VANCOCIN Capsule Ref.[11108] Active ingredients: Vancomycin

Source: FDA, National Drug Code (US)  Revision Year: 2020 

1. Indications and Usage

VANCOCIN is indicated for the treatment of Clostridioides difficile-associated diarrhea. VANCOCIN is also used for the treatment of enterocolitis caused by Staphylococcus aureus (including methicillin-resistant strains) in adult and pediatric patients less than 18 years of age.

Limitations of Use:

  • Parenteral administration of vancomycin is not effective for the above infections; therefore, VANCOCIN must be given orally for these infections.
  • Orally administered VANCOCIN is not effective for other types of infections.

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

2. Dosage and Administration

2.1 Adults

VANCOCIN capsules are used in treating C. difficile-associated diarrhea and staphylococcal enterocolitis.

  • C. difficile-associated diarrhea: The recommended dose is 125 mg administered orally 4 times daily for 10 days.
  • Staphylococcal enterocolitis: Total daily dosage is 500 mg to 2 g administered orally in 3 or 4 divided doses for 7 to 10 days.

2.2 Pediatric Patients (less than 18 years of age)

For both C. difficile-associated diarrhea and staphylococcal enterocolitis, the usual daily dosage is 40 mg/kg in 3 or 4 divided doses for 7 to 10 days. The total daily dosage should not exceed 2 g.

10. Overdosage

Supportive care is advised, with maintenance of glomerular filtration. Vancomycin is poorly removed by dialysis. Hemofiltration and hemoperfusion with polysulfone resin have been reported to result in increased vancomycin clearance.

To obtain current information about the treatment of overdose, contact a certified Poison Control Center (1-800-222-1222 or www.poison.org). In managing overdosage, consider the possibility of multiple drug overdoses, interaction among drugs, and unusual drug kinetics.

16.2. Storage and Handling

Store at 20° to 25°C (68° to 77°F); excursions permitted from 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].

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