Application Nr Approved Date Route Status External Links
NDA020666 None Oral None Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

Indications And Usage Albendazole Is Indicated For The Treatment Of The Following Infections: Neurocysticercosis: Albendazole Is Indicated For The Treatment Of Parenchymal Neurocysticercosis Due To Active Lesions Caused By Larval Forms Of The Pork Tapeworm, Taenia Solium . Lesions Considered Responsive To Albendazole Therapy Appear As Nonenhancing Cysts With No Surrounding Edema On Contrast-Enhanced Computerized Tomography. Clinical Studies In Patients With Lesions Of This Type Demonstrate A 74% To 88% Reduction In Number Of Cysts; 40% To 70% Of Albendazole-Treated Patients Showed Resolution Of All Active Cysts. Hydatid Disease: Albendazole Is Indicated For The Treatment Of Cystic Hydatid Disease Of The Liver, Lung, And Peritoneum, Caused By The Larval Form Of The Dog Tapeworm, Echinococcus Granulosus . This Indication Is Based On Combined Clinical Studies Which Demonstrated Non-Infectious Cyst Contents In Approximately 80 To 90% Of Patients Given Albendazole For 3 Cycles Of Therapy Of 28 Days Each (see Dosage And Administration ). Clinical Cure (disappearance Of Cysts) Was Seen In Approximately 30% Of These Patients, And Improvement (reduction In Cyst Diameter Of ≥25%) Was Seen In An Additional 40%. Note: When Medically Feasible, Surgery Is Considered The Treatment Of Choice For Hydatid Disease. When Administering Albendazole In The Pre- Or Post-Surgical Setting, Optimal Killing Of Cyst Contents Is Achieved When 3 Courses Of Therapy Have Been Given. Note: The Efficacy Of Albendazole In The Therapy Of Alveolar Hydatid Disease Caused By Echinococcus Multilocularis Has Not Been Clearly Demonstrated In Clinical Studies.

All Formulated Excipients (0 Total)


Active Ingredients ( 1 Total)

Name Structure ZINC ID(s)
1. Albendazole ALBENDAZOLE ZINC17146904