Application Nr Approved Date Route Status External Links
ANDA079157 None Intravenous None Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

1 Indications And Usage Myocardial Imaging: Technetium Tc 99m Sestamibi Injection Is A Myocardial Perfusion Agent That Is Indicated For Detecting Coronary Artery Disease By Localizing Myocardial Ischemia (Reversible Defects) And Infarction (Non-Reversible Defects), In Evaluating Myocardial Function And Developing Information For Use In Patient Management Decisions. Technetium Tc 99m Sestamibi Evaluation Of Myocardial Ischemia Can Be Accomplished With Rest And Cardiovascular Stress Techniques (E.g., Exercise Or Pharmacologic Stress In Accordance With The Pharmacologic Stress Agent’s Labeling). It Is Usually Not Possible To Determine The Age Of A Myocardial Infarction Or To Differentiate A Recent Myocardial Infarction From Ischemia. Breast Imaging: Technetium Tc 99m Sestamibi Is Indicated For Planar Imaging As A Second Line Diagnostic Drug After Mammography To Assist In The Evaluation Of Breast Lesions In Patients With An Abnormal Mammogram Or A Palpable Breast Mass. Technetium Tc 99m Sestamibi Is Not Indicated For Breast Cancer Screening, To Confirm The Presence Or Absence Of Malignancy, And It Is Not An Alternative To Biopsy. Technetium Tc 99m Sestamibi, Is A Myocardial Perfusion Agent Indicated For: • Detecting Coronary Artery Disease By Localizing Myocardial Ischemia (Reversible Defects) And Infarction (Non-Reversible Defects) ( 1 ) • Evaluating Myocardial Function And Developing Information For Use In Patient Management Decisions ( 1 )

All Formulated Excipients (0 Total)

None

Active Ingredients ( 1 Total)

Name Structure ZINC ID(s)
1. Technetium Tc-99m Sestamibi

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