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AZITHROMYCIN Tablets, Oral Suspension (GREENSTONE LLC)

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AZITHROMYCIN Tablets, Oral Suspension (GREENSTONE LLC) Quick Finder

HIGHLIGHTS OF PRESCRIBING INFORMATION

These highlights do not include all the...
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1 INDICATIONS AND USAGE

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 the specific...

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2 DOSAGE AND ADMINISTRATION

2.1 Adult Patients

[see

2.2 Pediatric Patients1

...

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3 DOSAGE FORMS AND STRENGTHS

Azithromycin 250 mg tablets are supplied as pink modified capsular shaped, engraved, film-coated tablets containing azithromycin dihydrate equivalent to 250 mg of azithromycin. Azithromycin 250...

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4 CONTRAINDICATIONS

4.1 Hypersensitivity

Azithromycin 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...

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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...

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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...

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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 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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11 DESCRIPTION

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,3S,4R,5R,8R...

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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...

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14 CLINICAL STUDIES

14.1 Adult Patients

Acute Bacterial...

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16 HOW SUPPLIED/STORAGE AND HANDLING

Azithromycin is supplied in the following strengths and package configurations:

...
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17 PATIENT COUNSELING INFORMATION

Advise the patient to read the FDA-approved patient labeling (Patient Information).

General Patient Counseling...

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