What is the next antibiotic to use for a child with ongoing otitis media if amoxicillin is ineffective?

From the Guidelines

If amoxicillin doesn't work for a child with otitis media, the next antibiotic to use is typically amoxicillin-clavulanate (90 mg/kg per day of amoxicillin, with 6.4 mg/kg per day of clavulanate in 2 divided doses) as recommended by the Pediatrics journal in 2013 1.

Key Considerations

• The justification for using amoxicillin-clavulanate is its effectiveness against common bacterial pathogens, safety, low cost, and narrow microbiologic spectrum.
• For children who have taken amoxicillin in the previous 30 days, those with concurrent conjunctivitis, or those for whom coverage for Moraxella catarrhalis is desired, therapy should be initiated with high-dose amoxicillin-clavulanate.

Alternative Treatments

• If the child is allergic to penicillin, alternative treatments include cefdinir (14 mg/kg per day in 1 or 2 doses), cefuroxime (30 mg/kg per day in 2 divided doses), or ceftriaxone (50 mg IM or IV for 3 days) as outlined in the study 1.
• Clindamycin (30–40 mg/kg per day in 3 divided doses) with or without a third-generation cephalosporin may also be considered in cases of treatment failure.

Important Notes

• The choice of antibiotic should be guided by the child's medical history, current symptoms, and potential allergies.
• Treatment failure may indicate resistant organisms, inadequate dosing, poor compliance, or possibly a viral etiology rather than bacterial infection, and referral to an otolaryngologist may be warranted in such cases 1.

From the FDA Drug Label

Protocol 2 In a non-comparative clinical and microbiologic trial performed in the United States, where significant rates of beta-lactamase producing organisms (35%) were found, 131 patients were evaluable for clinical efficacy. Protocol 3 In another controlled comparative clinical and microbiologic study of otitis media performed in the United States, azithromycin was compared to amoxicillin/clavulanate potassium (4:1). Protocol 4 In a double-blind, controlled, randomized clinical study of acute otitis media in pediatric patients from 6 months to 12 years of age, azithromycin (10 mg/kg per day for 3 days) was compared to amoxicillin/clavulanate potassium (7:1) in divided doses q12h for 10 days Protocol 5 A double blind, controlled, randomized trial was performed at nine clinical centers Pediatric patients from 6 months to 12 years of age were randomized 1:1 to treatment with either azithromycin (given at 30 mg/kg as a single dose on Day 1) or amoxicillin/clavulanate potassium (7:1), divided q12h for 10 days.

The next antibiotic to use for otitis media if amoxicillin doesn’t work is azithromycin.

• Clinical success rates for azithromycin in the treatment of otitis media were 84% at Day 11 and 70% at Day 30 in one study 2.
• Presumed bacteriologic eradication rates for azithromycin were 82% for S. pneumoniae, 80% for H. influenzae, and 80% for M. catarrhalis at Day 11 2.
• Common side effects of azithromycin include diarrhea, vomiting, and rash 2.

From the Research

Next Steps for Otitis Media Treatment

If amoxicillin doesn't work and a child still has ongoing otitis media, the next steps for treatment can be considered based on the following points:

• Alternative Antibiotics: Studies suggest that alternative antibiotics such as amoxicillin/clavulanate, ceftriaxone, or azithromycin can be used as second-line therapy for patients in whom amoxicillin is unsuccessful 3, 4.
• High-Dose Amoxicillin/Clavulanate: High-dose amoxicillin/clavulanate (90 mg/kg/day based on the amoxicillin component) has been shown to be effective against penicillin-resistant S. pneumoniae and beta-lactamase-producing pathogens 5, 4, 6.
• Ceftriaxone: Ceftriaxone is also an option for second-line therapy, especially for patients who have failed multiple courses of antibiotics 4.
• Azithromycin: Azithromycin can be considered as an alternative, although it may not be as effective as amoxicillin/clavulanate in eradicating certain pathogens 7, 6.
• Tympanocentesis: Tympanocentesis can be useful for identifying the causative pathogen and guiding further treatment 4.

Some key points to consider when selecting alternative antibiotics include:

• Pathogen Susceptibility: The most likely pathogens and their susceptibility patterns should be considered when selecting alternative antibiotics 3, 7.
• Antibiotic Efficacy: The clinical efficacy of the antibiotic against specific pathogens, as well as its pharmacokinetic/pharmacodynamic profile, should be taken into account 5, 4, 6.
• Adverse Reactions: The potential for adverse reactions, palatability, dosing schedules, and cost should also be considered when selecting alternative antibiotics 3.