Azithromycin

Product manufactured by Remedyrepack Inc.

Application Nr Approved Date Route Status External Links
ANDA065218 2005-11-14 Oral RX Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

1 Indications And Usage Azithromycin Tablets Are 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 Conditions Listed Below. Azithromycin Tablets Are A Macrolide Antibacterial Indicated For Mild To Moderate Infections Caused By Designated, Susceptible Bacteria: Mycobacterial Infections ( 1.2) To Reduce The Development Of Drug-Resistant Bacteria And Maintain The Effectiveness Of Azithromycin Tablets And Other Antibacterial Drugs, Azithromycin Tablets Should Be Used Only To Treat Or Prevent Infections That Are Proven Or Strongly Suspected To Be Caused By Susceptible Bacteria. (1.3) 1.2 Mycobacterial Infections Prophylaxis Of Disseminated Mycobacterium Avium Complex (mac) Disease Azithromycin Tablets, Taken Alone Or In Combination With Rifabutin At Its Approved Dose, Are Indicated For The Prevention Of Disseminated Mac Disease In Persons With Advanced Hiv Infection [see Dosage And Administration (2)] . Treatment Of Disseminated Mac Disease Azithromycin Tablets, Taken In Combination With Ethambutol, Are Indicated For The Treatment Of Disseminated Mac Infections In Persons With Advanced Hiv Infection [see Use In Specific Populations (8.4) And Clinical Studies (14.1)] . 1.3 Usage To Reduce The Development Of Drug-Resistant Bacteria And Maintain The Effectiveness Of Azithromycin Tablets And Other Antibacterial Drugs, Azithromycin Tablets Should Be Used Only To Treat 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 (8 Total)

Name Structure Kind Function Status
1. Croscarmellose Sodium CROSCARMELLOSE SODIUM Unresolved
2. Calcium Phosphate, Dibasic, Anhydrous CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS Molecular
3. Hypromelloses HYPROMELLOSES Unresolved
4. Lactose Monohydrate LACTOSE MONOHYDRATE Molecular
5. Polyethylene Glycols POLYETHYLENE GLYCOLS Unresolved
6. Magnesium Stearate MAGNESIUM STEARATE Molecular AF-Antifoaming (or defoaming) agent , MISC-Miscellaneous REG-Food additives for which a petition has been filed and a regulation issued.
7. Cellulose, Microcrystalline CELLULOSE, MICROCRYSTALLINE Unresolved
8. Sodium Citrate, Unspecified Form SODIUM CITRATE, UNSPECIFIED FORM Molecular

Active Ingredients ( 1 Total)

Name Structure ZINC ID(s)
1. Azithromycin Monohydrate

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