Cefadroxil is indicated for the treatment of the following infections:

• Streptococcal pharyngitis and tonsillitis
• Bronchopneumonia and bacterial pneumonia
• Uncomplicated urinary tract infections, including pyelonephritis and cystitis
• Skin and soft tissue infections, including abscesses, furunculosis, impetigo, erysipelas, pyoderma, and lymphadenitis

Cefadroxil inhibits bacterial cell wall synthesis by binding to one or more penicillin-binding proteins (PBPs). This action interferes with the final transpeptidation step of peptidoglycan synthesis in the bacterial cell wall, thereby preventing cell wall biosynthesis and assembly, which ultimately leads to bacterial cell death.

The dosage of Cefadroxil depends on the susceptibility of the pathogens, the severity of the disease and on the clinical status of the patient (renal and hepatic function).

Streptococcal pharyngitis and tonsillitis

• Adult and adolescents >40 kg with normal renal function: 1000 mg once a day over at least 10 days. Dosage may be decreased.
• Children <40 kg with normal renal function: 30 mg/kg/day once a day over at least 10 days.

Bronchopneumonia, bacterial pneumonia, Urinary tract infections, Skin & soft tissue infections

• Adult and adolescents >40 kg with normal renal function: 1000 mg twice a day.
• Children <40 kg with normal renal function: 30-35 mg/kg/day divided into two daily doses.

Children may benefit of increased posology up to 100 mg/kg/day. Depending on the severity of the infection, adults may require increased posology. The dosage maximum is 4 g per day. Chronic urinary tract infection may require a prolonged and intensive treatment with continued testing of susceptibility and clinical monitoring. Cefadroxil 500 mg is not recommended for infants and children under 6 years. For younger children and children with a body weight <40 kg, liquid dosage oral form is recommended.

Renal impairment patients:
In patients with renal impairment, the dose should be adjusted according to creatinine clearance rates to prevent accumulation of cefadroxil. In patients with creatinine clearance of 50 ml/min or less, the following reduced dosage schedule is recommended as a guideline.

• Creatinine clearance 50-25 ml/min/1.73 m2: 500 mg-1000 mg every 12 hours
• Creatinine clearance 25-10 ml/min/1.73 m2: 500 mg-1000 mg every 24 hours
• Creatinine clearance 10-0 ml/min/1.73 m2: 500 mg-1000 mg every 36 hours
• Children (<40 kg) with renal impairment:
• Cefadroxil is not indicated in children suffering from renal insufficiency and children requiring haemodialysis.
• Dosage for haemodialysis patients:
• Haemodialysis eliminates 63% of 1000 mg of cephalosporin after 6 to 8 hours of haemodialysis. Elimination half-time of cephalosporin is about 3 hours during dialysis. Patients with haemodialysis receive one additional dose of cefadroxil 500 mg-1000 mg at the end of the haemodialysis.

Hepatic impairment: No adjustment of posology is necessary.

• Elderly: As cefadroxil is excreted by renal route, the dosage should be adjusted if necessary as described under impaired renal function.

Mode of administration: Bioavailability is not affected by food and cefadroxil may be taken with meals or on an empty stomach. In case of gastro-intestinal disturbances, it may be administered with food.

Duration of therapy: Treatment should be applied for 2 to 3 further days after regression of the acute clinical symptoms or evidence of bacterial eradication has been obtained. In infections caused by Streptococcus pyogenes up to 10 days treatment may be considered.

Cefadroxil may prolong prothrombin time and increase the risk of bleeding when used with anticoagulants. Reduced elimination of cefadroxil has also been reported with probenecid.

Cefadroxil is contraindicated in patients with a known hypersensitivity to any cephalosporin. It is also contraindicated in patients with a history of severe hypersensitivity reactions to penicillins or any other beta-lactam antibiotics. Cefadroxil should not be used together with bacteriostatic antibiotics such as tetracycline, erythromycin, sulfonamides, or chloramphenicol, as an antagonistic effect may occur. Concomitant use with aminoglycoside antibiotics, polymyxin B, colistin, or high-dose loop diuretics should be avoided because these combinations may increase the risk of nephrotoxicity.

