CO-AMOXICLAV

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.

g. 1). This amoxicillin/clavulanic acid powder for solution for injection or infusion provides a total daily dose of 3000 mg amoxicillin and 600 mg clavulanic acid when administered as recommended below. If it is considered that a higher daily dose of amoxicillin is required, it is recommended that an alternative intravenous formulation of Co-amoxiclav 500 mg/100 mg Powder for Solution for Injection/Infusion is selected in order to avoid administration of unnecessarily high daily doses of clavulanic acid.

The duration of therapy should be determined by the response of the patient. g. osteomyelitis) require longer periods of treatment. 4 regarding prolonged therapy). Consideration should be given to local guidelines on appropriate dosing frequencies for amoxicillin/clavulanic acid.

1: 1000 mg/ 200 mg every 8 hours For surgical prophylaxis For procedures less than 1 hour in duration, the recommended dose is 1000 mg/200 mg to 2000 mg/200 mg given at induction of anaesthesia (Doses of 2000 mg/200 mg can be achieved by using an alternative intravenous formulation of Co-amoxiclav).

For procedures greater than 1 hour in duration, the recommended dose is 1000 mg/200 mg to 2000 mg/200 mg given at induction of anaesthesia, with up to 3 doses of 1000 mg/200 mg in 24 hours. Clear clinical signs of infection at operation will require a normal course of intravenous or oral therapy post-operatively.

Children < 40 kg Recommended doses: • Children aged 3 months and over: 25 mg/5 mg per kg every 8 hours • Children aged less than 3 months or weighing less than 4 kg: 25 mg/5 mg per kg every 12 hours. Elderly No dose adjustment is considered necessary.

Renal impairment Dose adjustments are based on the maximum recommended level of amoxicillin. No dose adjustment is required in patients with creatinine clearance (CrCl) greater than 30 ml/min. 5 mg per kg at the end of dialysis (as serum concentrations of both amoxicillin and clavulanic acid are decreased).

4). Method of administration Co-amoxiclav 500 mg/100 mg Powder for Solution for Injection/Infusion is for intravenous use. Co-amoxiclav 500 mg/100 mg Powder for Solution for Injection/Infusion may be administered either by slow intravenous injection over a period of 3 to 4 min directly into a vein or via a drip tube or by infusion over 30 to 40 min.

Co-amoxiclav is not suitable for intramuscular administration. Children aged less than 3 months should be administered amoxicillin/clavulanic acid by infusion only. Treatment with amoxicillin/clavulanic acid may be initiated by the use of an intravenous preparation and completed with an appropriate oral presentation as considered appropriate for the individual patient.

6.

The most commonly reported adverse drug reactions (ADRs) are diarrhoea, nausea and vomiting. The ADRs derived from clinical studies and post-marketing surveillance with amoxicillin/clavulanic acid, 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) 5 A moderate rise in AST and/or ALT has been noted in patients treated with beta- lactam 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. uk/yellowcard or search for MHRA Yellow Card in 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/clavulanic acid therapy should 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. 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.

This presentation of amoxicillin/clavulanic acid may not be suitable for use when there is a high risk that the presumptive pathogens have resistance to beta-lactam agents that is not mediated by beta-lactamases susceptible to inhibition by clavulanic acid.

As no specific data for T>MIC are available and the data for comparable oral presentations are borderline, this presentation (without additional amoxicillin) may not be suitable for the treatment of penicillin-resistant 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 amoxicillin/clavulanic acid 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.

These are usually reversible. Hepatic events may be severe and in extremely rare circumstances, deaths have been reported. 8). 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/clavulanic acid should immediately be discontinued, a physician be consulted and an appropriate therapy initiated. Anti-peristaltic drugs are contra-indicated in this situation.

Periodic assessment of organ system functions, including renal, hepatic and haematopoietic function is advisable during prolonged therapy. Prolongation of prothrombin time has been reported rarely in patients receiving amoxicillin/clavulanic acid.

Appropriate monitoring should be undertaken when anticoagulants are prescribed concomitantly. 8). 2). In patients with reduced urine output crystalluria (including acute renal injury) has been observed very rarely, predominantly with parenteral therapy.

During 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). During treatment with amoxicillin, enzymatic glucose oxidase methods should be used whenever testing for the presence of glucose in urine because false positive results may occur with non-enzymatic methods.

The presence of clavulanic acid in amoxicillin/clavulanic acid may cause a non-specific binding of IgG and albumin by red cell membranes leading to a false positive Coombs test. There have been reports of positive test results using the Bio-Rad Laboratories Platelia Aspergillus EIA test in patients receiving amoxicillin/clavulanic acid who were subsequently found to be free of Aspergillus infection.

Cross- reactions with non-Aspergillus polysaccharides and polyfuranoses with Bio- Rad Laboratories Platelia […]

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