Sorry, you need to enable JavaScript to visit this website.

ZITHROMAX® IV (azithromycin dihydrate) Highlights

HIGHLIGHTS OF PRESCRIBING INFORMATION

These highlights do not include all the information needed to use ZITHROMAX safely and effectively. See full prescribing information for ZITHROMAX.

ZITHROMAX® (azithromycin) for injection, for intravenous use
Initial U.S. Approval: 1991

INDICATIONS AND USAGE

ZITHROMAX is a macrolide antibacterial drug indicated for mild to moderate infections caused by designated, susceptible bacteria:

  • Community-acquired pneumonia in adults (1.1)
  • Pelvic inflammatory disease (1.2)

To reduce the development of drug-resistant bacteria and maintain the effectiveness of ZITHROMAX and other antibacterial drugs, ZITHROMAX should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. (1.3)

DOSAGE AND ADMINISTRATION

  • Community-acquired pneumonia: 500 mg as a single daily dose by the intravenous route for at least two days. (2.1)
  • Pelvic inflammatory disease in adults: 500 mg as a single daily dose by the intravenous route for one or two days. (2.2)

DOSAGE FORMS AND STRENGTHS

  • ZITHROMAX (azithromycin) for injection is supplied in lyophilized form in a 10 mL vial equivalent to 500 mg of azithromycin for intravenous administration. (3)

CONTRAINDICATIONS

  • 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)

WARNINGS AND PRECAUTIONS

  • Serious (including fatal) allergic reactions 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 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)
  • Clostridium difficile-Associated Diarrhea: Evaluate patients if diarrhea occurs. (5.5)
  • ZITHROMAX may exacerbate muscle weakness in persons with myasthenia gravis. (5.6)

ADVERSE REACTIONS

Most common adverse reactions are nausea (4%), diarrhea (4%), abdominal pain (3%), or vomiting (1%). (6)


To report SUSPECTED ADVERSE REACTIONS, contact Pfizer Inc. at 1-800-438-1985 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

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)

USE IN SPECIFIC POPULATIONS

  • Pediatric use: Safety and effectiveness in the treatment of patients under 16 years 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)

See 17 for PATIENT COUNSELING INFORMATION.

Revised: 4/2019

What's New

No Current Announcements.

Contact Pfizer Medical

Report an Adverse Event
1-800-438-1985

Search

Please enter your search term(s) for ZITHROMAX® IV