Cefadroxil
Visa No.: 893110495024
Product: Droxicef 500mg
API: Cefadroxil
Product Category: Antibiotics
Version approved leaflet: 402/QĐ-QLD_18/06/2024_201
INDICATIONS
Cefadroxil is administered orally for the treatment of infections caused by the following susceptible bacteria:
- Pharyngitis and tonsillitis caused by Streptococcus.
- Bronchopneumonia and bacterial pneumonia.
- Uncomplicated urinary tract infections: pyelonephritis, cystitis.
- Skin and soft tissue infections: abscesses, furuncles, impetigo, erysipelas, purulent dermatitis, lymphadenitis.
DOSAGE AND ADMINISTRATION
Dosage
Dosage depends on the susceptibility of the causative organism, the severity of the infection, and the patient’s renal function.
Adults and children ≥ 6 years with normal renal function
| Indication | Body weight > 40 kg | Body weight < 40 kg |
| Bacterial pharyngitis/tonsillitis | 1000 mg once daily for at least 10 days | 30mg/kg/day, once daily for at least 10 days |
| Bacterial bronchitis, bacterial pneumonia | 1000 mg twice daily | 30 - 50 mg/kg/day, pided into 2 doses |
| Urinary tract infections | 1000 mg twice daily | 30 - 50 mg/kg/day, pided into 2 doses |
| Skin and soft tissue infections | 1000 mg twice daily | 30 - 50 mg/kg/day, pided into 2 doses |
Efficacy may be achieved by increasing the dose up to 100 mg/kg/day in children.
Depending on the severity of the infection, dose escalation may be required in adults. The maximum recommended dose is 4 g/day. For chronic urinary tract infections, prolonged and intensive treatment may be necessary, accompanied by antimicrobial susceptibility testing and clinical monitoring of the patient’s condition.
Children under 6 years of age:
Cefadroxil 500 mg capsules are not recommended for children under 6 years due to dosage form limitations Oral liquid formulations (e.g. cefadroxil suspension 250 mg/5 mL or 500 mg/5 mL) should be used.
Patients with renal impairment
The dosage should be adjusted according to creatinine clearance to prevent accumulation of cefadroxil in the body. In patients with creatinine clearance ≤ 50 mL/min, the following adult dosage recommendations are advised::
| Creatinine clearance (ml/min/1.73m²) | Serum Creatinine (mg/100ml) | Initial dose | Maintenance dose | Dosing interval |
| 50 - 25 | 1,4 - 2,5 | 1000 mg | 500 mg - 1000 mg | Every 12 hours |
| 25 - 10 | 2,5 - 5,6 | 1000 mg | 500 mg - 1000 mg | Every 24 hours |
| 10 - 0 | > 5,6 | 1000 mg | 500 mg - 1000 mg | Every 36 hours |
Pediatric patients (< 40 kg) with renal impairment:
Cefadroxil is not indicated for children with renal impairment or those undergoing hemodialysis.
Dosage in Patients Undergoing Hemodialysis
Hemodialysis removes approximately 63% of a 1000 mg dose of a cephalosporin antibiotic after 6–8 hours. The elimination half-life of cephalosporins during hemodialysis is approximately 3 hours.
Patients undergoing hemodialysis should receive an additional dose of 500–1000 mg at the end of each dialysis session..
Patients with Hepatic Impairment:
No dosage adjustment is required.
Elderly Patients
Cefadroxil is primarily eliminated via the kidneys. As elderly patients are more likely to have reduced renal function, dosage should be adjusted according to the patient’s renal function.
Method of Administration
Food does not affect the bioavailability of cefadroxil. The medicine may be taken on an empty stomach or with meals. In patients with gastrointestinal disturbances, administration with food is recommended.
Tablets should be swallowed whole with plenty of water and must not be chewed.
Duration of Treatment
Treatment should be continued for 2–3 days after clinical symptoms have resolved or after evidence of bacterial eradication. In infections caused by Streptococcus pyogenes, treatment may be required for up to 10 days.
CONTRAINDICATIONS
- Hypersensitivity to cefadroxil, other cephalosporin antibiotics, or to any component of the product.
- History of severe hypersensitivity reactions to penicillin antibiotics or to any other beta-lactam antibiotics.
WARNINGS AND PRECAUTIONS
This medicine should be used only under medical supervision.
Carefully read the instructions before use.
If further information is required, consult a physician or pharmacist.
Keep out of reach of children..
