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

Amoxicillin paediatric Suspension is recommended for children under six months of age. Children weighing 40 kg or more should be prescribed the adult dosage. 4) Early stage: 25 to 50 mg/kg/day in three divided doses for 10 to 21 days Late stage (systemic involvement): 100 mg/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 ≥ 40 kg Children < 40 kg# greater than 30 no adjustment necessary no adjustment necessary 10 to 30 maximum 500 mg twice daily 15 mg/kg given twice daily (maximum 500 mg twice daily) less than 10 maximum 500 mg/day.

15 mg/kg given as a single daily dose (maximum 500 mg) # In the majority of cases, parenteral therapy is preferred. In patients receiving haemodialysis Amoxicillin may be removed from the circulation by haemodialysis. Haemodialysis Adults and children over 40 kg 500 mg every 24 h Prior to haemodialysis one additional dose of 500 mg should be administered.

In order to restore circulating drug levels, another dose of 500 mg should be administered after haemodialysis. Children under 40 kg 15 mg/kg/day given as a single daily dose (maximum 500 mg). Prior to haemodialysis one additional dose of 15 mg/kg should be administered.

In order to restore circulating drug levels, another dose of 15 mg/kg should be administered after haemodialysis. In patients receiving peritoneal dialysis Amoxicillin maximum 500 mg/day. 8). Method of administration Amoxicillin capsules is for oral use.

Absorption of Amoxicillin capsules is unimpaired by food. Therapy can be started parenterally according to the dosing recommendations of the intravenous formulation and continued with an oral preparation. Swallow with water without opening capsule.

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.

The following terminologies have been used in order to classify the occurrence of undesirable effects. Very common (≥1/10) Common (≥1/100 to <1/10) Uncommon (≥1/1,000 to <1/100) Rare (≥1/10,000 to <1/1,000) Very rare (<1/10,000) Not known (cannot be estimated from the available data) 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.

4). 4). 4). 4). 4). Black hairy tongue Not Known Drug-induced enterocolitis syndrome Hepatobiliary disorders Very rare Hepatitis and cholestatic jaundice. A moderate rise in AST and/or ALT. 4) and drug reaction with eosinophilia and systemic symptoms (DRESS).

Not known Linear IgA disease Renal and 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. 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 Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.

8). Serious and occasionally fatal hypersensitivity reactions (including anaphylactoid and severe cutaneous reactions) have been reported in patients on penicillin therapy. 8). These reactions are more likely to occur in individuals with a history of penicillin hypersensitivity and in atopic individuals.

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.

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.

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 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. Sodium Content This medicine contains less than 1 mmol sodium (23 mg) per capsule, that is to say essentially ‘sodium-free’.

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