Application Nr Approved Date Route Status External Links
ANDA065266 2006-05-31 Oral RX Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

Indications And Usage To Reduce The Development Of Drug-Resistant Bacteria And Maintain The Effectiveness Of Clarithromycin Tablet And Other Antibacterial Drugs, Clarithromycin Tablet 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. Clarithromycin Tablet Is Indicated For The Treatment Of Mild To Moderate Infections Caused By Susceptible Strains Of The Designated Microorganisms In The Conditions As Listed Below: Adults (clarithromycin Tablet) 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 Is Generally Effective In The Eradication Of S. Pyogenes From The Nasopharynx; However, Data Establishing The Efficacy Of Clarithromycin 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 Chlamydia 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 Tablet 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 Tablet In Combination With Prilosec (omeprazole) Capsules Or Tritec (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 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 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 Tablet) Pharyngitis/tonsillitis Due To Streptococcus Pyogenes. Community-Acquired Pneumonia Due To Mycoplasma Pneumoniae, Streptococcus Pneumoniae, Or Chlamydia 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 Clarithromycin Tablet Is Indicated For The Prevention Of Disseminated Mycobacterium Avium Complex (mac) Disease In Patients With Advanced Hiv Infection.

All Formulated Excipients (6 Total)

Name Structure Kind Function Status
1. Lactose Monohydrate LACTOSE MONOHYDRATE Molecular
2. Silicon Dioxide SILICON DIOXIDE Unresolved AC-Anticaking agent , MISC-Miscellaneous , STAB-Stabilizer GRAS-Generally recognized as safe.
3. Talc TALC Unresolved DYE-Dye GRAS-Generally recognized as safe.
4. 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.
5. Hypromelloses HYPROMELLOSES Unresolved
6. Titanium Dioxide TITANIUM DIOXIDE Unresolved DYE-Dye

Active Ingredients ( 1 Total)

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

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