Vancomycin Hydrochloride Capsules, USP for oral administration contain chromatographically purified vancomycin hydrochloride (a white to slightly red or slightly brown semi-solid matrix), a tricyclic glycopeptide antibiotic derived from
); 500 mg of the base is equivalent to 0.34 mmol.
125 mg capsules
contain vancomycin hydrochloride equivalent to 125 mg (0.08 mmol) vancomycin.
Vancomycin Hydrochloride Capsules, USP are indicated for the treatment of
-associated diarrhea. Vancomycin hydrochloride capsules, USP are also used for the treatment of enterocolitis caused by
(including methicillin-resistant strains). Parenteral administration of vancomycin is not effective for the above infections; therefore, vancomycin hydrochloride, USP must be given orally for these infections.
Orally administered vancomycin hydrochloride is not effective for other types of infections.
To reduce the development of drug-resistant bacteria and maintain the effectiveness of vancomycin hydrochloride, USP and other antibacterial drugs, vancomycin hydrochloride, USP 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.
Media Articles Related to Vancomycin
Vancomycin in Cataract Procedures May Cause Blindness
Source: Medscape Ophthalmology Headlines [2016.08.15]
Researchers have documented 35 eyes with severe hemorrhagic occlusive retinal vasculitis after treatment with vancomycin during cataract procedures.
Medscape Medical News
Vancomycin-Resistant Enterococci (VRE)
Source: MedicineNet Aches, Pain, Fever Specialty [2016.08.12]
Title: Vancomycin-Resistant Enterococci (VRE)
Category: Diseases and Conditions
Created: 5/8/2007 12:00:00 AM
Last Editorial Review: 8/12/2016 12:00:00 AM
S. Aureus Bacteremia Incidence, Mortality Higher in Indigenous Children, Infants
Source: Medscape Critical Care Headlines [2016.08.18]
Vancomycin may be inferior to beta-lactams for treating bacteremia due to methicillin-susceptible Staphylococcus aureus (MSSA) in children, new research suggests.
Reuters Health Information
Zyvox® shows cost savings for treatment of skin infections
Source: The Doctors Lounge - Infections
Oral Zyvox® shows cost savings for outpatient treatment of skin and other infections when compared to vancomycin.
Published Studies Related to Vancomycin
Health economic evaluation of patients treated for nosocomial pneumonia caused by
methicillin-resistant Staphylococcus aureus: secondary analysis of a multicenter
randomized clinical trial of vancomycin and linezolid. 
PURPOSE: Results from studies comparing health care resource use (HCRU), costs of
treatment, and cost-effectiveness of linezolid compared with vancomycin therapy
in the treatment of hospitalized patients with methicillin-resistant
Staphylococcus aureus (MRSA) nosocomial pneumonia are limited in the published
Resolution of Clostridium difficile-associated diarrhea in patients with cancer
treated with fidaxomicin or vancomycin. 
difficile-associated diarrhea (CDAD). Little is known about treatment response... CONCLUSION: For patients with cancer, fidaxomicin treatment was superior to
Randomised clinical trial: vancomycin or metronidazole in patients with primary
sclerosing cholangitis - a pilot study. 
in patients with PSC... CONCLUSIONS: Both vancomycin and metronidazole demonstrated efficacy; however,
Reduced acquisition and overgrowth of vancomycin-resistant enterococci and
Candida species in patients treated with fidaxomicin versus vancomycin for
Clostridium difficile infection. 
Fidaxomicin causes less disruption of anaerobic microbiota during treatment of
Clostridium difficile infection (CDI) than vancomycin and has activity against
many vancomycin-resistant enterococci (VRE). In conjunction with a multicenter
randomized trial of fidaxomicin versus vancomycin for CDI treatment, we tested
the hypothesis that fidaxomicin promotes VRE and Candida species colonization
less than vancomycin...
Meta-analysis of randomized controlled trials of vancomycin for the treatment of
patients with gram-positive infections: focus on the study design. 
of other antibiotics for the treatment of gram-positive infections... CONCLUSION: On the basis mainly of data from open-label trials, vancomycin is a
Clinical Trials Related to Vancomycin
Dose Enhancement of Vancomycin IN Everyday Patients [Recruiting]
Current Australian guidelines for vancomycin commonly underdoses individuals particularly in
the first 48 hours.
The aim of the trial is to compare two dosing regimens; the current Australian guidelines
versus a more appropriately modeled pharmacokinetic based regimen with the overall aim of
developing a new vancomycin dosing strategy that will enable patients to have more
individualised and therapeutically efficacious treatment.
The hypothesis is that dosing vancomycin according to a pharmacokinetically modeled regimen
increases the likelihood of achieving therapeutic trough levels of vancomycin within the
first 48 hours (or at steady state, whichever is sooner) compared to dosing vancomycin
according to the current Antibiotic guidelines.
Pharmacokinetics of Vancomycin for Inhalation in Cystic Fibrosis [Active, not recruiting]
The purpose of this study is to determine the pharmacokinetics and safety of inhaled
vancomycin in patients with cystic fibrosis.
