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Vancomycin (Systemic)


VA CLASSIFICATION
Primary: AM900

Commonly used brand name(s): Vancocin.

Note: For a listing of dosage forms and brand names by country availability, see Dosage Forms section(s).



Category:


Antibacterial (systemic)—

Indications

Note: Bracketed information in the Indications section refers to uses that are not included in U.S. product labeling.

General considerations
Vancomycin is a narrow-spectrum antibacterial agent that has excellent antimicrobial activity against gram-positive organisms, including Clostridium difficile , diphtheroids, most Enterococcus species, staphylococci, and streptococci {02}. Vancomycin is used to treat enterococcal infections in patients with a history of hypersensitivity to beta-lactam antibiotics, and infections due to beta-lactam–resistant microorganisms, including methicillin-resistant Staphylococcus aureus (MRSA), methicillin-resistant Staphylococcus epidermidis (MRSE), and penicillin-resistant enterococci. The increase in prevalence of disease due to MRSA and MRSE and of antibiotic resistance in general has led to an increase in the use of vancomycin.

One of the consequences of increased vancomycin use has been the emergence of vancomycin-resistant microorganisms. From 1989 through 1993, the Centers for Disease Control and Prevention (CDC) reported an increase in the percentage of nosocomial enterococcal infections caused by vancomycin-resistant enterococci, from 0.3 to 7.9% {01}. Since the determinants of vancomycin resistance in enterococci are located on a conjugative plasmid, vancomycin resistance may be transferred among enterococci and potentially to other gram-positive organisms {05}. Staphylococcus species are among the most common causes of community- and hospital-acquired infection; thus, the potential emergence of vancomycin resistance in clinical isolates of S. aureus and S. epidermidis is a public health concern. Several strains of S. aureus with reduced susceptibility to vancomycin have been isolated from patients in Japan {03} {29}. In the U.S., two strains of S. aureus and several strains of Staphylococcus hemolyticus with intermediate levels of resistance to vancomycin have been reported {03} {25}. The CDC has responded by developing guidelines and recommendations for the detection and prevention of the spread of vancomycin-resistant organisms {01} {03}. The CDC concludes that reduction in the overuse and misuse of vancomycin, as well as of antimicrobials in general, will decrease the risk of emergence of staphylococci with reduced susceptibility to vancomycin {03}.

Accepted

Bone and joint infections (treatment)
Pneumonia (treatment)
Septicemia, bacterial (treatment) or
Skin and soft tissue infections (treatment)—Intravenous vancomycin is indicated in the treatment of bone and joint infections (including osteomyelitis), pneumonia, septicemia, and skin and soft tissue infections caused by susceptible strains of Staphylococcus species (including methicillin-resistant strains). {02} {20}

Endocarditis, bacterial (prophylaxis)—Intravenous vancomycin is indicated for prophylaxis of bacterial endocarditis in penicillin-allergic patients with prosthetic heart valves or congenital, rheumatic, or other acquired valvular heart disease who are undergoing dental procedures or surgical procedures of the upper respiratory tract {02} {20}. However, this use is no longer recommended by the American Heart Association or the American Dental Association {14} {36}. Medical experts agree that although vancomycin should not be used routinely in these patients, vancomycin should be available for use in selected patients (including penicillin-allergic patients) based on need for a life-saving medication when microorganisms are resistant to usual antibacterials {08} {36}.
—[Vancomycin is indicated as a primary agent for the prophylaxis of bacterial endocarditis in penicillin-allergic patients with prosthetic heart valves or congenital or valvular heart disease who are undergoing gastrointestinal or genitourinary tract procedures; depending on the risk, gentamicin may be administered concurrently{14}{38} (Evidence rating: III).]1

Endocarditis, bacterial (treatment)—Intravenous vancomycin is indicated in the treatment of endocarditis caused by Staphylococcus species (including methicillin-resistant strains). {02} {20}
—Vancomycin is also indicated as a primary agent, alone or concurrently with an aminoglycoside or rifampin, in endocarditis caused by Corynebacterium species (diphtheroids) (including penicillin-resistant and cephalosporin-resistant strains) in penicillin-allergic patients, and as a secondary agent in endocarditis caused by Streptococcus viridans or Streptococcus bovis . {02}
—[Intravenous vancomycin is indicated as a primary agent, concurrently with gentamicin or streptomycin, in the treatment of endocarditis caused by enterococci (Enterococcus faecalis ) in penicillin-allergic patients{20} .]

