VANCOMYCIN HYDROCHLORIDE
Generic: VANCOMYCIN HYDROCHLORIDE
Basic Information
Manufacturer
Baxter Healthcare Corporation
Product Type
HUMAN PRESCRIPTION DRUG
Route of Administration
INTRAVITREAL
FDA Set ID
99e523d8-9bde-43cb-8434-497015e5dcbd
Indications & Usage
1 INDICATIONS AND USAGE Vancomycin Injection is a glycopeptide antibacterial indicated for the treatment of the following infections in adult and pediatric patients for whom appropriate dosing with this formulation can be achieved: • 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 and other antibacterial drugs, Vancomycin Injection should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria.
( 1.6 ) 1.1 Septicemia Vancomycin Injection is indicated in adults and pediatric patients for whom appropriate dosing with this formulation can be achieved [see Dosage and Administration (2) and Use in Specific Populations (8.4) ] 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 is indicated in adults and pediatric patients for whom appropriate dosing with this formulation can be achieved [see Dosage and Administration (2) and Use in Specific Populations (8.4) ] for the treatment of infective endocarditis due to: • Susceptible isolates of MRSA.
• Viridans group streptococci or Streptococcus gallolyticus (previously known as Streptococcus bovis ) and Enterococcus species and Corynebacterium species.
For enterococcal endocarditis ( e.g., E.
faecalis ), use Vancomycin 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 Injection is indicated in adults and pediatric patients 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 is indicated in adults and pediatric patients for whom appropriate dosing with this formulation can be achieved [see Dosage and Administration (2) and Use in Specific Populations (8.4) ] 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 Infection Vancomycin Injection is indicated in adults and pediatric patients (and older) for whom appropriate dosing with this formulation can be achieved [see Dosage and Administration (2) and Use in Specific Populations (8.4) ] 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 is indicated in adults and pediatric patients for whom appropriate dosing with this formulation can be achieved [see Dosage and Administration (2) and Use in Specific Populations (8.4) ] for the treatment of lower respiratory tract infections due to: • Susceptible isolates of MSRA.
• 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 and other antibacterial drugs, Vancomycin Injection 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.
( 1.6 ) 1.1 Septicemia Vancomycin Injection is indicated in adults and pediatric patients for whom appropriate dosing with this formulation can be achieved [see Dosage and Administration (2) and Use in Specific Populations (8.4) ] 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 is indicated in adults and pediatric patients for whom appropriate dosing with this formulation can be achieved [see Dosage and Administration (2) and Use in Specific Populations (8.4) ] for the treatment of infective endocarditis due to: • Susceptible isolates of MRSA.
• Viridans group streptococci or Streptococcus gallolyticus (previously known as Streptococcus bovis ) and Enterococcus species and Corynebacterium species.
For enterococcal endocarditis ( e.g., E.
faecalis ), use Vancomycin 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 Injection is indicated in adults and pediatric patients 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 is indicated in adults and pediatric patients for whom appropriate dosing with this formulation can be achieved [see Dosage and Administration (2) and Use in Specific Populations (8.4) ] 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 Infection Vancomycin Injection is indicated in adults and pediatric patients (and older) for whom appropriate dosing with this formulation can be achieved [see Dosage and Administration (2) and Use in Specific Populations (8.4) ] 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 is indicated in adults and pediatric patients for whom appropriate dosing with this formulation can be achieved [see Dosage and Administration (2) and Use in Specific Populations (8.4) ] for the treatment of lower respiratory tract infections due to: • Susceptible isolates of MSRA.
• 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 and other antibacterial drugs, Vancomycin Injection 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.
Adverse Reactions
6 ADVERSE REACTIONS The following clinically significant adverse reactions are described elsewhere in the labeling: • Infusion Reactions [see Warnings and Precautions (5.1) ] • Nephrotoxicity [see Warnings and Precautions (5.2) ] • Ototoxicity [see Warnings and Precautions (5.3) ] • Severe Dermatologic Reactions [see Warnings and Precautions (5.4) ] • Clostridioides Difficile -Associated Diarrhea [see Warnings and Precautions (5.5) ] • Hemorrhagic Occlusive Retinal Vasculitis [see Warnings and Precautions (5.6) ] • Neutropenia [see Warnings and Precautions (5.7) ] • Phlebitis and Other Administration Site Reactions [see Warnings and Precautions (5.8) ].
