Application Nr Approved Date Route Status External Links
ANDA065358 2007-08-13 Oral 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 Amoxicillin And Clavulanate Potassium For Oral Suspension, Usp And Other Antibacterial Drugs, Amoxicillin And Clavulanate Potassium For Oral Suspension, Usp Should Be Used Only To Treat 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. Amoxicillin And Clavulanate Potassium For Oral Suspension, Usp Is Indicated For The Treatment Of Pediatric Patients With Recurrent Or Persistent Acute Otitis Media Due To S. Pneumoniae (penicillin Mics ≤2 Mcg/ml), H. Influenzae (including Beta-Lactamase-Producing Strains), Or M. Catarrhalis (including Beta-Lactamase-Producing Strains) Characterized By The Following Risk Factors: •antibacterial Drug Exposure For Acute Otitis Media Within The Preceding 3 Months, And Either Of The Following: -Age 2 Years Or Younger -Daycare Attendance [see Clinical Pharmacology, Microbiology (12.4) ] Note: Acute Otitis Media Due To S. Pneumoniae Alone Can Be Treated With Amoxicillin. Amoxicillin And Clavulanate Potassium For Oral Suspension, Usp Is Not Indicated For The Treatment Of Acute Otitis Media Due To S. Pneumoniae With Penicillin Mic ≥4 Mcg/ml. Therapy May Be Instituted Prior To Obtaining The Results From Bacteriological Studies When There Is Reason To Believe The Infection May Involve Both S. Pneumoniae (penicillin Mic ≤2 Mcg/ml) And The Beta-Lactamase-Producing Organisms Listed Above. Amoxicillin And Clavulanate Potassium For Oral Suspension, Usp Is Indicated For The Treatment Of Pediatric Patients With Recurrent Or Persistent Acute Otitis Media Due To S. Pneumoniae (penicillin Mics ≤2 Mcg/ml), H. Influenzae (including Beta-Lactamase-Producing Strains), Or M. Catarrhalis (including Beta-Lactamase-Producing Strains) Characterized By The Following Risk Factors. (1) •antibacterial Drug Exposure For Acute Otitis Media Within The Preceding 3 Months, And Either Of The Following: 1) Age 2 Years Or Younger 2) Daycare Attendance.

All Formulated Excipients (5 Total)

Name Structure Kind Function Status
1. Citric Acid Monohydrate CITRIC ACID MONOHYDRATE Molecular
2. Silicon Dioxide SILICON DIOXIDE Unresolved AC-Anticaking agent , MISC-Miscellaneous , STAB-Stabilizer GRAS-Generally recognized as safe.
3. Cellulose, Microcrystalline CELLULOSE, MICROCRYSTALLINE Unresolved
4. Saccharin Sodium SACCHARIN SODIUM Molecular
5. Sodium Citrate, Unspecified Form SODIUM CITRATE, UNSPECIFIED FORM Molecular

Active Ingredients ( 2 Total)

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