Broad spectrum penicillins / antibiotics.

Amoxicillin [amoxycillin] - H pylori

Amoxil Paediatric Suspension contains 125 mg amoxicillin per 1.25 ml dose The amoxicillin is present as the trihydrate.

Amoxil Paediatric Suspension: citrus flavoured suspension. Presented as powder in bottles for preparing 20 ml.

Treatment of Infection: Amoxil is a broad spectrum antibiotic indicated for the treatment of commonly occurring bacterial infections such as: Upper respiratory tract infections Otitis media Acute and chronic bronchitis Chronic bronchial sepsis Lobar and bronchopneumonia Cystitis, urethritis, pyelonephritis Bacteriuria in pregnancy Gynaecological infections including puerperal sepsis and septic abortion Gonorrhoea Peritonitis Intra-abdominal sepsis Septicaemia Bacterial endocarditis Typhoid and paratyphoid fever Skin and soft tissue infections Osteomyelitis Dental abscess (as an adjunct to surgical management) In children with urinary tract infection the need for investigation should be considered. Prophylaxis of endocarditis: Amoxil may be used for the prevention of bacteraemia, associated with procedures such as dental extraction, 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.

Treatment of Infection:

Adult dosage (including elderly patients):

Oral:

Standard adult dosage: 250 mg three times daily, increasing to 500 mg three times daily for more 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.

Renal impairment:

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

Children's dosage (up to 10 years of age):

Oral:

Standard children's dosage: 125 mg three times daily, increasing to 250 mg three times daily for more severe infections.

Renal impairment in children under 40 kg:

Creatinine clearance >30mL/min: No adjustment necessary.

Creatinine clearance 10-30mL/min: 15 mg/kg given b.i.d (maximum 500mg/twice daily).

Creatinine clearance <10mL/min: 15 mg/kg given as a single daily dose (maximum 500mg).

Amoxil Paediatric Suspension is recommended for children under six months of age.

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.

Prophylaxis of endocarditis:

In renal impairment the excretion of the antibiotic will be delayed and, depending on the degree of impairment, it may be necessary to reduce the total daily dosage.

Prophylaxis of endocarditis: see table on previous page.

Administration:

Oral.

Treatment should be continued for 2 to 3 days following the disappearance of symptoms. It is recommended that at least 10 days treatment be given for any infection caused by beta-haemolytic streptococci in order to achieve eradictaion of the organism.

Amoxil is a penicillin and should not be given to penicillin-hypersensitive patients. Attention should be paid to possible cross-sensitivity with other beta-lactam antibiotics eg. cephalosporins.

Before initiating therapy with amoxicillin, careful enquiry should be made concerning previous hypersensitivity reactions to penicillins, cephalosporins.

Serious and occasionally fatal hypersensitivity (anaphylactoid) reactions have been reported in patients on penicillin therapy. These reactions are more likely to occur in individuals with a history of hypersensitivity to beta-lactam antibiotics.

Erythematous (morbilliform) rashes have been associated with glandular fever in patients receiving amoxicillin.

Prolonged use may also occasionally result in overgrowth of non-susceptible organisms.

In patients with reduced urine output, crystalluria has been observed very rarely, predominantly with parenteral therapy. During the administration of high doses of amoxicillin, it is advisable to maintain adequate fluid intake and urinary output in order to reduce the possibility of amoxicillin crystalluria.

In patients with renal impairment, the rate of excretion of amoxicillin will be reduced depending on the degree of impairment and it may be necessary to reduce the total daily unit amoxicillin dosage accordingly.

Probenecid decreases the renal tubular secretion of amoxicillin. Concurrent use with Amoxil may result in increased and prolonged blood levels of amoxicillin.

In common with other antibiotics, amoxicillin may affect the gut flora, leading to lower oestrogen reabsorption and reduced efficacy of combined oral contraceptives.

Concurrent administration of allopurinol during treatment with amoxicillin can increase the likelihood of allergic skin reactions.

Prolongation of prothrombin time has been reported rarely in patients receiving amoxicillin. Appropriate monitoring should be undertaken when anticoagulants are prescribed concurrently.

It is recommended that when testing for the presence of glucose in urine during amoxicillin treatment, enzymatic glucose oxidase methods should be used. Due to the high urinary concentrations of amoxicillin, false positive readings are common with chemical methods.

The following convention has been utilised for the classification of undesirable effects:-

Very common (>1/10), common (>1/100, <1/10), uncommon (>1/1000,<1/100), rare (>1/10,000, <1/1000), very rare (<1/10,000)

The majority of side effects listed below are not unique to amoxicillin and may occur when using other penicillins.

Unless otherwise stated, the frequency of adverse events has been derived from more than 30 years of post-marketing reports.

Infections and infestations

Blood and lymphatic system disorders

Immune system disorders

Nervous system disorders

Gastrointestinal disorders

Clinical Trial Data

Post-marketing Data

Hepato-biliary disorders

Skin and subcutaneous tissue disorders

Clinical Trial Data

Post-marketing Data

Renal and urinary tract disorders

*The incidence of these AEs was derived from clinical studies involving a total of approximately 6,000 adult and paediatric patients taking amoxicillin.

GlaxoSmithKline UK

(POM)

04 June 2009