Source: Υπουργείο Υγείας (CY) Revision Year: 2018 Publisher: Medochemie Ltd, 1-10 Constantinoupoleos street, 3011 Limassol, Cyprus
Amben is indicated in the treatment of the following infections when due to susceptible micro-organisms:
Respiratory tract infections:
Tonsillitis, pharyngitis, lobar and bronchopneumonia, acute and chronic bronchitis, pulmonary abscess, empyema, pleurisy, sinusitis, laryngitis, otitis media.
Skin and soft-tissue infections:
Lymphadenitis, abscesses, cellulitis, decubitus ulcers, mastitis, furunculosis, erysipelas.
Genitourinary tract infections:
Pyelonephritis, cystitis, urethritis, gynaecological infections.
Other infections:
Osteomyelitis, septic arthritis.
500mg to 1g twice a day, depending upon the severity of infection.
Alternatively, in skin and soft tissue and uncomplicated urinary tract infections, 1g once a day.
In the treatment of beta-haemolytic streptococcal infections, Amben should be administered for at least 10 days.
As for adults.
Children under 1 year:
Suspension formulation should be used. The dose is 25mg/kg daily in divided doses (e.g. 2.5ml of a 125mg/5ml suspension twice a day for a 6 month old infant weighing 5kg, or 5ml of a 125ml/5ml suspension twice a day for a 1 year old infant weighing 10kg)
Children 1-6 years:
Suspension formulation should be used. The dose is 250mg twice a day.
Children over 6 years:
Suspension formulation should be used. The dose is 500mg twice a day.
No specific dosage recommendations or precautions for use in the elderly except to monitor those patients with impaired renal function.
In patients with renal impairment, the dosage should be adjusted according to creatinine clearance rates to prevent drug accumulation and serum levels should be monitored.
A modified dosage schedule is unnecessary in patients with creatinine clearance rates of greater than 50ml/min. In those patients with creatinine clearance rates of 50ml/min or less, the following dosage schedule is recommended as a guideline, based upon the creatinine clearance rate (ml/min: 1.73 m²).
Patients with renal insufficiency may be treated with an initial dose of 500mg to 1000mg of Amben. Subsequent doses may be administered according to the following table:
| Creatinine Clearance | Dose | Dose Interval |
|---|---|---|
| 0-10 ml/min/1.73 m² | 500-1000 mg | 36 hrs |
| 11-25 ml/min/1.73 m² | 500-1000 mg | 24 hrs |
| 26-50 ml/min/1.73 m² | 500-1000 mg | 12 hrs |
Amben can be removed from the body by haemodialysis.
Oral administration
The bioavailability and consequent chemotherapeutic effects of cefadroxil are unaffected by food. It may, therefore, be taken with meals or on an empty stomach.
Ingestion of <250 mg/kg in children under six years of age was not associated with significant outcomes.
The patient should be observed and treated symptomatically. For amounts >250 mg/kg gastric lavage or stimulation of vomiting is appropriate.
36 months.
Store below 25°C in the original package, in order to protect from light.
PVC/PVDC /Alu blisters in cartons of 12 or 100 capsules and polypropylene securitainers of 100 capsules are available.
Not all pack sizes may be marketed.
No special requirements for disposal.
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