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)

None

Active Ingredients ( 1 Total)

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

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