—Intravenous vancomycin is indicated in the treatment of severe, potentially life-threatening staphylococcal infections in patients who cannot receive penicillins or cephalosporins or who have failed to respond to them. Vancomycin is also indicated in the treatment of staphylococcal infections that are resistant to other antibacterials, including methicillin. {02} {20}

Note: Not all species or strains of a particular organism may be susceptible to vancomycin.


Acceptance not established
Vancomycin has been used for the treatment of meningitis due to Streptococcus pneumoniae or staphylococci. (Evidence rating: III) There is currently not enough medical literature or clinical experience to recommend the use of vancomycin for this indication. {40}

Intravenous vancomycin, administered concurrently with an aminoglycoside (e.g., gentamicin) or rifampin, has been used in the treatment of serious infections caused by Staphylococcus species (including methicillin-resistant and multiresistant strains) in penicillin-allergic patients. (Evidence rating: III) The data are insufficient to recommend the use of vancomycin for this indication. {40}

Unaccepted
Vancomycin is not effective against most gram-negative organisms, Mycobacterium species, Bacteroides species, Rickettsia species, Chlamydia species, or fungi {02}.

The use of parenteral vancomycin is not recommended in the treatment of antibiotic-associated pseudomembranous colitis. {02}

1 Not included in Canadian product labeling.



Pharmacology/Pharmacokinetics

Physicochemical characteristics:

Chemical group—
    Tricyclic glycopeptide {02}.
Molecular weight—
    Vancomycin hydrochloride: 1485.74 {02}

Mechanism of action/Effect:

Bactericidal for most organisms; bacteriostatic for enterococci; inhibits bacterial cell wall synthesis at a site different from that of penicillins and cephalosporins by binding tightly to the D-alanyl- D-alanine portion of cell wall precursors and interfering with bacterial growth; this leads to activation of bacterial autolysins that destroy the cell wall by lysis {05} {30}. Vancomycin also may alter the permeability of bacterial cytoplasmic membranes and may selectively inhibit ribonucleic acid (RNA) synthesis {02}; vancomycin does not compete with penicillins for binding sites.

Absorption:

Intraperitoneal—Systemic absorption (up to 60%) may occur. {02}

Distribution:

Widely distributed to most tissues and body fluids; adequate therapeutic concentrations in serum and in pleural, pericardial, peritoneal, ascitic, and synovial fluids; high concentrations in urine; inadequate concentrations in bile; does not readily cross normal blood-brain barrier into cerebrospinal fluid (CSF); however, penetrates into CSF when meninges are inflamed and may achieve therapeutic concentrations. {02} {05} Crosses the placenta.

Vol D—Approximately 0.39 to 0.92 liter per kg {16}.

Protein binding:

Healthy adults—Moderate (approximately 37 to 55%) {02} {13}.

Adults with infections—Low (approximately 20%) {13}.

Half-life:


Normal renal function:

Adults: Approximately 6 hours {02} (range, 4 to 11 hours).

Newborn infants: Approximately 6 to 10 hours.

Older infants: Approximately 4 hours.

Children: Approximately 2 to 3 hours.



Impaired renal function (oliguric or anuric):

Adults: 6 to 10 days.


Peak serum concentration:

Approximately 49 mcg per mL immediately following a 500-mg intravenous dose infused over a 30-minute period; mean serum concentration is approximately 20 mcg per mL 1 to 2 hours after dosing {02} {20}.

Approximately 63 mcg per mL immediately following a 1-gram intravenous dose infused over a 60-minute period; mean serum concentration is approximately 23 to 30 mcg per mL 1 to 2 hours after dosing {02} {20}.

Elimination:
    Renal—Approximately 75 to 90% or more excreted by passive glomerular filtration unchanged in urine within 24 hours {02} {16}; slowly eliminated by unknown route and mechanism in anephric patients.
    Biliary—Small to moderate amounts may be excreted in bile.
    In dialysis—Not appreciably removed from the blood by hemodialysis or peritoneal dialysis. {02}


Precautions to Consider

Carcinogenicity

No long-term carcinogenicity studies have been performed in animals.

Mutagenicity

No mutagenic potential was found in standard laboratory tests.

Pregnancy/Reproduction
Fertility—
No definitive fertility studies have been performed.

