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Doses are expressed throughout in terms of amoxicillin/clavulanic acid content except when doses are stated in terms of an individual component. The dose of the drug that is selected to treat an individual infection should take into account: The expected pathogens and their likely susceptibility to antibacterial agents. The severity and the site of the infection The age, weight and renal function of the patient as shown below. Treatment should not be extended beyond 14 days without review.
Adults and children ≥ 40 kg: There is no experience with the drug suspension in adults and children ≥40 kg, and therefore no dose recommendation can be given.
Children < 40 kg (aged ≥3 months): The recommended dose of the drug suspension is 90/6.4 mg/kg/day in two divided doses. There are no clinical data on this drug in children under 3 months of age.
Renal impairment: No dose adjustment is required in patients with creatinine clearance (CrCl) greater than 30 ml/min. In patients with creatinine clearance less than 30 ml/min, the use of the drug is not recommended, as no recommendations for dose adjustments are available.
Hepatic impairment: Dose with caution and monitor hepatic function at regular intervals.
Method of administration: The drug is for oral use.
For full details see prescribing information.
Treatment of Acute otitis media in children aged at least 3 months and less than 40 kg body weight, caused or thought likely to be caused by penicillin-resistant Streptococcus pneumoniae.
Hypersensitivity to the active substances, to any of the penicillins or to any of the excipients. History of a severe immediate hypersensitivity reaction (e.g. anaphylaxis) to another beta-lactam agent (e.g. a cephalosporin, carbapenem or monobactam). History of jaundice/hepatic impairment due to amoxicillin/clavulanic acid.
Before initiating therapy with amoxicillin/clavulanic acid, careful enquiry should be made concerning previous hypersensitivity reactions to penicillins, cephalosporins or beta-lactam agents. Serious and occasionally fatal hypersensitivity (anaphylactoid) 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. 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.
Convulsions may occur in patients with impaired renal function or in those receiving high doses. 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. The occurrence at the treatment initiation of a feverish generalised erythema associated with pustula may be a symptom of acute generalised exanthemous pustulosis (AGEP). This reaction requires drug discontinuation and contra-indicates any subsequent administration of amoxicillin. Amoxicillin/clavulanic acid should be used with caution in patients with evidence of hepatic impairment. 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. These have almost always occurred in patients with serious underlying disease or taking concomitant medications known to have the potential for hepatic effects.
Antibiotic-associated colitis has been reported with nearly all antibacterial agents including amoxicillin and may range in severity from mild to life threatening. 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, the drug 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. Adjustments in the dose of oral anticoagulants may be necessary to maintain the desired level of anticoagulation.
In patients with reduced urine output, crystalluria 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. In patients with bladder catheters, a regular check of patency should be maintained.
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 this formulation 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 interpreted cautiously and confirmed by other diagnostic methods. The powder for oral suspension contains 2.72 mg of aspartame (E951) per ml, a source of phenylalanine. This medicine should be used with caution in patients with phenylketonuria. The drug powder for oral suspension contains maltodextrin (glucose). Patients with rare glucose-galactose malabsorption should not take this medicine.
See prescribing information for full details.
Mucocutaneous candidosis, nausea, vomiting, diarrhea.
See prescribing information for full details.
Oral anticoagulants: Oral anticoagulants and penicillin antibiotics have been widely used in practice without reports of interaction. However, in the literature there are cases of increased international normalised ratio in patients maintained on acenocoumarol or warfarin and prescribed a course of amoxicillin. If co-administration is necessary, the prothrombin time or international normalised ratio should be carefully monitored with the addition or withdrawal of amoxicillin. Moreover, adjustments in the dose of oral anticoagulants may be necessary.
Methotrexate: Penicillins may reduce the excretion of methotrexate causing a potential increase in toxicity.
Probenecid: Concomitant use of probenecid is not recommended. Probenecid decreases the renal tubular secretion of amoxicillin. Concomitant use of probenecid may result in increased and prolonged blood levels of amoxicillin but not of clavulanic acid.
In common with other broad-spectrum antibiotics, amoxicillin/clavulanate may reduce the efficacy of oral contraceptives.
Pregnancy and Lactation
Pregnancy: Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryonal /foetal development, parturition or postnatal development.
Lactation: Both substances are excreted into breast milk (nothing is known of the effects of clavulanic acid on the breast-fed infant).
See prescribing information for full details.
Symptoms and signs of overdose Gastrointestinal symptoms and disturbance of the fluid and electrolyte balances may be evident. Amoxicillin crystalluria, in some cases leading to renal failure, has been observed. Convulsions may occur in patients with impaired renal function or in those receiving high doses. Amoxicillin has been reported to precipitate in bladder catheters, predominantly after intravenous administration of large doses. A regular check of patency should be maintained.
Treatment of intoxication: Gastrointestinal symptoms may be treated symptomatically, with attention to the water/electrolyte balance. Amoxicillin/clavulanic acid can be removed from the circulation by haemodialysis.
Storage: Do not store above 25°C. For storage conditions of the reconstituted medicinal product, the expiry date of the product is indicated on the label and packaging. Reconstituted suspensions should be stored at 2°C – 8°C for up to 10 days.
Before/after meal: Administer at the start of a meal to minimise potential gastrointestinal intolerance and optimise absorption of amoxicillin/clavulanic acid.