Vancomycin Hydrocloride Recall
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Questions & Answers
Side Effects & Adverse Reactions
Rapid bolus administration (e.g., over several minutes) may be associated with exaggerated hypotension, including shock and, rarely, cardiac arrest. Vancomycin should be administered over a period of not less than 60 minutes to avoid rapid-infusion-related reactions. Stopping the infusion usually results in a prompt cessation of these reactions.
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 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 must be adjusted for patients with renal dysfunction (see PRECAUTIONS and DOSAGE AND ADMINISTRATION).
Clostridium difficile associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including Vancomycin Injection, USP, and may range in severity from mild diarrhea to fatal colitis. Treatment with antibacterial agents alters the normal flora of the colon leading to overgrowth of C. difficile.
C. difficile produces toxins A and B which contribute to the development of CDAD. Hypertoxin producing strains of C. difficile cause increased morbidity and mortality, as these infections can be refractory to antimicrobial therapy and may require colectomy. CDAD must be considered in all patients who present with diarrhea following antibiotic use. Careful medical history is necessary since CDAD has been reported to occur over two months after the administration of antibacterial agents.
If CDAD is suspected or confirmed, ongoing antibiotic use not directed against C. difficile may need to be discontinued. Appropriate fluid and electrolyte management, protein supplementation, antibiotic treatment of C. difficile, and surgical evaluation should be instituted as clinically indicated.
There is currently no legal information available for this drug.
FDA Safety Alerts
There are currently no FDA safety alerts available for this drug.
There is currently no manufacturer warning information available for this drug.
FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
To reduce the development of drug-resistant bacteria and maintain the effectiveness of vancomycin and other antibacterial drugs, vancomycin should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.
Vancomycin hydrochloride is indicated for the treatment of serious or severe infections caused by susceptible strains of methicillin-resistant (beta-lactam-resistant) staphylococci. It is indicated for penicillin-allergic patients, for patients who cannot receive or who have failed to respond to other drugs, including the penicillins or cephalosporins, and for infections caused by vancomycin-susceptible organisms that are resistant to other antimicrobial drugs. Vancomycin hydrochloride is indicated for initial therapy when methicillin-resistant staphylococci are suspected, but after susceptibility data are available, therapy should be adjusted accordingly.
Vancomycin hydrochloride is effective in the treatment of staphylococcal endocarditis.
Its effectiveness has been documented in other infections due to staphylococci, including septicemia, bone infections, lower respiratory tract infections, and skin and skin-structure infections. When staphylococcal infections are localized and purulent, antibiotics are used as adjuncts to appropriate surgical measures.
Vancomycin hydrochloride has been reported to be effective alone or in combination with an aminoglycoside for endocarditis caused by Streptococcus viridans or S. bovis. For endocarditis caused by enterococci (e.g. E. faecalis), vancomycin hydrochloride has been reported to be effective only in combination with an aminoglycoside.
Vancomycin hydrochloride has been reported to be effective for the treatment of diphtheroid endocarditis. Vancomycin hydrochloride has been used successfully in combination with either rifampin, an aminoglycoside, or both in early-onset prosthetic valve endocarditis caused by S. epidermidis or diphtheroids.
Specimens for bacteriologic cultures should be obtained in order to isolate and identify causative organisms and to determine their susceptibilities to vancomycin hydrochloride.
The parenteral form of vancomycin hydrochloride may be administered orally for treatment of antibiotic-associated pseudomembranous colitis produced by C. difficile and for staphylococcal enterocolitis. Parenteral administration of vancomycin hydrochloride alone is of unproven benefit for these indications. Vancomycin is not effective by the oral route for other types of infection.
There is currently no drug history available for this drug.
Vancomycin Hydrochloride for Injection USP is a lyophilized off-white powder, for preparing intravenous (IV) infusions, in a Pharmacy Bulk Package containing the equivalent of 10 g vancomycin base. 500 mg of the base are equivalent to 0.34 mmol. When reconstituted with Sterile Water for Injection to a concentration of 100 mg/mL, a clear, colorless solution of pH between 2.5 and 4.5 is formed. Vancomycin Hydrochloride for Injection USP should be administered intravenously in diluted solution (see DOSAGE AND ADMINISTRATION).
Vancomycin Hydrochloride for Injection USP is a tricyclic glycopeptide antibiotic derived from Amycolatopasis orientalis (formerly Nocardia orientalis).Vancomycin hydrochloride USP has the following structural formula:
The chemical name of Vancomycin Hydrochloride USP is (Sa) - (3S, 6R, 7R, 22R, 23S, 26S, 36R, 38aR ) - 44 - [[2 - O - (3-Amino-2, 3, 6 - trideoxy - 3 - C - methyl - α - L - lyxo - hexopyranosyl) - β- D glucopyranosyl] oxy] - 3 - (carbamoylmethyl) - 10, 19 - dichloro- 2, 3, 4, 5, 6, 7, 23, 24, 25, 26, 36, 37, 38, 38a - tetradecahydro- 7, 22, 28, 30, 32 – pentahydroxy -6 - [(2R) - 4 - methyl -2 - (methylamino) valeramido]- 2, 5, 24, 38, 39 - pentaoxo - 22 H - 8, 11 : 18, 21- dietheno - 23, 36 - (iminomethano) -13, 16: 31, 35-dimetheno-1H, 16H-[1, 6, 9] oxadiazacyclohexadecino [4, 5 - m] [10, 2, 16] benzoxadiazacyclotetracosine - 26 - carboxylic acid, monohydrochloride.
A Pharmacy Bulk Package is a sterile dosage form for parenteral use containing many single doses. The contents are intended for use in a pharmacy admixture program and are restricted to the preparation of admixtures for intravenous infusion (see DOSAGE AND ADMINISTRATION). AFTER RECONSTITUTION FURTHER DILUTION IS REQUIRED BEFORE USE.