Application Nr Approved Date Route Status External Links
ANDA076899 2005-01-27 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 Sulfamethoxazole And Trimethoprim Tablets And Other Antibacterial Drugs, Sulfamethoxazole And Trimethoprim 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. Urinary Tract Infections For The Treatment Of Urinary Tract Infections Due To Susceptible Strains Of The Following Organisms: Escherichia Coli, Klebsiella Species, Enterobacter Species, Morganella Morganii, Proteus Mirabilis And Proteus Vulgaris. It Is Recommended That Initial Episodes Of Uncomplicated Urinary Tract Infections Be Treated With A Single Effective Antibacterial Agent Rather Than The Combination. Acute Otitis Media For The Treatment Of Acute Otitis Media In Pediatric Patients Due To Susceptible Strains Of Streptococcus Pneumoniae Or Haemophilus Influenzae When In The Judgment Of The Physician Sulfamethoxazole And Trimethoprim Offers Some Advantage Over The Use Of Other Antimicrobial Agents. To Date, There Are Limited Data On The Safety Of Repeated Use Of Sulfamethoxazole And Trimethoprim In Pediatric Patients Under Two Years Of Age. Sulfamethoxazole And Trimethoprim Is Not Indicated For Prophylactic Or Prolonged Administration In Otitis Media At Any Age. Acute Exacerbations Of Chronic Bronchitis In Adults For The Treatment Of Acute Exacerbations Of Chronic Bronchitis Due To Susceptible Strains Of Streptococcus Pneumoniae Or Haemophilus Influenzae When In The Judgment Of The Physician Sulfamethoxazole And Trimethoprim Offers Some Advantage Over The Use Of A Single Antimicrobial Agent. Shigellosis For The Treatment Of Enteritis Caused By Susceptible Strains Of Shigella Flexneri And Shigella Sonnei When Antibacterial Therapy Is Indicated. Pneumocystis Carinii Pneumonia For The Treatment Of Documented Pneumocystis Carinii Pneumonia And For Prophylaxis Against Pneumocystis Carinii Pneumonia In Individuals Who Are Immunosuppressed And Considered To Be At An Increased Risk Of Developing Pneumocystis Carinii Pneumonia. Traveler’s Diarrhea In Adults For The Treatment Of Traveler’s Diarrhea Due To Susceptible Strains Of Enterotoxigenic E. Coli.

All Formulated Excipients (2 Total)

Name Structure Kind Function Status
1. 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.
2. Povidones POVIDONES Unresolved

Active Ingredients ( 2 Total)

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