Pregnancy—
Intravenous vancomycin crosses the placenta. In one small controlled study, infants whose mothers were treated with vancomycin in their second or third trimester of pregnancy had no sensorineural hearing loss or nephrotoxicity that was attributed to vancomycin therapy. {02} {15}

FDA Pregnancy Category C. {02}

Breast-feeding

Parenteral vancomycin is distributed into breast milk {02}. Although available data regarding the use of vancomycin while breast-feeding are limited, problems in humans have not been documented. {15}

Pediatrics

Close monitoring of vancomycin serum concentrations is recommended in premature neonates and young infants. {02}


Geriatrics


Elderly patients are more likely to have an age-related decrease in renal function, which may require dosage adjustments to avoid excessive vancomycin serum concentrations. Because of this, geriatric patients are at greater risk of vancomycin-induced ototoxicity (i.e., loss of hearing) and nephrotoxicity. {02}

Drug interactions and/or related problems
The following drug interactions and/or related problems have been selected on the basis of their potential clinical significance (possible mechanism in parentheses where appropriate)—not necessarily inclusive (» = major clinical significance):


Note: Combinations containing any of the following medications, depending on the amount present, may also interact with this medication.

» Aminoglycosides or
» Amphotericin B, parenteral or
Aspirin or other salicylates or
» Bacitracin, parenteral or
» Bumetanide, parenteral or
» Capreomycin or
Carmustine or
» Cisplatin or
» Cyclosporine or
» Ethacrynic acid, parenteral or
» Furosemide, parenteral or
» Paromomycin or
» Polymyxins or
» Streptozocin    (concurrent and/or sequential use of these medications with vancomycin may increase the potential for ototoxicity and/or nephrotoxicity {02} {04}; hearing loss may occur and may progress to deafness, even after discontinuation of the drug; hearing loss may be reversible, but usually is permanent {02}; serial audiometric function determinations may be required with concurrent or sequential use of other ototoxic antibacterials {02})

    (however, vancomycin and aminoglycosides often must be administered concurrently in the prophylaxis of bacterial endocarditis, in the treatment of endocarditis caused by Streptococcus species and diphtheroids, in the treatment of resistant staphylococcal infections, or in penicillin-allergic patients; appropriate monitoring will help to reduce the possibility of an interaction between vancomycin and aminoglycosides; renal function determinations, monitoring of serum concentrations, dosage reductions and/or dosage interval adjustments, or alternate antibacterials may be required)


Anesthetic agents or
» Vecuronium    (some clinical studies report that patients experienced vancomycin-dependent hypotension or enhancement of neuromuscular depression with administration of anesthetic agents or vecuronium, respectively {12} {32}; however, other clinicians report no effects or significant differences between patients administered vancomycin before or after induction of anesthesia {31}; it is recommended that vancomycin be administered by infusion over a period of at least 60 minutes, preferably prior to the induction of anesthesia, to minimize potential enhancement of the hypotensive or neuromuscular blockade effects of anesthetic agents or vecuronium {02} {37})


Antihistamines or
Buclizine or
Cyclizine or
Meclizine or
Phenothiazines or
Thioxanthenes or
Trimethobenzamide    (concurrent use of these medications with vancomycin may mask the symptoms of ototoxicity, such as tinnitus, dizziness, or vertigo)


» Dexamethasone    (studies in animals have demonstrated that concurrent administration of dexamethasone with vancomycin may impair the penetration of vancomycin into cerebrospinal fluid [CSF] {07} {26} {27}; however, the penetration of vancomycin into the CSF of children is better than that demonstrated in the rabbit model {39}; if dexamethasone is to be used as adjunctive therapy in bacterial meningitis, it is recommended that dexamethasone be administered either before or concurrently with the first dose of vancomycin {33} {37})



Laboratory value alterations
The following have been selected on the basis of their potential clinical significance (possible effect in parentheses where appropriate)—not necessarily inclusive (» = major clinical significance):

With physiology/laboratory test values
Blood urea nitrogen (BUN)    (concentrations may be increased)


Medical considerations/Contraindications
The medical considerations/contraindications included have been selected on the basis of their potential clinical significance (reasons given in parentheses where appropriate)— not necessarily inclusive (» = major clinical significance).


