDICATIONS AND USAGE

1.1 Uncomplicated Urinary Tract Infections

Cefixime for oral suspension and cefixime capsule 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 and cefixime capsule 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 [see Clinical Studies (14)].

1.3 Pharyngitis and Tonsillitis

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

1.4 Acute Exacerbations of Chronic Bronchitis

Cefixime for oral suspension and cefixime capsule 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 and cefixime capsule 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 and other antibacterial drugs, cefixime for oral suspension and cefixime capsule 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 capsule daily. For the treatment of uncomplicated cervical/urethral gonococcal infections, a single oral dose of 400 mg is recommended.

The capsule 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 and 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
		100 mg / 5 mL	200 mg / 5 mL
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
12.6 to 20.5	150	7.5	4
20.6 to 28	200	10	5
28.1 to 33	250	12.5	6
33.1 to 40	300	15	7.5
40.1 to 45	350	17.5	9
45.1 or greater	400	20	10

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

Otitis media should be treated with the suspension. Clinical trials 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 or capsule should not be substituted for the 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.