Application Nr Approved Date Route Status External Links
ANDA077066 2005-04-05 Oral RX Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

Indications And Usage Nitrofurantoin Capsules Usp (monohydrate/macrocrystals) Are Indicated Only For The Treatment Of Acute Uncomplicated Urinary Tract Infections (acute Cystitis) Caused By Susceptible Strains Of Escherichia Coli Or Staphylococcus Saprophyticus. Nitrofurantoin Is Not Indicated For The Treatment Of Pyelonephritis Or Perinephric Abscesses. To Reduce The Development Of Drug-Resistant Bacteria And Maintain The Effectiveness Of Nitrofurantoin Capsules Usp (monohydrate/macrocrystals) And Other Antibacterial Drugs, Nitrofurantoin Capsules Usp (monohydrate/macrocrystals) 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. Nitrofurantoins Lack The Broader Tissue Distribution Of Other Therapeutic Agents Approved For Urinary Tract Infections. Consequently, Many Patients Who Are Treated With Nitrofurantoin Capsules Usp (monohydrate/macrocrystals) Are Predisposed To Persistence Or Reappearance Of Bacteriuria (see Clinical Studies ). Urine Specimens For Culture And Susceptibility Testing Should Be Obtained Before And After Completion Of Therapy. If Persistence Or Reappearance Of Bacteriuria Occurs After Treatment With Nitrofurantoin Capsules Usp (monohydrate/macrocrystals), Other Therapeutic Agents With Broader Tissue Distribution Should Be Selected. In Considering The Use Of Nitrofurantoin Capsules Usp (monohydrate/macrocrystals), Lower Eradication Rates Should Be Balanced Against The Increased Potential For Systemic Toxicity And For The Development Of Antimicrobial Resistance When Agents With Broader Tissue Distribution Are Utilized.

All Formulated Excipients (3 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. Starch, Corn STARCH, CORN Unresolved
3. Compressible Sugar COMPRESSIBLE SUGAR Molecular

Active Ingredients ( 2 Total)