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ATC codes: J01CA04
EMLc
Indication
Acute otitis media ICD11 code: AB00
INN
Amoxicillin
Medicine type
Chemical agent
Antibiotic groups
List type
Core (EML)
(EMLc)
Formulations
Oral > Liquid: 125 mg per 5 mL (as trihydrate) powder for oral liquid (EMLc) ; 250 mg per 5 mL (as trihydrate) powder for oral liquid (EMLc)
Parenteral > General injections > unspecified: 250 mg in vial (as sodium) powder for injection ; 500 mg in vial (as sodium) powder for injection ; 1 g in vial (as sodium) powder for injection
Oral > Solid > dispersible tablet: 250 mg (scored) (as trihydrate) (EMLc) ; 500 mg (scored) (as trihydrate) (EMLc)
Oral > Solid > dosage form: 250 mg (as trihydrate) ; 500 mg (as trihydrate)
EML status history
First added in 2017 (TRS 1006)
Changed in 2023 (TRS 1049)
Sex
All
Age
Also recommended for children
Therapeutic alternatives
The recommendation is for this specific medicine
Patent information
Patents have expired in most jurisdictions
Wikipedia
DrugBank
Expert Committee recommendation
The Expert Committee recommended the inclusion of a new strength, child-friendly dispersible tablet formulation of amoxicillin + clavulanic acid (200 mg + 28.5 mg) as an Access group antibiotic on the core list of the EMLc for treatment of bacterial infections in children – specifically those infections for which amoxicillin + clavulanic acid is already recommended on the EMLc. The Committee noted that the 7:1 ratio of amoxicillin to clavulanic acid is associated with similar efficacy to the 4:1 ratio but has a reduced frequency of gastrointestinal adverse effects. The Committee endorsed the importance of age-appropriate formulations to better meet the dosing needs of children. Following the review of the age-appropriateness of formulations on the EMLc, the Expert Committee recommended: - the addition of new formulations of amoxicillin (dispersible, scored tablet, 250 mg and 500 mg) to the EMLc. - the addition of a new formulation of amoxicillin + clavulanic acid (dispersible tablet 250 mg + 62.5 mg) to the EMLc.
EML recommendations: Acute otitis media
First choice
Second choice