Cefurim

• Upper Respiratory Tract Infections:
  Acute bacterial sinusitis, pharyngitis, tonsillitis caused by susceptible strains of Streptococcus pyogenes, Haemophilus influenzae, Moraxella catarrhalis.
• Lower Respiratory Tract Infections:
  Acute bacterial bronchitis and community-acquired pneumonia caused by Streptococcus pneumoniae, Haemophilus influenzae, Moraxella catarrhalis.
• Urinary Tract Infections (Uncomplicated):
  Cystitis and urethritis caused by Escherichia coli, Proteus mirabilis.
• Skin and Soft Tissue Infections:
  Caused by susceptible strains of Staphylococcus aureus and Streptococcus pyogenes.
• Acute Otitis Media:
  Infections caused by Streptococcus pneumoniae, Haemophilus influenzae, Moraxella catarrhalis in pediatric patients.
• Early Lyme Disease:
  Treatment of erythema migrans caused by Borrelia burgdorferi.
• Off-label Uses:
  Some physicians may use for other infections caused by susceptible organisms based on clinical judgment.

Adults and Children ≥12 years:

• Typical Dose: 250 mg orally twice daily.
• Severe infections: 500 mg twice daily.
• Duration: Usually 7 to 14 days depending on infection.

Pediatric Patients (3 months to 12 years):

• Dose: 20 mg/kg/day divided into two doses (maximum 250 mg twice daily).
• Acute Otitis Media: Usually 10 mg/kg twice daily for 10 days.

Renal Impairment:

• Mild to Moderate Impairment: No adjustment necessary.
• Severe Impairment (CrCl <10 mL/min): Use cautiously; no established dose adjustments.

Administration:

• Taken orally with food to enhance absorption.
• Tablets or suspension should be swallowed whole or administered as directed.

Cefuroxime axetil is a prodrug that is rapidly hydrolyzed to active cefuroxime, a second-generation cephalosporin. Cefuroxime exerts bactericidal activity by inhibiting bacterial cell wall synthesis. It binds to specific penicillin-binding proteins (PBPs), blocking the transpeptidation step of peptidoglycan synthesis in the bacterial cell wall, leading to cell lysis and death. It is effective against a broad spectrum of Gram-positive and Gram-negative bacteria, including β-lactamase-producing strains.

• Absorption:
  Oral bioavailability is approximately 37% when taken without food, increased to 52% with food. Peak plasma concentrations occur 2 to 3 hours after oral administration.
• Distribution:
  Widely distributed into body tissues and fluids including respiratory tract secretions, middle ear fluid, and urine.
• Protein Binding:
  Approximately 33 to 50%.
• Metabolism:
  Cefuroxime axetil is a prodrug hydrolyzed to cefuroxime by esterases in the intestinal mucosa and blood; cefuroxime itself is not metabolized significantly.
• Elimination:
  Cefuroxime is excreted primarily unchanged via the kidneys by glomerular filtration and tubular secretion.
• Half-life:
  Approximately 1 to 1.5 hours in healthy adults; prolonged in renal impairment.

• Pregnancy:
  Classified as FDA Pregnancy Category B. Animal studies have not demonstrated fetal harm. Use only if clearly needed and benefit outweighs risk.
• Lactation:
  Cefuroxime is excreted in small amounts in human milk. Caution is advised when administered to nursing mothers.

• Primary Class: Second-generation cephalosporin antibiotic
• Subclass: Oral cephalosporin prodrug

• Known hypersensitivity to cefuroxime, cephalosporins, penicillins, or other β-lactam antibiotics.
• History of severe allergic reaction (anaphylaxis, Stevens-Johnson syndrome) to β-lactams.

• Hypersensitivity Reactions: Serious allergic reactions including anaphylaxis may occur; discontinue immediately if suspected.
• Clostridioides difficile-associated Diarrhea (CDAD): May occur; monitor for persistent diarrhea.
• Renal Impairment: Dose adjustments may be needed in severe renal dysfunction; monitor renal function.
• Superinfection: Prolonged use may result in overgrowth of resistant organisms or fungi.

Common:

• Gastrointestinal: Diarrhea, nausea, vomiting, abdominal pain.
• Dermatologic: Rash, urticaria, pruritus.
• Others: Headache, dizziness.

Serious/Rare:

• Anaphylaxis.
• Stevens-Johnson syndrome, toxic epidermal necrolysis (rare).
• Clostridioides difficile colitis.
• Hematologic: Eosinophilia, leukopenia (rare).

• Antacids and H2-receptor antagonists: May reduce absorption; separate administration by at least 2 hours.
• Probenecid: May increase cefuroxime plasma levels by inhibiting renal tubular secretion.
• Other β-lactams or nephrotoxic drugs: Monitor for additive toxicity.
• No significant CYP450 interactions.

• Remains recommended for uncomplicated respiratory, urinary tract infections, and Lyme disease.
• Updated guidance advises food co-administration to improve absorption.
• No recent black box warnings or major safety changes reported.

• Store at 20°C to 25°C (68°F to 77°F).
• Protect from moisture and light.
• Keep in a tightly closed container.
• Do not freeze.