What are the alternative antibiotics for otitis media in patients allergic to penicillin (PCN)?

From the Guidelines

For patients allergic to penicillin who have otitis media, cefdinir (14 mg/kg per day in 1 or 2 doses) or cefuroxime (30 mg/kg per day in 2 divided doses) are recommended as alternative antibiotics, as they are highly unlikely to be associated with cross-reactivity with penicillin allergy due to their distinct chemical structures 1. When considering alternative antibiotics for otitis media in patients allergic to penicillin, it's essential to evaluate the severity of the allergy and the patient's medical history.

• Cefdinir and cefuroxime are suitable options for patients without severe penicillin allergies, as they have a low risk of cross-reactivity 1.
• For patients with severe penicillin allergies, clindamycin (30-40 mg/kg per day in 3 divided doses) may be considered, although its use should be guided by local resistance patterns and patient-specific factors 1.
• The treatment duration typically ranges from 5-10 days, depending on the antibiotic and severity of infection.
• It's crucial to consider the type of penicillin allergy (immediate/severe vs. delayed/mild), local resistance patterns, and patient-specific factors such as age and comorbidities when prescribing alternative antibiotics 1.
• These alternatives target the common pathogens in otitis media, including Streptococcus pneumoniae, Haemophilus influenzae, and Moraxella catarrhalis. The American Academy of Pediatrics recommends cefdinir, cefuroxime, and cefpodoxime as alternative treatments for patients with penicillin allergies, as they have a low risk of cross-reactivity 1.
• Ceftriaxone (50 mg IM or IV per day for 1 or 3 days) may also be considered in cases of severe penicillin allergies or when other alternatives are not suitable 1.
• However, fluoroquinolones, such as levofloxacin, are generally avoided in children due to potential side effects and are typically reserved for adult patients with severe penicillin allergies 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.

Protocol 6 In a non-comparative clinical and microbiological trial, 248 patients from 6 months to 12 years of age with documented acute otitis media were dosed with a single oral dose of azithromycin (30 mg/kg on Day 1).

Alternative antibiotics for otitis media in patients allergic to penicillin (PCN)

• Azithromycin is an alternative for the treatment of otitis media in patients allergic to penicillin.
• The clinical success rate of azithromycin in the treatment of otitis media was 84% at the Day 11 visit and 70% at the Day 30 visit in one study 2.
• Azithromycin was compared to amoxicillin/clavulanate potassium in another study, with a clinical success rate of 88% for azithromycin vs. 100% for the control at the Day 11 visit, and 82% for azithromycin vs. 80% for the control at the Day 30 visit 2.
• The most common side effects of azithromycin were diarrhea, vomiting, and rash 2.

From the Research

Alternative Antibiotics for Otitis Media in Patients Allergic to Penicillin

• For patients allergic to penicillin, alternative antibiotics can be used to treat otitis media, including:
  • Erythromycin ethylsuccinate and sulfisoxazole or TMP-SMZ, as suggested by 3
  • Trimethoprim-sulfamethoxazole, erythromycin-sulfisoxazole, cefaclor, cefuroxime axetil, and cefixime, as listed by 4
• It is essential to consider the efficacy, cost, side effect profile, compliance issues, spectrum of coverage, and the age of the child when choosing an antibiotic, as mentioned in 4
• In cases where penicillin-resistant pneumococcus is suspected, high-dose amoxicillin, with or without clavulanate, or clindamycin may be considered, as stated in 3

Second-Line Agents for Otitis Media

• Second-line agents, such as amoxicillin/clavulanate, should be used if the patient does not respond to first-line treatment within 48 to 72 hours, as recommended by 5
• High-dose amoxicillin/clavulanate (90 mg/kg/day based on the amoxicillin component) and ceftriaxone are appropriate options for second-line therapy, as suggested by 6

Considerations for Antibiotic Selection

• The selection of antibiotics should be based on pharmacokinetic/pharmacodynamic principles, in addition to minimum inhibitory concentrations, as mentioned in 6
• The high prevalence of drug-resistant S. pneumoniae and beta-lactamase-producing organisms presents a clinical challenge for practitioners in the selection of empiric antimicrobial therapy, as noted in 6