Vancocin

Clinical summary

Indications and usage 1 INDICATIONS AND USAGE VANCOCIN is indicated for the treatment of Clostridioides difficil e-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. VANCOCIN is a glycopeptide antibacterial indicated in adult and pediatric patients (less than 18 years of age) for the treatment of: ( 1 ) • Clostridioides difficile -associated diarrhea • Enterocolitis caused by Staphylococcus aureus (including methicillin-resistant strains) Limitations of Use: ( 1 ) ( 5.1 ) • 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 bacteria. ( 1 ) Dosage and administration 2 DOSAGE AND ADMINISTRATION • C. difficile- associated diarrhea: • Adult Patients (18 years of age or greater): 125 mg orally 4 times daily for 10 days. ( 2.1 ) • Pediatric Patients (less than 18 years of age): 40 mg/kg in 3 or 4 divided doses for 7 to 10 days. The total daily dosage should not exceed 2 g. ( 2.2 ) • Staphylococcal enterocolitis: • Adult Patients (18 years of age or greater): 500 mg to 2 g orally in 3 or 4 divided doses for 7 to 10 days. ( 2.1 ) • Pediatric Patients (less than 18 years of age): 40 mg/kg in 3 or 4 divided doses for 7 to 10 days. The total daily dosage should not exceed 2 g. ( 2.2 ) 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. Warnings and cautions 5 WARNINGS AND PRECAUTIONS • VANCOCIN must be given orally for treatment of staphylococcal enterocolitis and C. difficile -associated diarrhea. Orally administered VANCOCIN is not effective for other types of infections. ( 5.1 ) • Clinically significant serum concentrations have been reported in some patients who have taken multiple oral doses of VANCOCIN for active C. difficile -associated diarrhea. Monitoring of serum concentrations may be appropriate in some instances. ( 5.2 ) • Nephrotoxicity has occurred following oral VANCOCIN therapy and can occur either during or after completion of therapy. The risk is increased in geriatric patients. ( 5.3 ) Monitor renal function. • Ototoxicity has occurred in patients receiving VANCOCIN. ( 5.4 ) Assessment of auditory function may be appropriate in some instances. • Severe Dermatologic Reactions: Discontinue VANCOCIN at the first appearance of skin rashes, mucosal lesions, or blisters. ( 5.5 ) • Prescribing VANCOCIN in the absence of a proven or strongly suspected bacterial infection is unlikely to provide benefit to the patient and increases the risk of the development of drug resistant bacteria. ( 5.6 ) 5.1 Oral Use Only VANCOCIN for the treatment of colitis is for oral use only and is not systemically absorbed. VANCOCIN must be given orally for treatment of staphylococcal enterocolitis and Clostridioides difficile- associated diarrhea. Orally administered VANCOCIN is not effective for other types of infections. Parenteral administration of vancomycin is not effective for treatment of staphylococcal enterocolitis and C. difficile -associated diarrhea. If parenteral vancomycin therapy is desired, use an intravenous preparation of vancomycin and consult the package insert accompanying that preparation. 5.2 Potential for Systemic Absorption Clinica