Application Nr Approved Date Route Status External Links
ANDA201722 2016-02-16 Oral RX Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

Indications And Usage: Nitrofurantoin Capsules, Usp (macrocrystals) Is Specifically Indicated For The Treatment Of Urinary Tract Infections When Due To Susceptible Strains Of Escherichia Coli, Enterococci, Staphylococcus Aureus, And Certain Susceptible Strains Of Klebsiella And Enterobacter Species. 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 (macrocrystals) And Other Antibacterial Drugs, Nitrofurantoin Capsules, Usp (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 (macrocrystals) Are Predisposed To Persistence Or Reappearance Of Bacteriuria. 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 (macrocrystals), Other Therapeutic Agents With Broader Tissue Distribution Should Be Selected. In Considering The Use Of Nitrofurantoin Capsules, Usp (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 (8 Total)

Name Structure Kind Function Status
1. Lactose Monohydrate LACTOSE MONOHYDRATE Molecular
2. Starch, Corn STARCH, CORN Unresolved
3. Talc TALC Unresolved DYE-Dye GRAS-Generally recognized as safe.
4. Titanium Dioxide TITANIUM DIOXIDE Unresolved DYE-Dye
5. Gelatin GELATIN Unresolved
6. Sodium Lauryl Sulfate SODIUM LAURYL SULFATE Molecular AF-Antifoaming (or defoaming) agent , CTG-Component or coating , EMUL-Emulsifier , SANI-Sanitizing agent , SDA-Solubilizing & dispersing agent REG-Food additives for which a petition has been filed and a regulation issued.
7. Shellac SHELLAC Unresolved
8. 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. Nitrofurantoin NITROFURANTOIN ZINC3875368