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Drug Information: Azithromycin
Indications and Usage
Azithromycin tablets are a macrolide antibacterial drug indicated for mild to moderate infections caused by designated, susceptible bacteria:
- Acute bacterial exacerbations of chronic bronchitis in adults
- Acute bacterial sinusitis in adults
- Uncomplicated skin and skin structure infections in adults
- Urethritis and cervicitis in adults
- Genital ulcer disease in men
- Acute otitis media in pediatric patients
- Community-acquired pneumonia in adults and pediatric patients
- Pharyngitis/tonsillitis in adults and pediatric patients
Dosing and Administration
Adults and Children over 10 years of age: Usual dose is one 100 mg, 150 mg or 200 mg capsule three times a day as needed for cough. If necessary to control cough, up to 600 mg daily in three divided doses may be given. Benzonatate should be swallowed whole. Benzonatate capsules are not to be broken, chewed, dissolved, cut or crushed.
Dosage Forms and Strengths
- 250 mg tablet
- 500 mg tablet
- 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.
Warnings and Precautions
- Serious (including fatal) allergic and skin reactions: Discontinue azithromycin if reaction occurs
- Hepatotoxicity: Severe, and sometimes fatal, hepatotoxicity has been reported. Discontinue azithromycin immediately if signs and symptoms of hepatitis occur
- 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.
- 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 of torsades de pointes, those with proarrhythmic conditions, and with other drugs that prolong the QT interval
- Clostridium difficile-Associated Diarrhea: Evaluate patients if diarrhea occurs.
- Azithromycin may exacerbate muscle weakness in persons with myasthenia gravis.
Most common adverse reactions are diarrhea (5 to 14%), nausea (3 to 18%), abdominal pain (3 to 7%), or vomiting (2 to 7%)
Nelfinavir: Close monitoring for known adverse reactions of azithromycin, such as liver enzyme abnormalities and hearing impairment, is warranted. ( 7.1)
Warfarin: Use with azithromycin may increase coagulation times; monitor prothrombin time.