Cefadroxil does not penetrate into the cerebrospinal fluid (CSF) and is therefore not indicated for the treatment of meningitis. Penicillin remains the first-line drug for the treatment of Streptococcus pyogenes infections and for the prevention of rheumatic fever; available data on cefadroxil are not sufficient to support its use for prophylaxis. Special caution is advised in patients with a history of severe allergy or asthma. In patients with a history of non-severe hypersensitivity to penicillins or other non-cephalosporin beta-lactam antibiotics, cefadroxil should be used with caution. Dose adjustment is necessary in patients with renal impairment according to the degree of renal dysfunction. Cefadroxil should also be used cautiously in patients with a history of gastrointestinal disorders, particularly colitis, as diarrhea may reduce the absorption and effectiveness of other medicines. If allergic reactions such as urticaria, rash, pruritus, hypotension, tachycardia, respiratory difficulty, or collapse occur, treatment should be stopped immediately and appropriate measures should be taken. During prolonged therapy, regular monitoring of blood counts and hepatic and renal function is recommended. Prolonged use may also result in superinfection with fungi, such as Candida. In cases of severe and persistent diarrhea, antibiotic-associated pseudomembranous colitis should be considered. If this occurs, cefadroxil must be discontinued immediately and appropriate treatment should be initiated. Coombs’ test results may become transiently positive during or after treatment with cefadroxil. This may also apply to newborns whose mothers received cephalosporins before delivery. During cefadroxil therapy, urinary glucose should be measured enzymatically, as reduction tests may produce falsely elevated results.

Infections and infestations: Uncommon side effects include vaginal mycoses and thrush.

Blood and lymphatic system disorders: Rare side effects include eosinophilia, thrombocytopenia, leukopenia, neutropenia, and agranulocytosis. Hemolytic anemia has been reported very rarely.

Immune system disorders: Serum sickness-like reactions occur rarely. Immediate allergic reactions, including anaphylactic shock, occur very rarely.

Nervous system disorders: Very rare side effects include headache, insomnia, dizziness, and nervousness.

Gastrointestinal disorders: Common side effects include nausea, vomiting, diarrhea, dyspepsia, abdominal pain, and glossitis. Pseudomembranous colitis has been reported very rarely.

Hepatobiliary disorders: Rare side effects include cholestasis and idiosyncratic hepatic failure.

Skin and subcutaneous tissue disorders: Common side effects include pruritus, rash, allergic exanthema, and urticaria. Stevens-Johnson syndrome and erythema multiforme have been reported very rarely.

Musculoskeletal and connective tissue disorders: Arthralgia occurs rarely.

Renal and urinary disorders: Interstitial nephritis has been reported rarely.

General disorders: Fever occurs rarely, while fatigue has been reported very rarely.

Although animal studies and clinical experience have not shown evidence of teratogenicity, the safe use of cefadroxil during pregnancy has not been established. Cefadroxil is excreted in low concentrations in breast milk; therefore, sensitization, diarrhea, or fungal colonization of the infant’s mucosa may occur. For this reason, the use of cefadroxil during pregnancy and lactation should be approached with strict caution.

Cefadroxil may bind to cholestyramine, which can reduce the bioavailability of cefadroxil. Concomitant administration with probenecid decreases the renal elimination of cefadroxil and may result in increased plasma concentrations.

No clinical reports of cefadroxil overdose are currently available. However, based on experience with other cephalosporins, possible symptoms may include nausea, hallucinations, hyperreflexia, extrapyramidal symptoms, altered consciousness, coma, and impairment of renal function.

First-generation cephalosporin antibiotic.

Store in a dry place, protected from light and heat. Keep out of the reach of children.