Pre-operative Prophylaxis With Vancomycin and Cefazolin in Pediatric Cardiovascular Surgery Patients [Active, not recruiting]
The investigators hope to learn 1) if the addition of prophylaxis with vancomycin will
decrease the rate of cefazolin non-susceptible SSI's, in high risk population 2) to develop
better understanding of vancomycin and cefazolin pharmacokinetics in children undergoing
cardiopulmonary bypass 3) to assess the barriers to vancomycin dosing peri-operatively 4) to
assess side effects and risks associated with peri-operative vancomycin administration. This
will allow us to improve patient care by better understanding the benefits or the risks of
peri-operative vancomycin administration and potentially decrease cefazolin-resistant
surgical site infections.
In addition, this study gives us the opportunity to evaluate cefazolin and vancomycin
pharmacokinetics on children on CPB.
The investigators will take blood samples from 20 patients. In 10 patients the investigators
will do Cefazolin pK analysis and in the other 10 the investigators will do pK Vancomycin
analysis. For the remainder of 292 patients, only prospective chart review will be done to
determine the incidence of SSI's.
This data will be compared with 936 controls who received only Cefazolin pre-operatively as
prophylaxis for SSI's.
Extended Treatment With Vancomycin for Clostridium Difficile Colitis [Withdrawn]
BACKGROUND: Clostridium difficile-associated colitis is an infection of the large bowel,
usually associated with previous use of antibiotics. The disease course may be complicated
by fulminant disease requiring removal of the colon or by multiple recurrences requiring
re-hospitalization. The incidence and severity of Clostridium difficile infection is rising,
and it poses an increasing burden on the health system. For example, in one of our previous
studies we found that 804 in-patients and 568 out-patients had a positive test for
Clostridium difficile toxin at Beaumont Laboratories in 2003. The standard treatment is a 2
week course of Vancomycin or Metronidazole. The clinical response to Metronidazole appears
to be declining, and many practicing clinicians prefer Vancomycin as a first-line treatment.
The recurrence rate after the treatment is similar for Vancomycin and Metronidazole and is
usually in the range of 15-25%, although recent reports noted a recurrence rate up to 50%
during outbreaks with a virulent strain. Recently, it has been suggested that a 2 week
duration of treatment might not be adequate in clearing the infection.
Our HYPOTHESIS is that a prolongation of Vancomycin treatment from 2 weeks to 4 weeks will
lead to a decrease rate of recurrent Clostridium Difficile colitis.
Dose Escalation Trial of Intrasite Vancomycin Pharmacokinetics [Suspended]
Surgical wound infections remain a serious problem despite aseptic techniques and the use of
prophylactic systemic antibiotics. Such infections can occur at rates up to ~20% in
high-risk patients receiving long segment instrumented spinal fusions for deformity
correction and present potentially catastrophic consequences. Given this, the high cost of
treatment, and a payer system unable to support such expenses, investigators must make every
effort to find new cost-effective ways to prevent these complications.
Increasingly surgeons have sought to address this problem by placing lyophilized Vancomycin
into spinal surgery wounds immediately prior to wound closure. This method, known as
"intrasite" application, is adapted from techniques used to prevent infection in joint
replacement surgeries. The motivation for this practice is to maximize antibiotic
concentration within the wound while minimizing systemic concentration and toxicity, (the
inverse of the situation when using IV antibiotics). While the popularity of intrasite
delivery has grown rapidly, this has occurred without prospective scientific evidence.
Recently, three retrospective papers including nearly 2,500 treated patients, indicated that
intrasite Vancomycin reduces wound infections without increasing adverse events[1-3].
However, there are no published data on the dosing or pharmacokinetics of intrasite
Vancomycin, let alone prospective trials of its efficacy and safety.
The investigators propose to perform the first prospective trial of intrasite Vancomycin
pharmacokinetics and safety. Study objectives will include standardizing application and
dosing, defining peak/trough concentrations and clearance parameters, verifying bactericidal
potency, and dose selection for use in future studies. This will be accomplished by
enrolling groups of patients (n=10) to receive one of three doses of intrasite lyophilized
Vancomycin (3, 6 or 12 mg/cm2), prior to wound closure. Vancomycin concentrations in venous
blood and wound seroma fluid will be measured at regular intervals after surgery to
establish pharmacokinetic parameters. Preliminary data regarding local and systemic adverse
events including wound healing, fusion rate, and toxicity will be prospectively collected.
The ultimate goal of this learning-phase study is to gather sufficient information regarding
application, dosing, pharmacokinetics, measurement strategies, and adverse events to prepare
for a Phase III efficacy trial.
Reports of Suspected Vancomycin Side Effects
Drug Rash With Eosinophilia and Systemic Symptoms (104),
Renal Failure Acute (100),
Renal Failure (45),
Septic Shock (35),
Toxic Epidermal Necrolysis (34),
Stevens-Johnson Syndrome (31),
Renal Impairment (28), more >>
Page last updated: 2016-08-18