Complete adverse effect profile including incidence rates and management
Important Safety Information
This is not a complete list of all possible side effects. Contact your healthcare provider if you experience any unexpected symptoms. For serious or life-threatening side effects, seek emergency medical attention immediately.
ADVERSE REACTIONS Infusion-Related Events During or soon after rapid infusion of vancomycin hydrochloride for injection, patients may develop anaphylactoid reactions, including hypotension (see ANIMAL PHARMACOLOGY ), 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.
Such events are infrequent if vancomycin hydrochloride for injection is given by a slow infusion over 60 minutes.
In studies of normal volunteers, infusion-related events did not occur when vancomycin hydrochloride for injection was administered at a rate of 10 mg/min or less.
Nephrotoxicity Systemic vancomycin exposure may result in acute kidney injury (AKI).
The risk of AKI increases as systemic exposure/serum levels increase.
Additional risk factors for AKI in patients receiving vancomycin include receipt of concomitant drugs known to be nephrotoxic, in patients with pre-existing renal impairment, or with co-morbidities that predispose to renal impairment.
Interstitial nephritis has also been reported in patients receiving vancomycin.
Gastrointestinal Onset of pseudomembranous colitis symptoms may occur during or after antibiotic treatment (see WARNINGS ).
WARNINGS Infusion Reactions Rapid bolus administration (e.g., over several minutes) may be associated with exaggerated hypotension, including shock and rarely cardiac arrest.
Vancomycin hydrochloride for injection should be administered in a diluted solution over a period of not less than 60 minutes to avoid rapid-infusion-related reactions.
Stopping the infusion usually results in prompt cessation of these reactions.
Nephrotoxicity Systemic vancomycin exposure may result in acute kidney injury (AKI).
The risk of AKI increases as systemic exposure/serum levels increase.
Like all medications, Vancomycin Hydrochloride can cause side effects. However, not everyone who takes this medication will experience them. Many side effects are dose-dependent and may improve as your body adjusts to the medication. Others may require dose adjustment or medical attention.
Contact your healthcare provider promptly if you experience:
Seek immediate emergency medical care if you experience signs of: