Azithromycin
Azithromycin Prescribing Information
Warnings and Precautions, Cardiovascular Death (
If CDAD is suspected or confirmed, ongoing antibiotic use not directed against
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.
- Adult Patients
Infection Recommended Dose/Duration of Therapy Community-acquired pneumonia (mild severity)
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 bronchitis (mild to moderate) 500 mg as a single dose on Day 1, followed by 250 mg once daily on Days 2 through 5 or 500 mg once daily for 3 days. Acute bacterial sinusitis 500 mg once daily for 3 days. Genital ulcer disease (chancroid)
Non-gonococcal urethritis and cervicitisOne single 1 gram dose. Gonococcal urethritis and cervicitis One single 2 gram dose. - Pediatric Patients
Infection Recommended Dose/Duration of Therapy Acute otitis media (6 months of age and older) 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 (6 months of age and older) 10 mg/kg once daily for 3 days. Community-acquired pneumonia (6 months of age and older) 10 mg/kg as a single dose on Day 1 followed by 5 mg/kg once daily on Days 2 through 5. Pharyngitis/tonsillitis (2 years of age and older) 12 mg/kg once daily for 5 days.
| InfectionDUE 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 tablets can be taken with or without food.
| InfectionDUE TO THE INDICATED ORGANISMS [see Indications and Usage (1.2)] | 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. |
Azithromycin for oral suspension can be taken with or without food.
(Age 6 months and above,
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 to 5 | Day 1 | Days 2 to 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 to 3 | Days 1 to 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.
(Age 2 years and above,
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 |
- Adult Patients ()
2.1 Adult Patients[see Indications and Usage (1.1)and Clinical Pharmacology (12.3)]InfectionDUE 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 5Acute 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 tablets can be taken with or without food.
Infection Recommended Dose/Duration of Therapy Community-acquired pneumonia (mild severity)
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 bronchitis (mild to moderate) 500 mg as a single dose on Day 1, followed by 250 mg once daily on Days 2 through 5 or 500 mg once daily for 3 days. Acute bacterial sinusitis 500 mg once daily for 3 days. Genital ulcer disease (chancroid)
Non-gonococcal urethritis and cervicitisOne single 1 gram dose. Gonococcal urethritis and cervicitis One single 2 gram dose. - Pediatric Patients ()
2.2 Pediatric Patients1InfectionDUE TO THE INDICATED ORGANISMS
[see
Indications and Usage (1.2)]Recommended Dose/Duration of Therapy 1 see dosing tables below for maximum doses evaluated by indicationAcute 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 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 WeightOTITIS MEDIA AND COMMUNITY-ACQUIRED PNEUMONIA: (5-Day Regimen)Effectiveness of the 3-day or 1-day regimen in pediatric patients with community-acquired pneumonia has not been established. 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 to 5 Day 1 Days 2 to 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 OTITIS MEDIA AND ACUTE BACTERIAL SINUSITIS: (3-Day Regimen)Effectiveness of the 5-day or 1-day regimen in pediatric patients with acute bacterial sinusitis has not been established. 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 to 3 Days 1 to 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 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.
The recommended dose of azithromycin for children with pharyngitis/tonsillitis is 12 mg/kg once daily for 5 days. (See chart below.)Pharyngitis/Tonsillitis:PEDIATRIC DOSAGE GUIDELINES FOR PHARYNGITIS/TONSILLITIS
(Age 2 years and above,[see Use in Specific Populations (8.4)])
Based on Body WeightPHARYNGITIS/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 Infection Recommended Dose/Duration of Therapy Acute otitis media (6 months of age and older) 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 (6 months of age and older) 10 mg/kg once daily for 3 days. Community-acquired pneumonia (6 months of age and older) 10 mg/kg as a single dose on Day 1 followed by 5 mg/kg once daily on Days 2 through 5. Pharyngitis/tonsillitis (2 years of age and older) 12 mg/kg once daily for 5 days.
Azithromycin tablets USP, 250 mg are supplied as white or almost white, capsular shaped, film-coated tablets containing azithromycin dihydrate equivalent to 250 mg of azithromycin. Azithromycin tablets USP, 250 mg are debossed with “L70” on one side and blank on the other. These are packaged in bottles and blister cards of 6 tablets.
Azithromycin tablets USP, 500 mg are supplied as white or almost white, capsular shaped, film-coated tablets containing azithromycin dihydrate equivalent to 500 mg of azithromycin. Azithromycin tablets USP, 500 mg are debossed with “L95” on one side and blank on the other. These are packaged in bottles and blister cards of 3 tablets.
- Pediatric use: Safety and effectiveness in the treatment of patients under 6 months of age have not been established. ()
8.4 Pediatric Use[see Clinical Pharmacology (12.3), Indications and Usage (1.2),andDosage 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 azithromycin 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. - Geriatric use: Elderly patients may be more susceptible to development of torsades de pointes arrhythmias. ()
8.5 Geriatric UseIn multiple-dose clinical trials of oral azithromycin, 9% of patients were at least 65 years of age (458/4949) and 3% of patients (144/4949) were at least 75 years of age. No overall differences in safety or effectiveness were observed between these subjects and younger subjects, and other reported clinical experience has not identified differences in response between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out.
Elderly patients may be more susceptible to development of torsades de pointes arrhythmias than younger patients.
[see Warnings and Precautions (5.4)]
- Patients with known hypersensitivity to azithromycin, erythromycin, any macrolide or ketolide drug. ()
4.1 HypersensitivityAzithromycin is contraindicated in patients with known hypersensitivity to azithromycin, erythromycin, any macrolide or ketolide drug.
- Patients with a history of cholestatic jaundice/hepatic dysfunction associated with prior use of azithromycin. ()
4.2 Hepatic DysfunctionAzithromycin is contraindicated in patients with a history of cholestatic jaundice/hepatic dysfunction associated with prior use of azithromycin.