What is the recommended dose of azithromycin (Zithromax) for pediatric patients based on weight?

From the Guidelines

The recommended dose of azithromycin for pediatric patients is 10 mg/kg on day 1, followed by 5 mg/kg once daily on days 2-5. This dosing regimen is based on the most recent and highest quality study available, which prioritizes morbidity, mortality, and quality of life as the outcome 1.

Key Considerations

• Weight-based dosing is crucial to ensure appropriate drug levels and minimize side effects.
• For children weighing less than 15 kg, azithromycin oral suspension is preferred over tablets for accurate dosing.
• The medication should be given at least 1 hour before or 2 hours after meals, as food can reduce absorption.
• Common side effects include diarrhea, nausea, and abdominal pain.

Dosing Regimen

• The dosing regimen of 10 mg/kg on day 1, followed by 5 mg/kg once daily on days 2-5, is recommended for most infections, including community-acquired pneumonia and atypical pneumonia 1.
• This regimen is supported by clinical practice guidelines from reputable organizations, including the Pediatric Infectious Diseases Society and the Infectious Diseases Society of America 1.

Important Notes

• Azithromycin works by inhibiting bacterial protein synthesis, and its long half-life allows for once-daily dosing and shorter treatment courses compared to other antibiotics.
• The maximum dose on day 1 is 500 mg, followed by 250 mg on days 2-5, as recommended by the most recent study 1.

From the FDA Drug Label

The recommended dose of azithromycin for oral suspension for the treatment of pediatric patients with acute otitis media is 30 mg/kg given as a single dose or 10 mg/kg once daily for 3 days or 10 mg/kg as a single dose on the first day followed by 5 mg/kg/day on Days 2 through 5.

Acute Bacterial Sinusitis The recommended dose of azithromycin for oral suspension for the treatment of pediatric patients with acute bacterial sinusitis is 10 mg/kg once daily for 3 days.

Community-Acquired Pneumonia The recommended dose of azithromycin for oral suspension for the treatment of pediatric patients with community-acquired pneumonia is 10 mg/kg as a single dose on the first day followed by 5 mg/kg on Days 2 through 5.

PEDIATRIC DOSAGE GUIDELINES FOR OTITIS MEDIA, ACUTE BACTERIAL SINUSITIS AND COMMUNITY-ACQUIRED PNEUMONIA (Age 6 months and above, see PRECAUTIONS—Pediatric Use.)

Pharyngitis/Tonsillitis The recommended dose of azithromycin for children with pharyngitis/tonsillitis is 12 mg/kg once daily for 5 days.

The recommended dose of azithromycin for pediatric patients based on weight is:

• 30 mg/kg as a single dose for acute otitis media
• 10 mg/kg once daily for 3 days for acute bacterial sinusitis
• 10 mg/kg as a single dose on the first day followed by 5 mg/kg on Days 2 through 5 for community-acquired pneumonia
• 12 mg/kg once daily for 5 days for pharyngitis/tonsillitis 2

From the Research

Pediatric Weight Dosing for Azithromycin

The recommended dose of azithromycin for pediatric patients is based on their weight.

• For children, azithromycin is usually given as either a 3-day course of 10 mg/kg/day or a 5-day course with 10 mg/kg on the first day, followed by 5 mg/kg/day for a further 4 days 3.
• In some cases, a dosage of 12 mg/kg/day for 5 days may be necessary, such as in the treatment of streptococcal pharyngitis or tonsillitis 3.
• Other dosing regimens, including single dose 30 mg/kg and 3-day 20-mg/kg/day regimens, have also been found to be well-tolerated, although they may be associated with more adverse effects 4.

Pharmacokinetics in Pediatric Patients

• The pharmacokinetics of azithromycin in pediatric patients have been studied after oral administration of multiple doses of suspension 5.
• The mean maximum concentration of drug in serum, time to maximum concentration of drug in serum, and area under the curve (0 to 24 h) were found to be 383 +/- 142 ng/ml, 2.4 +/- 1.1 h, and 3,109 +/- 1,033 ng.h/ml, respectively 5.
• Concentrations in serum at 0 h (predose) and at 24,48, and 72 h after the final dose were found to be 67 +/- 31,64 +/- 24,41 +/- 17, and 29 +/- 14 ng/ml, respectively 5.

Efficacy and Safety

• Azithromycin has been found to be effective in the treatment of various pediatric infections, including otitis media, streptococcal pharyngitis, and community-acquired pneumonia 3, 6, 7.
• The drug is generally well-tolerated, with most adverse events being mild to moderate in severity and gastrointestinal in nature 3, 4.
• The efficacy rate of azithromycin in the treatment of pediatric infectious diseases has been found to be around 87.5-93.9% 6, 7.