Application Nr Approved Date Route Status External Links
ANDA077746 2006-09-12 Oral RX Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

Indications And Usage Midodrine Hydrochloride Is Indicated For The Treatment Of Symptomatic Orthostatic Hypotension (oh). Because Midodrine Hydrochloride Can Cause Marked Elevation Of Supine Blood Pressure (bp>200 Mmhg Systolic), It Should Be Used In Patients Whose Lives Are Considerably Impaired Despite Standard Clinical Care, Including Non-Pharmacologic Treatment (such As Support Stockings), Fluid Expansion, And Lifestyle Alterations. The Indication Is Based On Midodrine Hydrochloride's Effect On Increases In 1-Minute Standing Systolic Blood Pressure, A Surrogate Marker Considered Likely To Correspond To A Clinical Benefit. At Present, However, Clinical Benefits Of Midodrine Hydrochloride, Principally Improved Ability To Perform Life Activities, Have Not Been Established. Further Clinical Trials Are Underway To Verify And Describe The Clinical Benefits Of Midodrine Hydrochloride. After Initiation Of Treatment, Midodrine Hydrochloride Should Be Continued Only For Patients Who Report Significant Symptomatic Improvement.

All Formulated Excipients (2 Total)

Name Structure Kind Function Status
1. Magnesium Stearate MAGNESIUM STEARATE Molecular AF-Antifoaming (or defoaming) agent , MISC-Miscellaneous REG-Food additives for which a petition has been filed and a regulation issued.
2. Cellulose, Microcrystalline CELLULOSE, MICROCRYSTALLINE Unresolved

Active Ingredients ( 1 Total)

Name Structure ZINC ID(s)
1. Midodrine Hydrochloride MIDODRINE HYDROCHLORIDE ZINC507

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