Application Nr Approved Date Route Status External Links
ANDA201679 None Oral None Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

Indications & Usage Nitrofurantoin Oral Suspension 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 Oral Suspension Is Not Indicated For The Treatment Of Pyelonephritis Or Perinephric Abscesses. Nitrofurantoins Lack The Broader Tissue Distribution Of Other Therapeutic Agents Approved For Urinary Tract Infections. Consequently, Many Patients Who Are Treated With Nitrofurantoin Oral Suspension 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 Oral Suspension, Other Therapeutic Agents With Broader Tissue Distribution Should Be Selected. In Considering The Use Of Nitrofurantoin Oral Suspension, 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 (0 Total)

None

Active Ingredients ( 1 Total)

Name Structure ZINC ID(s)
1. Nitrofurantoin NITROFURANTOIN ZINC3875368

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