Is cefixime (a third-generation cephalosporin antibiotic) effective?

Is Cefixime Effective?

Cefixime is effective for specific respiratory and urinary tract infections in adults and children, but it is no longer recommended for gonorrhea treatment due to rising resistance and inferior pharmacokinetics compared to ceftriaxone. 1, 2

Current Status for Gonorrhea (Critical Limitation)

The CDC removed cefixime from routine first-line gonorrhea treatment guidelines due to declining effectiveness and rising minimum inhibitory concentrations (MICs). 1, 2

• Between 2006 and 2011, isolates with elevated cefixime MICs increased from 0.2% to 1.4% nationally, with the West region showing an increase from 0.2% to 3.2%. 1
• Among men who have sex with men (MSM), elevated cefixime MICs increased from 0.2% in 2006 to 3.8% in 2011. 1, 2
• Cure rates for urogenital/anorectal gonorrhea are only 97.1-97.4% with cefixime compared to 99.1% with ceftriaxone. 3, 2
• Pharyngeal gonorrhea cure rate is approximately 91%, making cefixime unsuitable for this anatomic site. 2
• The 400-mg oral dose does not provide bactericidal levels as high or sustained as intramuscular 250-mg ceftriaxone. 3, 1

When Cefixime May Still Be Used for Gonorrhea

Cefixime 400 mg may be used as an alternative only when ceftriaxone is unavailable, combined with azithromycin 1 g orally, with mandatory test-of-cure at 1 week. 2

FDA-Approved Indications (Where Cefixime Remains Effective)

Cefixime is FDA-approved and effective for the following conditions in adults and pediatric patients ≥6 months: 4

Urinary Tract Infections

• Uncomplicated UTIs caused by Escherichia coli and Proteus mirabilis. 4
• Clinical studies show 94% cure rate in adults with UTI. 5
• Microbiological eradication achieved in 64 of 71 isolates (90%) from UTI patients. 5

Respiratory Tract Infections

• Acute exacerbations of chronic bronchitis caused by Streptococcus pneumoniae and Haemophilus influenzae. 4
• Clinical cure or improvement in 98% of adults with acute exacerbations of chronic bronchitis and 100% with pneumonia. 5
• Microbiological eradication in 40 of 45 isolates (89%) from respiratory tract infections. 5

Otitis Media

• Caused by Haemophilus influenzae, Moraxella catarrhalis, and Streptococcus pyogenes. 4
• Important caveat: For Streptococcus pneumoniae otitis media, overall response was approximately 10% lower for cefixime than comparators. 4
• Clinical cure or improvement in 96% of children with acute otitis media. 5
• Microbiological eradication in 35 of 36 isolates (97%) from children, including all S. pneumoniae isolates. 5

Pharyngitis and Tonsillitis

• Caused by Streptococcus pyogenes. 4
• Critical caveat: Penicillin remains the usual drug of choice for S. pyogenes infections. 4
• Data establishing efficacy in subsequent prevention of rheumatic fever is not available. 4
• Clinical cure or improvement in 100% of children with acute sinusitis. 5

Dosing Regimens

Adults

• Standard dose: 400 mg daily (may be given as single daily dose). 4
• For uncomplicated cervical/urethral gonorrhea (when used): single 400 mg dose. 4
• May be administered without regard to food. 4

Pediatric Patients (≥6 months)

• 8 mg/kg/day of suspension, administered as single daily dose or divided as 4 mg/kg every 12 hours. 4
• For Streptococcus pyogenes infections, administer for at least 10 days. 4

Pharmacokinetic Advantages

• 3-hour elimination half-life permits once or twice daily dosing, distinguishing it from many other oral cephalosporins. 6, 7
• Absorbed via carrier-mediated transport mechanism in the intestine. 7
• Comparable efficacy to multiple daily doses of co-trimoxazole or amoxicillin in UTIs. 6
• Similar effectiveness to cefaclor 20-40 mg/kg daily and amoxicillin 40 mg/kg daily in pediatric otitis media. 6

Safety Profile

• Most common adverse effects: diarrhea and stool changes (16% of patients). 8
• Generally mild to moderate in severity, transient, occurring mostly in first few days of treatment. 6
• Led to discontinuation in only 1.9% of pediatric patients. 8
• Drug-related adverse effects occurred in 24.3% of patients but were generally well-tolerated. 8

Common Pitfalls to Avoid

• Never use cefixime for gonorrhea treatment as routine first-line therapy given current CDC recommendations. 1, 2
• Do not use for pharyngeal gonorrhea infections given poor 91% efficacy at this site. 2
• Recognize that cefixime is approximately 10% less effective than comparators for S. pneumoniae otitis media. 4
• Remember that penicillin remains preferred for S. pyogenes pharyngitis/tonsillitis. 4
• Ensure orders specifying dose in milliliters include concentration, as cefixime suspension is available in two concentrations (100 mg/5 mL and 200 mg/5 mL). 4