What is the recommended dosing for Cefixime (Cefixime) in the treatment of bacterial infections?

Cefixime Dosing for Bacterial Infections

Cefixime is no longer recommended as a first-line treatment for gonorrhea due to rising resistance, but remains an effective option for urinary tract infections, otitis media, pharyngitis, and respiratory infections at a standard adult dose of 400 mg daily (either as a single dose or divided into 200 mg twice daily) and 8 mg/kg/day for pediatric patients. 1, 2, 3

Current Status for Gonococcal Infections

The CDC no longer recommends cefixime as a routine first-line regimen for gonorrhea treatment in the United States due to significantly increased resistance patterns, particularly in the Western United States and among men who have sex with men. 1, 2

Historical Context (No Longer Current Practice)

• Older guidelines from 1998-2002 recommended cefixime 400 mg orally as a single dose for uncomplicated gonococcal infections of the cervix, urethra, and rectum, achieving 97.1% cure rates. 1
• If cefixime must be used for gonorrhea (as an alternative only), it requires combination therapy with azithromycin 1 g orally as a single dose (preferred) or doxycycline 100 mg twice daily for 7 days, plus a test of cure in 1 week. 2
• The 400 mg oral dose does not provide bactericidal levels as high or sustained as ceftriaxone 250 mg IM, and demonstrates limited efficacy for pharyngeal gonorrhea. 1

FDA-Approved Indications and Dosing

Adults

Standard dose: 400 mg daily, administered as a single 400 mg capsule or divided as 200 mg twice daily. 3

Approved indications include: 3

• Uncomplicated urinary tract infections (E. coli, Proteus mirabilis)
• Otitis media (H. influenzae, M. catarrhalis, S. pyogenes)
• Pharyngitis and tonsillitis (S. pyogenes) - requires at least 10 days of therapy
• Acute exacerbations of chronic bronchitis (S. pneumoniae, H. influenzae)
• Uncomplicated cervical/urethral gonorrhea (as alternative only, see above)

Pediatric Patients (≥6 months)

Standard dose: 8 mg/kg/day of oral suspension, administered as a single daily dose or divided as 4 mg/kg every 12 hours. 3

Critical considerations: 3

• Children >45 kg or >12 years should receive the adult dose
• For otitis media, only the suspension formulation should be used (not tablets/capsules), as it achieves higher peak blood levels at equivalent doses
• For S. pyogenes infections, continue therapy for at least 10 days

Renal Impairment Dosing

Dose adjustments are required for creatinine clearance <60 mL/min: 3

• CrCl 21-59 mL/min: 260 mg daily (13 mL of 100 mg/5 mL suspension or 6.5 mL of 200 mg/5 mL suspension)
• CrCl ≤20 mL/min or on dialysis: 200 mg daily (8.6 mL of 100 mg/5 mL suspension or 4.4 mL of 200 mg/5 mL suspension)
• Neither hemodialysis nor peritoneal dialysis removes significant drug amounts

Clinical Efficacy Data

Urinary Tract Infections

Cefixime demonstrates excellent efficacy in uncomplicated UTIs, with eradication rates >94% for susceptible pathogens. 4 In comparative trials, cefixime 400 mg once daily or 200 mg twice daily showed equivalent efficacy to co-trimoxazole, with clinical and bacteriologic cure rates of 98% at 5-9 days post-therapy and 87-90% at 4-6 weeks. 5

Respiratory Infections

Clinical trials demonstrate comparable efficacy to amoxicillin, amoxicillin/clavulanate, and cefaclor in acute lower respiratory tract infections and pharyngitis/tonsillitis. 6 For pediatric otitis media, cefixime 8 mg/kg daily shows similar effectiveness to cefaclor 20-40 mg/kg daily and amoxicillin 40 mg/kg daily. 6

Pharmacokinetic Properties

Key pharmacokinetic characteristics: 7

• Elimination half-life: 3-4 hours (permits once or twice daily dosing)
• Bioavailability: 40-52% (oral absorption)
• Protein binding: ~31% (concentration-independent)
• Renal excretion: ~20% as active drug
• Peak serum concentrations are dose-proportional between 200-400 mg

Administration Considerations

Food effects: Capsules may be administered without regard to food. 3

Dosing frequency and tolerability: The twice-daily regimen (200 mg BID) is associated with significantly lower gastrointestinal adverse effects compared to once-daily dosing (400 mg), particularly diarrhea and stool changes. 4 For improved tolerability, consider dividing the daily dose into two administrations. 8

Common Pitfalls to Avoid

• Do not use cefixime as first-line therapy for gonorrhea - resistance patterns have rendered it unreliable as monotherapy 1, 2
• Do not substitute tablets/capsules for suspension in otitis media - suspension achieves superior peak levels 3
• Do not use cefixime for complicated UTIs without sensitivity testing - gram-positive and non-fermenting organisms may be resistant 8
• Do not forget dose adjustment in renal impairment - accumulation can occur with CrCl <60 mL/min 3
• Ensure all pediatric orders specify concentration (100 mg/5 mL vs 200 mg/5 mL) to prevent dosing errors 3