Application Nr Approved Date Route Status External Links
ANDA065179 None Intravenous None Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

Indications And Usage Azithromycin For Injection, Usp Is Indicated For The Treatment Of Patients With Infections Caused By Susceptible Strains Of The Designated Microorganisms In The Conditions Listed Below. As Recommended Dosages, Durations Of Therapy, And Applicable Patient Populations Vary Among These Infections, Please See Dosage And Administration For Dosing Recommendations. Community-Acquired Pneumonia Due To Chlamydia Pneumoniae, Haemophilus Influenzae, Legionella Pneumophila, Moraxella Catarrhalis, Mycoplasma Pneumoniae, Staphylococcus Aureus, Or Streptococcus Pneumoniae In Patients Who Require Initial Intravenous Therapy. Pelvic Inflammatory Disease Due To Chlamydia Trachomatis, Neisseria Gonorrhoeae, Or Mycoplasma Hominis In Patients Who Require Initial Intravenous Therapy. If Anaerobic Microorganisms Are Suspected Of Contributing To The Infection, An Antimicrobial Agent With Anaerobic Activity Should Be Administered In Combination With Azithromycin For Injection, Usp. Azithromycin For Injection, Usp Should Be Followed By Azithromycin By The Oral Route As Required (See Dosage And Administration ). Appropriate Culture And Susceptibility Tests Should Be Performed Before Treatment To Determine The Causative Microorganism And Its Susceptibility To Azithromycin. Therapy With Azithromycin May Be Initiated Before Results Of These Tests Are Known; Once The Results Become Available, Antimicrobial Therapy Should Be Adjusted Accordingly. To Reduce The Development Of Drug-Resistant Bacteria And Maintain The Effectiveness Of Azithromycin For Injection, Usp And Other Antibacterial Drugs, Azithromycin For Injection, Usp Should Be Used Only To Treat Or Prevent Infections That Are Proven Or Strongly Suspected To Be Caused By Susceptible Bacteria. When Culture And Susceptibility Information Are Available, They Should Be Considered In Selecting Or Modifying Antibacterial Therapy. In The Absence Of Such Data, Local Epidemiology And Susceptibility Patterns May Contribute To The Empiric Selection Of Therapy.

All Formulated Excipients (0 Total)

None

Active Ingredients ( 1 Total)

Name Structure ZINC ID(s)
1. Azithromycin Monohydrate

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