Highest Recommended Dose of Cefixime
The highest recommended dose of cefixime is 400 mg daily for adults, which can be administered as a single daily dose or divided into two 200 mg doses. 1
Standard Adult Dosing
- 400 mg daily is the maximum FDA-approved dose for adults 1
- Can be given as:
- 400 mg once daily
- 200 mg twice daily (preferred for reducing gastrointestinal side effects) 2
- For uncomplicated gonorrhea: 400 mg as a single oral dose 3, 4, 1
Special Populations and Conditions
Renal Impairment Dosing
- Normal dose (400 mg daily) for creatinine clearance ≥60 mL/min
- Reduced dosing for renal impairment 1:
- Creatinine clearance 21-59 mL/min: 300 mg daily
- Creatinine clearance ≤20 mL/min or on dialysis: 200 mg daily
Pediatric Dosing
- Maximum pediatric dose is 400 mg daily (for children >45 kg) 4, 1
- Standard pediatric dosing: 8 mg/kg/day (can be given once daily or divided twice daily) 1
- Weight-based dosing chart 4, 1:
Patient Weight (kg) Daily Dose (mg) 5 to 7.5 50 mg 7.6 to 10 80 mg 10.1 to 12.5 100 mg 12.6 to 20.5 150 mg 20.6 to 28 200 mg 28.1 to 33 250 mg 33.1 to 40 300 mg 40.1 to 45 350 mg >45 400 mg
Clinical Considerations
Efficacy and Safety
- The 400 mg dose has demonstrated 97.4% cure rate for uncomplicated urogenital and anorectal gonococcal infections 3
- Studies have shown that 400 mg cefixime is as effective as 250 mg ceftriaxone IM for uncomplicated gonorrhea 5
- Lower doses (200 mg) have shown 95% efficacy for uncomplicated gonorrhea, but are not recommended for routine treatment 6
Administration Considerations
- Can be administered without regard to food 1
- For Streptococcus pyogenes infections, treatment should continue for at least 10 days 1
- Available in two formulations:
- Oral suspension (100 mg/5 mL and 200 mg/5 mL)
- Capsules (400 mg)
Common Side Effects
- Gastrointestinal effects (diarrhea and stool changes) are more common with once-daily 400 mg dosing compared to twice-daily 200 mg dosing 2
- Side effects are usually mild to moderate and transient, occurring mainly in the first few days of treatment 7
Important Caveats
- Cefixime does not provide as high or sustained bactericidal levels as ceftriaxone 125 mg IM 3, 4
- For otitis media, the suspension formulation is preferred over tablets/capsules due to higher peak blood levels 1
- Not effective against Staphylococcus aureus or Pseudomonas aeruginosa 7
- When treating gonorrhea, additional treatment for chlamydia should be considered if not ruled out 3, 4
While some studies have investigated 800 mg doses 5, the FDA-approved maximum dose remains 400 mg daily, and there is no evidence that higher doses provide additional clinical benefit with an acceptable safety profile.