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azithromycin for injection, USP - VIAL
azithromycin for injection, USP - VIAL Quick Finder
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...
2 DOSAGE AND ADMINISTRATION
[see Indications and Usage (1) and ...
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.
Azithromycin for Injection is contraindicated in patients with known hypersensitivity to azithromycin, erythromycin, any...
5 WARNINGS AND PRECAUTIONS
Serious allergic reactions, including angioedema, anaphylaxis, and dermatologic reactions including Acute Generalized...
6 ADVERSE REACTIONS
The following clinically significant adverse reactions are described elsewhere in labeling:
- Hypersensitivity [see...
7 DRUG INTERACTIONS
Co-administration of nelfinavir at steady-state with a single oral dose of azithromycin resulted in increased azithromycin serum...
8 USE IN SPECIFIC POPULATIONS
Available data from...
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...
Azithromycin for Injection, USP contains the active ingredient azithromycin, an azalide, a subclass of macrolide antibiotics, for intravenous injection. Azithromycin has the chemical name (...
12 CLINICAL PHARMACOLOGY
12.1 Mechanism of Action
Azithromycin is a macrolide antibacterial drug [see ...
13 NONCLINICAL TOXICOLOGY
13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility
Long-term studies in animals have not been performed to evaluate carcinogenic...
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...
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...
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:
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