Application Nr Approved Date Route Status External Links
NDA022110 None Intravenous None Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

1 Indications And Usage Vibativ Is A Lipoglycopeptide Antibacterial Drug Indicated For The Treatment Of The Following Infections In Adult Patients Caused By Designated Susceptible Bacteria: Complicated Skin And Skin Structure Infections (Csssi) ( 1.1 ) Hospital-Acquired And Ventilator-Associated Bacterial Pneumonia (Habp/vabp) Caused By Susceptible Isolates Of Staphylococcus Aureus . Vibativ Should Be Reserved For Use When Alternative Treatments Are Not Suitable. ( 1.2 ) To Reduce The Development Of Drug-Resistant Bacteria And Maintain The Effectiveness Of Vibativ And Other Antibacterial Drugs Vibativ Should Only Be Used To Treat Or Prevent Infections That Are Proven Or Strongly Suspected To Be Caused By Bacteria. 1.1 Complicated Skin And Skin Structure Infections Vibativ Is Indicated For The Treatment Of Adult Patients With Complicated Skin And Skin Structure Infections (Csssi) Caused By Susceptible Isolates Of The Following Gram-Positive Microorganisms: Staphylococcus Aureus (Including Methicillin-Susceptible And -Resistant Isolates), Streptococcus Pyogenes , Streptococcus Agalactiae , Streptococcus Anginosus Group (Includes S. Anginosus, S. Intermedius, And S. Constellatus) , Or Enterococcus Faecalis (Vancomycin-Susceptible Isolates Only). 1.2 Habp/vabp Vibativ Is Indicated For The Treatment Of Adult Patients With Hospital-Acquired And Ventilator-Associated Bacterial Pneumonia (Habp/vabp), Caused By Susceptible Isolates Of Staphylococcus Aureus (Both Methicillin-Susceptible And -Resistant Isolates). Vibativ Should Be Reserved For Use When Alternative Treatments Are Not Suitable. 1.3 Usage Combination Therapy May Be Clinically Indicated If The Documented Or Presumed Pathogens Include Gram-Negative Organisms. Appropriate Specimens For Bacteriological Examination Should Be Obtained In Order To Isolate And Identify The Causative Pathogens And To Determine Their Susceptibility To Telavancin. Vibativ May Be Initiated As Empiric Therapy Before Results Of These Tests Are Known. To Reduce The Development Of Drug-Resistant Bacteria And Maintain The Effectiveness Of Vibativ And Other Antibacterial Drugs, Vibativ Should Be Used Only To Treat Infections That Are Proven Or Strongly Suspected To Be Caused By Susceptible Bacteria. When Culture And Susceptibility Information Are Available, They Should Be Considered In Selecting Or Modifying Antibacterial Therapy. In The Absence Of Such Data, Local Epidemiology And Susceptibility Patterns May Contribute To The Empiric Selection Of Therapy.

All Formulated Excipients (0 Total)

None

Active Ingredients ( 1 Total)

Name Structure ZINC ID(s)
1. Telavancin Hydrochloride

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