Background
Vancocin capsules are a glycopeptide antibacterial agent. Its bactericidal activity is primarily a result of its ability to inhibit cell-wall biosynthesis.
Microbiology
Vancocin capsules are active against most strains of:
- - Clostridium difficile (the most common cause of antibiotic-associated pseudomembranous colitis); and
- - Staphylococcus aureus, including methicillin-resistant strains associated with enterocolitis.
Clinical Pharmacology
Vancomycin is poorly absorbed after oral administration. With repeated dosing, fecal concentrations exceed 3100 mg/kg.
Vancocin capsules are not systemically absorbed and are not effective for the treatment of systemic infections.
After multiple-dose oral administration of vancomycin, measurable serum concentrations may infrequently occur in patients with C. difficile-induced pseudomembranous colitis, and, in the presence of renal impairment, the possibility of accumulation exists.
Indications
Vancocin capsules may be used to treat antibiotic-associated pseudomembranous colitis caused by C. difficile and enterocolitis caused by S. aureus (including methicillin-resistant strains).
Parenteral vancomycin hydrochloride is not effective for the treatment of either of the above listed indications.
Contraindications
Known hypersensitivity to vancomycin.
Precautions
Prescribing Vancocin capsules in the absence of a proven or strongly suspected bacterial infection or a prophylactic indication are unlikely to provide benefit to the patient and increases the risk of the development of drug-resistant bacteria.
Clinically significant serum concentrations have been reported in some patients who have taken multiple oral doses of vancomycin for active C. difficile-induced pseudomembranous colitis; therefore, monitoring of serum concentrations may be appropriate in some instances, e.g., in patients with renal insufficiency and/or colitis. Some patients with inflammatory disorders of the intestinal mucosa may have significant systemic absorption of vancomycin and, therefore, may be at risk for the development of adverse reactions associated with the parenteral administration of vancomycin. (See package insert accompanying the intravenous preparation.) The risk is greater if renal impairment is present. It should be noted that the total systemic and renal clearances of vancomycin are reduced in the elderly.
Ototoxicity has occurred in patients receiving Vancocin capsules. It may be transient or permanent. It has been reported mostly in patients who have been given excessive intravenous doses, who have an underlying hearing loss, or who are receiving concomitant therapy with another ototoxic agent, such as an aminoglycoside. 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.
When patients with underlying renal dysfunction or those receiving concomitant therapy with an aminoglycoside are being treated, serial monitoring of renal function should be performed.
Use of vancomycin may result in the overgrowth of nonsusceptible organisms. If superinfection occurs during therapy, appropriate measures should be taken.
Pregnancy Category
Category B.
Dosage and Administration
Adults: 500 mg to 2 g administered orally in 3 or 4 divided doses for 7 to 10 days.
Pediatric Patients: Daily dosage of 40 mg/kg divided into 3 or 4 doses for 7 to 10 days. Total daily dose not to exceed 2 g.
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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 reaction, 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.