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RTIs & Acute Otitis MediaUpper Respiratory Tract Infections (Upper RTIs)Acute Bacterial SinusitisPharyngitis/TonsillitisAcute Otitis MediaAcute Otitis MediaLower Respiratory Tract Infections (Lower RTIs)Community-Acquired PneumoniaAcute Bacterial Exacerbation of Chronic BronchitisSTIsSexually Transmitted Infections (STIs)Infections by Chlamydia trachomatisInfections by Neisseria gonorrhoeaeChancroid/Genital Ulcers MenSSTIsSkin and Soft-Tissue Infections (SSTIs)Uncomplicated Skin and Soft-Tissue InfectionsSafetySafetySafetyAdditional InformationAdditional InformationIndication and SusceptibilityFormulationsMode of ActionReconstitution of Powder for Oral Suspension for PediatricsPediatric AdministrationResourcesResourcesPrescribing InformationEventsMaterialsVideos

RTIs & Acute Otitis Media  |  Upper Respiratory Tract Infections  |  Acute Bacterial Sinusitis

Acute Bacterial Sinusitis

Administration

Pathogens

Epidemiology

Efficacy

Tab Number 5

Administration

Adults1

500 mg once daily for 3 days, or an alternative of 500 mg on Day 1, then 250 mg daily on Days 2-5

Pediatrics1

10 mg/kg once daily for 3 days, or an alternative of 10 mg/kg on Day 1, then 5 mg/kg on Days 2-5

  • ZITHROMAX should be given as a single daily dose1
  • ZITHROMAX tablets and suspension can be taken with or without food1
  • 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 and Haemophilus influenzae are the two main bacterial pathogens, accounting for more than 50% of bacterial infections
  • Moraxella catarrhalis is a less common pathogen in adults, but accounts for 25% of cases in children
  • Streptococcus pyogenesStaphylococcus aureus, gram-negative bacilli, and oral anaerobes are also less common pathogens
Epidemiology Approximately 6% to 7% of children with respiratory symptoms have acute rhinosinusitis (ARS). An estimated 16% of adults are diagnosed with acute bacterial rhinosinusitis annually3 ARS accounts for 1 in 5 antibiotic prescriptions for adults, making it the fifth most common reason for an antibiotic prescription3
EfficacyZITHROMAX – A single daily dose delivers high success rates in upper respiratory tract infections4

Clinical Success Rate Following Treatment With Azithromycin in Adults >18 Years

Adapted from Donde et al. 20144

Clinical Success Rate Among Children and Adolescents Age ≤18 years

Adapted from Donde et al. 20144

Donde et al. 20144
  • An open-label, prospective, multicenter, non-interventional study to assess the safety and tolerability of azithromycin in acute bacterial upper respiratory tract infections (URTIs)
  • Primary objective: assess the effectiveness of azithromycin in acute bacterial URTIs
  • In general, in children a total single dose of 30 mg/kg was given over a period of 3–5 days; the maximum recommended total dose of azithromycin was 1,500 mg
  • Overall success rate for clinical outcome in the evaluable (278 of 410) population was 98.92%

ZITHROMAX – Clinical Cure Rates as Effective as Erythromycin When Treating Sinusitis5

Adapted from Felstead et al. 19915

Felstead et al. 19915
  • Two randomized, multicenter studies comparing azithromycin and erythromycin in the treatment of URTIs
  • Clinical cure was recorded in 84/101 (83%) treated with azithromycin, and in 85/108 (79%) erythromycin-treated URTI patients
  • Cure rates in sinusitis were 85% in the 68 patients treated with azithromycin, and 75% in the 74 patients treated with erythromycin
TitleZITHROMAX 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 Pharyngitis/Tonsillitis Find out more LoadingAcute Otitis Media Acute Otitis Media Find out more LoadingResources ZITHROMAX® Mode of Action Watch now LoadingReferences:Pfizer Malaysia ZITHROMAX Prescribing Information. Available at: https://labeling.pfizer.com/ShowLabeling.aspx?id=17705. Accessed January 2024.Kaplan A, et al. Can Fam Physician. 2014;60:227–34.DeBoer DL, et al. [Updated August 2022]. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2023 Jan. Available at: https://www.ncbi.nlm.nih.gov/books/NBK547701/. Accessed June 2023.Donde S, et al. Indian J Otolaryngol Head Neck Surg. 2014;66(Suppl. 1):S225–S230.Felstead SJ, et al. J Int Med Res. 1991;19:363–72.
Upper Respiratory Tract Infections  ZITHROMAX® Safety Information Find out more Loading
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