ZITHROMAX

In patients hospitalized with community-acquired pneumonia receiving single daily one-hour intravenous infusions for 2 to 5 days of 500 mg azithromycin at a concentration of 2 mg/mL, the mean C max ± S.D. achieved was 3.63 ± 1.60 mcg/mL, while the 24-hour trough level was 0.20 ± 0.15 mcg/mL, and the AUC 24 was 9.60 ± 4.80 mcg∙hr/mL. The mean C max , 24-hour trough and AUC 24 values were 1.14 ± 0.14 mcg/mL, 0.18 ± 0.02 mcg/mL, and 8.03 ±0.86 mcg∙hr/mL, respectively, in normal volunteers receiving...

14.1 Community-Acquired Pneumonia In a controlled trial of community-acquired pneumonia performed in the U.S., azithromycin (500 mg as a single daily dose by the intravenous route for 2 to 5 days, followed by 500 mg/day by the oral route to complete 7 to 10 days therapy) was compared to cefuroxime (2,250 mg/day in three divided doses by the intravenous route for 2 to 5 days followed by 1,000 mg/day in two divided doses by the oral route to complete 7 to 10 days therapy), with or without erythromycin. For the 291 patients who were evaluable for clinical efficacy, the clinical outcome rates, i.e...

The following clinically significant adverse reactions are described elsewhere in labeling:

• Hypersensitivity [see Warnings and Precautions (5.1) ]
• Hepatotoxicity [see Warnings and Precautions (5.2) ]
• Infantile Hypertrophic Pyloric Stenosis (IHPS) [see Warnings and Precautions (5.3) ]
• QT Prolongation [see Warnings and Precautions (5.4) ]
• Cardiovascular Death [see Warnings and Precautions (5.5) ]
• Clostridioides difficile- Associated Diarrhea (CDAD) [see Warnings and Precautions (5.6) ]...

• Patients with known hypersensitivity to azithromycin, erythromycin, any macrolide, or ketolide antibacterial drug. ( 4.1 )
• Patients with a history of cholestatic jaundice/hepatic dysfunction associated with prior use of azithromycin. ( 4.2 ) 4.1 Hypersensitivity ZITHROMAX is contraindicated in patients with known hypersensitivity to azithromycin, erythromycin, any macrolide or ketolide drugs. ...

• Serious (including fatal) allergic and skin reactions. Discontinue ZITHROMAX and initiate appropriate therapy if reaction occurs. ( 5.1 )
• Hepatotoxicity: Severe and sometimes fatal, hepatoxicity has been reported. Discontinue ZITHROMAX 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 th...

7 DRUG INTERACTIONS

• 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. ( 7.2 ) 7.1 Nelfinavir Co-administration of nelfinavir at steady-state with a single oral dose of azithromycin resulted in increase...