Amoxicillin (Otitis Media / Sinusitis)

Source: UK SPC (eMC) for Amoxicillin 250 mg/5 ml Powder for Oral Suspension Sugar Free, §4.2 (https://www.medicines.org.uk/emc/product/14145/smpc). IMPORTANT SOURCE CAVEAT: the §4.2 dose table was flattened into running text during fetch, so indication-to-dose pairing must be confirmed against the SPC table before publication. As fetched, the text reads '…Acute bacterial sinusitis / Asymptomatic bacteriuria in pregnancy — 250 mg to 500 mg every 8 hours or 750 mg to 1 g every 12 hours; Acute pyelonephritis / Dental abscess with spreading cellulitis — for severe infections 750 mg to 1 g every 8 hours; Acute cystitis — may be treated with 3 g twice daily for one day; Acute otitis media — 500 mg every 8 hours, 750 mg to 1 g every 12 hours; Acute streptococcal tonsillitis and pharyngitis / Acute exacerbations of chronic bronchitis — for severe infections 750 mg to 1 g every 8 hours for 10 days'. The dose selected should take account of the expected pathogens and their likely susceptibility, the severity and site of the infection, and the age, weight and renal function of the patient; official treatment guidelines for each indication should be consulted. The duration of therapy should be determined by the type of infection and the response of the patient and should generally be as short as possible. No maximum daily dose is stated in §4.2 for otitis media or sinusitis (maxima of 4 g/day and 6 g/day are stated only for early and late Lyme disease respectively). ELDERLY: no dose adjustment is considered necessary. HEPATIC IMPAIRMENT: dose with caution and monitor hepatic function at regular intervals. METHOD OF ADMINISTRATION: for oral use; absorption is unimpaired by food; therapy can be started parenterally according to the IV formulation's dosing recommendations and continued with an oral preparation. §4.5 (interactions) was NOT present in the fetched bundle — source the interaction section separately.

SPC §4.2, children weighing < 40 kg, for acute bacterial sinusitis, acute otitis media, community acquired pneumonia, acute cystitis, acute pyelonephritis and dental abscess with spreading cellulitis: '20 to 90 mg/kg/day in divided doses'. A range is given rather than a single figure, so dosePerKg is left null — use the quoted range. (By contrast the SPC gives 40 to 90 mg/kg/day for acute streptococcal tonsillitis and pharyngitis, and 100 mg/kg/day in three divided doses for typhoid and paratyphoid fever.) Amoxicillin Paediatric Suspension is recommended for children under six months of age. Renal impairment in children < 40 kg: GFR > 30 mL/min no adjustment; GFR 10 to 30 mL/min 15 mg/kg twice daily; GFR < 10 mL/min 15 mg/kg as a single daily dose. Verify all paediatric dosing against a children's formulary.