Contraindications:
Vancomycin hydrochloride is contraindicated in patients with known hypersensitivity to this antibiotic.
Warnings and Precautions:
Warnings
Rapid bolus administration (e.g. over several minutes) may be associated with exaggerated hypotension, including shock, and rarely, cardiac arrest. Vancomycin hydrochloride should be administere in a dilute solution over a period of not less than 60 minutes to void rapid-infusion-related reactions. Stopping the infusion usually results in prompt cessation of these reactions. Ototoxicity has occurred in patients receiving vancomycin hydrochloride. It may be transient or permanent. It has been reported mostly in patients who have been given excessive doses, who have an underlying hearing loss, or who are receiving concomitant therapy with another ototoxic agent, such as an aminoglycoside. Vancomycin should be used with caution in patients with renal insufficiency because the risk of toxicity is appreciably increased by high, prolonged blood concentrations. Dosage of vancomycin hydrochloride must be adjusted for patients with renal dysfunction (see Precaution and Dosage and Administration). Pseudomembraneous colitis has been reported with virtually all broad-spectrum antibiotics (including macrolides semisynthetic penicillins, and cephalosporins); therefore, it is important to consider its diagnosis in patients who develop diarrhea in association with the use of antibiotics. Such colitis may range in severity from mild to life threatening. Mild cases of pseudomembranous colitis usually respond to drug continuous alone. In moderate to severe cases, appropriate measures should be taken.
Precautions
General
Clinically significant serum concentration have been reported in some patients who have taken multiple oral doses of vancomycin for active C. difficile-induced pseudomembranous colitis. Prolonged use of vancomycin hydrochloride may result in the overgrowth of nonsusceptible organisms. Careful observation of the patient is essential. If superinfection occurs during therapy, appropriate measures should be taken. In order to minimize the risk of nephrotoxicity when treating patients with underlying renal dysfunction or patients receiving concomitant therapy with an aminoglycoside, serial monitoring of renal function should be performed and particular care should be taken in following appropriate dosing schedules(see Dosage and Administration)
Serial tests of auditory function may be helpful in order to minimize the risk of ototoxicity.
Reversible neutropenia has been reported in patients receiving concomitant drugs that may cause neutropenia should have periodic monitoring of the leukocyte count.
Vancomycin hydrochloride is irritating to tissue and must be given by a secure intravenous route of administration. Pain, tenderness, and necrosis occur with intramuscular injection of vancomycin hydrochloride or with inadvertent extravasation. Thrombophlebitis may occur, the frequency and severity of which can b minimized by administering the drug slowly as a dilute solution (2.5 to 5 g/L) and by rotating the sites of infusion.
There have been reports that the frequency of infusion-related events (including hypotension, flushing, erythema, urticaria, and pruritus) increases with the concomitant administration of anesthetic agents. Infusion-related events may be minimized by the administration of vancomycin hydrochloride as a 60-minute infusion prior to anesthetic induction.
The safety and efficacy of vancomycin hydrochloride administration by the intrathecal (intralumbar or intraventricular) routes have not been assessed. Reports have revealed that administration of sterile vancomycin HCl by the intraperitoneaal route during continuous ambulatory peritoneal dialysis (CAPD) has resulted in a syndrome of chemical peritonitis. To date, this syndrome has ranged from a cloudy dialysate alone to a cloudy dialysate accompanied by variable degrees of abdominal pain and fever. This syndrome appears to be short-lived after discontinuation of intraperitoneal vancomycin.
Drug Interactions
Concomitant administration of vancomycin and anesthetic agents has been associated with erythema and histamine-like flushing (see usage in Pediatrics under Precautions) and anaphylactoid reactions (see Adverse Events)
Concurrent and/or sequential systemic or topical use of other potentially neurotoxic and/or nephrotoxic drugs, such as amphotericin B, aminoglycosides, bacitracin, polymyxin B, colistin, viomycin, or cisplatin, when indicated, requires careful monitoring
Carcinogenesis, Mutagenesis, Impairment of Fertility
Although no long-term studies in animals have been performed to evaluate carcinogenic potential, no mutagenic potential of vancomycin was found in standard laboratory tests. No definitive fertility studies have been performed.
Usage in Pregnancy
The highest doses of vancomycin tested were not teratogenic in rats given up to 200 mg/kg/day IV (1,180 mg/m2 or 1 times the recommended maximum human dose based on a mg/m2 basis) or in rabbits given up to 120/kg/day IV (1,320 mg/m2 or 1.1 times the recommended maximum human dose based on a mg/m2 basis). No effects on fetal weight or development were seen in rats at the highest dose tested or in rabbits given 80mg/kg/day (880 mg/m2 or 1.4 times less than the recommended maximum human dose based on mg/m2). In a controlled clinical study, the potential ototoxic and nephrotoxic effects of vancomycin hydrochloride on infants were evaluated when the drug was administered intravenously to pregnant women for serious staphylococcal infections complicating intravenous drug abuse.
Vancomyin hydrochloride was found in cord blood. No sensorineural hearing loss or nephrotoxicity attributable to vancomycin hydrochloride was noted. One infant whose mother received vancomycin hydrochloride in the third trimester experienced conductive hearing loss that was not attributed to the administration of vancomycin hydrochloride. Because the number of patients treated in this study was limited and vancomycin hydrochloride was administered only in the second and trimesters, it is not known whether vancomycin hydrochloride causes fetal harm. Because animal reproduction studies are not always predictive of human response, vancomycin hydrochloride should be given to a pregnant woman only if clearly needed.
Nursing Mothers
Vancomycin hydrochloride is excreted in human milk. Caution should be exercised when vancomycin hydrochloride is administered to a nursing woman. Because the potential for adverse events, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug in the mother.
Usage in Pediatrics
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 (see Adverse Events)
Geriatrics
The natural decrement 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 (see Dosage and Administration)