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 ≥ 40kg Standard dosage:

For less severe infections the usual adult dose is 250 mg three times daily. In more severe conditions the dosage may be doubled.

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 In simple, acute urinary tract infection in adults: two 3 g doses with 10 - 12 hours between the doses.

A single dose of 3g is recommended for the treatment of gonorrhoea. Dental abscess: two 3 g doses with 8 hours between the doses. 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 more than 40 kg should be given the usual adult dosage. 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.

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 Tonsillitis 50mg/kg/day in two divided doses +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 ** In areas with high prevalence of pneumococci with reduced susceptibility to penicillins, dosage regimens should be guided by national/local recommendations.

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) Mot known (cannot be estimated from the available data).

The majority of adverse events 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 Very rare Mucocutaneous candidiasis Blood and lymphatic system disorders: Very rare Reversible leucopenia (including severe neutropenia and agranulocytosis), reversible thrombocytopenia and haemolytic anaemia have been reported.

4). 4). If a hypersensitivity reaction occurs, the treatment must be discontinued (see also skin and subcutaneous tissue disorders). 4). 4). Convulsions may occur in patients with impaired renal function or in those receiving high doses.

4). 4). Black hairy tongue Superficial tooth discolouration# Not known Drug-induced enterocolitis syndrome Hepatobiliary disorders Very rare Hepatitis and cholestatic jaundice. A moderate rise in AST and/or ALT, but the significance of this is unclear.

Skin and subcutaneous tissue disorders Clinical trial data *Common:

Skin rash *Uncommon: Urticaria and pruritus. 4), drug reaction with eosinophilia and systemic symptoms (DRESS), symmetrical drug- related intertriginous and flexural exanthema (SDRIDE) (baboon syndrome) (see also Immune system disorders).

8). 3). These reactions are more likely to occur in individuals with a history of penicillin hypersensitivity and in atopic individuals. Hypersensitivity reactions can also progress to Kounis syndrome, a serious allergic reaction that can result in myocardial infarction.

8). If an allergic reaction occurs, amoxicillin therapy must be discontinued and appropriate alternative therapy institute. 8). Drug-induced enterocolitis syndrome is an allergic reaction with the leading symptom of protracted vomiting (1-4 hours after medicinal product administration) in the absence of allergic skin or respiratory symptoms.

Further symptoms could comprise abdominal pain, lethargy, diarrhoea, hypotension or leucocytosis with neutrophilia. In severe cases, drug-induced enterocolitis syndrome can progress to shock. Erythematous (morbilliform) rashes have been associated with glandular fever in patients receiving amoxicillin.

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). 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.

Serious anaphylactoid reactions require immediate emergency treatment with adrenaline. Oxygen, intravenous steroids, and airway management, including intubation, should be administered as indicated. Precaution should be taken in premature children and during the neonatal period: renal, hepatic and haematological functions should be monitored.

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.

1. g. g. ampicillin, cephalosporins carbapenem or monobactam).