AMBEN Powder for oral suspension Ref.[28106] 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: 25mg/kg daily in divided doses.

Children 1-6 years: 250mg twice a day.

Children over 6 years: 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 less than 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

3 years.

Once reconstituted the mixture has 7 days validity at a temperature not exceeding 25°C and 14 days at 4°C (in refrigerator).

6.4. Special precautions for storage

Store below 25°C.

For storage conditions after reconstitution of the medicinal product, see section 6.3.

6.5. Nature and contents of container

Pack sizes of 100 ml & 60 ml in amber glass bottles 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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