Is it appropriate to give a toddler azithromycin for an uncomplicated upper respiratory tract infection?

1.

Elsevier ClinicalKey Drug Class Overview

Content last updated: January 1, 2012.

Both azithromycin and erythromycin are FDA-approved for use in neonates and older, while clarithromycin is established in pediatric patients as young as 6 months. However, the safety and efficacy of fidaxomicin has not been established in pediatric patients.

2.

Schleiss, Mark R. (2025). In Nelson Textbook of Pediatrics (pp. 1671). DOI: 10.1016/B978-0-323-88305-4.00225-X

The macrolide antibiotics most often used in pediatric practice includeerythromycin,clarithromycin, andazithromycin. This class of antimicrobials exerts its antibiotic effect through binding to the 50S subunit of the bacterial ribosome, producing a block in elongation of bacterial polypeptides. Clarithromycin is metabolized to 14-hydroxy clarithromycin, and this active metabolite also has potent antimicrobial activity. The spectrum of antibiotic activity includes many gram-positive bacteria. Unfortunately, resistance to these agents amongS. aureusand group A streptococcus is fairly widespread, limiting the usefulness of macrolides for many skin and soft tissue infections and for streptococcal pharyngitis. Azithromycin and clarithromycin have demonstrated efficacy for otitis media. All macrolide members have an important role in the management of pediatric respiratory infections, including atypical pneumonia caused byM. pneumoniae, Chlamydophila pneumoniae,andLegionella pneumophila,as well as infections caused byBordetella pertussis. Telithromycin, a ketolide antibiotic derived from erythromycin, was initially FDA-approved for the treatment in adults of mild to moderate community-acquired pneumonia, acute exacerbations of chronic bronchitis, and acute sinusitis, having good activity against the agents causing these infections (S. pneumoniae,M. pneumoniae, C. pneumoniae,andL. pneumophilafor community-acquired pneumonia;M. catarrhalisandH. influenzaefor sinusitis). Reports of liver failure and myasthenia gravis from telithromycin prompted the withdrawal of the drug from the market.Solithromycinis a related next-generation oral and IV fluoroketolide in phase 3 clinical development for the treatment of community-acquired pneumonia. Drug interactions are common with erythromycin and to a lesser extent with clarithromycin.

3.

Elsevier ClinicalKey Drug Monograph

Content last updated: May 3, 2024.

Description Zmax Pediatric is a semisynthetic antibiotic belonging to the macrolide subgroup of azalides and is similar in structure to erythromycin. Zmax Pediatric offers the advantage that it can be dosed once daily and produces less GI intolerance than does erythromycin. Zmax Pediatric has a wider spectrum of activity than erythromycin against M. avium complex (MAC), H. influenzae , nontuberculous mycobacteria, and C. trachomatis. Another apparent advantage over erythromycin is that zmax pediatric reaches higher intracellular concentrations, thus increasing its efficacy and duration of action. These advantages are demonstrated in studies that show that single doses of zmax pediatric are effective for the treatment of acute otitis media and sexually transmitted diseases (STDs) due to chlamydia and gonorrhea. Zmax Pediatric is better tolerated and offers shorter treatment durations compared with clarithromycin. Zmax Pediatric is used for the treatment of a variety of respiratory infections, including otitis media, pharyngitis/tonsillitis, pertussis, community-acquired pneumonia, and sinusitis. However, macrolides are not recommended for empiric monotherapy of acute bacterial sinusitis due to high rates of S. pneumoniae resistance (approximately 30%). Zmax Pediatric is also used for the treatment of STDs due to chlamydia and gonorrhea, and for the prophylaxis and treatment of M. avium complex (MAC) disease. An ophthalmic preparation is used for the treatment of bacterial conjunctivitis. Long-term zmax pediatric is used off-label to improve lung function and decrease pulmonary exacerbation in cystic fibrosis patients 6 years and older who have sputum cultures persistently positive for P. aeruginosa.

Indications And Dosage Oral dosage (immediate-release) Adults: 500 mg PO once daily for 5 days as an alternative in patients allergic to penicillin. The FDA-approved dose is 500 mg PO once daily for 1 day, followed by 250 mg PO once daily for 4 days. Children and Adolescents 2 to 17 years: 12 mg/kg/dose (Max: 500 mg/dose) PO once daily for 5 days as an alternative in patients allergic to penicillin. Infants † (off-label indication) and Children 1 year† (off-label indication): 12 mg/kg/dose PO once daily for 5 days as an alternative in patients allergic to penicillin.

