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ZITHROMAX® TABLET, SUSPENSION (azithromycin dihydrate TABLET, SUSPENSION)
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.
ZITHROMAX® TABLET, SUSPENSION Quick Finder
Highlights
Indications and Usage
1 INDICATIONS AND USAGE
ZITHROMAX (azithromycin) is a macrolide antibacterial drug indicated for the treatment of patients with mild to moderate infections caused by susceptible strains of the designated microorganisms in...
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Dosage and Administration
2 DOSAGE AND ADMINISTRATION
2.1 Adult Patients
[see Indications and Usage (1.1) and Clinical Pharmacology (...
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Dosage Forms and Strengths
3 DOSAGE FORMS AND STRENGTHS
ZITHROMAX 250 mg tablets are supplied as pink modified capsular shaped, engraved, film-coated tablets containing azithromycin dihydrate equivalent to 250 mg of azithromycin. ZITHROMAX 250 mg...
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Contraindications
4 CONTRAINDICATIONS
4.1 Hypersensitivity
ZITHROMAX is contraindicated in patients with known hypersensitivity to azithromycin, erythromycin, any macrolide or ketolide...
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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...
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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 at 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
ZITHROMAX (azithromycin tablets and azithromycin for oral suspension) contain the active ingredient azithromycin, a macrolide antibacterial drug, for oral administration. Azithromycin has the chemical name (2R...
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Clinical Pharmacology
12 CLINICAL PHARMACOLOGY
12.1 Mechanism of Action
Azithromycin is a macrolide antibacterial drug. [see Microbiology (12.4)...
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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 Adult Patients
Acute Bacterial Exacerbations of Chronic...
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How Supplied/Storage and Handling
16 HOW SUPPLIED/STORAGE AND HANDLING
ZITHROMAX is supplied in the following strengths and package configurations:
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Medication Guide
17 PATIENT COUNSELING INFORMATION
Advise the patient to read the FDA-approved patient labeling (Patient Information).
General Patient...
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FDA-Approved Patient Labeling
Patient Information
ZITHROMAX® (Zith-roe-maks)
(azithromycin)
Tablets
ZITHROMAX®
(azithromycin)
Oral...
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Resources
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.