Application Nr Approved Date Route Status External Links
ANDA074077 None Oral None Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

Indications And Usage For The Prevention And Treatment Of Portal-Systemic Encephalopathy, Including The Stages Of Hepatic Pre-Coma And Coma. Controlled Studies Have Shown That Lactulose Solution Therapy Reduced The Blood Ammonia Levels By 25-50%; This Is Generally Paralleled By An Improvement In The Patients’ Mental State And By An Improvement In Eeg Patterns. The Clinical Response Has Been Observed In About 75% Of The Patients, Which Is At Least As Satisfactory As That Resulting From Neomycin Therapy. An Increase In Patients’ Protein Tolerance Is Also Frequently Observed With Lactulose Therapy. In The Treatment Of Chronic Portal-Systemic Encephalopathy, Lactulose Has Been Given For Over 2 Years In Controlled Studies.

All Formulated Excipients (0 Total)

None

Active Ingredients ( 1 Total)

Name Structure ZINC ID(s)
1. Lactulose LACTULOSE ZINC3977952

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