Co-amoxiclav 625mg (Augmentin)

SCOPE: the fetched §4.2 gives ONE general adult regimen for this product and does not break dosing down by indication; §4.1 (therapeutic indications) was not part of the fetched bundle, so this SPC neither confirms nor excludes the specific ENT indications named on the page (acute otitis media after amoxicillin failure, acute rhinosinusitis, peritonsillar abscess, dental-origin ENT infection) — those, and their course lengths, must come from a UK antimicrobial guideline. What is published above is the SPC's general adult dose for this exact product, which is the dose the page is built around. Verbatim posology: 'Adults and children ≥ 40 kg — One 500 mg/125 mg dose taken three times a day.' Both components of the fixed combination are quantified (amoxicillin 500 mg + clavulanic acid 125 mg = the page's 625 mg tablet). Doses 'are expressed throughout in terms of amoxicillin/clavulanic acid content'. DURATION: no course length is published above because the SPC does not give one — 'The duration of therapy should be determined by the response of the patient. Some infections (e.g. osteomyelitis) require longer periods of treatment. Treatment should not be extended beyond 14 days without review.' 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.' Elderly: 'No dose adjustment is considered necessary.' Choice of dose: 'The dose of Augmentin that is selected to treat an individual infection should take into account: • The expected pathogens and their likely susceptibility to antibacterial agents (see section 4.4) • The severity and the site of the infection • The age, weight and renal function of the patient as shown below.' If a higher amoxicillin dose is needed, 'it is recommended that another preparation of Augmentin is selected in order to avoid administration of unnecessarily high daily doses of clavulanic acid'. De-escalation (§4.4): '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.'

dosePerKg is deliberately NULL: the SPC gives a RANGE, not a single per-dose figure — 'Children < 40 kg 20 mg/5 mg/kg/day to 60 mg/15 mg/kg/day given in three divided doses' (expressed per day, and as amoxicillin/clavulanic acid). Choosing any single point value from that range would not be verbatim, so the regimen is left in prose for the prescriber. TABLET RESTRICTIONS (§4.2): 'As the tablets cannot be divided, children weighing less than 25 kg must not be treated with Augmentin tablets'; 'Children aged 6 years and below or weighing less than 25 kg should preferably be treated with Augmentin suspension or paediatric sachets.' The SPC's worked table for a single 500/125 mg tablet gives amoxicillin per single dose of 12.5 mg/kg at 40 kg, 14.3 mg/kg at 35 kg, 16.7 mg/kg at 30 kg and 20.0 mg/kg at 25 kg (clavulanic acid 3.1, 3.6, 4.2 and 5.0 mg/kg respectively) — i.e. weight-banded for the tablet, which is why no single per-kg value is set. 'No clinical data are available on doses of Augmentin 4:1 formulations higher than 40 mg/10 mg/kg per day in children under 2 years.' Children weighing 40 kg or more take the adult regimen (one 500 mg/125 mg dose three times a day). concentration is NULL because this SPC is for a tablet and the bundle contains no UK suspension strength; the only suspension strength in the bundle (600 mg/42.9 mg per 5 mL) is a US product that does not correspond to this UK page, so it must not be used to compute a volume here.