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

ZITHROMAX® 600 MG tablets Quick Finder

HIGHLIGHTS OF PRESCRIBING INFORMATION

These highlights do not include all the...
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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

2.1 Sexually Transmitted Diseases

The recommended dose of ZITHROMAX for the treatment of non-gonococcal urethritis and cervicitis due to...

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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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6 ADVERSE REACTIONS

6.1 Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the...

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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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12 CLINICAL PHARMACOLOGY

12.1 Mechanism of Action

Azithromycin is a macrolide antibacterial drug. [see

12.2 Pharmacodynamics

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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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