Application Nr Approved Date Route Status External Links
ANDA065096 2002-10-29 Oral RX Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

Indications And Usage Amoxicillin And Clavulanate Potassium Tablets Are Indicated In The Treatment Of Infections Caused By Susceptible Strains Of The Designated Organisms In The Conditions Listed Below: Lower Respiratory Tract Infections Caused By Β-Lactamase-Producing Strains Of H. Influenzae And M. Catarrhalis. Otitis Media Caused By Β-Lactamase-Producing Strains Of H. Influenzae And M. Catarrhalis. Sinusitis Caused By Β-Lactamase-Producing Strains Of H. Influenzae And M. Catarrhalis. Skin And Skin Structure Infections Caused By Β-Lactamase-Producing Strains Of S. Aureus, E. Coli, And Klebsiella Spp. Urinary Tract Infections Caused By Β-Lactamase-Producing Strains Of E. Coli, Klebsiella Spp., And Enterobacter Spp. While Amoxicillin And Clavulanate Potassium Tablets Are Indicated Only For The Conditions Listed Above, Infections Caused By Ampicillin-Susceptible Organisms Are Also Amenable To Treatment With Amoxicillin And Clavulanate Potassium Tablets Due To Their Amoxicillin Content; Therefore, Mixed Infections Caused By Ampicillin-Susceptible Organisms And Β-Lactamase-Producing Organisms Susceptible To Amoxicillin And Clavulanate Potassium Should Not Require The Addition Of Another Antibiotic. Because Amoxicillin Has Greater In Vitro Activity Against S. Pneumoniae Than Does Ampicillin Or Penicillin, The Majority Of S. Pneumoniae Strains With Intermediate Susceptibility To Ampicillin Or Penicillin Are Fully Susceptible To Amoxicillin And Amoxicillin And Clavulanate Potassium (see Microbiology). To Reduce The Development Of Drug-Resistant Bacteria And Maintain The Effectiveness Of Amoxicillin And Clavulanate Potassium Tablets And Other Antibacterial Drugs, Amoxicillin And Clavulanate Potassium 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. Bacteriological Studies, To Determine The Causative Organisms And Their Susceptibility To Amoxicillin And Clavulanate Potassium, Should Be Performed Together With Any Indicated Surgical Procedures.

All Formulated Excipients (7 Total)

Name Structure Kind Function Status
1. Silicon Dioxide SILICON DIOXIDE Unresolved AC-Anticaking agent , MISC-Miscellaneous , STAB-Stabilizer GRAS-Generally recognized as safe.
2. Hypromelloses HYPROMELLOSES Unresolved
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. Polydextrose POLYDEXTROSE Unresolved MISC-Miscellaneous REG-Food additives for which a petition has been filed and a regulation issued.
6. Polyethylene Glycols POLYETHYLENE GLYCOLS Unresolved
7. Titanium Dioxide TITANIUM DIOXIDE Unresolved DYE-Dye

Active Ingredients ( 2 Total)

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