AMOXICILLIN

4) • The severity and the site of the infection • The age, weight and renal function of the patient; as shown below • The duration of therapy should be determined by the type of infection and the response of the patient, and should generally be as short as possible.

4 regarding prolonged therapy). Adults (including the elderly) Standard adult dosage 250mg three times daily, increasing to 500mg three times daily for more severe infections. High dose therapy 3g twice daily is recommended in appropriate cases for the treatment of severe or recurrent purulent infection of the respiratory tract (max daily dose 6 g).

Short course therapy Simple acute UTI: two 3g doses with 10-12 hours between the doses.

Gonorrhoea:

Single 3g dose. g. g. 4) Early stage: 500mg to 1g every 8 hours up to a maximum of 4 g/day in divided doses for 14 days (10 to 21 days) Late stage (systemic involvement): 500mg to 2g every 8 hours up to a maximum of 6g/day in divided doses for 10 to 30 days *Consideration should be given to the official treatment guidelines for each indication Children < 40kg Children may be treated with Amoxicillin capsules, dispersible tablets suspensions or sachets.

Amoxicillin 125mg/5ml Suspension is recommended for children under six months of age. 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 40kg should be given the usual adult dosage.

Recommended doses:

Indication Dose Acute bacterial sinusitis Acute otitis media Community acquired pneumonia Acute cystitis Acute pyelonephritis Dental abscess with spreading cellulitis 20 to 90mg/kg/day in 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.

4) Early stage: 25 to 50mg/kg/day in three divided doses for 10 to 21 days Late stage (systemic involvement): 100mg/kg/day in three divided doses for 10 to 30 days + Consideration should be given to the official treatment guidelines for each indication.

*Twice daily dosing regimens should only be considered when the dose is in the upper range. Elderly No dose adjustment is considered necessary. Renal impairment GFR (ml/min) Adults and children ≥ 40kg Children < 40kg# greater than 30 no adjustment necessary no adjustment necessary 10 to 30 maximum 500mg twice daily 15mg/kg given twice daily (maximum 500mg twice daily) less than 10 maximum 500mg/day 15mg/kg given as a single daily dose (maximum 500mg) # In the majority of cases, parenteral therapy is preferred.

In patients receiving haemodialysis Dosage in impaired renal function:

The dose should be reduced in patients with severe renal function impairment. 2).

Renal impairment in children under 40kg:

Creatinine clearance ml/min Dose Interval between administration > 30 Usual dose No adjustment necessary 10 - 30 Usual dose 12 h (corresponding to 2/3 of the dose) < 10 Usual dose 24 h (corresponding to 1/3 of the dose) Amoxicillin may be removed from the circulation by haemodialysis.

Haemodialysis Adults and children ≥ 40kg 15mg/kg/day given as a single daily dose. Prior to haemodialysis one additional dose of 15mg/kg should be administered. In order to restore circulating drug levels, another dose of 15mg/kg should be administered after haemodialysis.

In patients receiving peritoneal dialysis Amoxicillin maximum 500mg/day. 8). Method of administration Amoxicillin is for oral use. Absorption of Amoxicillin is unimpaired by food. Therapy can be started parenterally according to the dosing […]

The most commonly reported adverse drug reactions (ADRs) are diarrhoea, nausea and skin rash. The ADRs derived from clinical studies and post-marketing surveillance with amoxicillin, presented by MedDRA System Organ Class are listed below.

There are no modern clinical studies available that can be used to determine the frequency of undesirable effects. The following terminologies have been used for the classification of undesirable effects: Very common (≥1/10) Common (≥1/100 and <1/10) Uncommon (≥1/1000 and <1/100) Rare (≥1/10000 and <1/1000) Very rare (<1/10000) Not known (cannot be estimated from the available data) The majority of side effects listed below are not unique to amoxicillin and may occur when using other penicillins.

Infections and infestations Very rare Mucocutaneous candidiasis Blood and lymphatic system disorders Very Rare Reversible leucopenia (including severe neutropenia or agranulocytosis), reversible thrombocytopenia and haemolytic anaemia.

