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ZITHROMAX® 600 MG tablets (azithromycin dihydrate - ZITHROMAX® 600 MG tablets)

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HIGHLIGHTS OF PRESCRIBING INFORMATION

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1 INDICATIONS AND USAGE

ZITHROMAX 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 the specific...

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2 DOSAGE AND ADMINISTRATION

[see Indications and Usage (1)]

ZITHROMAX for oral suspension (single dose 1 g packet) can be taken with or without food after constitution....

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3 DOSAGE FORMS AND STRENGTHS

ZITHROMAX 600 mg tablets (engraved on front with "PFIZER" and on back with "308") are supplied as white, modified oval-shaped, film-coated tablets containing azithromycin dihydrate equivalent to...

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4 CONTRAINDICATIONS

4.1 Hypersensitivity

ZITHROMAX is contraindicated in patients with known hypersensitivity to azithromycin, erythromycin, any macrolide, or...

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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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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

...

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10 OVERDOSAGE

Adverse reactions experienced in higher than recommended doses were similar to those seen at normal doses. In the event of overdosage, general symptomatic and supportive measures are indicated as required....

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11 DESCRIPTION

ZITHROMAX (azithromycin tablets and oral suspension) contains the active ingredient azithromycin, a macrolide antibacterial drug, for oral administration. Azithromycin has the chemical name (...

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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 Clinical Studies in Patients with Advanced HIV Infection for the Prevention and Treatment of Disease Due to Disseminated Mycobacterium avium...

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15 REFERENCES

  1. Griffith DE, Aksamit T, Brown-Elliot BA, et al. An official ATS/IDSA statement: Diagnosis, treatment, and prevention of nontuberculous mycobacterial diseases. Am J Respir Crit Care...
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16 HOW SUPPLIED/STORAGE AND HANDLING

ZITHROMAX 600 mg tablets (engraved on front with "PFIZER" and on back with "308") are supplied as white, modified oval-shaped, film-coated tablets containing azithromycin dihydrate...

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17 PATIENT COUNSELING INFORMATION

ZITHROMAX tablets may be taken with or without food. However, increased tolerability has been observed when tablets are taken with food.

ZITHROMAX for oral suspension in single 1 g...

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Licensed from Pliva

This product's label may have been updated. For current full prescribing information, please visit www.pfizer.com.

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Report Adverse Event
Pfizer Safety

To report an adverse event related to a Pfizer product 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 to report an adverse event related to a Pfizer product, please call Pfizer Medical Information 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.