Application Nr Approved Date Route Status External Links
ANDA204652 2017-07-07 Oral RX Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

Indications And Usage Flucytosine Capsules Usp Is Indicated Only In The Treatment Of Serious Infections Caused By Susceptible Strains Of Candida And/or Cryptococcus. Candida: Septicemia, Endocarditis And Urinary System Infections Have Been Effectively Treated With Flucytosine. Limited Trials In Pulmonary Infections Justify The Use Of Flucytosine. Cryptococcus: Meningitis And Pulmonary Infections Have Been Treated Effectively. Studies In Septicemias And Urinary Tract Infections Are Limited, But Good Responses Have Been Reported. Flucytosine Capsules Usp Should Be Used In Combination With Amphotericin B For The Treatment Of Systemic Candidiasis And Cryptococcosis Because Of The Emergence Of Resistance To Flucytosine Capsules Usp (see Microbiology).

All Formulated Excipients (9 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. Talc TALC Unresolved DYE-Dye GRAS-Generally recognized as safe.
3. Water WATER Molecular
4. Ferrosoferric Oxide FERROSOFERRIC OXIDE Molecular
5. Fd&c Blue No. 1 FD&C BLUE NO. 1 Molecular DYE-Dye
6. Shellac SHELLAC Unresolved
7. Potassium Hydroxide POTASSIUM HYDROXIDE Molecular B&N-Buffer & neutralizing agent , MISC-Miscellaneous FS-Substances permitted as optional ingredient in a standardized food.
8. Titanium Dioxide TITANIUM DIOXIDE Unresolved DYE-Dye
9. Povidones POVIDONES Unresolved

Active Ingredients ( 1 Total)

Name Structure ZINC ID(s)
1. Flucytosine FLUCYTOSINE ZINC896546