Approved Date Route External Links
2016-08-25 Oral Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

1 Indications And Usage Clarithromycin Tablets Are 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 Tablets And Other Antibacterial Drugs, Clarithromycin Tablets Should Be Used Only To Treat Or Prevent Infections That Are Proven Or Strongly Suspected To Be Caused By Bacteria. (1.10) 1.1 Acute Bacterial Exacerbation Of Chronic Bronchitis Clarithromycin Tablets Are 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. 1.2 Acute Maxillary Sinusitis Clarithromycin Tablets Are Indicated For The Treatment Of Mild To Moderate Infections Caused By Susceptible Isolates Due To Haemophilus Influenzae, Moraxella Catarrhalis, Or Streptococcus Pneumoniae. 1.3 Community-Acquired Pneumonia Clarithromycin Tablets Are Indicated 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 Tablets [in Adults And Pediatric Patients]) 1.4 Pharyngitis/tonsillitis Clarithromycin Tablets Are 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 Tablets Are Indicated For The Treatment Of Mild To Moderate Infections Caused By Susceptible Isolates Due To Staphylococcus Aureus, Or Streptococcus Pyogenes. 1.6 Acute Otitis Media Clarithromycin Tablets Are 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 Tablets Are Indicated For The Treatment Of Mild To Moderate Infections Caused By Susceptible Isolates Due To Mycobacterium Avium Or Mycobacterium Intracellulare In Patients With Advanced Hiv Infection [see Clinical Studies (14.1)]. 1.8 Helicobacter Pylori Infection And Duodenal Ulcer Disease Clarithromycin Tablets Are Given In Combination With Other Drugs In Adults As Described Below To Eradicate H. Pylori. The Eradication Of H. Pylori Has Been Demonstrated To Reduce The Risk Of Duodenal Ulcer Recurrence [see Clinical Studies (14.3)]. Clarithromycin Tablets In Combination With Amoxicillin And Prevacid (lansoprazole) Or Prilosec (omeprazole) Delayed-Release Capsules, As Triple Therapy, Are Indicated For The Treatment Of Patients With H. Pylori Infection And Duodenal Ulcer Disease (active Or Five-Year History Of Duodenal Ulcer) To Eradicate H. Pylori. Clarithromycin Tablets In Combination With Prilosec (omeprazole) Capsules Are Indicated For The Treatment Of Patients With An Active Duodenal Ulcer Associated With H. Pylori Infection. Regimens Which Contain Clarithromycin Tablets As The Single Antibacterial Agent Are More Likely To Be Associated With The Development Of Clarithromycin Resistance Among Patients Who Fail Therapy. Clarithromycin-Containing Regimens Should Not Be Used In Patients With Known Or Suspected Clarithromycin Resistant Isolates Because The Efficacy Of Treatment Is Reduced In This Setting. 1.10 Usage To Reduce The Development Of Drug-Resistant Bacteria And Maintain The Effectiveness Of Clarithromycin Tablets And Other Antibacterial Drugs, Clarithromycin Tablets 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. Vanillin VANILLIN Molecular GRAS-Generally recognized as safe.
2. Propylene Glycol PROPYLENE GLYCOL Molecular MISC-Miscellaneous FS-Substances permitted as optional ingredient in a standardized food.
3. Ferric Oxide Yellow FERRIC OXIDE YELLOW Unresolved
4. Titanium Dioxide TITANIUM DIOXIDE Unresolved DYE-Dye
5. Hypromelloses HYPROMELLOSES Unresolved
6. Povidones POVIDONES Unresolved
7. 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.
8. Silicon Dioxide SILICON DIOXIDE Unresolved AC-Anticaking agent , MISC-Miscellaneous , STAB-Stabilizer GRAS-Generally recognized as safe.
9. Croscarmellose Sodium CROSCARMELLOSE SODIUM Unresolved
10. Cellulose, Microcrystalline CELLULOSE, MICROCRYSTALLINE Unresolved

Active Ingredients ( 1 Total)

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

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