Risk-benefit should be considered when the following medical problems exist
Hypersensitivity to vancomycin{02}
» Loss of hearing, or deafness, history of    (vancomycin rarely may cause hearing loss or deafness {02})


» Renal function impairment    (because vancomycin is excreted primarily through the kidneys, patients with renal function impairment may need an adjustment in dosage {02})



Patient monitoring
The following may be especially important in patient monitoring (other tests may be warranted in some patients, depending on condition; » = major clinical significance):

» Audiograms{02} and
» Renal function determinations{02}    (may be required prior to, periodically during, and following treatment in patients with pre-existing renal or eighth-cranial-nerve impairment, especially in patients older than 60 years of age, and with concurrent or sequential administration of other ototoxic antibacterials; twice-weekly or weekly audiometric testing to detect high-frequency hearing loss in patients old enough to be tested; daily renal function determinations may also be required in patients on high-dose or prolonged therapy, especially if renal function is changing or borderline)


» Urinalyses{04}    (may be required prior to treatment and periodically during treatment to detect albumin, casts, and cells in the urine, as well as decreased specific gravity)


» Vancomycin serum concentrations{02}    (may be required periodically in patients with renal function impairment, especially if renal function is changing or borderline, and in patients older than 60 years of age; peak concentrations should not be maintained in excess of approximately 40 mcg per mL, and trough concentrations should not exceed approximately 10 mcg per mL {11}; serum concentrations greater than 80 mcg per mL are considered to be in the toxic range {06})


White blood cell count{02}    (should be monitored periodically to detect possible neutropenia)




Side/Adverse Effects

Note: Side/adverse effects were relatively common with early formulations of vancomycin. Many of these side effects (e.g., chills, fever, hypotension, nephrotoxicity, skin rash, thrombophlebitis, pain at the injection site) were attributed to impurities. Because of subsequent purification, the incidence of these side effects has been substantially reduced.

The following side/adverse effects have been selected on the basis of their potential clinical significance (possible signs and symptoms in parentheses where appropriate)—not necessarily inclusive:

Those indicating need for medical attention
Incidence less frequent
    
Nephrotoxicity {02}{04}(change in frequency of urination or amount of urine; difficulty in breathing; drowsiness; increased thirst; loss of appetite; nausea or vomiting; weakness)
    
neutropenia {02}(chills; coughing; difficulty in breathing; fever; sore throat)—usually reversible
    
“red man syndrome” {02}{04}(chills or fever; fainting; fast heartbeat; hives; hypotension; itching of skin; nausea or vomiting; rash or redness of the face, base of neck, upper body, back, and arms)—may result from histamine release due to rapid infusion

Incidence rare
    
Chemical peritonitis {28}{34}(abdominal pain and cramps; abdominal tenderness)—in patients receiving high doses by intraperitoneal administration
    
linear IgA bullous dermatosis {21}{22}{23}{24}(large blisters on arms, legs, hands, feet, or upper body)
    
ototoxicity {02}{11}(loss of hearing; ringing or buzzing or a feeling of fullness in the ears)
    
pseudomembranous colitis {02}{04}(abdominal or stomach cramps and pain, severe; abdominal tenderness; diarrhea, watery and severe, which may also be bloody; fever)
    
thrombocytopenia {02}{04}(abnormal bleeding or bruising)



Those indicating possible ototoxicity, nephrotoxicity, or pseudomembranous colitis and the need for medical attention if they occur or progress after medication is discontinued
    
Abdominal or stomach cramps and pain, severe
    
abdominal tenderness
    
change in frequency of urination or amount of urine
    
diarrhea, watery and severe, which may also be bloody
    
difficulty in breathing
    
drowsiness
    
fever
    
increased thirst
    
loss of appetite
    
loss of hearing
    
nausea or vomiting
    
ringing or buzzing or a feeling of fullness in the ears
    
weakness




Overdose
For more information on the management of overdose or unintentional ingestion, contact a Poison Control Center (see Poison Control Center Listing ).

Clinical effects of overdose
Vancomycin overdose may result in oliguria and acute renal function failure. Two cases of vancomycin overdose have been reported. An adult who received 1 gram of parenteral vancomycin every 4 hours, for a total of 56 grams over a 10-day period, developed acute renal failure. A 47-day-old premature infant inadvertently was given three 12-mg doses and six 240-mg doses of parenteral vancomycin. Both patients survived. {04}

Treatment of overdose
To enhance elimination—Poorly removed by dialysis; hemofiltration and hemoperfusion with polysulfone resin have been used to reduce elevated serum concentrations of vancomycin {02}.

Monitoring—Patients should be monitored for electrolytes, fluid, hearing function, hematologic status (especially platelet and white blood cell counts), renal function, and vestibular function {04}.

