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RTIs & Acute Otitis Media  |  Acute Otitis Media

Acute Otitis Media





Tab Number 5



30 mg/kg as a single dose
10 mg/kg once daily for 3 days
10 mg/kg on day 1 then 5 mg/kg once daily on days 2 to 5

  • ZITHROMAX should be given as a single daily dose1
  • ZITHROMAX tablets and suspension can be taken with or without food.1
  • ZITHROMAX tablets should only be administered to children weighing more than 45 kg1
  • Administration of ZITHROMAX suspension should follow adults dosage for children weighing more than 45 kg1
Resources Pediatrics: How to Properly Administer ZITHROMAX® Watch nowLoadingRenal Impairment1

No dose adjustment is necessary in patients with mild to moderate renal impairment (glomerular filtration rate [GFR] of 10–80 mL/min). Caution should be exercised when ZITHROMAX is administered to patients with severe renal impairment (GFR <10 mL/min)

Hepatic Impairment1

The same dosage as in patients with normal hepatic function may be used in patients with mild to moderate hepatic impairment

PathogensMain Bacterial Pathogens2
  • Streptococcus pneumoniae
  • Group A Streptococcus
  • Streptococcus faecalis
  • Hemophilus influenzae
  • Enteric Gram-negative bacilli
  • Moraxella catarrhalis

It is estimated that there are 709 million acute otitis media cases each year globally, with 51% of these occurring in children under five years of age3

The incidence rate of acute otitis media varies globally, ranging from 3.6 for Europe to 43.4 for West and Central Sub-Saharan Africa3

EfficacyZITHROMAX – Once daily over 5 days is as effective as 10 days of amoxicillin/clavulanate three-times-daily in acute otitis media4 Clinical Response in Evaluable Acute Otitis Media in Children Aged 1-15 Years at Day 11

Adapted from McLinn et al. 19964

McLinn. 19964
  • A multicenter, randomized, double dummy fashion comparison of azithromycin and amoxicillin/clavulanate for the treatment of acute otitis media in children
  • Clinical response rates (cured and improved) at 11 days were 87.5% with azithromycin and 87.9% with amoxicillin/clavulanate; rates at 30 days were 73.5% and 71.2%, respectively. 
  • Treatment-related side effects, primarily gastrointestinal, were reported in 8.8% of children on azithromycin, and 30.8% with amoxicillin/clavulanate (p<0.0001)
  • In children with acute otitis media, azithromycin given once daily for 5 days and amoxicillin/clavulanate given three times daily for 10 days had similar efficacy; however, azithromycin was significantly better tolerated
ZITHROMAX is contraindicated in patients with a known hypersensitivity to azithromycin, erythromycin, any macrolide or ketolide antibiotic, or to any of the excipients.1
As with erythromycin and other macrolides, rare serious allergic reactions, including angioedema and anaphylaxis (rarely fatal), dermatologic reactions including Acute Generalized Exanthematous Pustulosis (AGEP), Stevens-Johnson Syndrome (SJS), Toxic Epidermal Necrolysis (TEN) (rarely fatal), and Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) have been reported.1
As with any antibiotic preparation, observation for signs of superinfection with non-susceptible organisms including fungi is recommended. Clostridium difficile associated diarrhea has been reported with azithromycin, and may range in severity from mild diarrhea to fatal colitis.1
You might also be interested in...Upper Respiratory Tract Infections Acute Bacterial Sinusitis Find out moreLoadingUpper Respiratory Tract Infections Pharyngitis/Tonsillitis Find out moreLoadingResources ZITHROMAX® Mode of Action Watch nowLoadingReferences:Pfizer Malaysia ZITHROMAX Prescribing Information. Available at: Accessed January 2024.Turner D, et al. Ped Infect Dis J. 2002;21:669–74.Monasta L, et al. PLoS One. 2012;7(4):e36226.McLinn S. Pediatr Infect Dis J. 1996;15(9):20–3.
Acute Otitis Media ZITHROMAX® Safety Information Find out more Loading
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