ZITHROMAX® TABLET, SUSPENSION Highlights

(azithromycin dihydrate TABLET, SUSPENSION)

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) 250 mg and 500 mg tablets, for oral use
ZITHROMAX (azithromycin) for oral suspension
Initial U.S. Approval: 1991

RECENT MAJOR CHANGES

Warnings and Precautions, Cardiovascular Death (5.5)

11/2021

INDICATIONS AND USAGE

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

•
Acute bacterial exacerbations of chronic bronchitis in adults (1.1)
•
Acute bacterial sinusitis in adults (1.1)
•
Uncomplicated skin and skin structure infections in adults (1.1)
•
Urethritis and cervicitis in adults (1.1)
•
Genital ulcer disease in men (1.1)
•
Acute otitis media in pediatric patients (6 months of age and older) (1.2)
•
Community-acquired pneumonia in adults and pediatric patients (6 months of age and older) (1.1, 1.2)
•
Pharyngitis/tonsillitis in adults and pediatric patients (2 years of age and older) (1.1, 1.2)

Limitation of Use:

Azithromycin should not be used in patients with pneumonia who are judged to be inappropriate for oral therapy because of moderate to severe illness or risk factors. (1.3)

To reduce the development of drug-resistant bacteria and maintain the effectiveness of ZITHROMAX (azithromycin) and other antibacterial drugs, ZITHROMAX (azithromycin) should be used only to treat infections that are proven or strongly suspected to be caused by susceptible bacteria. (1.4)

DOSAGE AND ADMINISTRATION

•
Adult Patients (2.1)
InfectionRecommended Dose/Duration of Therapy

Community-acquired pneumonia (mild severity)
Pharyngitis/tonsillitis (second-line therapy)
Skin/skin structure (uncomplicated)

500 mg as a single dose on Day 1, followed by 250 mg once daily on Days 2 through 5.

Acute bacterial exacerbations of chronic bronchitis (mild to moderate)

500 mg as a single dose on Day 1, followed by 250 mg once daily on Days 2 through 5 or 500 mg once daily for 3 days.

Acute bacterial sinusitis

500 mg once daily for 3 days.

Genital ulcer disease (chancroid)
Non-gonococcal urethritis and cervicitis

One single 1 gram dose.

Gonococcal urethritis and cervicitis

One single 2 gram dose.

•
Pediatric Patients (2.2)
InfectionRecommended Dose/Duration of Therapy

Acute otitis media (6 months of age and older)

30 mg/kg as a single dose or 10 mg/kg once daily for 3 days or 10 mg/kg as a single dose on Day 1 followed by 5 mg/kg/day on Days 2 through 5.

Acute bacterial sinusitis (6 months of age and older)

10 mg/kg once daily for 3 days.

Community-acquired pneumonia (6 months of age and older)

10 mg/kg as a single dose on Day 1 followed by 5 mg/kg once daily on Days 2 through 5.

Pharyngitis/tonsillitis (2 years of age and older)

12 mg/kg once daily for 5 days.

DOSAGE FORMS AND STRENGTHS

•
ZITHROMAX tablets 250 mg and 500 mg (3)
•
ZITHROMAX for oral suspension 100 mg/5 mL and 200 mg/5 mL (3)

CONTRAINDICATIONS

•
Patients with known hypersensitivity to azithromycin, erythromycin, any macrolide or ketolide 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 ZITHROMAX if reaction occurs. (5.1)
•
Hepatotoxicity: Severe, and sometimes fatal, hepatotoxicity 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)
•
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 ZITHROMAX. (5.5)
•
Clostridioides difficile-Associated Diarrhea: Evaluate patients if diarrhea occurs. (5.6)
•
ZITHROMAX may exacerbate muscle weakness in persons with myasthenia gravis. (5.7)

ADVERSE REACTIONS

Most common adverse reactions are diarrhea (5 to 14%), nausea (3 to 18%), abdominal pain (3 to 7%), or vomiting (2 to 7%). (6.1)

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 6 months 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 and FDA-approved patient labeling.