Supportive care—Patients in whom intentional overdose is confirmed or suspected should be referred for psychiatric consultation.


Patient Consultation
As an aid to patient consultation, refer to Advice for the Patient, Vancomycin (Systemic) .
In providing consultation, consider emphasizing the following selected information (» = major clinical significance):

Before using this medication
»   Conditions affecting use, especially:
Hypersensitivity to vancomycin

Pregnancy—Vancomycin crosses the placenta





Breast-feeding—Vancomycin is distributed into breast milk





Use in the elderly—Elderly patients may be at greater risk of nephrotoxicity and ototoxicity
Other medications, especially aminoglycosides, amphotericin B, bacitracin, bumetanide, capreomycin, cisplatin, cyclosporine, dexamethasone, ethacrynic acid, furosemide, paromomycin, polymyxins, streptozocin, or vecuronium
Other medical problems, especially a history of hearing loss or deafness, or renal function impairment

Proper use of this medication
» If medication is being given at home, carefully following physician's instructions

» Importance of receiving medication for full course of therapy and on regular schedule

» Proper dosing
Missed dose: Taking as soon as possible; not taking if almost time for next dose; not doubling doses


Side/adverse effects
Signs of potential side effects, especially nephrotoxicity, neutropenia, “red man syndrome,” chemical peritonitis, linear IgA bullous dermatosis, ototoxicity, pseudomembranous colitis, and thrombocytopenia


General Dosing Information
Since vancomycin is highly irritating to tissues and causes necrosis and severe pain on intramuscular administration or extravasation, parenteral vancomycin must be administered by intravenous (or intraperitoneal) infusion only. Avoid extravasation. Sterile vancomycin hydrochloride also may be administered orally for treatment of Clostridium difficile colitis, but oral vancomycin is not effective in systemic infections.

Parenteral vancomycin should be administered over a period of at least 60 minutes. To help reduce the incidence of administration rate–related side effects (e.g., cardiac arrest [rarely], hypotension, “red man syndrome”), this medication should not be administered rapidly or as a bolus injection. Vancomycin should be administered intermittently in at least 100 to 200 mL of 5% dextrose injection or 0.9% sodium chloride injection. Veins into which vancomycin is infused should be rotated to help prevent the development of thrombophlebitis, unless vancomycin is being administered via a central venous catheter. {02}

Patients with impaired renal or auditory function may require (1) a reduction in the maintenance dose by administration of the usual dose at prolonged intervals, or (2) discontinuation of vancomycin {35}. Since vancomycin is not metabolized and is excreted primarily in the urine, toxic concentrations may accumulate in patients with impaired renal function. Therapeutic concentrations of vancomycin may persist for 7 to 21 days after dosing, especially in anuric patients.

Serum concentrations should be monitored during therapy, especially during prolonged therapy or in patients with impaired renal function or a history of hearing loss or deafness {02}. Peak concentrations should not be maintained in excess of approximately 40 mcg per mL, and trough concentrations should not exceed approximately 10 mcg per mL {11}. Serum concentrations greater than 80 mcg per mL are considered to be in the toxic range {06}.

Therapy should be continued for at least 4 weeks or longer in the treatment of staphylococcal endocarditis.


Parenteral Dosage Forms

Note: Bracketed information in the Dosage Forms section refers to uses that are not included in U.S. product labeling.

Note: The dosing and strengths of the dosage forms available are expressed in terms of vancomycin base (not the hydrochloride salt).


STERILE VANCOMYCIN HYDROCHLORIDE USP

Usual adult and adolescent dose
Antibacterial, treatment
Intravenous infusion, 7.5 mg (base) per kg of body weight or 500 mg every six hours; or 15 mg per kg of body weight or 1 gram every twelve hours {02} {05}.

Note: After an initial loading dose of 750 mg to 1 gram (base), but not less than 15 mg per kg of body weight, adults with impaired renal function may require a reduction in dose as indicated in the table below. However, the preferred method is to adjust dosage based on serum vancomycin concentrations.

