Application Nr Approved Date Route Status External Links
NDA050824 2011-02-08 None 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 Omeclamox-Pak™ And Other Antibacterial Drugs, Omeclamox-Pak™ Should Be Used Only To Treat Or Prevent Infections That Are Proven Or Strongly Suspected To Be Caused By 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. Omeclamox-Pak™, A Copackaged Product Containing A Proton Pump Inhibitor, A Macrolide Antimicrobial, And A Penicillin Class Antibacterial, Is Indicated For The Treatment Of Patients With Helicobacter Pylori Infection And Duodenal Ulcer Disease (active Or Up To One-Year History) To Eradicate H. Pylori. (1.1) 1.1 Eradication Of Helicobacter Pylori In Patients With Active Duodenal Ulcer Or History Of Duodenal Ulcer Disease Omeprazole Delayed-Release Capsules, Clarithromycin Tablets, And Amoxicillin Capsules Taken Together Are Indicated For The Treatment Of Patients With Helicobacter Pylori Infection And Duodenal Ulcer Disease (active Or One-Year History) To Eradicate H. Pylori In Adults. Eradication Of H. Pylori Has Been Shown To Reduce The Risk Of Duodenal Ulcer Recurrence [see Clinical Studies (14.1) ]. In Patients Who Fail Therapy With Omeclamox-Pak™, Perform Susceptibility Testing. If Resistance To Clarithromycin Is Demonstrated Or Susceptibility Testing Is Not Possible, Institute Alternative Antimicrobial Therapy [see Clinical Pharmacology, Microbiology (12.4) ].

All Formulated Excipients (6 Total)

Name Structure Kind Function Status
1. Hypromelloses HYPROMELLOSES Unresolved
2. Lactose, Unspecified Form LACTOSE, UNSPECIFIED FORM 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. Mannitol MANNITOL Molecular NUTR-Nutrient GRAS-Generally recognized as safe.
5. Meglumine MEGLUMINE Molecular
6. Methacrylic Acid Copolymer METHACRYLIC ACID COPOLYMER Unresolved

Active Ingredients ( 3 Total)