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 and children ≥40 kg Indication* Dose* Acute bacterial sinusitis Asymptomatic bacteriuria in pregnancy Acute pyelonephritis Dental abscess with spreading cellulitis Acute cystitis 250 mg to 500 mg every 8 hours or 750 mg to 1 g every 12 hours For severe infections 750 mg to 1 g every 8 hours Acute cystitis may be treated with 3 g twice daily for one day Acute otitis media Acute streptococcal tonsillitis and pharyngitis Acute exacerbations of chronic bronchitis 500 mg every 8 hours, 750 mg to 1 g every 12 hours For severe infections 750 mg to 1 g every 8 hours for 10 days Community acquired pneumonia 500 mg to 1 g every 8 hours Typhoid and paratyphoid fever 500 mg to 2 g every 8 hours Prosthetic joint infections 500 mg to 1 g every 8 hours Prophylaxis of endocarditis 2 g orally, single dose 30 to 60 minutes before procedure.

g. g. clarithromycin, metronidazole) for 7 days. 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 Oral 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.

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 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).

Not known:

Aseptic meningitis Cardiac disorders Not known: Kounis syndrome Gastrointestinal disorders Clinical trial data *Common: diarrhoea and nausea. 4). Black hairy tongue.

Superficial tooth discolouration # Not known:

Drug-induced enterocolitis syndrome Hepato-biliary disorders Very rare: hepatitis and cholestatic jaundice. A moderate rise in AST and/or ALT. Skin and subcutaneous tissue disorders Clinical trial data *Common: skin rash *Uncommon: urticaria and pruritus.

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. # Superficial tooth discolouration has been reported in children.

8). Serious and occasionally fatal hypersensitivity reactions (including anaphylactoid and severe cutaneous adverse 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 intake) 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 contraindicates 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 contraindicated in this situation. Prolonged therapy Periodic assessment of organ system functions; including renal, hepatic and haematopoietic function is advisable during prolonged therapy.

1. g. g. acephalosporin, carbapenem or monobactam).