Cefadroxil capsules for bacterial urinary tract and skin infections

Cefadroxil capsules contain a cephalosporin antibiotic used orally to treat bacterial infections. This antibiotic works by inhibiting bacterial cell wall synthesis, leading to bacterial cell death. It is prescribed mainly for urinary tract infections, skin and soft tissue infections, and throat infections caused by specific susceptible bacteria.

Cefadroxil capsules are approved to treat infections caused by susceptible bacteria, including:

• Uncomplicated urinary tract infections caused by Escherichia coli, Proteus mirabilis, and Klebsiella species.
• Skin and skin structure infections caused by staphylococci and/or streptococci.
• Pharyngitis and/or tonsillitis caused by Group A beta-hemolytic Streptococcus pyogenes.

Use should be limited to infections proven or strongly suspected to be bacterial to reduce bacterial resistance. It is not established for prophylaxis of rheumatic fever despite effectiveness in eradicating streptococci from the oropharynx.

Cefadroxil monohydrate USP equivalent to 500 mg of cefadroxil

Cefadroxil is a semisynthetic cephalosporin antibiotic that kills bacteria by interfering with their ability to form cell walls. Without a proper cell wall, bacterial cells cannot maintain their structure and die. This action makes cefadroxil bactericidal against susceptible gram-positive and gram-negative bacteria, including beta-hemolytic streptococci and staphylococci, as well as certain urinary pathogens such as E. coli.

Adults:

• Uncomplicated urinary tract infection: 1 to 2 grams per day orally, given once daily or divided into two doses.
• Other urinary tract infections: 2 grams per day divided into two doses.
• Skin and skin structure infections: 1 gram per day, once daily or divided twice daily.
• Pharyngitis and tonsillitis due to Group A streptococcus: 1 gram per day orally, once or twice daily for 10 days.

Children:

• Urinary tract infections: 30 mg/kg/day divided every 12 hours.
• Pharyngitis, tonsillitis, impetigo: 30 mg/kg/day given once daily or divided every 12 hours.
• Other skin and skin structure infections: 30 mg/kg/day divided every 12 hours.

Renal impairment:

Dose adjustment is required for patients with creatinine clearance less than 50 mL/min/1.73 m². For example, with creatinine clearance 0-10 mL/min, the maintenance dose is 500 mg every 36 hours after an initial 1000 mg dose.

Administration:

Oral capsules may be taken with or without food. Taking with food may reduce gastrointestinal discomfort.

Cefadroxil is contraindicated in patients with known allergy to cephalosporin antibiotics.

• Allergic reactions: Cross-sensitivity with penicillins occurs in up to 10% of penicillin-allergic patients. Severe hypersensitivity reactions, including anaphylaxis, may require emergency treatment.
• Clostridium difficile–associated diarrhea (CDAD): Use of cefadroxil can lead to CDAD, which may occur during or up to two months after antibiotic treatment. CDAD symptoms range from mild diarrhea to fatal colitis and require prompt evaluation and management.
• Renal function: Dose adjustment and careful monitoring are important in patients with impaired renal function to avoid toxicity.
• Superinfection: Prolonged use may result in overgrowth of nonsusceptible organisms. Monitor patients closely.
• Diarrhea: Can occur during therapy; watery or bloody stools warrant medical attention.

Common and mild:

• Diarrhea
• Dyspepsia
• Nausea and vomiting
• Allergic skin reactions such as rash, urticaria, pruritus

Serious but rare:

• Anaphylaxis
• Pseudomembranous colitis
• Hepatic dysfunction including cholestasis and elevated liver enzymes
• Neutropenia, agranulocytosis, thrombocytopenia
• Erythema multiforme, Stevens-Johnson syndrome
• Serum sickness, arthralgia
• Toxic epidermal necrolysis
• Hemolytic anemia, aplastic anemia
• Seizures especially in renal impairment if dose not adjusted

Cefadroxil may cause positive direct Coombs' test results, which can interfere with blood typing and cross-matching. No other specific drug interactions are detailed.

Pregnancy:

Animal studies at doses up to 11 times the human dose showed no harm to fertility or fetus. There are no adequate well-controlled studies in pregnant women. Use only if clearly needed.

Labor and delivery:

Not studied; administer only if clearly needed.

Lactation:

Exercise caution when administering to nursing mothers.

Ingesting less than 250 mg/kg in children under six years is unlikely to cause significant adverse effects. Higher doses (>250 mg/kg) may warrant gastric emptying. Cefadroxil is partially removed by hemodialysis in anuric patients.

Store at 25°C (77°F); excursions permitted between 15° to 30°C (59° to 86°F) as per USP Controlled Room Temperature standards.