Prolongation of bleeding time and prothrombin. 4). 4), serum sickness and hypersensitivity vasculitis. If a hypersensitivity reaction is reported, the treatment must be discontinued. (See also skin and subcutaneous tissue disorders). 4).

Nervous system disorders Very rare Hyperkinesia, dizziness and convulsions. 4). Not known Aseptic meningitis Gastrointestinal disorders Clinical Trial Data *Common Diarrhoea, indigestion, nausea. *Uncommon Vomiting Post-Marketing Data Very rare Antibiotic associated colitis (including pseudomembraneous colitis and haemorrhagic colitis).

Black hairy tongue. Superficial tooth discolouration has been reported in children. Good oral hygiene may help to prevent tooth discolouration as it can usually be removed by brushing. Not known Drug-induced enterocolitis syndrome Hepato-biliary disorders Very rare Hepatitis and cholestatic jaundice.

A moderate rise in AST and/or ALT. The significance of a rise in AST and/or ALT is unclear. 4) Not known Linear IgA disease Renal & urinary tract disorders Very rare Interstitial nephritis. Not known Crystalluria (including acute renal injury) * The incidence of these AEs was derived from clinical studies involving a total of approximately 6,000 adult and paediatric patients taking amoxicillin.

# Superficial tooth discolouration has been reported in children. Good oral hygiene may help to prevent tooth discolouration as it can usually be removed by brushing. Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important.

It allows continued monitoring of the benefit/risk balance of the medicinal product. uk/yellowcard or search for MHRA Yellow Cardin the Google Play or Apple App Store.

8). Serious and occasionally fatal hypersensitivity (anaphylactoid and severe cutaneous reactions) reactions have been reported in patients on penicillin therapy. 8). 3). If an allergic reaction occurs, amoxicillin therapy must be discontinued and appropriate alternative therapy instituted.

8). DIES is an allergic reaction with the leading symptom of protracted vomiting (1-4 hours after drug administration) in the absence of allergic skin or respiratory symptoms. Further symptoms could comprise abdominal pain, diarrhoea, hypotension or leucocytosis with neutrophilia.

There have been severe cases including progression to shock. 1). This particularly applies when considering the treatment of patients with urinary tract infections and severe infections of the ear, nose and throat. Prolonged use may also occasionally result in overgrowth of non-susceptible organisms.

g. 8). 2). 8). This reaction requires amoxicillin discontinuation and contra-indicates any subsequent administration. Amoxicillin should be avoided if infectious mononucleosis is suspected since the occurrence of a morbilliform rash has been associated with this condition following the use of amoxicillin.

Erythematous (morbilliform) rashes have been associated with glandular fever in patients receiving amoxicillin. 8). It results directly from the bactericidal activity of amoxicillin on the causative bacteria of Lyme disease, the spirochaete Borrelia burgdorferi.

Patients should be reassured that this is a common and usually self-limiting consequence of antibiotic treatment of Lyme disease. Overgrowth of non-susceptible microorganisms Prolonged use may occasionally result in overgrowth of non-susceptible organisms.

8). Therefore, it is important to consider this diagnosis in patients who present with diarrhoea during, or subsequent to, the administration of any antibiotics. Should antibiotic-associated colitis occur, amoxicillin should immediately be discontinued, a physician consulted and an appropriate therapy initiated.

Anti-peristaltic medicinal products are contra- indicated in this situation. Prolonged therapy Precaution should be taken in premature children and during the neonatal period: renal, hepatic and haematological functions should be monitored.

Periodic assessment of organ system functions; including renal, hepatic and haematopoietic function is advisable during prolonged therapy. 8). Anticoagulants Prolongation of prothrombin time has been reported rarely in patients receiving amoxicillin.

Appropriate monitoring should be undertaken when anticoagulants are prescribed concomitantly. 8). Crystalluria In patients with reduced urine output, crystalluria (including acute renal injury) 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. 9) Interference with diagnostic tests Elevated serum and urinary levels of amoxicillin are likely to affect certain laboratory tests.

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

The presence of amoxicillin may distort assay results for oestriol in pregnant women. 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. Important information about excipients The medicine contains […]

1. g. g. a cephalosporin, carbapenem or monobactam).