Source: FDA, National Drug Code (US) Revision Year: 2020
ZITHROMAX (azithromycin) is a macrolide antibacterial drug indicated for the treatment of patients with mild to moderate infections caused by susceptible strains of the designated microorganisms in the specific conditions listed below. Recommended dosages and durations of therapy in adult and pediatric patient populations vary in these indications [see Dosage and Administration (2)].
[see Use in Specific Populations (8.4) and Clinical Studies (14.2)]
Azithromycin should not be used in patients with pneumonia who are judged to be inappropriate for oral therapy because of moderate to severe illness or risk factors such as any of the following:
To reduce the development of drug-resistant bacteria and maintain the effectiveness of ZITHROMAX (azithromycin) and other antibacterial drugs, ZITHROMAX (azithromycin) should be used only to treat infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.
[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 |
* DUE TO THE INDICATED ORGANISMS [see Indications and Usage (1.1)]
ZITHROMAX tablets can be taken with or without food.
| Infection* | 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. |
1 see dosing tables below for maximum doses evaluated by indication
* DUE TO THE INDICATED ORGANISMS [see Indications and Usage (1.2)]
ZITHROMAX for oral suspension can be taken with or without food.
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 | ||
| 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 | ||
* Effectiveness of the 3-day or 1-day regimen in pediatric patients with community-acquired pneumonia has not been established.
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 | ||
| 5 | 2.5 mL; (½ 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 | |
* Effectiveness of the 3-day or 1-day regimen in pediatric patients with community-acquired pneumonia has not been established.
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;(¾ 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.)
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.
Adverse reactions experienced at higher than recommended doses were similar to those seen at normal doses particularly nausea, diarrhea, and vomiting. In the event of overdosage, general symptomatic and supportive measures are indicated as required.
Store dry powder below 30°C (86°F). Store constituted suspension between 5° to 30°C (41° to 86°F) and discard when full dosing is completed.
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