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ATC codes: J01CR02
EMLc
Indication
Bacterial pneumonia ICD11 code: CA40.0Z
INN
Amoxicillin + clavulanic acid
Medicine type
Chemical agent
Antibiotic groups
List type
Core
Formulations
Parenteral > General injections > IV: 500 mg (as sodium salt) + 100 mg (as potassium salt) powder for injection ; 1000 mg (as sodium salt) + 200 mg (as potassium salt) powder for injection
Oral > Liquid: 125 mg (as trihydrate) + 31.25 mg (as potassium salt) powder for oral liquid (EMLc) ; 250 mg (as trihydrate) + 62.5 mg (as potassium salt) powder for oral liquid (EMLc)
Oral > Solid: 500 mg (as trihydrate) + 125 mg (as potassium salt) ; 875 mg (as trihydrate) + 125 mg (as potassium salt) (EML)
Oral > Solid > dispersible tablet: 200 mg (as trihydrate) + 28.5 mg (as potassium salt) (EMLc) ; 250 mg (as trihydrate) + 62.5 mg (as potassium salt) (EMLc)
EML status history
First added in 2017 (TRS 1006)
Changed in 2021 (TRS 1035)
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
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 strength formulations of cefotaxime (powder for injection: 500 mg; 1 g; 2 g (as sodium) in vial) to the EML and EMLc. - the addition of a new strength formulation of ceftriaxone (powder for injection: 500 mg (as sodium) in vial) to the EML and EMLc. - the addition of a new formulation of amoxicillin (dispersible, scored tablet, 250 mg and 500 mg) to the EMLc. - the addition of new strength formulations of doxycycline (powder for oral liquid 25 mg/5 mL (monohydrate), oral liquid 50 mg/5 mL (calcium), and dispersible tablet 100 mg (as monohydrate) on the EMLc.
EML recommendations: Bacterial pneumonia
First choice
Second choice
Community-acquired pneumonia - mild to moderate
Community-acquired pneumonia - severe [children]
Community-acquired pneumonia - severe
First choice
Second choice