Azithromycin
Azithromycin Prescribing Information
Azithromycin tablets are 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
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 cervicitis | One single 1 gram dose. |
| Gonococcal urethritis and cervicitis | One single 2 gram dose. |
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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 | 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, 500 mg tablets are supplied as pink modified capsule shaped, film-coated tablet debossed with “591” on one side and “L” on the other side containing azithromycin dihydrate equivalent to 500 mg of azithromycin, USP. These are packaged in bottles of 30 tablets 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)
• Geriatric use: Elderly patients may be more susceptible to development of torsades de pointes arrhythmias. (8.5)
· Patients with known hypersensitivity to azithromycin, erythromycin, any macrolide or ketolide drug. (4.1)
· Patients with a history of cholestatic jaundice/hepatic dysfunction associated with prior use of azithromycin. (4.2)
· Serious (including fatal) allergic and skin reactions: Discontinue azithromycin if reaction occurs. (5.1)
· Hepatotoxicity: Severe, and sometimes fatal, hepatotoxicity has been reported, Discontinue azithromycin immediately if signs and symptoms of hepatitis occur. (5.2)
• Infantile Hypertrophic Pyloric Stenosis (IHPS): Following the use of azithromycin in neonates (treatment up to 42 days of life), IHPS has been reported. Direct parents and caregivers to contact their physician if vomiting or irritability with feeding occurs. (5.3)
· Prolongation of QT interval and cases of torsades de pointes have been reported. This risk which can be fatal should be considered in patients with certain cardiovascular disorders including known QT prolongation or history torsades de pointes, those with proarrhythmic conditions, and with other drugs that prolong the QT interval. (5.4)
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· Azithromycin may exacerbate muscle weakness in persons with myasthenia gravis. (5.6)