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

FULL PRESCRIBING INFORMATION: CONTENTS*

1 INDICATIONS AND USAGE

1.1 Sexually Transmitted Diseases

1.2 Mycobacterial Infections

1.3 Usage

2 DOSAGE AND ADMINISTRATION

2.1 Sexually Transmitted Diseases

2.2 Mycobacterial Infections

3 DOSAGE FORMS AND STRENGTHS

4 CONTRAINDICATIONS

4.1 Hypersensitivity

4.2 Hepatic Dysfunction

5 WARNINGS AND PRECAUTIONS

5.1 Hypersensitivity

5.2 Hepatotoxicity

5.3 Infantile Hypertrophic Pyloric Stenosis (IHPS)

5.4 QT Prolongation

5.5 Cardiovascular Death

5.6 Clostridioides difficile-Associated Diarrhea (CDAD)

5.7 Exacerbation of Myasthenia Gravis

5.8 Use in Sexually Transmitted Infections

5.9 Development of Drug-Resistant Bacteria

6 ADVERSE REACTIONS

6.1 Clinical Trials Experience

6.2 Postmarketing Experience

6.3 Laboratory Abnormalities

7 DRUG INTERACTIONS

7.1 Nelfinavir

7.2 Warfarin

7.3 Potential Drug-Drug Interaction with Macrolides

8 USE IN SPECIFIC POPULATIONS

8.1 Pregnancy

8.2 Lactation

8.4 Pediatric Use

8.5 Geriatric Use

10 OVERDOSAGE

11 DESCRIPTION

12 CLINICAL PHARMACOLOGY

12.1 Mechanism of Action

12.2 Pharmacodynamics

12.3 Pharmacokinetics

12.4 Microbiology

13 NONCLINICAL TOXICOLOGY

13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility

13.2 Animal Toxicology

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 Complex (MAC)

15 REFERENCES

16 HOW SUPPLIED/STORAGE AND HANDLING

17 PATIENT COUNSELING INFORMATION

*
Sections or subsections omitted from the full prescribing information are not listed.
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