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azithromycin for Injection, USP - ADD-VANTAGE
If you provide additional keywords, you may be able to browse through our database of Scientific Response Documents.
Our scientific content is evidence-based, scientifically balanced and non-promotional. It undergoes rigorous internal medical review and is updated regularly to reflect new information.
azithromycin for Injection, USP - ADD-VANTAGE Quick Finder
Highlights
Indications and Usage
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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Dosage and Administration
2 DOSAGE AND ADMINISTRATION
[see Indications and Usage (1) and ...
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Dosage Forms and Strengths
3 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...
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Contraindications
4 CONTRAINDICATIONS
4.1 Hypersensitivity
Azithromycin for Injection is contraindicated in patients with known hypersensitivity to azithromycin, erythromycin, any...
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Warnings and Precautions
5 WARNINGS AND PRECAUTIONS
5.1 Hypersensitivity
Serious allergic reactions, including angioedema, anaphylaxis, and dermatologic reactions including Acute Generalized...
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Adverse Reactions
6 ADVERSE REACTIONS
The following clinically significant adverse reactions are described elsewhere in labeling:
- Hypersensitivity [see Warnings and Precautions (5....
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Drug Interactions
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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Use in Specific Populations
8 USE IN SPECIFIC POPULATIONS
8.1 Pregnancy
Risk Summary
Available data from...
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Overdosage
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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Description
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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Clinical Pharmacology
12 CLINICAL PHARMACOLOGY
12.1 Mechanism of Action
Azithromycin is a macrolide antibacterial drug [see ...
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Nonclinical Toxicology
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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Clinical Studies
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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How Supplied/Storage and Handling
16 HOW SUPPLIED/STORAGE AND HANDLING
Azithromycin for Injection, USP is supplied as white to off-white lyophilized powder in a single-dose ADD-Vantage® vial equivalent to 500 mg of azithromycin for...
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Medication Guide
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
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:
*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.
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.
(800)-332-1088.