Application Nr Approved Date Route Status External Links
NDA022275 None Oral None Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

1 Indications And Usage Samsca ® Is Indicated For The Treatment Of Clinically Significant Hypervolemic And Euvolemic Hyponatremia (serum Sodium <125 Meq/l Or Less Marked Hyponatremia That Is Symptomatic And Has Resisted Correction With Fluid Restriction), Including Patients With Heart Failure And Syndrome Of Inappropriate Antidiuretic Hormone (siadh). Samsca Is A Selective Vasopressin V 2 -Receptor Antagonist Indicated For The Treatment Of Clinically Significant Hypervolemic And Euvolemic Hyponatremia [serum Sodium <125 Meq/l Or Less Marked Hyponatremia That Is Symptomatic And Has Resisted Correction With Fluid Restriction], Including Patients With Heart Failure And Syndrome Of Inappropriate Antidiuretic Hormone (siadh) ( 1 ) Important Limitations: Patients Requiring Intervention To Raise Serum Sodium Urgently To Prevent Or To Treat Serious Neurological Symptoms Should Not Be Treated With Samsca ( 1 ) It Has Not Been Established That Samsca Provides A Symptomatic Benefit To Patients ( 1 ) Important Limitations Patients Requiring Intervention To Raise Serum Sodium Urgently To Prevent Or To Treat Serious Neurological Symptoms Should Not Be Treated With Samsca. It Has Not Been Established That Raising Serum Sodium With Samsca Provides A Symptomatic Benefit To Patients.

All Formulated Excipients (0 Total)

None

Active Ingredients ( 1 Total)

Name Structure ZINC ID(s)
1. Tolvaptan TOLVAPTAN ZINC1490477

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