CO-AMOXICLAV

Posology Doses are expressed throughout in terms of amoxicillin/clavulanic acid content except when doses are stated in terms of an individual component. 4) • The severity and the site of the infection • The age, weight and renal function of the patient as shown below.

Usual dosages for the treatment of severe infection Adults (including the elderly) and children over 12 years: One tablet three times a day, preferably every 8 hours. Treatment should not exceed 14 days without review by a physician.

For adults and children ≥ 40 kg, this formulation of Co-amoxiclav Tablets provides a total daily dose of 1500 mg amoxicillin/375 mg clavulanic acid, when administered as recommended below. For children < 40 kg, this formulation of Co-amoxiclav Tablets provides a maximum daily dose of 2400 mg amoxicillin/600 mg clavulanic acid, when administered as recommended below.

1). Adults and children ≥ 40 kg One 500 mg/125 mg dose taken three times a day. Children < 40 kg 20 mg/5 mg/kg/day to 60 mg/15 mg/kg/day given in three divided doses. As the tablets cannot be divided, children weighing less than 25 kg must not be treated with Co-Amoxiclav Tablets.

The table below presents the received dose (mg/kg body weight) in children weighing 25 kg to 40 kg upon administering a single 500/125 mg tablet. 67 – 5 Children aged 6 years and below or weighing less than 25 kg should preferably be treated with Co-amoxiclav suspension or paediatric sachets.

No clinical data are available on doses of Co-amoxiclav 4:1 formulations higher than 40 mg/10 mg/kg per day in children under 2 years. Elderly No dose adjustment is considered necessary.

Use in patients with renal impairment:

Mild impairment, (creatinine clearance >30 ml/min): No change in dosage.

Moderate impairment, (creatinine clearance 10-30 ml/min):

One tablet 12 hourly. Severe impairment, (creatinine clearance <10 ml/min): not recommended. 75 mg/kg twice daily (maximum 500 mg/125 mg twice daily). 75 mg/kg as a single daily dose (maximum 500 mg/125 mg). 75 mg/kg per day once daily.

75 mg/kg. 75 mg per kg should be administered after haemodialysis. 4). Method of administration For oral use. The tablets should be taken at the start of a meal to minimise gastro- intestinal disturbance. They should be swallowed whole with fluid and not broken or chewed.

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

The following terminologies have been used in order to classify the occurrence of undesirable effects. 4 2 Nausea is more often associated with higher oral doses. If gastrointestinal reactions are evident, they may be reduced by taking amoxicillin/clavulanic acid with a meal.

4) 4 A moderate rise in AST and/or ALT has been noted in patients treated with betalactam class antibiotics, but the significance of these findings is unknown. 4). 4). 4 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.

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.

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. If an allergic reaction occurs, amoxicillin/clavulanic acid therapy must be discontinued and appropriate alternative therapy instituted. In the case that an infection is proven to be due to an amoxicillin-susceptible organisms(s) then consideration should be given to switching from amoxicillin/clavulanic acid to amoxicillin in accordance with official guidance.

g. penicillin-insusceptible S. pneumoniae). 8). Amoxicillin/clavulanic acid 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.

Concomitant use of allopurinol during treatment with amoxicillin can increase the likelihood of allergic skin reactions. Prolonged use may occasionally result in overgrowth of non-susceptible organisms. 8). This reaction requires Co-amoxiclav discontinuation and contra-indicates any subsequent administration of amoxicillin.

8). Hepatic events have been reported predominantly in males and elderly patients and may be associated with prolonged treatment. These events have been very rarely reported in children. In all populations, signs and symptoms usually occur during or shortly after treatment but in some cases may not become apparent until several weeks after treatment has ceased.

1. g. g. a cephalosporin, carbapenem or monobactam). 8).