Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2018 Publisher: Sandoz Limited, Frimley Business Park, Frimley, Surrey GU16 7SR, United Kingdom
Treatment of following infections caused by cefadroxil-susceptible organisms (see section 5.1), when an oral therapy is indicated:
Consideration should be given to official local guidance regarding the appropriate use of antibacterial agents.
The dosage depends on the susceptibility of the pathogens, the severity of the disease and on the clinical status of the patient (renal and hepatic function).
| Indication | Adults and adolescents > 40 kg with normal renal function | Children (< 40 kg) with normal renal function |
|---|---|---|
| Streptococcal pharyngitis / tonsillitis | Dosage may be decreased to 1000 mg once a day over at least 10 days | 30 mg/kg/day once a day over at least 10 days |
| Bronchopneumonia, bacterial pneumonia | 1000 mg twice a day | 30-50 mg/kg/day divided into two daily doses |
| Urinary tract infections | 1000 mg twice a day | 30-50 mg/kg/day divided into two daily doses |
| Skin & soft tissue infections | 1000 mg twice a day | 30-50 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 capsules is not recommended for infants and children under 6 years. For younger children and children with a body weight < 40 kg, liquid oral forms (Cefadroxil 250 mg/ 5 ml or 500 mg/ 5 ml suspension) are available.
The dosage 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 for adults:
| Creatinine clearance (ml/min/1.73 m²) | Serum Creatinine (mg/100ml) | Initial dose | Following dose | Dosage 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 |
Cefadroxil is not indicated in children suffering from renal insufficiency and children requiring haemodialysis.
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 500 mg – 1000 mg at the end of the haemodialysis. Hepatic impairment:
No adjustment of posology is necessary.
As cefadroxil is excreted by renal route, the dosage should be adjusted if necessary as described under impaired renal function.
Bioavailability is not affected by food and cefadroxil may be taken with meals or on an empty stomach. In case of gastrointestinal disturbances, it may be administered with food. The capsules are taken unchewed with a liberal quantity of fluid.
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.
No clinical reports are as yet available on cefadroxil in this respect. However in view of experience gained with other cephalosporins the following symptoms are possible: nausea, hallucinations, hyperreflexia, extrapyramidal symptoms, clouded consciousness, or even coma and renal functional impairment. First aid after intake of toxic doses: induce vomiting at once or gastric lavage, if necessary haemodialysis. Monitor and if necessary correct the water and electrolyte balance, monitor renal function.
3 years.
Store in the original package.
Single packs of 10, 12, 14, 16, 20, 30, 40 and 100 (100 × 1) capsules.
Hospital packs of 100 (10 × 10) and 1000 (100 × 10) capsules in polyvinylchloride/polyvinylidene (PVC/PVDC)-Alu-blister strips.
Not all pack sizes may be marketed.
No special requirements.
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