Cefador

Approved Indications:

• Upper Respiratory Tract Infections: Pharyngitis and tonsillitis caused by Streptococcus pyogenes (Group A β-hemolytic streptococci).
• Lower Respiratory Tract Infections: Mild to moderate bronchitis or secondary infections in chronic bronchitis due to susceptible strains of bacteria.
• Skin and Soft Tissue Infections: Including cellulitis, impetigo, and infected wounds caused by Staphylococcus aureus (including β-lactamase–negative strains) and Streptococcus pyogenes.
• Urinary Tract Infections (UTIs): Including cystitis and pyelonephritis caused by Escherichia coli, Proteus mirabilis, and Klebsiella species.

Clinically Accepted Off-label Uses:

• Dental Infections: As an alternative to penicillin for prophylaxis or treatment in cases of penicillin allergy.
• Otitis Media: For susceptible organisms, although not a first-line therapy.

Adults:

• Pharyngitis/Tonsillitis: 1 g orally once daily or in two divided doses for 10 days.
• UTIs: 1–2 g per day in one or two divided doses.
• Skin and Soft Tissue Infections: 1 g/day in one or two divided doses.

Pediatric Patients:

• Pharyngitis/Tonsillitis & Skin Infections:
  30 mg/kg/day in a single or divided dose for 10 days.
• UTIs:
  30–50 mg/kg/day in divided doses every 12 hours.

Elderly:

• Dose as for adults, but with careful monitoring of renal function.

Renal Impairment:

• Dose adjustment required. If creatinine clearance (CrCl) is <50 mL/min, extend dosing interval or reduce dose:
• CrCl 10–50 mL/min: 500 mg every 12 hours
• CrCl <10 mL/min: 500 mg every 24 hours

Administration Route:

• Oral; can be taken with or without food. For GI tolerance, take with meals.

Duration:

• Typically 7–10 days depending on infection type and clinical response.

Cefadroxil Monohydrate is a first-generation cephalosporin antibiotic that inhibits bacterial cell wall synthesis. It binds to penicillin-binding proteins (PBPs) located inside the bacterial cell wall, interfering with the final transpeptidation step of peptidoglycan synthesis. This inhibition weakens the cell wall structure, leading to cell lysis and death in actively dividing bacteria. It is bactericidal and exhibits activity primarily against Gram-positive organisms and some Gram-negative species.

• Absorption: Rapidly and nearly completely absorbed after oral administration (~90–95% bioavailability).
• Onset of Action: Within 1–2 hours.
• Peak Plasma Concentration: Reached in 1–2 hours post-dose.
• Protein Binding: Approximately 20%.
• Distribution: Widely distributed to body tissues and fluids; penetrates well into respiratory tissues, skin, and urine.
• Metabolism: Not significantly metabolized.
• Half-life: 1.5 to 2 hours (prolonged in renal impairment).
• Excretion: Primarily excreted unchanged in urine via glomerular filtration and tubular secretion.

• Pregnancy: Category B (No evidence of risk in animal studies; use only if clearly needed).
• Lactation: Small amounts are excreted in breast milk. No significant adverse effects have been reported in breastfed infants; considered compatible with breastfeeding. Monitor infant for potential GI disturbances such as diarrhea or candidiasis.

• Primary Class: First-generation cephalosporin antibiotic
• Subclass: β-lactam antimicrobial (bactericidal)

• Known hypersensitivity to cefadroxil, other cephalosporins, or β-lactam antibiotics.
• History of severe anaphylactic reaction to penicillin.
• Severe renal impairment without proper dose adjustment.

• Hypersensitivity Reactions: Risk of cross-reactivity in patients with penicillin allergy; discontinue immediately if signs of hypersensitivity (e.g., rash, angioedema, anaphylaxis) occur.
• Renal Dysfunction: Requires dose adjustment; monitor creatinine clearance.
• Prolonged Use: May lead to superinfection, including Clostridium difficile-associated diarrhea (CDAD).
• Seizure Risk: Rare, but higher in patients with renal dysfunction receiving high doses.
• Coagulopathy: Cephalosporins may rarely cause hypoprothrombinemia and bleeding; caution in patients on anticoagulants.

Common (≥1%):

• Gastrointestinal: Nausea, vomiting, diarrhea, abdominal pain, dyspepsia
• Hypersensitivity: Rash, urticaria, pruritus

Less Common:

• CNS: Headache, dizziness
• Hematologic: Eosinophilia, neutropenia

Serious/Rare:

• Anaphylaxis
• Stevens-Johnson syndrome
• Pseudomembranous colitis
• Hepatic dysfunction (transient elevations in liver enzymes)

Timing: Most mild effects appear within a few days of therapy initiation; serious effects are rare and often dose or duration-dependent.

• Probenecid: Decreases renal excretion of cefadroxil, increasing its plasma concentration and half-life.
• Oral Contraceptives: Theoretical risk of reduced contraceptive efficacy due to altered gut flora.
• Live Vaccines (e.g., typhoid): May be less effective during concurrent use with antibiotics.
• Nephrotoxic Drugs (e.g., aminoglycosides, loop diuretics): Increased risk of nephrotoxicity with high-dose or prolonged use.

CYP450 Involvement: Not metabolized via the CYP450 system; low potential for CYP-related drug interactions.

• No major changes in approved indications or safety warnings in recent FDA or EMA updates as of 2024.
• Still recommended as a first-line or alternative agent for uncomplicated pharyngitis in penicillin-allergic patients by IDSA and AAP guidelines.
• Emphasis on antibiotic stewardship: Cefadroxil should be reserved for susceptible infections, and not used empirically when resistance is suspected.

• Temperature: Store below 25°C (77°F); avoid excessive heat and humidity.
• Humidity/Light: Keep in a dry, light-resistant container.
• Oral Suspension: After reconstitution, store in a refrigerator (2°C–8°C) and use within 14 days. Shake well before each use.
• Handling Precautions: Do not freeze reconstituted suspension. Discard any unused suspension after 14 days.