Dosage And Administration Pharyngitis/tonsillitis (2 years of age and older) 12 mg/kg once daily for 5 days. 2.1 Adult Patients [see Indications and Usage (1.1) and Clinical Pharmacology (12.3) ] Infection DUE TO THE INDICATED ORGANISMS [see Indications and Usage (1.1) ] Recommended Dose/Duration of Therapy Community-acquired pneumonia Pharyngitis/tonsillitis (second-line therapy) Skin/skin structure (uncomplicated) 500 mg as a single dose on Day 1, followed by 250 mg once daily on Days 2 through 5 Acute bacterial exacerbations of chronic obstructive pulmonary disease 500 mg once daily for 3 days OR 500 mg as a single dose on Day 1, followed by 250 mg once daily on Days 2 through 5 Acute bacterial sinusitis 500 mg once daily for 3 days Genital ulcer disease (chancroid) One single 1 gram dose Non-gonococcal urethritis and cervicitis One single 1 gram dose Gonococcal urethritis and cervicitis One single 2 gram dose Azithromycin (azithromycin monohydrate) tablets can be taken with or without food. 2.2 Pediatric Patients see dosing tables below for maximum doses evaluated by indication Infection DUE TO THE INDICATED ORGANISMS [see Indications and Usage (1.2) ] Recommended Dose/Duration of Therapy Acute otitis media 30 mg/kg as a single dose or 10 mg/kg once daily for 3 days or 10 mg/kg as a single dose on Day 1 followed by 5 mg/kg/day on Days 2 through 5. Acute bacterial sinusitis 10 mg/kg once daily for 3 days. Community-acquired pneumonia 10 mg/kg as a single dose on Day 1 followed by 5 mg/kg once daily on Days 2 through 5. Pharyngitis/tonsillitis 12 mg/kg once daily for 5 days. Azithromycin (azithromycin monohydrate) for oral suspension can be taken with or without food.

4.

Elsevier ClinicalKey Clinical Overview

Treatment Azithromycin Oral suspension; Children and Adolescents 2 to 17 years: 12 mg/kg/dose (Max: 500 mg/dose) PO once daily for 5 days. Azithromycin Oral tablet; Adults: 500 mg PO once daily for 5 days. Clarithromycin NOTE: Use with caution in patients with heart disease, as a potential increased risk of heart problems or death can occur years later. Clarithromycin Oral suspension; Infants 1 to 5 months†: 7.5 mg/kg/dose PO every 12 hours for 10 days. Clarithromycin Oral suspension; Infants, Children, and Adolescents 6 months to 17 years: 7.5 mg/kg/dose (Max: 250 mg/dose) PO every 12 hours for 10 days. Clarithromycin Oral tablet; Adults: 250 mg PO every 12 hours for 10 days. First-generation cephalosporins Owing to allergy cross-reactivity potential, do not use in patients with an anaphylactic reaction history to penicillin unless previous treatment given without adverse effects. Cephalexin Cephalexin Monohydrate Oral suspension; Infants†, Children, and Adolescents: 20 mg/kg/dose (Max: 500 mg/dose) PO every 12 hours for 10 days. Cephalexin Monohydrate Oral capsule; Adults: 500 mg PO every 12 hours for 10 days. Cefadroxil Cefadroxil Oral suspension; Infants, Children, and Adolescents: 30 mg/kg/dose (Max: 1 g/dose) PO once daily for 10 days. Cefadroxil Oral capsule; Adults: 1 g PO once daily for 10 days. Clindamycin

5.

Food and Drug Administration (DailyMed).

Publish date: September 5, 2023.

Pediatric Use 8.4 Pediatric Use [see Clinical Pharmacology (12.3), Indications and Usage (1.2), and Dosage and Administration (2.2) ] Safety and effectiveness in the treatment of pediatric patients with acute otitis media, acute bacterial sinusitis and community-acquired pneumonia under 6 months of age have not been established. Use of Zithromax (azithromycin dihydrate) for the treatment of acute bacterial sinusitis and community-acquired pneumonia in pediatric patients (6 months of age or greater) is supported by adequate and well-controlled trials in adults. Pharyngitis/Tonsillitis: Safety and effectiveness in the treatment of pediatric patients with pharyngitis/tonsillitis under 2 years of age have not been established.