Afix

Approved Indications:

• Acute otitis media (caused by H. influenzae, M. catarrhalis, S. pyogenes)
• Pharyngitis and tonsillitis (as an alternative to penicillin)
• Acute bacterial bronchitis and acute exacerbation of chronic bronchitis
• Uncomplicated urinary tract infections (UTIs)
• Uncomplicated gonorrhea (cervical, urethral, or rectal)
• Community-acquired pneumonia (mild to moderate)

Clinically Accepted Off-Label Uses:

• Typhoid fever (especially in regions with multidrug resistance)
• Shigellosis (resistant cases)
• Pediatric bacterial diarrhea (susceptible strains)
• Early-stage prostatitis (mild cases due to E. coli)

Adults and Adolescents (≥12 years or ≥45 kg):

• 200 mg every 12 hours or 400 mg once daily
• Duration: 5–10 days based on severity
• For gonorrhea: single 400 mg dose

Children (6 months–12 years):

• 8 mg/kg/day as a single dose or in two divided doses
• Max daily dose: 400 mg

Infants <6 months:

• Safety and efficacy not established

Renal Impairment:

• CrCl 21–60 mL/min: administer every 24 hours
• CrCl ≤20 mL/min or on dialysis: extend interval to every 48 hours

Hepatic Impairment:

• No adjustment necessary

Administration Notes:

• Can be taken with or without food
• Shake suspension well before use; refrigerate after reconstitution as directed

Cefixime is a third-generation oral cephalosporin that works by binding to penicillin-binding proteins (PBPs) in the bacterial cell wall. This inhibits the final transpeptidation step of peptidoglycan synthesis, weakening the cell wall and resulting in bacterial cell lysis. It exhibits bactericidal activity and is stable against many beta-lactamases, especially from gram-negative organisms.

• Absorption: ~40–50% orally absorbed; unaffected significantly by food
• Tmax: 2–6 hours post-dose
• Distribution: Protein binding ~65%, well distributed in tissues and fluids
• Metabolism: Not significantly metabolized
• Excretion: ~50% unchanged in urine; rest via biliary/fecal route
• Half-life: ~3–4 hours; prolonged in renal impairment

Pregnancy:

• FDA Category B
• No fetal harm observed in animal studies; use if clearly needed in humans

Lactation:

• Small amounts excreted in breast milk
• Generally safe during breastfeeding; monitor infant for GI disturbances (e.g., diarrhea, candidiasis)

• Therapeutic Class: Antibiotic
• Subclass: Third-generation cephalosporin (beta-lactam)

• Known hypersensitivity to cefixime or other cephalosporins
• History of severe allergic reaction to penicillin (due to possible cross-reactivity)

• Hypersensitivity Reactions: Risk of anaphylaxis, rash; especially in penicillin-allergic patients
• Clostridioides difficile-associated diarrhea (CDAD): Ranges from mild to fatal colitis
• Use caution in:
• Renal impairment (requires dosage adjustment)
• Patients with history of gastrointestinal disease, especially colitis
• May cause false-positive Coombs’ test

Common:

• Diarrhea
• Nausea
• Abdominal pain
• Dyspepsia

Less Common:

• Headache
• Dizziness
• Vaginitis
• Rash or urticaria

Serious/Rare:

• Stevens-Johnson syndrome
• Hepatitis or cholestatic jaundice
• Anaphylaxis
• Hemolytic anemia
• Thrombocytopenia or leukopenia

• Probenecid: Reduces renal clearance, increasing cefixime levels
• Warfarin: May increase anticoagulant effect—monitor INR
• Live typhoid vaccine: Efficacy may be decreased
• Carbamazepine: Increased levels reported in isolated cases

• WHO includes cefixime as part of empiric treatment in typhoid fever in resistant regions
• CDC guidelines note cefixime as a backup option for gonorrhea if ceftriaxone is not feasible
• Emerging resistance in some E. coli and Neisseria strains noted—culture and sensitivity testing recommended when possible

• Tablets: Store at 20–25°C (68–77°F); protect from moisture
• Dry powder for oral suspension: Store below 25°C
• After reconstitution: Refrigerate (2–8°C), use within 14 days
• Do not freeze
• Shake suspension well before each dose