Creatinine clearance
(mL/min)/(mL/sec) 
Intravenous dose
(base) 
> 80/1.33  See Usual adult and adolescent dose
50–80/0.83–1.33   1 gram every 1 to 3 days 
10–50/0.17–0.83  1 gram every 3 to 7 days 
< 10/0.17  1 gram every 7 to 14 days  



[Endocarditis, prophylaxis, in penicillin-allergic patients with prosthetic heart valves or congenital, rheumatic, or other acquired valvular heart disease who are undergoing gastrointestinal or genitourinary tract procedures]1
Intravenous infusion, 1 gram (base) over a period of one to two hours, with or without gentamicin (administered intramuscularly or intravenously at a dose of 1.5 mg per kg of body weight up to 120 mg), depending on risk of bacterial endocarditis; the infusion/injection should be completed within one-half hour of the start of surgery {14}.


Usual adult prescribing limits
3 to 4 grams (base) a day have been used intravenously for short periods of time in very severe infections.

Usual pediatric dose
Antibacterial, treatment
Neonates up to 1 week of age: Intravenous infusion, 15 mg (base) per kg of body weight initially, followed by 10 mg per kg of body weight every twelve hours {02}.

Infants 1 week to 1 month of age: Intravenous infusion, 15 mg (base) per kg of body weight initially, followed by 10 mg per kg of body weight every eight hours {02}.

Infants and children 1 month to 12 years of age: Intravenous infusion, 10 mg (base) per kg of body weight every six hours {02}; or 20 mg per kg of body weight every twelve hours.

Note: Doses of up to 60 mg (base) per kg of body weight per day have been used in some infections (e.g., staphylococcal infections of the central nervous system [CNS]).


[Endocarditis, prophylaxis, in penicillin-allergic patients with prosthetic heart valves or congenital, rheumatic, or other acquired valvular heart disease who are undergoing gastrointestinal or genitourinary tract procedures]1
Intravenous infusion, 20 mg (base) per kg of body weight over a period of one to two hours, with or without gentamicin (administered intramuscularly or intravenously at a dose of 1.5 mg per kg of body weight), depending on degree of risk; the infusion/injection should be completed within one-half hour of the start of surgery {14}.


Strength(s) usually available
U.S.—


500 mg (base) (may be available in ADD-Vantage® vials) (Rx) [Vancocin]{02}[Generic]


1 gram (base) (may be available in ADD-Vantage® vials) (Rx) [Vancocin]{02}[Generic]


5 grams (base) (Rx)[Generic]

Canada—


500 mg (base) (may be available in ADD-Vantage® vials) (Rx) [Vancocin]{20}[Generic]


1 gram (base) (may be available in ADD-Vantage® vials) (Rx) [Vancocin]{20}[Generic]


5 grams (base) (Rx)[Generic]

Packaging and storage:
Prior to reconstitution, store below 40 °C (104 °F), preferably between 15 and 30 °C (59 and 86 °F), unless otherwise specified by manufacturer.

Preparation of dosage form:


For intravenous use:
To prepare initial dilution for intravenous use, 10 or 20 mL of sterile water for injection should be added to each 500-mg or 1-gram vial, respectively. For intermittent intravenous infusion (preferred), the 10-mL or 20-mL solution should be further diluted in 100 or 200 mL, respectively, of 5% dextrose injection or 0.9% sodium chloride injection. The resulting solution should be administered over a 60-minute period or longer. {02}

For continuous intravenous infusion (used only when intermittent infusion is not feasible), 1 to 2 grams (20 to 40 mL) may be added to a sufficiently large volume of 5% dextrose injection or 0.9% sodium chloride injection to permit the total daily dose to be administered slowly by intravenous drip over a 24-hour period. Avoid extravasation.

For reconstitution of ADD-Vantage® vials, see manufacturer's labeling for instructions.



For oral use:
See Vancomycin (Oral-Local) .


Stability:
After reconstitution with 5% dextrose injection or 0.9% sodium chloride injection, solutions retain their potency for 14 days if refrigerated {02}.

Incompatibilities:
The admixture of supplementary medication and vancomycin is not recommended. Vancomycin is incompatible with alkaline solutions and may be precipitated by heavy metals. It has also been found to be incompatible with aminophylline, amobarbital sodium, aztreonam, chloramphenicol sodium succinate, chlorothiazide sodium, dexamethasone sodium phosphate, heparin sodium, methicillin sodium, pentobarbital sodium, phenobarbital sodium, secobarbital sodium, and sodium bicarbonate. {17} {18}

Vancomycin should not be added to solutions containing albumin, cefepime,– ceftazidime, foscarnet sodium, penicillin G, or piperacillin sodiumtazobactam sodium. If these solutions are administered concurrently, they should be administered at separate sites. {09} {10} {17}


VANCOMYCIN HYDROCHLORIDE FOR INJECTION USP

Usual adult and adolescent dose
See Sterile Vancomycin Hydrochloride USP .

