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Vancomycin (Vancomycin Hydrochloride) - Warnings and Precautions

 
 



WARNINGS AND PRECAUTIONS


Oral Use Only

This preparation for the treatment of colitis is for oral use only and is not systemically absorbed.  Vancomycin hydrochloride capsules must be given orally for treatment of staphylococcal enterocolitis and Clostridium difficile-associated diarrhea.  Orally administered vancomycin hydrochloride capsules are not effective for other types of infections.

Parenteral administration of vancomycin is not effective for treatment of staphylococcal enterocolitis and C. difficile-associated diarrhea.  If parenteral vancomycin therapy is desired, use an intravenous preparation of vancomycin and consult the package insert accompanying that preparation.


Potential for Systemic Absorbtion

Clinically significant serum concentrations have been reported in some patients who have taken multiple oral doses of vancomycin hydrochloride for active C.difficile -associated diarrhea.  Some patients with inflammatory disorders of the intestinal mucosa also may have significant systemic absorption of vancomycin.  These patients may be at risk for the development of adverse reactions associated with higher doses of vancomycin; therefore, monitoring of serum concentrations of vancomycin may be appropriate in some instances, e.g., in patients with renal insufficiency and/or colitis or in those receiving concomitant therapy with an aminoglycoside antibiotic.

Nephrotoxicity

Nephrotoxicity (e.g., reports of renal failure, renal impairment, blood creatinine increased) has occurred following oral vancomycin hydrochloride therapy in randomized controlled clinical studies, and can occur either during or after completion of therapy.

The risk of nephrotoxicity is increased in patients >65 years of age [see Adverse Reactions, Clinical Trial Experience   and Use In Specific Populations, Geriatric Use ] .

In patients >65 years of age, including those with normal renal function prior to treatment, renal function should be monitored during and following treatment with vancomycin hydrochloride to detect potential vancomycin induced nephrotoxicity.

Ototoxicity

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 [see Adverse Reactions, Postmarketing Experience ].

Superinfection

Use of vancomycin may result in the overgrowth of nonsusceptible bacteria.  If superinfection occurs during therapy, appropriate measures should be taken.

Development of Drug-Resistant Bacteria

Prescribing vancomycin hydrochloride in the absence of a proven or strongly suspected bacterial infection is unlikely to provide benefit to the patient and increases the risk of the development of drug resistant bacteria.

USE IN SPECIFIC POPULATIONS

Pregnancy

Pregnancy Category B – The highest doses of vancomycin tested were not teratogenic in rats given up to 200 mg/kg/day IV (1180 mg/m2 or 1 times the recommended maximum human dose based on body surface area) or in rabbits given up to 120 mg/kg/day IV (1320 mg/m2 or 1.1 times the recommended maximum human dose based on body surface area).  No effects on fetal weight or development were seen in rats at the highest dose tested or in rabbits given 80 mg/kg/day (880 mg/m2 or 0.74 times the recommended maximum human dose based on body surface area).

In a controlled clinical study, the potential ototoxic and nephrotoxic effects of vancomycin on infants were evaluated when the drug was administered intravenously to pregnant women for serious staphylococcal infections complicating intravenous drug abuse.  Vancomycin was found in cord blood.  No sensorineural hearing loss or nephrotoxicity attributable to vancomycin was noted.  One infant whose mother received vancomycin in the third trimester experienced conductive hearing loss that was not attributed to the administration of vancomycin.  Because the number of subjects treated in this study was limited and vancomycin was administered only in the second and third trimesters, it is not known whether vancomycin 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 is excreted in human milk based on information obtained with the intravenous administration of vancomycin.  However, systemic absorption of vancomycin is very low following oral administration of vancomycin hydrochloride [see Clinical Pharmacology, Pharmacokinetics ] .  It is not known whether vancomycin is excreted in human milk, as no studies of vancomycin concentration in human milk after oral administration have been done.  Caution should be exercised when vancomycin hydrochloride is administered to a nursing woman. Because of the potential for adverse events, a decision should be made whether to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother.

Pediatric Use

Safety and effectiveness in pediatric patients have not been established.

Geriatric Use

In clinical trials, 54% of vancomycin hydrochloride-treated subjects were >65 years of age.  Of these, 40% were between the ages of >65 and 75, and 60% were >75 years of age.

Clinical studies with vancomycin hydrochloride in diarrhea associated with Clostridium   difficile have demonstrated that geriatric subjects are at increased risk of developing nephrotoxicity following treatment with oral vancomycin hydrochloride, which may occur during or after completion of therapy.  In patients >65 years of age, including those with normal renal function prior to treatment, renal function should be monitored during and following treatment with vancomycin hydrochloride to detect potential vancomycin- induced nephrotoxicity [see Warnings and Precautions, Nephrotoxicity ; Adverse Reactions, Clinical Trial Experience   and Clinical Studies, Diarrhea Associated with Clostridium difficile ].

Patients >65 years of age may take longer to respond to therapy compared to patients ≤65 years of age [see Clinical Studies, Diarrhea Associated with Clostridium difficile ].   Clinicians should be aware of the importance of appropriate duration of vancomycin hydrochloride treatment in patients >65 years of age and not discontinue or switch to alternative treatment prematurely.

Page last updated: 2012-06-25

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