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.