Acute otitis media in children
Acute middle ear infection in children, commonly secondary to viral URI. Antibiotic decisions depend on age, severity, and laterality.
ICD-10 H66.03 drugs
Also known as: AOM
Drugs used for this condition
- AAmoxicillinFirst line · Penicillins with extended spectrumIn children with acute otitis media, Amoxicillin is the first-choice antibiotic per AAP 2013, NICE NG91 (2018, updated 2022) and the Spanish SEIP/AEPap consensus 2023. Pain relief with Paracetamol or Ibuprofen is the basis of treatment. Antibiotics are started at once for moderate or severe disease (severe pain, fever of 39 °C or higher, otorrhoea) and, per AAP 2013, for bilateral disease at 6–23 months; for non-severe disease from 6 months of age, 48–72 hours of observation with a delayed prescription is acceptable. Dosing depends on the guideline: AAP 2013 and the 2023 consensus use high-dose Amoxicillin (80–90 mg/kg/day, in two doses per AAP), NICE NG91 uses standard age-based doses three times daily. Course: 5–7 days for uncomplicated disease (NICE, 2023 consensus), up to 10 days under 2 years or with severe disease (AAP). Amoxicillin/clavulanate is used if Amoxicillin was given in the last 30 days, with purulent conjunctivitis, or with a history of recurrent otitis that did not respond to Amoxicillin. Cochrane 2023 found a modest reduction in pain with antibiotics and more vomiting, diarrhoea and rash. Per the label, Amoxicillin is contraindicated in penicillin allergy and after anaphylaxis to another beta-lactam; NICE suggests Clarithromycin for allergic children. Avoid Amoxicillin if infectious mononucleosis is suspected (morbilliform rash). Antibiotic-associated colitis can occur. Interactions: Methotrexate (increased toxicity), Allopurinol (more rash), oral anticoagulants (monitor prothrombin time).
- BAmoxicillin + Clavulanic AcidFirst line · Fixed-dose combination: aminopenicillin plus beta-lactamase inhibitorAcute otitis media in children when antibiotics are indicated (age under 6 months, bilateral otitis in children under 2 years, severe pain, fever >39 °C, otorrhea with perforation). Amoxicillin-clavulanate is not the default starting antibiotic here: AAP 2013 and the Spanish consensus (SEIP/SEPEAP/SEUP/AEPap 2012, updated in 2023 with SEORL-CCC) name high-dose amoxicillin as the drug of choice. The combination is started up front if the child received amoxicillin in the last 30 days, has purulent conjunctivitis, or has recurrences unresponsive to amoxicillin (AAP 2013), and, per the Spanish 2012 consensus, in infants under 6 months, in severe illness (fever >39 °C or severe pain) and with a family history of otitis sequelae. If amoxicillin fails at 48–72 hours, it is the second line. Clavulanate blocks the beta-lactamases of H. influenzae and M. catarrhalis; it does nothing against pneumococcal resistance, which is covered by the high amoxicillin dose. In two placebo-controlled RCTs (Hoberman 2011, Tähtinen 2011) the drug reduced treatment failure, with more diarrhea and diaper dermatitis. Dose: 80–90 mg/kg/day of amoxicillin (AAP 2013: 90 mg/kg/day in two doses with the 14:1 formulation; Spanish consensus: 80 mg/kg/day); in Spain the high dose is given with the 8:1 suspension (100/12.5 mg/ml), 4:1 formulations are unsuitable because of excess clavulanate. Duration per AAP 2013: 10 days under 2 years and in severe illness, 7 days at 2–5 years, 5–7 days from 6 years; the Spanish 2023 consensus allows 5–7 days in mild uncomplicated otitis without risk factors. Contraindications (AEMPS SmPC, 4.3): penicillin allergy, anaphylaxis to other beta-lactams, and a history of jaundice or liver injury with amoxicillin-clavulanate.
- BCefuroxime axetilSecond line · Second-generation oral cephalosporinUsed in acute otitis media in children and adults as an alternative to amoxicillin/clavulanate when penicillins are intolerable without anaphylaxis. AAP 2013 and the Spanish 2024 pediatric consensus set amoxicillin 80–90 mg/kg/day or amoxicillin/clavulanate (with suspected resistance) as first-line. Cefuroxime axetil in children: 30 mg/kg/day in 2 doses for 5–10 days. In children over 2 without severe disease, delayed antibiotic prescription over 48–72 hours is an option.
How to read tiers A–F
Evidence tiers belong to the drug-indication pair, not to the drug as a whole: the same substance can be A for one condition and F for another.
- AStrong evidence – first or second line in international guidelines
- BRecommended in selected cases
- CStudy data contradict each other
- DBenefit not proven, no documented harm
- FDocumented harm, or risk without benefit