Cefadroxil

These indications are based on manufacturer information for both originator and generic products. For product specific registered indications, please refer to product specific manufacturer information

Registered South African indications:

• Respiratory tract infections
• Urinary tract infections
• Skin and soft tissue infections 

Contraindications

• Hypersensitivity to the active ingredient or any of its excipients
• History of severe reactions to penicillins or to any other beta-lactam drugs

Cautions

• Renal impairment
• History of non-severe hypersensitivity to penicillins, or other non-cephalosporin beta–lactam drugs
• History of severe allergies or asthma
• History of gastrointestinal disturbances
• Prolonged use

Forms avail. in SA and covered in this monograph: sus, cap

Infections caused by:  Gram-positive organisms (excluding Penicillin-resistant  S. pneumoniae, Methicillin-resistant S. aureus); Some Gram-negative organisms (E. Coli, Klebsiella pneumoniae, Haemophilus influenzea, Shigella and Proteus mirabilis)

General dosing range

• Oral (sus, cap): 500-1000mg, 12hrly

Specific doses based on individual indications

Please note that the dosages below should be used in combination with regional guidelines, taking into account local antibiotic sensitivities

Urinary tract infection
- Uncomplicated

• Oral (sus, cap): 1-2g/day as a single dose

- Complicated

• Oral (sus, cap): 1g, 12hrly; Treatment duration: 7-10 days

Skin and skin structure infections

• Oral (sus, cap): 1g/day as a single dose or 2 divided doses

Upper respiratory tract infection

• Oral (sus, cap): 500mg, 12hrly

Group A ß-haemolytic streptococcal pharyngitis and tonsillitis

• Oral (sus, cap): 1g/day as a single dose; Treatment duration: 10 days

Lower respiratory tract infections

• Oral (sus, cap): 500-1000mg, 12hrly

Paed. forms avail. in SA and covered in this monograph: sus, cap

Infections caused by:  Gram-positive organisms (excluding Penicillin-resistant  S. pneumoniae, Methicillin-resistant S. aureus); Some Gram-negative organisms (E. Coli, Klebsiella pneumoniae, Haemophilus influenzea, Shigella and Proteus mirabilis)

General dosing range

• Younger than 28 days: Not established for use
• Older than 28 days: Oral (sus): 30mg/kg/day, in 2 divided doses; Max: 2g/24hrs

Specific doses based on individual indications

Please note that the dosages below should be used in combination with regional guidelines, taking into account local antibiotic sensitivities

Urinary tract infections
- Uncomplicated

• Oral (sus, cap): 12.5-25mg/kg, 12hrly

- Complicated

• Oral (sus, cap): 25mg/kg, 12hrly; Treatment duration: 7-10 days

Skin and skin structure infections

• Oral (sus, cap): 30-50mg/kg/day in 1-2 divided doses

Upper respiratory tract infection
Lower respiratory tract infection

• Oral (sus, cap): 25mg/kg, 12hrly

Group A ß-haemolytic streptococcal pharyngitis and tonsillitis

• Oral (sus, cap): 30mg/kg/day as single dose; Treatment duration: 10 days

Capsule not recommended for use in children below 6 years

Pregnancy

• Caution
• Although animal studies and clinical experience have not shown any evidence of teratogenicity, the safe use during pregnancy has not been established
• The use of cefadroxil during pregnancy should therefore be handled very strictly

Breastfeeding

• Caution
• Cefadroxil is present in low concentrations in breast milk; sensitization, diarrhoea or colonization of the infants' mucosa with fungi are possible
• The use of cefadroxil in breastfeeding mothers should therefore be handled very strictly

Renal Impairment

• Caution; dose adjustment recommended

Adult: Initial: 1g as a single dose; Maintenance:

Infants, Children, and Adolescents: Dosing based on a usual dose of 30 mg/kg/day in divided doses given 12hrly:

Hepatic Impairment

• No dose adjustment recommended

Elderly            

• No dose adjustment recommended

Porphyria Information

• Probably not porphyrinogenic (PNP)

Drugs in Sport

• Permitted - No warning

Central Nervous System Disorders

• Headache
• Sleeplessness
• Dizziness
• Nervousness
• Fatigue

Gastrointestinal Disorders

• Nausea and vomiting
• Diarrhoea
• Dyspepsia
• Abdominal pain
• Glossitis
• Pseudomenbranous colitis

Hepatobiliary Disorders

• Cholestase and idiosyncratic hepatic failure 
• Increase in serum transaminases 
• Increase in alcaline phosphatases

Genitourinary Disorders

• Interstitial nephritis 

Endocrine and Metabolic disorders

• Direct and indirect positive Coombs tests 

Musculoskeletal Disorders

• Arthralgia

Skin and Subcutaneous Tissue Disorders

• Pruritus
• Rash
• Allergic exanthema
• Urticaria
• Angioneurotic oedema
• Stevens Johnson syndrome
• Erythema multiforma

Immune, Blood and Lymphatic System Disorders

• Vaginal mycoses
• Thrush 
• Eosinophilia
• Thrombocytopenia
• Leucopenia
• Neutropenia
• Agranulocytosis
• Haemolytic anemia 
• Serum sickness-like reactions
• Immediate allergic reaction 
• Drug fever

• Anti-peristaltics
• Bacteriostatic antibiotics 
• Aminoglycoside antibiotics
• Polymyxin B
• Colistin 
• High-dose loop diuretics 
• Anticoagulants 
• Thrombocyte aggregation inhibitors
• Probenecid
• Cholestyramine 

• Full blood count
• Hepatic function
• Renal function

Cefadroxil is a semisynthetic antibiotic with a broad spectrum of bactericidal activity. It inhibits bacterial wall synthesis of actively dividing cells by binding to one or more penicillin-binding proteins. The result is formation of a defective cell wall that is osmotically unstable, and bacterial cell lysis.

Spectrum of activity: Gram-positive organisms (excluding Penicillin-resistant  S. pneumoniae, Methicillin-resistant S. aureus); Some Gram-negative organisms (E. Coli, Klebsiella pneumoniae, Haemophilus influenzea, Shigella and Proteus mirabilis)

Capsule 500mg

• Dacef (Pharmacare)

Suspension (per 5ml) 250mg

• Dacef (Pharmacare)

Suspension (per 5ml) 500mg

• Dacef (Pharmacare)