Application Nr Approved Date Route Status External Links
ANDA065387 2007-03-26 Oral RX Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

1 Indications And Usage Amoxicillin Is A Penicillin-Class Antibacterial Indicated For Treatment Of Infections Due To Susceptible Strains Of Designated Microorganisms. •infections Of The Ear, Nose, Throat, Genitourinary Tract, Skin And Skin Structure, And Lower Respiratory Tract. (1.1 – 1.5) •in Combination For Treatment Of H. Pylori Infection And Duodenal Ulcer Disease. (1.5) To Reduce The Development Of Drug-Resistant Bacteria And Maintain The Effectiveness Of Amoxicillin And Other Antibacterial Drugs, Amoxicillin Should Be Used Only To Treat Infections That Are Proven Or Strongly Suspected To Be Caused By Bacteria. (1.6) 1.1 Infections Of The Ear, Nose, And Throat Amoxicillin Is Indicated In The Treatment Of Infections Due To Susceptible (only Β-Lactamase–negative) Isolates Of Streptococcus Species. (α- And Β-Hemolytic Isolates Only), Streptococcus Pneumoniae, Staphylococcus Spp., Or Haemophilusinfluenzae. 1.2 Infections Of The Genitourinary Tract Amoxicillin Is Indicated In The Treatment Of Infections Due To Susceptible (only Β-Lactamase–negative) Isolates Of Escherichia Coli, Proteus Mirabilis, Or Enterococcus Faecalis. 1.3 Infections Of The Skin And Skin Structure Amoxicillin Is Indicated In The Treatment Of Infections Due To Susceptible (only Β-Lactamase–negative) Isolates Of Streptococcus Spp. (α- And Β-Hemolytic Isolates Only), Staphylococcus Spp., Or E. Coli. 1.4 Infections Of The Lower Respiratory Tract Amoxicillin Is Indicated In The Treatment Of Infections Due To Susceptible (only Β-Lactamase–negative) Isolates Of Streptococcus Spp. (α- And Β-Hemolytic Isolates Only), S. Pneumoniae, Staphylococcus Spp., Or H. Influenzae. 1.5 Helicobacter Pylori Infection Triple Therapy For Helicobacter Pylori With Clarithromycin And Lansoprazole Amoxicillin, In Combination With Clarithromycin Plus Lansoprazole As Triple Therapy, Is Indicated For The Treatment Of Patients With H. Pylori Infection And Duodenal Ulcer Disease (active Or 1-Year History Of A Duodenal Ulcer) To Eradicate H. Pylori. Eradication Of H. Pylori Has Been Shown To Reduce The Risk Of Duodenal Ulcer Recurrence. Dual Therapy For H. Pylori With Lansoprazole Amoxicillin, In Combination With Lansoprazole Delayed-Release Capsules As Dual Therapy, Is Indicated For The Treatment Of Patients With H. Pylori Infection And Duodenal Ulcer Disease (active Or 1-Year History Of A Duodenal Ulcer) Who Are Either Allergic Or Intolerant To Clarithromycin Or In Whom Resistance To Clarithromycin Is Known Or Suspected. (see The Clarithromycin Package Insert, Microbiology.) Eradication Of H. Pylori Has Been Shown To Reduce The Risk Of Duodenal Ulcer Recurrence. 1.6 Usage To Reduce The Development Of Drug-Resistant Bacteria And Maintain The Effectiveness Of Amoxicillin And Other Antibacterial Drugs, Amoxicillin Should Be Used Only To Treat 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.

All Formulated Excipients (5 Total)

Name Structure Kind Function Status
1. Titanium Dioxide TITANIUM DIOXIDE Unresolved DYE-Dye
2. Gelatin GELATIN Unresolved
3. Ferrosoferric Oxide FERROSOFERRIC OXIDE Molecular
4. Shellac SHELLAC Unresolved
5. Propylene Glycol PROPYLENE GLYCOL Molecular MISC-Miscellaneous FS-Substances permitted as optional ingredient in a standardized food.

Active Ingredients ( 1 Total)

Name Structure ZINC ID(s)
1. Amoxicillin AMOXICILLIN ZINC3830215

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