Azithromycin

Product manufactured by Unit Dose Services

Application Nr Approved Date Route Status External Links
ANDA065211 2005-11-14 Oral RX Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

1 Indications And Usage To Reduce The Development Of Drug-Resistant Bacteria And Maintain The Effectiveness Of Azithromycin And Other Antibacterial Drugs, Azithromycin 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. 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 Conditions Listed Below. Recommended Dosages And Durations Of Therapy In Adult And Pediatric Patient Populations Vary In These Indications. [see Dosage And Administration (2)] Azithromycin Is A Macrolide Antibacterial Drug Indicated For Mild To Moderate Infections Caused By Designated, Susceptible Bacteria: •acute Bacterial Exacerbations Of Chronic Bronchitis In Adults (1.1) •acute Bacterial Sinusitis In Adults (1.1) •uncomplicated Skin And Skin Structure Infections In Adults (1.1) •urethritis And Cervicitis In Adults (1.1) •genital Ulcer Disease In Men (1.1) •acute Otitis Media In Pediatric Patients (1.2) •community-Acquired Pneumonia In Adults And Pediatric Patients (1.1, 1.2) •pharyngitis/tonsillitis In Adults And Pediatric Patients (1.1, 1.2) Limitation Of Use: Azithromycin Should Not Be Used In Patients With Pneumonia Who Are Judged To Be Inappropriate For Oral Therapy Because Of Moderate To Severe Illness Or Risk Factors. (1.3) To Reduce The Development Of Drug-Resistant Bacteria And Maintain The Effectiveness Of Azithromycin And Other Antibacterial Drugs, Azithromycin Should Be Used Only To Treat Infections That Are Proven Or Strongly Suspected To Be Caused By Susceptible Bacteria 1.1 Adult Patients •acute Bacterial Exacerbations Of Chronic Bronchitis Due To Haemophilus Influenzae, Moraxella Catarrhalis, Or Streptococcus Pneumoniae. •acute Bacterial Sinusitis Due To Haemophilus Influenzae, Moraxella Catarrhalis, Or Streptococcus Pneumoniae. •community-Acquired Pneumonia Due To Chlamydophila Pneumoniae, Haemophilus Influenzae, Mycoplasma Pneumoniae, Or Streptococcus Pneumoniae In Patients Appropriate For Oral Therapy. •pharyngitis/tonsillitis Caused By Streptococcus Pyogenes As An Alternative To First-Line Therapy In Individuals Who Cannot Use First-Line Therapy. •uncomplicated Skin And Skin Structure Infections Due To Staphylococcus Aureus, Streptococcus Pyogenes, Or Streptococcus Agalactiae. •urethritis And Cervicitis Due To Chlamydia Trachomatis Or Neisseria Gonorrhoeae. •genital Ulcer Disease In Men Due To Haemophilus Ducreyi (chancroid). Due To The Small Number Of Women Included In Clinical Trials, The Efficacy Of Azithromycin In The Treatment Of Chancroid In Women Has Not Been Established. 1.2 Pediatric Patients [see Use In Specific Populations (8.4) And Clinical Studies (14.2)] •acute Otitis Media (>6 Months Of Age) Caused By Haemophilus Influenzae, Moraxella Catarrhalis, Or Streptococcus Pneumoniae •community-Acquired Pneumonia (>6 Months Of Age) Due To Chlamydophila Pneumoniae, Haemophilus Influenzae, Mycoplasma Pneumonia, Or Streptococcus Pneumoniae In Patients Appropriate For Oral Therapy. •pharyngitis/tonsillitis (>2 Years Of Age) Caused By Streptococcus Pyogenes As An Alternative To First-Line Therapy In Individuals Who Cannot Use First-Line Therapy. 1.3 Limitations Of Use Azithromycin Should Not Be Used In Patients With Pneumonia Who Are Judged To Be Inappropriate For Oral Therapy Because Of Moderate To Severe Illness Or Risk Factors Such As Any Of The Following: •patients With Cystic Fibrosis, •patients With Nosocomial Infections, •patients With Known Or Suspected Bacteremia, •patients Requiring Hospitalization, •elderly Or Debilitated Patients, Or •patients With Significant Underlying Health Problems That May Compromise Their Ability To Respond To Their Illness (including Immunodeficiency Or Functional Asplenia).

All Formulated Excipients (7 Total)

Name Structure Kind Function Status
1. Silicon Dioxide SILICON DIOXIDE Unresolved AC-Anticaking agent , MISC-Miscellaneous , STAB-Stabilizer GRAS-Generally recognized as safe.
2. Lecithin LECITHIN Unresolved
3. 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.
4. Cellulose, Microcrystalline CELLULOSE, MICROCRYSTALLINE Unresolved
5. Polyvinyl Alcohol POLYVINYL ALCOHOL Unresolved
6. Sodium Lauryl Sulfate SODIUM LAURYL SULFATE Molecular AF-Antifoaming (or defoaming) agent , CTG-Component or coating , EMUL-Emulsifier , SANI-Sanitizing agent , SDA-Solubilizing & dispersing agent REG-Food additives for which a petition has been filed and a regulation issued.
7. Talc TALC Unresolved DYE-Dye GRAS-Generally recognized as safe.

Active Ingredients ( 1 Total)

Name Structure ZINC ID(s)
1. Azithromycin Monohydrate

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