azithromycin for Injection, USP - ADD-VANTAGE Highlights

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HIGHLIGHTS OF PRESCRIBING INFORMATION

These highlights do not include all the information needed to use Azithromycin safely and effectively. See full prescribing information for Azithromycin.
AZITHROMYCIN for injection, for intravenous use
Initial U.S. Approval: 2009

RECENT MAJOR CHANGES

Warnings and Precautions, Cardiovascular Death (5.5)11/2021

INDICATIONS AND USAGE

Azithromycin 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 azithromycin and other antibacterial drugs, azithromycin 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

Azithromycin for Injection is supplied as white to off-white lyophilized powder in a single-dose ADD-Vantage 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 and skin reactions. Discontinue azithromycin and initiate appropriate therapy if reaction occurs. (5.1)
  • Hepatotoxicity: Severe and sometimes fatal, hepatoxicity 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)
  • Cardiovascular Death: Some observational studies have shown an approximately two-fold increased short-term potential risk of acute cardiovascular death in adults exposed to azithromycin relative to other antibacterial drugs, including amoxicillin. Consider balancing this potential risk with treatment benefits when prescribing azithromycin. (5.5)
  • Clostridioides difficile-Associated Diarrhea: Evaluate patients if diarrhea occurs. (5.6)
  • Azithromycin may exacerbate muscle weakness in persons with myasthenia gravis. (5.7)

ADVERSE REACTIONS

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

To report SUSPECTED ADVERSE REACTIONS, contact Hospira, Inc. at 1-800-441-4100, 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: 2/2022

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Highlights

HIGHLIGHTS OF PRESCRIBING INFORMATION

These highlights do not include all the information needed to use Azithromycin safely and effectively. See full prescribing information for Azithromycin.
AZITHROMYCIN for injection, for intravenous use
Initial U.S. Approval: 2009

RECENT MAJOR CHANGES

Warnings and Precautions, Cardiovascular Death (5.5)11/2021

INDICATIONS AND USAGE

Azithromycin 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 azithromycin and other antibacterial drugs, azithromycin 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

Azithromycin for Injection is supplied as white to off-white lyophilized powder in a single-dose ADD-Vantage 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 and skin reactions. Discontinue azithromycin and initiate appropriate therapy if reaction occurs. (5.1)
  • Hepatotoxicity: Severe and sometimes fatal, hepatoxicity 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)
  • Cardiovascular Death: Some observational studies have shown an approximately two-fold increased short-term potential risk of acute cardiovascular death in adults exposed to azithromycin relative to other antibacterial drugs, including amoxicillin. Consider balancing this potential risk with treatment benefits when prescribing azithromycin. (5.5)
  • Clostridioides difficile-Associated Diarrhea: Evaluate patients if diarrhea occurs. (5.6)
  • Azithromycin may exacerbate muscle weakness in persons with myasthenia gravis. (5.7)

ADVERSE REACTIONS

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

To report SUSPECTED ADVERSE REACTIONS, contact Hospira, Inc. at 1-800-441-4100, 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: 2/2022

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