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.

g. 4. 1). For adults and children ≥ 40 kg, Co-amoxiclav 250 mg/125 mg film-coated tablets provides a total daily dose of 750 mg amoxicillin/ 375 mg clavulanic acid, when administered as recommended below. 1). Treatment should not be extended beyond 14 days without review.

Adults and children ≥ 40 kg One 250 mg/125 mg tablet taken three times a day. Children < 40 kg Co-amoxiclav 250 mg/125 mg film-coated tablets are not recommended in children < 40 kg. Elderly No dose adjustment is considered necessary.

Renal impairment Dose adjustments are based on the maximum recommended level of amoxicillin. No adjustment in dose is required in patients with creatinine clearance (CrCl) greater than 30 ml/min. Adults and children ≥ 40 kg CrCl: 10-30 ml/min 250 mg/125 mg twice daily CrCl < 10 ml/min 250 mg/125 mg once daily Haemodialysis Two doses of 250 mg/125 mg every 24 hours, plus two doses of 250 mg/125 mg during dialysis, to be repeated at the end of dialysis (as serum concentration of both amoxicillin and clavulanic acid are decreased) Children < 40 kg In children < 40 kg with creatinine clearance less than 30 ml/min, the use of amoxicillin/clavulanic acid presentations with an amoxicillin to clavulanic acid ratio of 2:1 is not recommended, as no dose adjustments are available.

In such patients, amoxicillin/clavulanic acid formulations with an amoxicillin to clavulanic acid ratio of 4:1 are recommended. 4). Method of administration Co-amoxiclav 250 mg/125 mg film-coated tablets are for oral use. Administer at the start of a meal to minimise potential gastrointestinal intolerance and optimise absorption of amoxicillin/clavulanic acid.

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 undesirables effects. 4 3Nausea is more often associated with higher oral doses. If gastrointestinal reactions are evident, they may be reduced by taking amoxicillin/clavulanic acid at the start of a meal.

4) 5A 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). 9. 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.

8). Serious and occasionally fatal hypersensitivity reactions (including anaphylactoid and severe cutaneous adverse reactions) have been reported in patients on penicillin therapy. 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 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. In 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. 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 an 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 medicinal products 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 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). 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 Aspergillus EIA test have been reported. Therefore, positive test results in patients receiving amoxicillin/clavulanic acid should be […]

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