Vancocin

Cross-resistance has not been demonstrated between vancomycin and other classes of antibiotics. Laboratory-induced resistance has been reported to occur in a slow stepwise fashion. The development of resistance to vancomycin by staphylococci has not been reported in clinical use. Its activity is not significantly altered by changes in pH or by the presence of serum. Vancomycin is active against most strains of the following organisms in vitro and in clinical infections: S. aureus (including heterogeneous methicillin-resistant strains), C. difficile, S. epidermidis (including heterogeneous methicillin-resistant strains), S. pneumoniae (including multiple-resistant strains), S. pyogenes (group A beta-hemolytic), S. agalactiae (group B beta-hemolytic), S. bovis, Alpha-hemolytic streptococci (viridans groups), Enterococci (e.g., E. faecalis), Bacillus species, L. monocytogenes, Lactobacillus species, Neisseria species, Diphtheroids, Actinomyces species.

Note: Many strains of streptococci, staphylococci, C. difficile and other gram-positive bacteria are sensitive in vitro to concentrations of 0.5 to 5 µg/mL. Staphylococci are generally susceptible to less than 5 µg/mL, but a small proportion of S. aureus strains requires 10 to 20 µg/mL for inhibition.

In vitro resistance to vancomycin has been reported among some enterococcal and staphylococcal isolates.

Vancomycin is not effective in vitro against gram-negative bacilli, mycobacteria, or fungi.

Renal Insufficiency: Infusions of 1 g vancomycin in 250 mL D5-W were given over 30 minutes to 29 anephric patients. After 18 days with intermittent dialysis at 3-day intervals, the serum concentration was still 3.5 µg/mL. The elimination half-life was about 7.5 days.

Oral Administration: Vancomycin is poorly absorbed after oral administration, only trace amounts being found in blood or urine. Following 125 mg orally 4 times daily, the mean concentration of vancomycin in stools was approximately 350 µg/g. Following up to 10 daily oral doses of 2 g, a mean level of 3100 µg/g with a range of 905 to 8760 µg/g was detected in feces of patients with pseudomembranous colitis.

Central Nervous System: Vancomycin does not readily diffuse across normal meninges into the spinal fluid; but, when the meninges are inflamed, penetration into the spinal fluid occurs.

Other Tissues and Fluids: Vancomycin concentration in human pericardial, pleural, bile, ascitic and synovial fluids reaches approximately one third of the equivalent serum level after single i.v. doses. A level of 7.6 µg/mL was achieved in the brain cyst of one infant following i.v. infusion of 40 mg/kg daily for 4 days.

The natural decrease of glomerular filtration with increasing age may lead to elevated vancomycin serum concentrations if dosage is not adjusted. Vancomycin dosage schedules should be adjusted in elderly patients.

VANCOCIN is excreted in human milk. Caution should be exercised if VANCOCIN is administered to a nursing woman. Because of the potential for adverse events, a decision should be made whether to discontinue nursing or discontinue administration of the drug, taking into account the importance of the drug to the mother.

In premature neonates and young infants, it may be appropriate to confirm desired vancomycin serum concentrations. Concomitant administration of vancomycin and anesthetic agents has been associated with erythema and histamine-like flushing in children.

VANCOCIN should be given to a pregnant woman only if clearly needed. In a controlled clinical study, VANCOCIN was administered to 10 pregnant women for serious staphylococcal infections complicating intravenous drug abuse to evaluate potential ototoxic and nephrotoxic effects on the infant. VANCOCIN levels of 13.2 and 16.6 µg/mL were measured in cord blood of two patients. No sensorineural hearing loss or nephrotoxicity attributable to VANCOCIN was noted. One infant whose mother received VANCOCIN in the third trimester experienced conductive hearing loss that was not attributed to the administration of VANCOCIN. Because the number of patients treated in this study was limited and VANCOCIN was administered only in the second and third trimesters, it is not known whether VANCOCIN causes fetal harm.

Each pale brown and dark blue capsule, imprinted in white ink with "VANCOCIN HCL 250 mg" on one side and "3126" on the other side, contains: vancomycin HCl equivalent to vancomycin 250 mg. Nonmedicinal ingredients: FD&C Blue No. 2, gelatin, iron oxide, polyethylene glycol and titanium dioxide. Unit dose packages of 20.

Each peach and dark blue capsule, imprinted in white ink with "VANCOCIN HCL 125 mg" on one side and "3125" on the other side, contains: vancomycin HCl equivalent to vancomycin 125 mg. Nonmedicinal ingredients: FD&C Blue No. 2, gelatin, iron oxide, polyethylene glycol and titanium dioxide. Unit dose packages of 20.

Rarely, renal failure, principally manifested by increased serum creatinine or BUN concentrations, especially in patients given large doses of VANCOCIN, has been reported. Rare cases of interstitial nephritis have been reported. Most of these have occurred in patients who were given aminoglycosides concomitantly or who had pre-existing kidney dysfunction. When VANCOCIN was discontinued, azotemia resolved in most patients.

Anaphylaxis, drug fever, nausea, chills, eosinophilia, hypotension, wheezing, dyspnea, urticaria, pruritus flushing of the upper body (“red neck”), pain and muscle spasm of the chest and back, rashes, including exfoliative dermatitis, Stevens-Johnson syndrome, linear IgA bullous dermatosis and rare cases of vasculitis have been associated with the administration of VANCOCIN.

A few dozen cases of hearing loss associated with VANCOCIN have been reported. Most of these patients had kidney dysfunction, pre-existing hearing loss, or concomitant treatment with an ototoxic drug. Vertigo, dizziness, and tinnitus have been reported rarely.

Reversible neutropenia, usually starting one week or more after onset of therapy with VANCOCIN or after a total dose of more than 25 g, has been reported in several dozen patients. Neutropenia appears to be promptly reversible when VANCOCIN is discontinued. Thrombocytopenia has rarely been reported. Although a causal relationship has not been established, reversible agranulocytosis (granulocyte count less than 500/mm³) has been reported rarely.

Other than general supportive treatment, no specific antidote is known. Dialysis does not remove significant amounts of vancomycin. Hemofiltration and hemoperfusion with polysulfone resin have been reported to result in increased vancomycin clearance.

In managing overdosage, consider the possibility of multiple drug overdoses, interaction among drugs, and unusual drug kinetics in your patient.