AZITHROMYCIN INJ (azithromycin for injection) | Pfizer Medical Information

azithromycin for injection, USP - VIAL Quick Finder

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HIGHLIGHTS OF PRESCRIBING INFORMATION

These highlights do not include all the...

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1 INDICATIONS AND USAGE

Azithromycin for Injection, USP 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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2 DOSAGE AND ADMINISTRATION

[see Indications and Usage (1) and ...

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3 DOSAGE FORMS AND STRENGTHS

Azithromycin 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

Azithromycin for Injection is contraindicated in patients with known hypersensitivity to azithromycin, erythromycin, any...

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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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6 ADVERSE REACTIONS

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

Hypersensitivity [see...

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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

Azithromycin for Injection, USP contains the active ingredient azithromycin, an azalide, a subclass of macrolide antibiotics, for intravenous injection. Azithromycin has the chemical name (...

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12 CLINICAL PHARMACOLOGY

12.1 Mechanism of Action

Azithromycin is a macrolide antibacterial drug [see ...

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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

Azithromycin for Injection, USP 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...

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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 Azithromycin for Injection:

Diarrhea...

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Report Adverse Event

Pfizer Safety

To report an adverse event related to Pfizer-BioNTech COVID-19 Vaccine (also known as COMIRNATY®, COVID-19 mRNA, Vaccine BNT162b2 or BNT162) or Pfizer COVID-19 Treatment (also known as PAXLOVID™ (nirmatrelvir tablets; ritonavir tablets)), and you are not part of a clinical trial* for this product, click the link below to submit your information:

Pfizer Safety Reporting Site

*If you are involved in a clinical trial for either product, adverse events should be reported to your coordinating study site.

If you cannot use the above website or would like to report an adverse event related to a different Pfizer product, please call Pfizer Safety at
(800) 438-1985.

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.