Clarithromycin

Product manufactured by Sandoz Inc

Application Nr Approved Date Route Status External Links
ANDA065283 2007-09-04 Oral RX Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

1 Indications And Usage Clarithromycin Is A Macrolide Antimicrobial Indicated For Mild To Moderate Infections Caused By Designated, Susceptible Bacteria In The Following: •acute Bacterial Exacerbation Of Chronic Bronchitis In Adults (1.1) •acute Maxillary Sinusitis (1.2) •community-Acquired Pneumonia (1.3) •pharyngitis/tonsillitis (1.4) •uncomplicated Skin And Skin Structure Infections (1.5) •acute Otitis Media In Pediatric Patients (1.6) •treatment And Prophylaxis Of Disseminated Mycobacterial Infections (1.7) • Helicobacter Pylori Infection And Duodenal Ulcer Disease In Adults (1.8) To Reduce The Development Of Drug-Resistant Bacteria And Maintain The Effectiveness Of Clarithromycin And Other Antibacterial Drugs, Clarithromycin Should Be Used Only To Treat Or Prevent Infections That Are Proven Or Strongly Suspected To Be Caused By Bacteria. (1.9) 1.1 Acute Bacterial Exacerbation Of Chronic Bronchitis Clarithromycin Is Indicated In Adults For The Treatment Of Mild To Moderate Infections Caused By Susceptible Isolates Due To Haemophilus Influenzae, Haemophilus Parainfluenzae, Moraxella Catarrhalis, Or Streptococcus Pneumoniae [see I Ndications And Usage (1.9)]. 1.2 Acute Maxillary Sinusitis Clarithromycin Is Indicated For The Treatment Of Mild To Moderate Infections Caused By Susceptible Isolates Due To Haemophilus Influenzae, Moraxella Catarrhalis, Or Streptococcus Pneumoniae [see Indications And Usage (1.9)]. 1.3 Community-Acquired Pneumonia Clarithromycin Is Indicated [see Indications And Usage (1.9)]for The Treatment Of Mild To Moderate Infections Caused By Susceptible Isolates Due To: • Haemophilus Influenzae (in Adults) • Mycoplasma Pneumoniae, Streptococcus Pneumoniae, Chlamydophila Pneumoniae Clarithromycin [in Adults And Pediatric Patients] 1.4 Pharyngitis/tonsillitis Clarithromycin Is Indicated For The Treatment Of Mild To Moderate Infections Caused By Susceptible Isolates Due To Streptococcus Pyogenes As An Alternative In Individuals Who Cannot Use First Line Therapy. 1.5 Uncomplicated Skin And Skin Structure Infections Clarithromycin Is Indicated For The Treatment Of Mild To Moderate Infections Caused By Susceptible Isolates Due To Staphylococcus Aureus, Or S Treptococcus Pyogenes. 1.6 Acute Otitis Media Clarithromycin Is Indicated In Pediatric Patients For The Treatment Of Mild To Moderate Infections Caused By Susceptible Isolates Due To Haemophilus Influenzae, Moraxella Catarrhalis, Or Streptococcus Pneumoniae [see Clinical Studies ( 14.2)]. 1.7 Treatment And Prophylaxis Of Disseminated Mycobacterial Infections Clarithromycin Is Indicated For The Treatment Of Mild To Moderate Infections Caused By Susceptible Isolates Due To Mycobacterium Avium Or Myc Obacterium Intracellulare In Patients With Advanced Hiv Infection [see Clinical Studies ( 14.1 )]. 1.10 Usage To Reduce The Development Of Drug-Resistant Bacteria And Maintain The Effectiveness Of Clarithromycin And Other Antibacterial Drugs, Clarithromycin 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 (10 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. Glyceryl Monostearate GLYCERYL MONOSTEARATE Molecular
3. Hypromelloses HYPROMELLOSES Unresolved
4. Maltodextrin MALTODEXTRIN Unresolved GRAS-Generally recognized as safe.
5. Polyethylene Glycols POLYETHYLENE GLYCOLS Unresolved
6. Polysorbate 80 POLYSORBATE 80 Unresolved AF-Antifoaming (or defoaming) agent , EMUL-Emulsifier , MISC-Miscellaneous , SDA-Solubilizing & dispersing agent REG-Food additives for which a petition has been filed and a regulation issued.
7. Potassium Sorbate POTASSIUM SORBATE Molecular PRES-Chemical preservative GRAS-Generally recognized as safe.
8. Povidones POVIDONES Unresolved
9. Titanium Dioxide TITANIUM DIOXIDE Unresolved DYE-Dye
10. Triethyl Citrate TRIETHYL CITRATE Molecular MISC-Miscellaneous GRAS-Generally recognized as safe.

Active Ingredients ( 1 Total)

Name Structure ZINC ID(s)
1. Clarithromycin CLARITHROMYCIN ZINC85534098

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