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 |
|---|---|
| |
| 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 | |
| |
| 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
| 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 | ||
| ||||||
| 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 | ||
| 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 | ||
| ||||
| 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 | |
| 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
| 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.