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 short as possible.

4 regarding prolonged therapy). 1 1 g to 2 g every 4, 6 or 8 hours, maximum of 12g/day *Consideration should be given to the official treatment guidelines for each indication. Intramuscular Maximum daily dosage: 4 g/day. Maximum single dose: 1 g.

1 50 to 150 mg/kg/day given in 3 equally divided doses of up to 25 mg/kg or infusions of up to 50 mg/kg *Consideration should be given to the official treatment guidelines for each indication. 1 Usual daily dose of 50 to 150 mg/kg/day given in 3 equally divided doses of up to 25 mg/kg or infusions of up to 50 mg/kg *Consideration should be given to the official treatment guidelines for each indication.

1 Usual daily dose of 50 to 100 mg/kg/day given in 2 equally divided doses of up to 25 mg/kg or infusions of up to 50 mg/kg *Consideration should be given to the official treatment guidelines for each indication.

Intramuscular:

Maximum daily dosage: 120 mg/kg/day as 2 to 6 equally divided doses. Elderly No adjustment needed; as for adults. Renal impairment Adults and children > 40 kg Children < 40 kg GFR (ml/min) Intravenous Intramuscular Intravenous Intramuscular greater than 30 No adjustment No adjustment No adjustment No adjustment 10 to 30 1g stat, then 500 mg to 1 g twice day 500 mg every 12 hours 25 mg/kg twice daily 15 mg/kg every 12 hours less than 10 1 g stat, then 500 mg/day 500 mg/day given as a single dose 25 mg/kg/day given as a single dose 15 mg/kg/day given as a single dose In patients receiving haemodialysis and peritoneal dialysis Amoxicillin may be removed from the circulation by haemodialysis.

5 mg/kg at the end of the dialysis, then 25 mg/kg/day 15 mg/kg during and at the end of dialysis, then […]

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). 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).

4).

Not known Linear IgA disease Renal and urinary tract disorders Very rare:

Interstitial nephritis Crystalluria (including acute renal injury. 9) * 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

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. Serious and occasionally fatal hypersensitivity reactions (including anaphylactoid and severe cutaneous adverse reactions) have been reported in patients on penicillin therapy.

Parenteral:

Lidocaine or benzyl alcohol may be used only when administering amoxicillin by the intramuscular route. Information on sodium content This medicine contains less than 1 mmol sodium (23mg) per vial, that is to say essentially ‘sodium-free’.

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