Revised: 10/2023

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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) 250 mg and 500 mg tablets, for oral use
ZITHROMAX (azithromycin) for oral suspension
Initial U.S. Approval: 1991

RECENT MAJOR CHANGES

Warnings and Precautions, Cardiovascular Death (5.5)

11/2021

INDICATIONS AND USAGE

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

•
Acute bacterial exacerbations of chronic bronchitis in adults (1.1)
•
Acute bacterial sinusitis in adults (1.1)
•
Uncomplicated skin and skin structure infections in adults (1.1)
•
Urethritis and cervicitis in adults (1.1)
•
Genital ulcer disease in men (1.1)
•
Acute otitis media in pediatric patients (6 months of age and older) (1.2)
•
Community-acquired pneumonia in adults and pediatric patients (6 months of age and older) (1.1, 1.2)
•
Pharyngitis/tonsillitis in adults and pediatric patients (2 years of age and older) (1.1, 1.2)

Limitation of Use:

Azithromycin should not be used in patients with pneumonia who are judged to be inappropriate for oral therapy because of moderate to severe illness or risk factors. (1.3)

To reduce the development of drug-resistant bacteria and maintain the effectiveness of ZITHROMAX (azithromycin) and other antibacterial drugs, ZITHROMAX (azithromycin) should be used only to treat infections that are proven or strongly suspected to be caused by susceptible bacteria. (1.4)

DOSAGE AND ADMINISTRATION

•
Adult Patients (2.1)
InfectionRecommended Dose/Duration of Therapy

Community-acquired pneumonia (mild severity)
Pharyngitis/tonsillitis (second-line therapy)
Skin/skin structure (uncomplicated)

500 mg as a single dose on Day 1, followed by 250 mg once daily on Days 2 through 5.

Acute bacterial exacerbations of chronic bronchitis (mild to moderate)

500 mg as a single dose on Day 1, followed by 250 mg once daily on Days 2 through 5 or 500 mg once daily for 3 days.

Acute bacterial sinusitis

500 mg once daily for 3 days.

Genital ulcer disease (chancroid)
Non-gonococcal urethritis and cervicitis

One single 1 gram dose.

Gonococcal urethritis and cervicitis

One single 2 gram dose.

•
Pediatric Patients (2.2)
InfectionRecommended Dose/Duration of Therapy

Acute otitis media (6 months of age and older)

30 mg/kg as a single dose or 10 mg/kg once daily for 3 days or 10 mg/kg as a single dose on Day 1 followed by 5 mg/kg/day on Days 2 through 5.

Acute bacterial sinusitis (6 months of age and older)

10 mg/kg once daily for 3 days.

Community-acquired pneumonia (6 months of age and older)

10 mg/kg as a single dose on Day 1 followed by 5 mg/kg once daily on Days 2 through 5.

Pharyngitis/tonsillitis (2 years of age and older)

12 mg/kg once daily for 5 days.

DOSAGE FORMS AND STRENGTHS

•
ZITHROMAX tablets 250 mg and 500 mg (3)
•
ZITHROMAX for oral suspension 100 mg/5 mL and 200 mg/5 mL (3)

CONTRAINDICATIONS

•
Patients with known hypersensitivity to azithromycin, erythromycin, any macrolide or ketolide 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 ZITHROMAX if reaction occurs. (5.1)
•
Hepatotoxicity: Severe, and sometimes fatal, hepatotoxicity 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)
•
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 ZITHROMAX. (5.5)
•
Clostridioides difficile-Associated Diarrhea: Evaluate patients if diarrhea occurs. (5.6)
•
ZITHROMAX may exacerbate muscle weakness in persons with myasthenia gravis. (5.7)

ADVERSE REACTIONS

Most common adverse reactions are diarrhea (5 to 14%), nausea (3 to 18%), abdominal pain (3 to 7%), or vomiting (2 to 7%). (6.1)

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 6 months 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 and FDA-approved patient labeling.

Revised: 10/2023
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