From the Guidelines
A viral upper respiratory infection (URI) with otitis media should be managed with supportive care while considering antibiotics only if bacterial infection is suspected, with amoxicillin being the first-line antibiotic at a dosage of 80 to 90 mg per kg per day for children, as recommended by the AAP and AAFP guideline 1. For symptom relief, use acetaminophen (325-650mg every 4-6 hours) or ibuprofen (400-600mg every 6-8 hours) for pain and fever.
- Nasal saline irrigation and decongestants like pseudoephedrine (30-60mg every 4-6 hours) can help with congestion.
- For the otitis media component, watchful waiting is appropriate for mild cases in adults and older children, as most cases resolve spontaneously within 7-10 days.
- If symptoms are severe, persist beyond 48-72 hours, or occur in young children, amoxicillin (children: 80-90mg/kg/day divided into two doses) for 5-7 days is the first-line antibiotic, as it is generally effective against susceptible and intermediate resistant pneumococci, and has an acceptable taste and narrow microbiologic spectrum 1.
- For penicillin-allergic patients, alternative antibiotics such as cefdinir, cefpodoxime, or cefuroxime can be considered, as recommended by the AAP and AAFP guideline 1. Adequate hydration, rest, and avoiding irritants like smoke are essential for recovery.
- The viral URI causes inflammation and congestion of the nasal passages and Eustachian tubes, leading to fluid accumulation in the middle ear, which can become infected with bacteria, resulting in otitis media.
- Most cases are viral in origin and will resolve without antibiotics, which should be used judiciously to prevent antibiotic resistance, as emphasized in the clinical practice guideline for the diagnosis and management of acute bacterial sinusitis in children aged 1 to 18 years 1.
From the FDA Drug Label
CLINICAL STUDIES SECTION Pediatric Patients From the perspective of evaluating pediatric clinical trials, Days 11 to 14 were considered on-therapy evaluations because of the extended half-life of azithromycin. Day 11 to 14 data are provided for clinical guidance. Day 24 to 32 evaluations were considered the primary test of cure endpoint Acute Otitis MediaSafety and efficacy using azithromycin 30 mg/kg given over 5 daysProtocol 1 In a double-blind, controlled clinical study of acute otitis media performed in the United States, azithromycin (10 mg/kg on Day 1 followed by 5 mg/kg on Days 2 to 5) was compared to amoxicillin/clavulanate potassium (4:1). For the 553 patients who were evaluated for clinical efficacy, the clinical success rate (i. e., cure plus improvement) at the Day 11 visit was 88% for azithromycin and 88% for the control agent.
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. The combined clinical success rate (i.e., cure and improvement) at the Day 11 visit was 84% for azithromycin.
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). For the 240 patients who were evaluable for clinical modified Intent-to-Treat (MITT) analysis, the clinical success rate (i.e., cure plus improvement) at Day 10 was 89% and for the 242 patients evaluable at Day 24 to 28, the clinical success rate (cure) was 85%.
The treatment of viral URI with otitis media is not directly addressed in the provided drug labels. However, the labels do provide information on the treatment of acute otitis media with azithromycin.
- Azithromycin has been shown to be effective in the treatment of acute otitis media, with clinical success rates ranging from 73% to 89% in various studies 2, 2.
- The most common side effects of azithromycin were gastrointestinal, including diarrhea, vomiting, and abdominal pain.
- Amoxicillin is also indicated for the treatment of infections due to susceptible isolates of Streptococcus species, Streptococcus pneumoniae, Staphylococcus species, or Haemophilus influenzae, but its use in the treatment of viral URI with otitis media is not directly addressed in the provided label 3. It is essential to note that the treatment of viral URI with otitis media should be guided by clinical judgment and should take into account the severity of the infection, the patient's medical history, and the potential for antibiotic resistance.
From the Research
Viral URI with Otitis Media
- Viral upper respiratory tract infections (URTI) are a common cause of otitis media (OM) in children 4, 5.
- The pathogenesis of viral otitis media involves the invasion of the middle ear space by viruses, leading to an inflammatory response and the formation of middle ear effusion 5.
- The management of acute upper respiratory tract infection, including otitis media, aims to alleviate symptoms and prevent the transmission of the virus 6.
- Early intervention with mucoadhesive gel nasal sprays has shown promising results in preventing the development of acute URTI and reducing symptom severity 6.
Treatment of Otitis Media
- The treatment of otitis media typically involves symptom management with over-the-counter drugs, such as paracetamol or non-steroidal anti-inflammatory drugs (NSAIDs) 7, 8.
- Paracetamol and ibuprofen have been shown to be effective in relieving pain in children with otitis media, with low-quality evidence suggesting that both are more effective than placebo 8.
- There is insufficient evidence to determine the effectiveness of ibuprofen plus paracetamol versus paracetamol alone in relieving pain in children with otitis media 8.