Usual adult and adolescent prescribing limits
See Sterile Vancomycin Hydrochloride USP .

Usual pediatric dose
See Sterile Vancomycin Hydrochloride USP .

Strength(s) usually available
U.S.—


10 grams (base) (Rx) [Vancocin]{02}[Generic]

Canada—


10 grams (base) (Rx) [Vancocin]{02}

Packaging and storage:
Prior to reconstitution, store below 40 C (104 F), preferably between 15 and 30 C (59 and 86 F), unless otherwise specified by manufacturer.

Preparation of dosage form:


For intravenous use:
For reconstitution of pharmacy bulk vials, 95 mL of sterile water for injection should be added to each 10-gram vial to provide a solution of 100 mg per mL. Using aseptic technique, the closure should be penetrated only once after reconstitution using a suitable sterile dispensing set that allows measured dispensing of the contents. Use of a syringe and needle is not recommended as leakage may occur.

Reconstituted solutions of 5 mL containing 500 mg of vancomycin should" be diluted with at least 100 mL of suitable diluent (see manufacturers labeling instructions), and reconstituted solutions of 10 mL containing 1 gram of vancomycin should be diluted with at least 200 mL of suitable diluent. The final dose should be administered by intermittent intravenous infusion over a period of at least 60 minutes.



For oral use:
See Vancomycin (Oral-Local) .


Stability:
After reconstitution, the solution should be dispensed within 4 hours.

Incompatibilities:
The admixture of supplementary medication and vancomycin is not recommended. Vancomycin is incompatible with alkaline solutions and may be precipitated by heavy metals. It also has been found to be incompatible with aminophylline, amobarbital sodium, aztreonam, chloramphenicol sodium succinate, chlorothiazide sodium, dexamethasone sodium phosphate, heparin sodium, methicillin sodium, pentobarbital sodium, phenobarbital sodium, secobarbital sodium, and sodium bicarbonate. {17} {18}

Vancomycin should not be added to solutions containing albumin, cefepime, ceftazidime, foscarnet sodium, penicillin G, or piperacillin sodium–tazobactam sodium. If these solutions are administered concurrently, they should be administered at separate sites. {09} {10} {17}


VANCOMYCIN INJECTION USP

Usual adult and adolescent dose
See Sterile Vancomycin Hydrochloride USP .

Usual adult and adolescent prescribing limits
See Sterile Vancomycin Hydrochloride USP .

Usual pediatric dose
See Sterile Vancomycin Hydrochloride USP .

Strength(s) usually available
U.S.—


500 mg per 100 mL (Rx) [Vancocin]{19}

Canada—
Not commercially available.

Packaging and storage:
Store between –20 and –10 °C (–4 and 14 °F), unless otherwise specified by manufacturer.

Preparation of dosage form:
Vancomycin Injection USP should be administered only by the intravenous route. For oral administration of parenteral vancomycin, see Vancomycin (Oral-Local) .

Frozen containers should be thawed at room temperature (25 C [77 F]) or under refrigeration (5 C [41 F]). Thawing should not be forced by immersion in water baths or by microwave irradiation. {19}

Do not use plastic containers in series connections. Such use may result in an air embolism because of residual air being drawn from the primary container before administration of the fluid from the secondary container is complete. {19}

Stability:
Once thawed, solutions remain stable for 72 hours at room temperature, or for 30 days when refrigerated. Thawed solutions should not be refrozen. {19}

Do not use if solution is cloudy or contains a precipitate. {19}

Incompatibilities:
The admixture of supplementary medication and vancomycin is not recommended. Vancomycin is incompatible with alkaline solutions and may be precipitated by heavy metals. It has also been found to be incompatible with aminophylline, amobarbital sodium, aztreonam, chloramphenicol sodium succinate, chlorothiazide sodium, dexamethasone sodium phosphate, heparin sodium, methicillin sodium, pentobarbital sodium, phenobarbital sodium, secobarbital sodium, and sodium bicarbonate. {17} {18}

Vancomycin should not be added to solutions containing albumin, cefepime,– ceftazidime, foscarnet sodium, penicillin G, or piperacillin sodiumtazobactam sodium. If these solutions are administered concurrently, they should be administered at separate sites. {09} {10} {17}



