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ZITHROMAX® (azithromycin dihydrate)

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ZITHROMAX® Quick Finder

Dosage and Administration

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2 DOSAGE AND ADMINISTRATION

2.1 Adult Patients

[see Indications and Usage (1.1) and Clinical Pharmacology (12.3)]

Infection* Recommended Dose/Duration of Therapy
*
DUE TO THE INDICATED ORGANISMS [see Indications and Usage (1.1)]
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

ZITHROMAX tablets can be taken with or without food.

2.2 Pediatric Patients1

Infection* Recommended Dose/Duration of Therapy
1 see dosing tables below for maximum doses evaluated by indication
*
DUE TO THE INDICATED ORGANISMS [see Indications and Usage (1.2)]
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.

ZITHROMAX for oral suspension can be taken with or without food.

PEDIATRIC DOSAGE GUIDELINES FOR OTITIS MEDIA, ACUTE BACTERIAL SINUSITIS, AND COMMUNITY-ACQUIRED PNEUMONIA
(Age 6 months and above, [see Use in Specific Populations (8.4)])
Based on Body Weight

OTITIS MEDIA AND COMMUNITY-ACQUIRED PNEUMONIA: (5-Day Regimen)*
Dosing Calculated on 10 mg/kg/day Day 1 and 5 mg/kg/day Days 2 to 5.
Weight 100 mg/5 mL 200 mg/5 mL Total mL per Treatment Course Total mg per Treatment Course
Kg Day 1 Days 2–5 Day 1 Days 2–5
*
Effectiveness of the 3-day or 1-day regimen in pediatric patients with community-acquired pneumonia has not been established.
5 2.5 mL; (½ tsp) 1.25 mL;(¼ tsp) 7.5 mL 150 mg
10 5 mL; (1tsp) 2.5 mL; (½ tsp) 15 mL 300 mg
20 5 mL; (1 tsp) 2.5 mL; (½ tsp) 15 mL 600 mg
30 7.5 mL; (1½ tsp) 3.75 mL; (¾ tsp) 22.5 mL 900 mg
40 10 mL; (2 tsp) 5 mL; (1 tsp) 30 mL 1200 mg
50 and above 12.5 mL; (2½ tsp) 6.25 mL; (1¼ tsp) 37.5 mL 1500 mg
OTITIS MEDIA AND ACUTE BACTERIAL SINUSITIS: (3-Day Regimen)*
Dosing Calculated on 10 mg/kg/day.
Weight 100 mg/5 mL 200 mg/5 mL Total mL per Treatment Course Total mg per Treatment Course
Kg Days 1–3 Days 1–3
*
Effectiveness of the 5-day or 1-day regimen in pediatric patients with acute bacterial sinusitis has not been established.
5 2.5 mL; (1/2 tsp) 7.5 mL 150 mg
10 5 mL; (1 tsp) 15 mL 300 mg
20 5 mL (1 tsp) 15 mL 600 mg
30 7.5 mL (1½ tsp) 22.5 mL 900 mg
40 10 mL (2 tsp) 30 mL 1200 mg
50 and above 12.5 mL (2 ½ tsp) 37.5 mL 1500 mg
OTITIS MEDIA: (1-Day Regimen)
Dosing Calculated on 30 mg/kg as a single dose.
Weight 200 mg/5 mL Total mL per Treatment Course Total mg per Treatment Course
Kg 1-Day Regimen
5 3.75 mL;(3/4 tsp) 3.75 mL 150 mg
10 7.5 mL;(1½ tsp) 7.5 mL 300 mg
20 15 mL;(3 tsp) 15 mL 600 mg
30 22.5 mL;(4½ tsp) 22.5 mL 900 mg
40 30 mL;(6 tsp) 30 mL 1200 mg
50 and above 37.5 mL;(7½ tsp) 37.5 mL 1500 mg

The safety of re-dosing azithromycin in pediatric patients who vomit after receiving 30 mg/kg as a single dose has not been established. In clinical studies involving 487 patients with acute otitis media given a single 30 mg/kg dose of azithromycin, 8 patients who vomited within 30 minutes of dosing were re-dosed at the same total dose.

Pharyngitis/Tonsillitis: The recommended dose of ZITHROMAX for children with pharyngitis/tonsillitis is 12 mg/kg once daily for 5 days. (See chart below.)

PEDIATRIC DOSAGE GUIDELINES FOR PHARYNGITIS/TONSILLITIS
(Age 2 years and above, [see Use in Specific Populations (8.4)])
Based on Body Weight

PHARYNGITIS/TONSILLITIS: (5-Day Regimen)
Dosing Calculated on 12 mg/kg/day for 5 days.
Weight 200 mg/5 mL Total mL per Treatment Course Total mg per Treatment Course
Kg Day 1–5
8 2.5 mL; (½ tsp) 12.5 mL 500 mg
17 5 mL; (1 tsp) 25 mL 1000 mg
25 7.5 mL; (1½ tsp) 37.5 mL 1500 mg
33 10 mL; (2 tsp) 50 mL 2000 mg
40 12.5 mL; (2½ tsp) 62.5 mL 2500 mg

Constituting instructions for ZITHROMAX Oral Suspension 300, 600, 900, 1200 mg bottles. The table below indicates the volume of water to be used for constitution:

Amount of water to be added Total volume after constitution
(azithromycin content)
Azithromycin concentration after constitution
9 mL (300 mg) 15 mL (300 mg) 100 mg/5 mL
9 mL (600 mg) 15 mL (600 mg) 200 mg/5 mL
12 mL (900 mg) 22.5 mL (900 mg) 200 mg/5 mL
15 mL (1200 mg) 30 mL (1200 mg) 200 mg/5 mL

Shake well before each use. Oversized bottle provides shake space. Keep tightly closed.

After mixing, store suspension at 5° to 30°C (41° to 86°F) and use within 10 days. Discard after full dosing is completed.

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