Clostridium difficile Information

Clostridium difficile is a bacterium not usually found in the intestinal tract but which, under the right circumstances such as after or during antibiotic therapy, can colonize and overgrow in the lower gastrointestinal tract. Following colonization of the colon, some C. difficile produce toxins, which cause inflammation of the colon and diarrhea.

C. difficile infection has become one of the most common infections acquired in hospitals or nursing homes. According to the U.S. Centers for Disease Control and Prevention, there are approximately 3,000,000 cases of antibiotic associated diarrhea (AAD) per year,¹ of which 15 to 25 percent are caused by C. difficile.

Gastrointestinal infections due to C. difficile range in severity from asymptomatic colonization to severe diarrhea, pseudomembranous colitis (PMC), toxic megacolon, and occasionally death.² Vancocin^® HCl Capsules (vancomycin hydrochloride capsules, USP) can be used to treat antibiotic-associated pseudomembranous colitis caused by C. difficile.

Virtually every case of pseudomembranous colitis is associated with prior exposure to antibiotic therapy. Although most antimicrobial agents have been implicated, the antibiotics most commonly associated with this condition include clindamycin, cephalosporins, fluoroquinolones and penicillins. Antibiotic treatment results in disruption of the normal bacterial flora in the lower gastrointestinal tract, providing an opportunity for the overgrowth of C. difficile and production of its toxins.

The most common symptoms of C. difficile associated disease (CDAD) include watery diarrhea, fever, loss of appetite, nausea and abdominal pain or tenderness. The risk for disease including pseudomembranous colitis is highest in patients who have been on an antibiotic within the last 30-days, are ≥ 65 years of age, have had recent gastrointestinal surgery or manipulation, have been in a healthcare facility as an inpatient for an extended period of time, or have a serious underlying illness or immunocompromising conditions.

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Centers for Disease Control and Prevention Clostridium difficile General Information

For full prescribing information, click here.

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

To reduce the development of drug-resistant bacteria and maintain the effectiveness of Vancocin Capsules and other antibacterial drugs, Vancocin Capsules should only be used to treat or prevent infections that are proven or strongly suspected to be caused by a susceptible bacteria. When culture and sensitivity are available, they should be considered in selecting or modifying antibacterial therapy.

Adverse events include nephrotoxicity, ototoxicity, reversible neutropenia, thrombocytopenia, and “Red Man’s Syndrome”. In patients with renal dysfunction or those receiving concomitant therapy with an aminoglycoside, serial renal function testing should be performed. In patients receiving concomitant therapy with another ototoxic agent, serial tests of auditory function may be helpful in order to minimize the risk of ototoxicity. Infrequently allergic reation, including anaphylaxis, and exfoliative dermatitis have been reported.

Clinically significant serum concentrations of vancomycin have been reported in some patients treated with Vancocin capsules for pseudomembranous colitis caused by Clostridium difficile. It is noteworthy that total systemic and renal clearance of vancomcyin are reduced in the elderly. Monitoring of serum concentrations may be appropriate in patients with renal insufficiency and/or colitis.

Vancocin capsules are contraindicated in patients with a known hypersensitivity to vancomycin.

References

1. NNIS data - Am J Infection Control 1999, 27; 52032

2. Gerding DN, Johnson S, Peterson LR, et. al. SHEA Position Paper: Clostridium difficile-associated diarrhea and colitis. Infect Control and Hospital Epidemiology 1995;16:459-460



Clostridium difficile Information Clostridium difficile is a bacterium not usually found in the intestinal tract but which, under the right circumstances such as after or during antibiotic therapy, can colonize and overgrow in the lower gastrointestinal tract. Following colonization of the colon, some C. difficile produce toxins, which cause inflammation of the colon and diarrhea. C. difficile infection has become one of the most common infections acquired in hospitals or nursing homes. According to the U.S. Centers for Disease Control and Prevention, there are approximately 3,000,000 cases of antibiotic associated diarrhea (AAD) per year,¹ of which 15 to 25 percent are caused by C. difficile. Gastrointestinal infections due to C. difficile range in severity from asymptomatic colonization to severe diarrhea, pseudomembranous colitis (PMC), toxic megacolon, and occasionally death.² Vancocin^® HCl Capsules (vancomycin hydrochloride capsules, USP) can be used to treat antibiotic-associated pseudomembranous colitis caused by C. difficile. Virtually every case of pseudomembranous colitis is associated with prior exposure to antibiotic therapy. Although most antimicrobial agents have been implicated, the antibiotics most commonly associated with this condition include clindamycin, cephalosporins, fluoroquinolones and penicillins. Antibiotic treatment results in disruption of the normal bacterial flora in the lower gastrointestinal tract, providing an opportunity for the overgrowth of C. difficile and production of its toxins. The most common symptoms of C. difficile associated disease (CDAD) include watery diarrhea, fever, loss of appetite, nausea and abdominal pain or tenderness. The risk for disease including pseudomembranous colitis is highest in patients who have been on an antibiotic within the last 30-days, are ≥ 65 years of age, have had recent gastrointestinal surgery or manipulation, have been in a healthcare facility as an inpatient for an extended period of time, or have a serious underlying illness or immunocompromising conditions. Want to learn more about C. difficile? Centers for Disease Control and Prevention Clostridium difficile General Information For full prescribing information, click here. VANCOCIN HCl Capsules may be administered orally for treatment of enterocolitis caused by Staphylococcus aureus (including methicillin-resistant strains) and antibiotic-associated pseudomembranous colitis caused by Clostridium difficile. Parenteral administration of vancomycin is not effective for the above indications; therefore, VANCOCIN HCl Capsules must be given orally for these indications. Orally administered VANCOCIN HCl Capsules are not effective for other types of infection. To reduce the development of drug-resistant bacteria and maintain the effectiveness of Vancocin Capsules and other antibacterial drugs, Vancocin Capsules should only be used to treat or prevent infections that are proven or strongly suspected to be caused by a susceptible bacteria. When culture and sensitivity are available, they should be considered in selecting or modifying antibacterial therapy. Adverse events include nephrotoxicity, ototoxicity, reversible neutropenia, thrombocytopenia, and “Red Man’s Syndrome”. In patients with renal dysfunction or those receiving concomitant therapy with an aminoglycoside, serial renal function testing should be performed. In patients receiving concomitant therapy with another ototoxic agent, serial tests of auditory function may be helpful in order to minimize the risk of ototoxicity. Infrequently allergic reation, including anaphylaxis, and exfoliative dermatitis have been reported. Clinically significant serum concentrations of vancomycin have been reported in some patients treated with Vancocin capsules for pseudomembranous colitis caused by Clostridium difficile. It is noteworthy that total systemic and renal clearance of vancomcyin are reduced in the elderly. Monitoring of serum concentrations may be appropriate in patients with renal insufficiency and/or colitis. Vancocin capsules are contraindicated in patients with a known hypersensitivity to vancomycin. References 1. NNIS data - Am J Infection Control 1999, 27; 52032 2. Gerding DN, Johnson S, Peterson LR, et. al. SHEA Position Paper: Clostridium difficile-associated diarrhea and colitis. Infect Control and Hospital Epidemiology 1995;16:459-460