What are the indications and dosages of cefixime (Cefixime) for adults and children?

Cefixime Indications and Dosing

Cefixime is no longer recommended as first-line therapy for gonorrhea due to rising resistance, but remains FDA-approved for urinary tract infections, otitis media, pharyngitis/tonsillitis, acute exacerbations of chronic bronchitis, and uncomplicated gonorrhea (with significant caveats). 1, 2

FDA-Approved Indications

Adults

• Uncomplicated urinary tract infections: 400 mg orally once daily 2
• Acute exacerbations of chronic bronchitis: 400 mg orally once daily 2
• Pharyngitis and tonsillitis: 400 mg orally once daily 2
• Uncomplicated gonorrhea (cervical/urethral): 400 mg orally as a single dose 2

Pediatric Patients (≥6 months old)

• Standard dosing: 8 mg/kg/day orally, given as a single daily dose or divided into two doses 2
• Maximum daily dose: 400 mg 2
• Available formulations: Oral suspension (100 mg/5 mL or 200 mg/5 mL) for children; capsules (400 mg) for adults 2

Critical Limitations for Gonorrhea Treatment

The CDC explicitly recommends AGAINST using cefixime as first-line therapy for gonorrhea since 2012. 1, 3, 4

Why Cefixime Fell from First-Line Status:

• Inferior cure rates: Only 97.1-97.4% for urogenital/anorectal gonorrhea versus 99.1% for ceftriaxone 1, 3
• Poor pharyngeal efficacy: Only 91% cure rate for pharyngeal gonorrhea, below the 95% threshold required for first-line therapy 4, 5
• Rising resistance: Isolates with elevated MICs increased from 0.1% (2006) to 1.5% (2011) nationally, with 3.8% among MSM by 2011 5
• Lower bactericidal levels: Provides less sustained blood levels than ceftriaxone 125 mg IM 1, 3

Current CDC Recommendations for Gonorrhea:

• First-line: Ceftriaxone 250 mg IM plus azithromycin 1 g orally 1, 4
• Alternative (only when ceftriaxone unavailable): Cefixime 400 mg orally plus azithromycin 1 g orally, with mandatory test-of-cure at 1 week 1, 4, 5
• Never use cefixime alone without azithromycin or doxycycline co-treatment 5
• Avoid for pharyngeal infections given suboptimal 91% efficacy 4

Dosing Adjustments

Renal Impairment

• Creatinine clearance <60 mL/min: Dose adjustment required 2
• Creatinine clearance 21-60 mL/min: 75% of standard dose (300 mg daily for adults) 2
• Creatinine clearance ≤20 mL/min or hemodialysis: 50% of standard dose (200 mg daily for adults) 2

Special Populations

• Pregnancy: Use only if clearly needed (Category B) 2
• Nursing mothers: Consider discontinuing nursing temporarily during treatment 2
• Infants <6 months: Safety and efficacy not established 2
• Elderly: No specific dose adjustment needed, but monitor renal function 2

Common Pitfalls to Avoid

1. Using cefixime as monotherapy for gonorrhea: Always combine with azithromycin 1 g orally or doxycycline 100 mg twice daily for 7 days 1, 5
2. Treating pharyngeal gonorrhea with cefixime: Use ceftriaxone instead due to 91% vs >95% cure rates 4, 5
3. Forgetting test-of-cure: Mandatory at 1 week when cefixime is used for gonorrhea 1, 4
4. Ignoring geographic resistance patterns: Higher resistance in Western U.S. and among MSM populations 3, 5

Adverse Effects

• Most common: Diarrhea (16%), nausea (7%), loose stools (6%), abdominal pain (3%), dyspepsia (3%), vomiting 2
• Gastrointestinal effects: Usually mild-to-moderate, transient, occur in first few days of treatment 6, 7
• Hypersensitivity: Rare but can include shock and fatalities; discontinue if reaction occurs 2
• Clostridium difficile-associated diarrhea: Evaluate if diarrhea develops during or after treatment 2

Drug Interactions

• Carbamazepine: Elevated levels reported with concomitant use 2
• Warfarin/anticoagulants: Increased prothrombin time with or without bleeding 2