1INDICATIONS AND USAGE
Vancomycin Hydrochloride for Injection is a glycopeptide antibacterial indicated in adult and pediatric patients less than 18 years of age as follows:
Vancomycin Hydrochloride for Injection administered intravenously is indicated for the treatment of:
o Septicemia (1.1)
o Infective Endocarditis (1.2)
o Skin and Skin Structure Infections (1.3)
o Bone Infections (1.4)
o Lower Respiratory Tract Infections (1.5)
Vancomycin Hydrochloride for Injectionadministered orally is indicated for the treatment of:
o Clostridioides difficile-associated diarrhea (1.6)
o Enterocolitis caused by Staphylococcus aureus (including methicillin-resistant strains) (1.7)
Limitations of Use (1.8)
Vancomycin Hydrochloride for Injection administered intravenously is not approved for the treatment of C. difficile-associated diarrhea and enterocolitis caused by susceptible isolates of Staphylococcus aureus because it is not effective.
Vancomycin Hydrochloride for Injection administered orally is not approved for the treatment of septicemia, infective endocarditis, skin and skin structure infections, bone infections and lower respiratory tract infections because it is not effective.
To reduce the development of drug-resistant bacteria and maintain the effectiveness of Vancomycin Hydrochloride for Injection and other antibacterial drugs, Vancomycin Hydrochloride for Injection should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. (1.9)
1.1 Septicemia
Vancomycin Hydrochloride for Injection administered intravenously is indicated in adults and pediatric patients less than 18 years of age 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 Hydrochloride for Injection administered intravenously is indicated in adults and pediatric patients less than 18 years of age 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 Hydrochloride for Injection 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 Hydrochloride for Injection administered intravenously is indicated in adults and pediatric patients less than 18 years of age 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 Hydrochloride for Injection administered intravenously is indicated in adults and pediatric patients less than 18 years of age 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 Hydrochloride for Injection administered intravenously is indicated in adults and pediatric patients less than 18 years of age 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 Hydrochloride for Injection administered intravenously is indicated in adults and pediatric patients less than 18 years of age 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 Clostridioides difficile-Associated Diarrhea
Vancomycin Hydrochloride for Injection administered orally is indicated for the treatment of C. difficile-associated diarrhea (CDAD) in adult and pediatric patients less than 18 years of age.
1.7 Enterocolitis Caused by S. aureus (including methicillin-resistant strains)
Vancomycin Hydrochloride for Injection administered orally is indicated for the treatment of enterocolitis caused by susceptible isolates of Staphylococcus aureus in adults and pediatric patients less than 18 years of age.
1.8 Limitations of Use
Vancomycin Hydrochloride for Injection administered intravenously is not approved for the treatment of the following conditions because it is not effective:
C. difficile-Associated Diarrhea
Enterocolitis caused by susceptible isolates of Staphylococcus aureus
Vancomycin Hydrochloride for Injection administered orally is not approved for the treatment of the following conditions because it is not effective:
Septicemia due to susceptible isolates of MRSA or methicillin-susceptible staphylococci
Infective endocarditis due to susceptible isolates of MRSA, methicillin susceptible staphylococci, Viridans group streptococci Streptococcus gallolyticus, Enterococcus species and Corynebacterium species, or for the treatment of early-onset prosthetic valve endocarditis caused by Staphylococcus epidermidis in combination with rifampin and an aminoglycoside
Skin and skin structure infections due to susceptible isolates of MRSA and methicillin susceptible staphylococci
Bone infections due to susceptible isolates of MRSA and lower respiratory tract infections due to susceptible isolates of MRSA and methicillin susceptible staphylococci
1.9 Usage
To reduce the development of drug-resistant bacteria and maintain the effectiveness of Vancomycin Hydrochloride for Injection and other antibacterial drugs, Vancomycin Hydrochloride for Injection should be usedonly 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.