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AUGMENTIN is a brand name for Amoxicillin. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Augmentin is indicated for the treatment of the following infections in adults and children (see sections 4.2, 4.4 and 5.1): • Acute bacterial sinusitis (adequately diagnosed) • Acute otitis media • Acute exacerbations of chronic bronchitis (adequately diagnosed) • Community acquired pneumonia • Cystitis •…
Verbatim from this product's MHRA label. Tap a section to expand.
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. 1). For children < 40 kg, this formulation of Augmentin provides a maximum daily dose of 1000- 2800 mg amoxicillin/143-400 mg clavulanic acid, when administered as recommended below. 1). The duration of therapy should be determined by the response of the patient.
g. osteomyelitis) require longer periods of treatment. 4 regarding prolonged therapy). Children ≥ 40 kg should be treated with the adult formulations of Augmentin. Children < 40 kg Children may be treated with Augmentin tablets, suspensions or paediatric sachets.
4 mg/kg/day given as two divided doses; • up to 70 mg/10 mg/kg/day given as two divided doses may be considered for some infections (such as otitis media, sinusitis and lower respiratory tract infections). 4 mg per kg per day in children under 2 years.
There are no clinical data for Augmentin 7:1 formulations for patients under 2 months of age. Dosing recommendations in this population therefore cannot be made. Elderly No dose adjustment is considered necessary. 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 Augmentin presentations with an amoxicillin to clavulanic acid ratio of 7:1 is not recommended, as no recommendations for dose adjustments are available. 4). Method of administration Augmentin is for oral use.
Augmentin should be administered with a meal to minimise potential gastrointestinal intolerance. Therapy can be started parenterally according to the SmPC of the IV-formulation and continued with an oral preparation. Shake to loosen powder, add water as directed, invert and shake.
6). 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 Augmentin, 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 beta- lactam class antibiotics, but the significance of these findings is unknown. 4). 4). 4 9 Superficial tooth discolouration has been reported very rarely in children.
Good oral hygiene may help to prevent tooth discolouration as it can usually be removed by brushing. 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 by searching 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.
This presentation of Augmentin is not 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.
This presentation should not be used to treat 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 Augmentin discontinuation and contraindicates any subsequent administration of amoxicillin.
1. g. g. a cephalosporin, carbapenem or monobactam). 8).
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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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 contraindicated 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 Augmentin 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.
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