The most common adverse reactions are anaphylaxis, “vancomycin infusion reaction”, acute kidney injury, hearing loss, neutropenia.
( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Baxter Healthcare at 1-866-888-2472 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
The following adverse reactions associated with the use of vancomycin were identified in clinical trials: Immune System Disorders: Anaphylaxis and “vancomycin infusion reaction” Renal and urinary Disorders: Acute kidney injury and interstitial nephritis Ear and Labyrinth Disorders: Hearing loss, vertigo, and tinnitus Skin and subcutaneous tissue disorders : Rashes including exfoliative dermatitis, and Stevens-Johnson syndrome (SJS) Gastrointestinal Disorders: Clostridioides difficile colitis, nausea Blood and Lymphatic System Disorders: Agranulocytosis, neutropenia, pancytopenia, leukopenia, thrombocytopenia, eosinophilia Cardiac Disorders: Cardiac arrest, chest pain General Disorders and Administration Site Conditions : General discomfort, drug fever, chills, phlebitis, injection site irritation, injection site pain and necrosis following intramuscular injection, chemical peritonitis following intraperitoneal administration (Vancomycin Injection is not approved for intramuscular and intraperitoneal administration) Laboratory Abnormalities: Elevated blood urea nitrogen, elevated serum creatinine Musculoskeletal and connective tissue disorders: Muscle pain Nervous system disorders: Dizziness Respiratory, thoracic and mediastinal disorders: Wheezing, dyspnea Vascular disorders: Hypotension, shock, vasculitis 6.2 Postmarketing Experience The following adverse reactions have been identified during postmarketing use of vancomycin.
Because these reactions are reported voluntarily from a population of uncertain size, it is not possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Immune System Disorders: Acute myocardial ischemia with or without myocardial infarction may occur as part of an allergic reaction.
Skin and Subcutaneous Tissue Disorders: Severe dermatologic reactions such as toxic epidermal necrolysis (TEN), Drug reaction with eosinophilia and systemic symptoms (DRESS), acute generalized exanthematous pustulosis (AGEP), and linear IgA bullous dermatosis (LABD).
Blood and lymphatic system disorders : Hemolytic anemia
The most common adverse reactions are anaphylaxis, “vancomycin infusion reaction”, acute kidney injury, hearing loss, neutropenia.
( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Baxter Healthcare at 1-866-888-2472 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
The following adverse reactions associated with the use of vancomycin were identified in clinical trials: Immune System Disorders: Anaphylaxis and “vancomycin infusion reaction” Renal and urinary Disorders: Acute kidney injury and interstitial nephritis Ear and Labyrinth Disorders: Hearing loss, vertigo, and tinnitus Skin and subcutaneous tissue disorders : Rashes including exfoliative dermatitis, and Stevens-Johnson syndrome (SJS) Gastrointestinal Disorders: Clostridioides difficile colitis, nausea Blood and Lymphatic System Disorders: Agranulocytosis, neutropenia, pancytopenia, leukopenia, thrombocytopenia, eosinophilia Cardiac Disorders: Cardiac arrest, chest pain General Disorders and Administration Site Conditions : General discomfort, drug fever, chills, phlebitis, injection site irritation, injection site pain and necrosis following intramuscular injection, chemical peritonitis following intraperitoneal administration (Vancomycin Injection is not approved for intramuscular and intraperitoneal administration) Laboratory Abnormalities: Elevated blood urea nitrogen, elevated serum creatinine Musculoskeletal and connective tissue disorders: Muscle pain Nervous system disorders: Dizziness Respiratory, thoracic and mediastinal disorders: Wheezing, dyspnea Vascular disorders: Hypotension, shock, vasculitis 6.2 Postmarketing Experience The following adverse reactions have been identified during postmarketing use of vancomycin.
Because these reactions are reported voluntarily from a population of uncertain size, it is not possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Immune System Disorders: Acute myocardial ischemia with or without myocardial infarction may occur as part of an allergic reaction.
Skin and Subcutaneous Tissue Disorders: Severe dermatologic reactions such as toxic epidermal necrolysis (TEN), Drug reaction with eosinophilia and systemic symptoms (DRESS), acute generalized exanthematous pustulosis (AGEP), and linear IgA bullous dermatosis (LABD).
Blood and lymphatic system disorders : Hemolytic anemia