Fazimax Azithromycin Dihydrate USP 250 mg Capsules

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) ] Azithromycin is 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 ce …

The following clinically significant adverse reactions are described elsewhere in labeling: • Hypersensitivity [see ] • Hepatotoxicity [see ] • Infantile Hypertrophic Pyloric Stenosis (IHPS) [see ] • QT Prolongation [see Warnings and Precautions (5.4) ] • Cardiovascular Death [see ] • Clostridioides difficile- Associated Diarrhea (CDAD) [see ] • Exacerbation of Myasthenia Gravis [see ] Most common adverse reactions are diarrhea (5 to 14%), nausea (3 to 18%), abdominal pain (3 to 7%), or vomiting (2 to 7%). ( ) To report SUSPECTED ADVERSE REACTIONS, contact Aurobindo Pharma USA, Inc. at 1-866-850-2876 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. …

• 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. () 4.1 Hypersensitivity Azithromycin tablets are contraindicated in patients with known hypersensitivity to azithromycin, erythromycin, any macrolide or ketolide drug. …

• 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. …

8.1 Pregnancy Risk Summary Available data from published literature and postmarketing experience over several decades with azithromycin use in pregnant women have not identified any drug-associated risks for major birth defects, miscarriage, or adverse maternal or fetal outcomes (see Data) . …