AMBEN Capsule, hard Ref.[28105] Active ingredients: Cefadroxil

Source: Υπουργείο Υγείας (CY)  Revision Year: 2018  Publisher: Medochemie Ltd, 1-10 Constantinoupoleos street, 3011 Limassol, Cyprus

4.1. Therapeutic indications

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.

4.2. Posology and method of administration

Posology

Adults

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.

Paediatric population

Children Weighing More Than 40kg (88lbs)

As for adults.

Children Weighing Less Than 40kg (88lbs)

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.

Elderly

No specific dosage recommendations or precautions for use in the elderly except to monitor those patients with impaired renal function.

Renal Impairment

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.

Method of administration

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.

4.9. Overdose

Symptoms

Ingestion of <250 mg/kg in children under six years of age was not associated with significant outcomes.

Management

The patient should be observed and treated symptomatically. For amounts >250 mg/kg gastric lavage or stimulation of vomiting is appropriate.

6.3. Shelf life

36 months.

6.4. Special precautions for storage

Store below 25°C in the original package, in order to protect from light.

6.5. Nature and contents of container

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.

6.6. Special precautions for disposal and other handling

No special requirements for disposal.

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