Vancocin Information
Vancocin (Vancomycin hydrochloride)
Vancocin (Vancomycin hydrochloride) Description
Vancocin (Vancomycin hydrochloride) HCl Capsules (Vancomycin Hydrochloride Capsules, USP) contain chromatographically purified vancomycin hydrochloride, a tricyclic glycopeptide antibiotic derived from (formerly ), which has the chemical formula CHClNO•HCl. The molecular weight of vancomycin hydrochloride is 1485.73; 500 mg of the base is equivalent to 0.34 mmol.
The capsules contain vancomycin hydrochloride equivalent to 125 mg (0.08 mmol) or 250 mg (0.17 mmol) vancomycin. The capsules also contain F D & C Blue No. 2, gelatin, iron oxide, polyethylene glycol, titanium dioxide, and other inactive ingredients.
Vancomycin hydrochloride has the following structural formula:
Vancocin (Vancomycin hydrochloride) Clinical Pharmacology
Vancomycin is poorly absorbed after oral administration. During multiple dosing of 250 mg every 8 hours for 7 doses, fecal concentrations of vancomycin in volunteers exceeded 100 mg/kg in the majority of samples. No blood concentrations were detected and urinary recovery did not exceed 0.76%. Additional data using an oral solution follow. In anephric patients with no inflammatory bowel disease, blood concentrations of vancomycin were barely measurable (0.66 μg/mL) in 2 of 5 subjects who received 2 g of vancomycin HCl for Oral Solution daily for 16 days. No measurable blood concentrations were attained in the other 3 patients. With doses of 2 g daily, very high concentrations of drug can be found in the feces (>3100 mg/kg) and very low concentrations (
Vancocin (Vancomycin hydrochloride) Indications And Usage
Vancocin (Vancomycin hydrochloride) HCl Capsules may be administered orally for treatment of enterocolitis caused by (including methicillin-resistant strains) and antibiotic-associated pseudomembranous colitis caused by Parenteral administration of vancomycin is not effective for the above indications; therefore, Vancocin (Vancomycin hydrochloride) HCl Capsules must be given orally for these indications.
To reduce the development of drug-resistant bacteria and maintain the effectiveness of Vancocin (Vancomycin hydrochloride) HCl Capsules and other antibacterial drugs, Vancocin (Vancomycin hydrochloride) HCl Capsules 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 (Vancomycin hydrochloride) Contraindication
Vancocin (Vancomycin hydrochloride) HCl Capsules are contraindicated in patients with known hypersensitivity to vancomycin.
Vancocin (Vancomycin hydrochloride) Precautions
Prescribing Vancocin (Vancomycin hydrochloride) HCl Capsules in the absence of a proven or strongly suspected bacterial infection or a prophylactic indication is 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 -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 vancomycin. 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.
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.
No long-term carcinogenesis studies in animals have been conducted.
At concentrations up to 1000 μg/mL, vancomycin had no mutagenic effect in the mouse lymphoma forward mutation assay or the primary rat hepatocyte unscheduled DNA synthesis assay. The concentrations tested were above the peak plasma vancomycin concentrations of 20 to 40 μg/mL usually achieved in humans after slow infusion of the maximum recommended dose of 1 g. Vancomycin had no mutagenic effect in the Chinese hamster sister chromatid exchange assay (400 mg/kg IP) or the mouse micronucleus assay (800 mg/kg IP).
No definitive fertility studies have been conducted.
Clinical studies of vancomycin HCl for oral use did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.
Clinically significant serum concentrations have been reported in some patients who have taken multiple oral doses of vancomycin HCl for active -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. 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 ( ).
Vancocin (Vancomycin hydrochloride) Adverse Reactions
Nephrotoxicity —
Ototoxicity —
Hematopoietic —
Miscellaneous —
A condition has been reported that is similar to the IV–induced syndrome with symptoms consistent with anaphylactoid reactions, including hypotension, wheezing, dyspnea, urticaria, pruritus, flushing of the upper body (“Red Man Syndrome”), pain and muscle spasm of the chest and back. These reactions usually resolve within 20 minutes but may persist for several hours.
Vancocin (Vancomycin hydrochloride) 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.
Vancocin (Vancomycin hydrochloride) Dosage And Administration
Adults —
C. difficile
Pediatric Patients —
Vancocin (Vancomycin hydrochloride) How Supplied
Vancocin (Vancomycin hydrochloride) HCl Capsules (Vancomycin Hydrochloride Capsules, USP) are available in:
The 125 mg* capsules have an opaque blue cap and opaque brown body imprinted with “3125” on the cap and “Vancocin (Vancomycin hydrochloride) HCL 125 MG” on the body in white ink.
They are available in:
The 250 mg* capsules have an opaque blue cap and opaque lavender body imprinted with “3126” on the cap and “Vancocin (Vancomycin hydrochloride) HCL 250 MG” on the body in white ink.
They are available in:
Store at controlled room temperature, 59° to 86°F (15° to 30°C).
*Equivalent to vancomycin.
Vancocin (Vancomycin hydrochloride) is a registered U.S. trademark owned by ViroPharma Incorporated.
Rx Only
© ViroPharma Incorporated 2005. All rights reserved.
Distributed by: ViroPharma Incorporated, Exton, PA 19341, USA
Rev. 10/2005
Vancocin (Vancomycin hydrochloride)
Vancocin (Vancomycin hydrochloride)
Vancocin (Vancomycin hydrochloride)
Vancocin (Vancomycin hydrochloride)
