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azithromycin for injection, USP - VIAL

azithromycin for injection, USP - VIAL Quick Finder

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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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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