Application Nr Approved Date Route Status External Links
NDA020255 None Intravenous None Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

Indications And Usage Dobutamine Hydrochloride In 5% Dextrose Injection Is Indicated When Parenteral Therapy Is Necessary For Inotropic Support In The Short-Term Treatment Of Patients With Cardiac Decompensation Due To Depressed Contractility Resulting Either From Organic Heart Disease Or From Cardiac Surgical Procedures. Experience With Intravenous Dobutamine In Controlled Trials Does Not Extend Beyond 48 Hours Of Repeated Boluses And/or Continuous Infusions. Whether Given Orally, Continuously Intravenously, Or Intermittently Intravenously, Neither Dobutamine Nor Any Other Cyclic-Amp-Dependent Inotrope Has Been Shown In Controlled Trials To Be Safe Or Effective In The Long-Term Treatment Of Congestive Heart Failure. In Controlled Trials Of Chronic Oral Therapy With Various Such Agents, Symptoms Were Not Consistently Alleviated, And The Cyclic-Amp-Dependent Inotropes Were Consistently Associated With Increased Risks Of Hospitalization And Death. Patients With Nyha Class Iv Symptoms Appeared To Be At Particular Risk.

All Formulated Excipients (0 Total)

None

Active Ingredients ( 1 Total)

Name Structure ZINC ID(s)
1. Dobutamine Hydrochloride DOBUTAMINE HYDROCHLORIDE ZINC57278

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