Cefuroxime axetil tablets for bacterial infections in adults and adolescents

Cefuroxime axetil tablets are an oral cephalosporin antibiotic approved for treating various bacterial infections in adults and adolescents aged 13 years and older. The tablets are available in 250 mg and 500 mg strengths and treat mild-to-moderate infections caused by susceptible bacteria.

Cefuroxime axetil tablets are indicated for the treatment of infections caused by susceptible bacteria in adults and pediatric patients aged 13 years and older, including:

• Mild-to-moderate pharyngitis/tonsillitis due to Streptococcus pyogenes
• Mild-to-moderate acute bacterial maxillary sinusitis caused by non-β-lactamase–producing Streptococcus pneumoniae or Haemophilus influenzae
• Mild-to-moderate acute bacterial exacerbations of chronic bronchitis caused by susceptible strains of Streptococcus pneumoniae, β-lactamase–negative Haemophilus influenzae, or Haemophilus parainfluenzae
• Uncomplicated skin and skin-structure infections due to Staphylococcus aureus (including β-lactamase–producing strains) or Streptococcus pyogenes
• Uncomplicated urinary tract infections caused by Escherichia coli or Klebsiella pneumoniae
• Uncomplicated gonorrhea (urethral, endocervical, and rectal in females) caused by penicillinase-producing and non-penicillinase–producing Neisseria gonorrhoeae
• Early Lyme disease (erythema migrans) caused by Borrelia burgdorferi

Additionally, in pediatric patients younger than 13 years who can swallow tablets whole, cefuroxime axetil tablets treat acute bacterial otitis media caused by Streptococcus pneumoniae, Haemophilus influenzae (including β-lactamase–producing strains), Moraxella catarrhalis (including β-lactamase–producing strains), or Streptococcus pyogenes.

Cefuroxime axetil

Cefuroxime axetil is a cephalosporin antibacterial that works by inhibiting the synthesis of bacterial cell walls. It targets and kills susceptible bacteria responsible for infections, thus helping to clear bacterial infections in the body.

Adults and adolescents (13 years and older):

• Pharyngitis/tonsillitis: 250 mg every 12 hours for 10 days
• Acute bacterial maxillary sinusitis: 250 mg every 12 hours for 10 days
• Acute bacterial exacerbations of chronic bronchitis: 250 mg or 500 mg every 12 hours for 10 days
• Uncomplicated skin and skin-structure infections: 250 mg or 500 mg every 12 hours for 10 days
• Uncomplicated urinary tract infections: 250 mg every 12 hours for 7 to 10 days
• Uncomplicated gonorrhea: single 1,000 mg dose
• Early Lyme disease: 500 mg every 12 hours for 20 days

Pediatric patients younger than 13 years who can swallow tablets:

• Acute bacterial otitis media: 250 mg every 12 hours for 10 days
• Acute bacterial maxillary sinusitis: 250 mg every 12 hours for 10 days

Important administration notes:

• Administer tablets with or without food
• Tablets should be swallowed whole; crushing causes a strong, persistent bitter taste
• Tablets and oral suspension are not bioequivalent and not substitutable milligram-for-milligram
• Patients aged 13 and older who cannot swallow tablets whole should receive the oral suspension

Dosage adjustment for renal impairment (based on creatinine clearance):

• ≥30 mL/min: no adjustment
• 10 to <30 mL/min: give the standard dose every 24 hours
• <10 mL/min (no hemodialysis): give the standard dose every 48 hours
• Hemodialysis patients: give a single additional standard dose at the end of each dialysis session

Cefuroxime axetil tablets are contraindicated in patients with a known hypersensitivity to cefuroxime axetil or other β-lactam antibacterial drugs, including penicillins and cephalosporins, due to risk of severe allergic reactions such as anaphylaxis.

Serious hypersensitivity reactions:

Anaphylactic and other serious allergic reactions, including fatalities, have occurred with cefuroxime axetil and other β-lactam antibiotics. These reactions are more common in patients with a history of β-lactam allergy or multiple allergies. Discontinue cefuroxime axetil immediately if a serious reaction occurs and initiate appropriate treatment.

Clostridioides difficile-associated diarrhea (CDAD):

Antibiotic treatment can alter normal gut flora, leading to CDAD, which may range from mild diarrhea to fatal colitis. Symptoms can occur during or up to 2 months after antibiotic use. If CDAD is suspected or confirmed, discontinue antibiotics not targeting C. difficile and initiate proper medical management.

Superinfection risk:

Use of cefuroxime axetil may lead to overgrowth of fungal or resistant bacterial pathogens during therapy.

Antibiotic resistance risk:

Using cefuroxime axetil when bacterial infection is not proven or strongly suspected increases the risk of resistant bacteria development.

Interference with glucose testing:

False-positive urine glucose may occur with copper reduction tests, and false-negative blood/plasma glucose results may occur with ferricyanide tests while taking cefuroxime axetil.

Common adverse reactions (≥3% incidence):

• Diarrhea
• Nausea and vomiting
• Jarisch-Herxheimer reaction (especially in early Lyme disease treatment)
• Vaginitis (noted during early Lyme disease treatment)

Other reported adverse effects (≥1% incidence in multiple-dose regimens):

• Eosinophilia
• Transient elevations in liver enzymes (AST, ALT, LDH)

Less common adverse reactions (0.1%–1%):

• Hives, swollen tongue
• Anorexia
• Headache, dizziness, somnolence
• Abdominal pain, cramping, flatulence, indigestion, mouth ulcers
• Rash, itching, erythema, urticaria
• Chest pain, tachycardia, shortness of breath
• Vaginal itching and discharge
• Positive Coombs’ test
• Chills, sleepiness, thirst

Post-marketing serious adverse reactions:

• Hemolytic anemia, leukopenia, pancytopenia, thrombocytopenia
• Pseudomembranous colitis
• Hepatic impairment including hepatitis, cholestasis, jaundice
• Anaphylaxis, serum sickness-like reaction
• Stevens-Johnson syndrome, toxic epidermal necrolysis, angioedema
• Seizures, encephalopathy
• Renal dysfunction

Cefuroxime axetil may cause false-positive urine glucose results with copper reduction tests and false-negative blood/plasma glucose results with ferricyanide tests. No other specific drug interactions are detailed in the supplied evidence.