Application Nr Approved Date Route Status External Links
NDA205436 None Intravenous None Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

1 Indications And Usage Sivextro Is An Oxazolidinone-Class Antibacterial Drug Indicated In Adult And Pediatric Patients 12 Years Of Age And Older For The Treatment Of Acute Bacterial Skin And Skin Structure Infections (Absssi) Caused By Designated Susceptible Bacteria. ( 1.1 ) To Reduce The Development Of Drug-Resistant Bacteria And Maintain The Effectiveness Of Sivextro And Other Antibacterial Drugs, Sivextro Should Be Used Only To Treat Or Prevent Infections That Are Proven Or Strongly Suspected To Be Caused By Susceptible Bacteria. 1.1 Acute Bacterial Skin And Skin Structure Infections Sivextro ® Is An Oxazolidinone-Class Antibacterial Indicated In Adult And Pediatric Patients 12 Years Of Age And Older For The Treatment Of Acute Bacterial Skin And Skin Structure Infections (Absssi) Caused By Susceptible Isolates Of The Following Gram-Positive Microorganisms: Staphylococcus Aureus (Including Methicillin-Resistant [Mrsa] And Methicillin-Susceptible [Mssa] Isolates), Streptococcus Pyogenes , Streptococcus Agalactiae , Streptococcus Anginosus Group (Including Streptococcus Anginosus , Streptococcus Intermedius , And Streptococcus Constellatus ), And Enterococcus Faecalis . 1.2 Usage To Reduce The Development Of Drug-Resistant Bacteria And Maintain The Effectiveness Of Sivextro And Other Antibacterial Drugs, Sivextro Should Be Used Only To Treat Absssi 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. Tedizolid Phosphate

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