Application Nr Approved Date Route Status External Links
ANDA065178 2004-05-25 Oral RX Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

Indications And Usage Clarithromycin Tablets, Usp Are Indicated For The Treatment Of Mild To Moderate Infections Caused By Susceptible Isolates Of The Designated Bacteria In The Conditions As Listed Below: Adults (clarithromycin Tablets, Usp) Pharyngitis/tonsillitis Due To Streptococcus Pyogenes (the Usual Drug Of Choice In The Treatment And Prevention Of Streptococcal Infections And The Prophylaxis Of Rheumatic Fever Is Penicillin Administered By Either The Intramuscular Or The Oral Route. Clarithromycin Tablets, Usp Are Generally Effective In The Eradication Of S. Pyogenes From The Nasopharynx; However, Data Establishing The Efficacy Of Clarithromycin Tablets, Usp In The Subsequent Prevention Of Rheumatic Fever Are Not Available At Present.) Acute Maxillary Sinusitis Due To Haemophilus Influenzae, Moraxella Catarrhalis Or Streptococcus Pneumoniae. Acute Bacterial Exacerbation Of Chronic Bronchitis Due To Haemophilus Influenzae,haemophilus Parainfluenzae, Moraxella Catarrhalis, Or Streptococcus Pneumoniae. Community-Acquired Pneumonia Due To Haemophilus Influenzae, Mycoplasma Pneumoniae, Streptococcus Pneumoniae, Or Chlamydophila Pneumoniae (twar). Uncomplicated Skin And Skin Structure Infections Due To Staphylococcus Aureus, Or Streptococcus Pyogenes (abscesses Usually Require Surgical Drainage). Disseminated Mycobacterial Infections Due To Mycobacterium Avium, Or Mycobacterium Intracellulare. Clarithromycin Tablets, Usp In Combination With Amoxicillin And Prevacid (lansoprazole) Or Prilosec (omeprazole) Delayed-Release Capsules, As Triple Therapy, Are Indicated For The Treatment Of Patients With Helicobacter Pylori Infection And Duodenal Ulcer Disease (active Or Five-Year History Of Duodenal Ulcer) To Eradicate H. Pylori. Clarithromycin Tablets, Usp In Combination With Prilosec (omeprazole) Capsules Or Tirtec (ranitidine Bismuth Citrate) Tablets Are Also Indicated For The Treatment Of Patients With An Active Duodenal Ulcer Associated With H. Pylori Infection. However, Regimens Which Contain Clarithromycin Tablets, Usp As The Single Antimicrobial 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. In Patients Who Fail Therapy, Susceptibility Testing Should Be Done If Possible. If Resistance To Clarithromycin Tablets, Usp Is Demonstrated, A Non-Clarithromycin-Containing Therapy Is Recommended. (for Information On Development Of Resistance See Microbiology Section.) The Eradication Of H. Pylori Has Been Demonstrated To Reduce The Risk Of Duodenal Ulcer Recurrence. Children (clarithromycin Tablets, Usp) Pharyngitis/tonsillitis Due To Streptococcus Pyogenes. Community-Acquired Pneumonia Due To Mycoplasma Pneumoniae, Streptococcus Pneumoniae, Or Chlamydophila Pneumoniae (twar). Acute Maxillary Sinusitis Due To Haemophilus Influenzae, Moraxella Catarrhalis, Or Streptococcus Pneumoniae. Acute Otitis Media Due To Haemophilus Influenzae, Moraxella Catarrhalis, Or Streptococcus Pneumoniae. Note: For Information On Otitis Media, See Clinical Studies – Otitis Media . Uncomplicated Skin And Skin Structure Infections Due To Staphylococcus Aureus, Or Streptococcus Pyogenes (abscesses Usually Require Surgical Drainage). Disseminated Mycobacterial Infections Due To Mycobacterium Avium, Or Mycobacterium Intracellulare. Prophylaxis Clarithromycin Tablets, Usp Are Indicated For The Prevention Of Disseminated Mycobacterium Avium Complex (mac) Disease In Patients With Advanced Hiv Infection. To Reduce The Development Of Drug-Resistant Bacteria And Maintain The Effectiveness Of Clarithromycin Tablets, Usp And Other Antibacterial Drugs, Clarithromycin Tablets, 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 (6 Total)

Name Structure Kind Function Status
1. Croscarmellose Sodium CROSCARMELLOSE SODIUM Unresolved
2. Lactose Monohydrate LACTOSE MONOHYDRATE Molecular
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. Povidones POVIDONES Unresolved
6. Stearic Acid STEARIC ACID 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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