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ZITHROMAX® IV (azithromycin dihydrate IV)

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ZITHROMAX® IV Quick Finder

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HIGHLIGHTS OF PRESCRIBING INFORMATION

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1 INDICATIONS AND USAGE

ZITHROMAX (azithromycin) for injection is a macrolide antibacterial drug indicated for the treatment of patients with infections caused by susceptible strains of the designated microorganisms in the...

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3 DOSAGE FORMS AND STRENGTHS

ZITHROMAX for injection is supplied as white to off-white lyophilized powder in a single-dose vial equivalent to 500 mg of azithromycin for intravenous administration.

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4 CONTRAINDICATIONS

4.1 Hypersensitivity

ZITHROMAX is contraindicated in patients with known hypersensitivity to azithromycin, erythromycin, any macrolide or ketolide...

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5 WARNINGS AND PRECAUTIONS

5.1 Hypersensitivity

Serious allergic reactions, including angioedema, anaphylaxis, and dermatologic reactions including Acute Generalized...

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7 DRUG INTERACTIONS

7.1 Nelfinavir

Co-administration of nelfinavir at steady-state with a single oral dose of azithromycin resulted in increased azithromycin serum...

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8 USE IN SPECIFIC POPULATIONS

8.1 Pregnancy

Risk Summary

Available data from...

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10 OVERDOSAGE

Adverse reactions experienced in higher than recommended doses were similar to those seen at normal doses particularly nausea, diarrhea, and vomiting. In the event of overdosage, general symptomatic and...

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11 DESCRIPTION

ZITHROMAX for injection contains the active ingredient azithromycin, an azalide, a subclass of macrolide antibacterial drug, for intravenous injection. Azithromycin has the chemical name...

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13 NONCLINICAL TOXICOLOGY

13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility

Long-term studies in animals have not been performed to evaluate carcinogenic...

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14 CLINICAL STUDIES

14.1 Community-Acquired Pneumonia

In a controlled trial of community-acquired pneumonia performed in the U.S., azithromycin (500 mg as a single...

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16 HOW SUPPLIED/STORAGE AND HANDLING

ZITHROMAX for injection is supplied as white to off-white lyophilized powder under a vacuum in a single-dose vial equivalent to 500 mg of azithromycin for intravenous administration....

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17 PATIENT COUNSELING INFORMATION

Patients should be informed of the following serious and potentially serious adverse reactions that have been associated with ZITHROMAX®

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This product's label may have been updated. For current full prescribing information, please visit www.pfizer.com.

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Resources

website
FDA Drug Safety Communication (DSC) : Azithromycin (Zithromax or Zmax)
 
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FDA Medwatch
You may also contact the U.S. Food and Drug Administration (FDA) directly to report adverse events or product quality concerns either online at www.fda.gov/medwatchor by calling
(800)-332-1088.