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Vancocin (Vancomycin Hydrochloride) - Summary

 
 



VANCOCIN SUMMARY

Pulvules® Vancocin® HCl (Vancomycin Hydrochloride Capsules, USP) contain chromatographically purified vancomycin hydrochloride, a tricyclic glycopeptide antibiotic derived from Amycolatopsis orientalis (formerly Nocardia orientalis), which has the chemical formula C66H75Cl2N9O24¬∑HCl.

Vancocin HCl Pulvules may be administered orally for treatment of enterocolitis caused by Staphylococcus aureus (including methicillin-resistant strains) and antibiotic-associated pseudomembranous colitis caused by C. difficile. Parenteral administration of Vancocin HCl is not effective for the above indications; therefore, Vancocin HCl must be given orally for these indications. Orally administered Vancocin HCl is not effective for other types of infection.

To reduce the development of drug-resistant bacteria and maintain the effectiveness of Vancocin HCl and other antibacterial drugs, Vancocin HCl 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.


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NEWS HIGHLIGHTS

Media Articles Related to Vancocin (Vancomycin)

Vancomycin May Protect Against C. Diff Recurrence
Source: MedPage Today Gastroenterology [2014.09.07]
WASHINGTON (MedPage Today) -- Prophylaxis with oral vancomycin (Vancocin) appeared to protect at-risk patients from experiencing a recurrence of Clostridium difficile infection, researchers reported here.

Vancomycin-Resistant Enterococci (VRE)
Source: MedicineNet ICU Psychosis Specialty [2014.01.22]
Title: Vancomycin-Resistant Enterococci (VRE)
Category: Diseases and Conditions
Created: 5/8/2007 12:00:00 AM
Last Editorial Review: 1/22/2014 12:00:00 AM

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.

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Published Studies Related to Vancocin (Vancomycin)

Reduced acquisition and overgrowth of vancomycin-resistant enterococci and Candida species in patients treated with fidaxomicin versus vancomycin for Clostridium difficile infection. [2012]
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. [2012]
of other antibiotics for the treatment of gram-positive infections... CONCLUSION: On the basis mainly of data from open-label trials, vancomycin is a

Efficacy and safety of tigecycline monotherapy compared with vancomycin-aztreonam in the treatment of complicated skin and skin structure infections in patients from India and Taiwan. [2011.04]
BACKGROUND: To compare the monotherapy of tigecycline with vancomycin-aztreonam in hospitalized patients from India and Taiwan with complicated skin and skin structure infections (cSSSIs)... CONCLUSIONS: Tigecycline monotherapy is a safe and effective therapy for cSSSIs in geographically distinct populations in Asia. Copyright (c) 2011. Published by Elsevier B.V.

Fidaxomicin versus vancomycin for Clostridium difficile infection. [2011.02.03]
BACKGROUND: Clostridium difficile infection is a serious diarrheal illness associated with substantial morbidity and mortality. Patients generally have a response to oral vancomycin or metronidazole; however, the rate of recurrence is high. This phase 3 clinical trial compared the efficacy and safety of fidaxomicin with those of vancomycin in treating C. difficile infection... CONCLUSIONS: The rates of clinical cure after treatment with fidaxomicin were noninferior to those after treatment with vancomycin. Fidaxomicin was associated with a significantly lower rate of recurrence of C. difficile infection associated with non-North American Pulsed Field type 1 strains. (Funded by Optimer Pharmaceuticals; ClinicalTrials.gov number, NCT00314951.)

Telavancin versus vancomycin for hospital-acquired pneumonia due to gram-positive pathogens. [2011.01.01]
BACKGROUND: Telavancin is a lipoglycopeptide bactericidal against gram-positive pathogens... CONCLUSIONS: The primary end point of the studies was met, indicating that telavancin is noninferior to vancomycin on the basis of clinical response in the treatment of HAP due to gram-positive pathogens.

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Clinical Trials Related to Vancocin (Vancomycin)

Trial of Prophylactic Versus Empirical Vancomycin for the Prevention of Streptococcal Sepsis After Hematopoietic Cell Transplantation [Completed]
This is a randomized 2-arm study to compare two different times of giving the drug vancomycin. Half of the patients will begin vancomycin two days before a bone marrow transplant. The other half will get it as soon as they have the first fever.

Streptococci are bacteria that live in one's mouth and gut. These bacteria can escape into the blood when the lining of the mouth and gut weakens from cancer therapy. This can make the person who is undergoing a bone marrow transplant very sick. All patients who get this infection are treated with antibiotics. Vancomycin is one drug that is used to treat this bloodstream infection once it is diagnosed. Studies have shown that giving vancomycin before a bone marrow transplant seems to prevent this infection. However, giving vancomycin too soon may increase the chance that the kidneys will be irritated. It may also increase the chance that other bacteria will become resistant to this drug. We, the investigators at Memorial Sloan-Kettering Cancer Center, do not know if waiting to start vancomycin until the patient has a first fever can also prevent this infection.

Intracolonic Vancomycin Therapy in Severe C. Diff Colitis [Recruiting]
Clostridium difficile is a bacteria that can infect the colon and cause severe diarrhea in patients after recent antibiotic use. The current standard of care treatment for severe C. diff. consists of oral vancomycin and/or intravenous metronidazole. When treatment is unsuccessful, it can lead to need for removal of the entire colon or even death. In fact, mortality rates in the literature range from 11-37% for C. diff. The most commonly quoted mortality rate is 14% for severe infection. It is believed that the failure of treatment may stem from an adynamic ileus (paralysis of the small bowel). This ileus may prevent the oral vancomycin from reaching the colon and therefore it does not treat the problem. Vancomycin functions by direct contact with the colon. Therefore, if the vancomycin is instilled directly into the colon, it can come into contact with and be its intended target. : The objective of the study is to improve treatment of severe C. diff. colitis . C. diff. infection is defined as severe if there is evidence of ileus accompanied by any one of the following: fever greater than 38. 30C, , acidemia, serum albumin less than 2. 5, or white blood cell count greater than 14,000.

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.

Pre-operative Prophylaxis With Vancomycin and Cefazolin in Pediatric Cardiovascular Surgery Patients [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.

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Dose Escalation Trial of Intrasite Vancomycin Pharmacokinetics [Not yet recruiting]
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.

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Page last updated: 2014-09-07

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