Adverse Events
Infusion-Related Events
During or soon after rapid infusion of vancomycin hydrochloride, patients may develop anaphylactoid reactions, including hypotension, wheezing, dyspnea, urticaria, or pruritus. Rapid infusion may also cause flushing of the upper body (“red neck”) or pain and muscle spasm of the chest and back. These reactions usually resolve within 20 minutes but may persist for several hours. In animal studies, hypotension and bradycardia occurred in animals given large doses of vancomycin at high concentrations and rates.. such events are infrequent if vancomycin hydrochloride is given by a slow infusion over 60 minutes. In studies of normal volunteers, infusion-related events did not occur when vancomycin hydrochloride was administered at a rate of 10mg/min or less.
Nephrotoxicity
Rarely, renal failure, principally manifested by increased serum creatinine or BUN concentrations, especially in patients given large doses of vancomycin hydrochloride, 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 preexisting kidney dysfunction.
When vancomycin hydrochloride was discontinued, azotemia resolved in most patients. Abnormal kidney function tests have been reported.
Gastrointestinal
Onset of pseudomembranous colitis symptoms may occur during or after antibiotic treatment (see Warnings)
Ototoxicity
A few dozen cases of hearing loss associated with vancomyin hydrochloride have been reported. Most of these patients had kidney dysfunction or a preexisting hearing loss or were receiving concomitant treatment with an ototoxic drug. Vertigo, dizziness, and tinnitus have been reported rarely.
Hematooietic
Reversible neutropenia, usually starting 1 week or more after onset of therapy with vancomycin hydrochloride or after a total dosage of more than 25g, has been reported for several dozen patients. Neutropenia appears to be promptly reversible when vancomycin hydrochloride is discontinued. Thrombocytopenia has rarely been reported. Although a casual relationship has not been established, reversible agranulocytosis (granulocyte <500/mm3) has been reported rarely.
Phlebitis: Inflammation at the injection site has been reported
Skin and Appendages : Exfoliative dermatitis; Linear IgA bullous dermatosis; Rash; Stevens-Johnson syndrome; “Red Man” syndrome; Toxic epidermal necrolysis; Vasculitis
Miscellaneous
Infrequently, patients have been reported to have had anaphylaxis, drug fever, nausea, chill, and eosinophilia, in association with administration of vancomycin hydrochloride. Chemical peritonitis has been reported following intraperitoneal administration of vancomycin (see Precautions)