Qualitative and quantitative composition
Amoxicillin trihydrate equivalent to 500mg Amoxycillin per capsule.

For a full list of excipients, see section 6.1.

Pharmaceutical form
Hard Capsules.

White to off-white granular powder filled in hard gelatine capsule shells size '0'. Scarlet colour cap, buff colour body printed with 'AMOXY' on cap and '500' on body.

Clinical particulars

Therapeutic indications
The treatment of bacterial infections caused by amoxicillin-susceptible organisms.

It is principally indicated for respiratory, middle ear and urinary tract infections.

Respiratory tract - pneumonia, acute and chronic bronchitis, upper respiratory tract infections

Chronic bronchial sepsis

Lobar and bronchopneumonia

ENT - otitis media

Urinary tract - cystitis, urethritis, pyelonephritis

Biliary and intra-abdominal infections

Bacteriuria in pregnancy

Gynaecological infections including puerperal sepsis and septic abortion

Gonorrhoea

Peritonitis

Intra-abdominal sepsis

Septicaemia

Bacterial endocarditis

Skin and soft tissue infections

Osteomyelitis

Meningitis (seek expert advice)

Enteric fevers (typhoid and paratyphoid fevers - seek expert advice)

Dental abscess (as an adjunct to surgical management)

In children with urinary tract infection the need for investigation should be considered.

Prophylaxis of endocarditis: The prevention of bacteraemia, associated with procedures (e.g. dental), in patients at risk of developing bacterial endocarditis.

Consideration should be given to official local guidance (e.g. national requirements) on the appropriate use of antibacterial agents. Susceptibility of the causative organism to the treatment should be tested (if possible), although the therapy may be initiated before the results are available.

Posology and method of administration
Route of administration: Oral

Treatment of Infection:

Adult dosage (including elderly patients):

Standard adult dosage: 250mg every 8 hours, increasing to 500mg every 8 hours in severe infections.

High dosage therapy (maximum recommended oral dosage 6 g daily in divided doses): A dosage of 3 g twice daily is recommended in appropriate cases for the treatment of severe or recurrent purulent infection of the respiratory tract.

Short course therapy: Simple acute urinary tract infection: two 3 g doses with 10-12 hours between the doses. Dental abscess: two 3 g doses with 8 hours between the doses. Gonorrhoea: single 3 g dose.

Dosage in impaired renal function:

The dose should be reduced in patients with severe renal function impairment. In patients with a creatinine clearance of less than 30 ml/min an increase in the dosage interval and a reduction in the total daily dose is recommended (see section 4.4 and 5.2): Glomerular filtration rate>30ml/min No adjustment necessary.

Glomerular filtration rate 10-30ml/min: Amoxicillin. max.500mg b.d

Glomerular filtration rate<10ml/min: Amoxicillin. Max. 500mg/day

Helicobacter eradication in peptic (duodenal and gastric) ulcer disease:

Amoxicillin is recommended at a dose of twice daily in association with a proton pump inhibitor and antimicrobial agents as detailed below:

Omeprazole 40 mg daily, Amoxicillin 1G BID, Clarithromycin 500mg

BID x 7days

or

Omeprazole 40mg daily, Amoxicillin750mg-1G BID, Metronidazole 400mg

TID x 7 days

Children's

Children weighing < 40 kg

The daily dosage for children is 40 - 90 mg/kg/day in two to three divided doses* (not exceeding 3 g/day) depending on the indication, severity of the disease and the susceptibility of the pathogen (see special dosage recommendations below and sections 4.4, 5.1 and 5.2).

*PK/PD data indicate that dosing three times daily is associated with enhanced efficacy, thus twice daily dosing is only recommended when the dose is in the upper range.

Children weighing more than 40 kg should be given the usual adult dosage.

Renal impairment in children under 40 kg:

Tonsillitis: 50 mg/kg/day in two divided doses.

Acute otitis media

In areas with high prevalence of pneumococci with reduced susceptibility to penicillins, dosage regimens should be guided by national/local recommendations. In severe or recurrent acute otitis media, especially where compliance may be a problem, 750 mg twice a day for two days may be used as an alternative course of treatment in children aged 3 to 10 years.

Early Lyme disease (isolated erythema migrans)

50 mg/kg/day in three divided doses, over 14-21days.