Application Nr Approved Date Route Status External Links
NDA211962 None Intravenous None Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

1 Indications And Usage Vancomycin Injection, Usp Is A Glycopeptide Antibacterial Indicated In Adult And Pediatric Patients (1 Month And Older) For The Treatment Of: Septicemia ( 1.1 ) Infective Endocarditis ( 1.2 ) Skin And Skin Structure Infections ( 1.3 ) Bone Infections ( 1.4 ) Lower Respiratory Tract Infections ( 1.5 ) To Reduce The Development Of Drug-Resistant Bacteria And Maintain The Effectiveness Of Vancomycin Injection, Usp And Other Antibacterial Drugs, Vancomycin Injection, Usp Should Be Used Only To Treat Or Prevent Infections That Are Proven Or Strongly Suspected To Be Caused By Susceptible Bacteria. ( 1.6 ) 1.1 Septicemia Vancomycin Injection, Usp Is Indicated In Adults And Pediatric Patients (1 Month And Older) For The Treatment Of Septicemia Due To: Susceptible Isolates Of Methicillin-Resistant Staphylococcus Aureus (Mrsa) And Coagulase Negative Staphylococci. Methicillin-Susceptible Staphylococci In Penicillin-Allergic Patients, Or Those Patients Who Cannot Receive Or Who Have Failed To Respond To Other Drugs, Including Penicillins Or Cephalosporins. 1.2 Infective Endocarditis Vancomycin Injection, Usp Is Indicated In Adults And Pediatric Patients (1 Month And Older) For The Treatment Of Infective Endocarditis Due To: Susceptible Isolates Of Mrsa. Viridans Group Streptococci Streptococcus Gallolyticus (Previously Known As Streptococcus Bovis ), Enterococcus Species And Corynebacterium Species. For Enterococcal Endocarditis, Use Vancomycin Injection, Usp In Combination With An Aminoglycoside. Methicillin-Susceptible Staphylococci In Penicillin-Allergic Patients, Or Those Patients Who Cannot Receive Or Who Have Failed To Respond To Other Drugs, Including Penicillins Or Cephalosporins. Vancomycin Injection, Usp Is Indicated In Adults And Pediatric Patients (1 Month And Older) For The Treatment Of Early-Onset Prosthetic Valve Endocarditis Caused By Staphylococcus Epidermidis In Combination With Rifampin And An Aminoglycoside. 1.3 Skin And Skin Structure Infections Vancomycin Injection, Usp Is Indicated In Adults And Pediatric Patients (1 Month And Older) For The Treatment Of Skin And Skin Structure Infections Due To: Susceptible Isolates Of Mrsa And Coagulase Negative Staphylococci. Methicillin-Susceptible Staphylococci In Penicillin-Allergic Patients, Or Those Patients Who Cannot Receive Or Who Have Failed To Respond To Other Drugs, Including Penicillins Or Cephalosporins. 1.4 Bone Infections Vancomycin Injection, Usp Is Indicated In Adults And Pediatric Patients (1 Month And Older) For The Treatment Of Bone Infections Due To: Susceptible Isolates Of Mrsa And Coagulase Negative Staphylococci. Methicillin-Susceptible Staphylococci In Penicillin-Allergic Patients, Or Those Patients Who Cannot Receive Or Who Have Failed To Respond To Other Drugs, Including Penicillins Or Cephalosporins. 1.5 Lower Respiratory Tract Infections Vancomycin Injection, Usp Is Indicated In Adults And Pediatric Patients (1 Month And Older) For The Treatment Of Lower Respiratory Tract Infections Due To: Susceptible Isolates Of Mrsa Methicillin-Susceptible Staphylococci In Penicillin-Allergic Patients, Or Those Patients Who Cannot Receive Or Who Have Failed To Respond To Other Drugs, Including Penicillins Or Cephalosporins. 1.6 Usage To Reduce The Development Of Drug-Resistant Bacteria And Maintain The Effectiveness Of Vancomycin Injection, Usp And Other Antibacterial Drugs, Vancomycin Injection, Usp Should Be Used Only To Treat Or Prevent 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. Vancomycin

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