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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.

Clostridium difficile-associated diahrrea (CDAD) 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.2

Gastrointestinal infections due to C. difficile range in severity from no symptoms to severe diarrhea, pseudomembranous colitis (PMC), toxic megacolon, and occasionally death.3  VANCOCIN® HCL Capsules (vancomycin hydrochloride capsules, USP) can be used to treat antibiotic-associated pseudomembranous colitis caused by C. difficile.

Many cases of pseudomembranous colitis are associated with prior exposure to antibiotic therapy. Although most antimicrobial agents have been implicated, the antibiotics most commonly associated with this condition include: clindamycin, third generation 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 CDAD include watery diarrhea, fever, loss of appetite, nausea, and abdominal pain or tenderness. The risk for developing CDAD is highest in patients who have been on an antibiotic within the last 30 days, are 65 years of age or older, 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.4

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Centers for Disease Control and Prevention Clostridium difficile General Information

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 HCl Capsules and other antibacterial drugs, VANCOCIN HCl 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 reaction, including anaphylaxis, and exfoliative dermatitis have been reported.

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

VANCOCIN HCl Capsules are contraindicated in patients with a known hypersensitivity to vancomycin.

References

  1. Centers for Disease Control and Prevention. (1999). National Nosocomial Infections Surveillance (NNIS) system report, data summary from January 1990–May 1999. American Journal of Infection Control 27, 520-32.
  2. Bartlett JG. Clostridium difiicile: history of its role as an enteric pathogen and the current state of knowledge about the organism. Clinical Infectious Disease. 1994;18(suppl 4):S265-272.
  3. Owens RC, Valenti AJ. Clostridium difficile-associated disease in the new millenium. "The perfect storm" has arrived. Infectious Disease In Clinical Practice.2007;15(5):299-315.
  4. Bartlett JG, Gerding DN. Clinical Recognition and Diagnosis of Clostridium Difficile Infection. cid.2008;46:S12-18.