Revised: 06/15/1999



References
  1. Centers for Disease Control and Prevention. Recommendations for preventing the spread of vancomycin resistance. MMWR Morb Mortal Wkly Rep 1995; 44(RR–12): [20 screens]. Cited 11/18/97. Available from: URL: http://www.cdc.gov/epo/mmwr/ind95_rr.htm
  1. Vancocin for injection package insert (Eli Lilly—US), Rev 6/97, Rec 9/97.
  1. Centers for Disease Control and Prevention. Interim guidelines for prevention and control of staphylococcal infection associated with reduced susceptibility to vancomycin. MMWR Morb Mortal Wkly Rep 1997; 46(27): [10 screens]. Cited 8/8/97. Available from: URL: http://www.cdc.gov/epo/mmwr/mmwr_wk.html
  1. Ellenhorn MJ, editor. Ellenhorn's medical toxicology. Baltimore: Williams & Wilkins; 1997. p. 236-8.
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  1. Panel comments, 2/98.
  1. Cefepime package insert (Maxipime, Bristol-Meyers Squibb—US), Rev 5/97, Rec 8/97.
  1. Ceftazidime package insert (Ceptaz, Glaxo Wellcome—US), Rev 9/96, Rec 8/97.
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  1. Dajani AS, Taubert KA, Wilson W, et al. Prevention of bacterial endocarditis. JAMA 1997; 277(22): 1794-801.
  1. Reyes MP, Ostrea EM, Cabinian AE, et al. Vancomycin during pregnancy: does it cause hearing loss or nephrotoxicity in the infant? Am J Obstet Gynecol 1989; 161: 977-81.
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  1. Chandler SW, Folstad J, Trissel LA. Aztreonam-vancomycin incompatibility. Am J Hosp Pharm 1990; 47: 1970.
  1. Vancomycin injection package insert (Vancocin—Eli Lilly), Rev 11/93, Rec 8/94.
  1. Vancocin (Eli Lilly). In: Gillis MC, editor. CPS Compendium of pharmaceuticals and specialties. 32nd ed. Ottawa, Canada: Canadian Pharmaceutical Association; 1997. p. 1682-4.
  1. Baden LA, Apovian C, Imber MJ, et al. Vancomycin-induced linear IgA bullous dermatosis [letter]. Arch Dermatol 1988; 124: 1186-8.
  1. Carpenter S, Berg D, Sidhu-Malik N, et al. Vancomycin-associated linear IgA dermatosis. J Am Acad Dermatol 1992; 26: 45-8.
  1. Whitworth JM, Thomas I, Peltz SA, et al. Vancomycin-induced linear IgA bullous dermatosis (LABD). J Am Acad Dermatol 1996; 34: 809-11.
  1. Kuechle MK, Stegemeir E, Maynard B, et al. Drug-induced linear IgA bullous dermatosis: report of six cases and review of the literature. J Am Acad Dermatol 1994; 30: 187-92.
  1. Centers for Disease Control and Prevention. Update: Staphylococcus aureus with reduced susceptibility to vancomycin. MMWR Morb Mortal Wkly Rep 1997; 46(35): 813-5.
  1. Paris MM, Hickey SM, Uscher MI, et al. Effect of dexamethasone on therapy of experimental penicillin- and cephalosporin-resistant pneumococcal meningitis. Antimicrob Agents Chemother 1994; 38(6): 1320-4.
  1. Cabellos C, Martinez-Lacasa J, Martos A, et al. Influence of dexamethasone on efficacy of ceftriaxone and vancomycin therapy in experimental pneumococcal meningitis. Antimicrob Agents Chemother 1995; 39(9): 2158-60.
  1. Panel comment, 2/98.
  1. Hiramatsu K, Aritaka N, Hanaki H, et al. Dissemination in Japanese hospitals of strains of Staphylococcus aureus heterogeneously resistant to vancomycin. Lancet 1997; 350: 1670-3.
  1. Panel comment, 2/98.
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  1. Tunkel AR, Scheld WM. Issues in the management of bacterial meningitis. Am Fam Physician 1997; 56(5): 1355-62.
  1. Charney DI, Gouge SF. Chemical peritonitis secondary to intraperitoneal vancomycin. Am J Kidney Dis 1991; 17(1): 76-9.
  1. Panel comment, 2/98.
  1. Panel comment, 5/98.
  1. Reviewers' consensus on monograph revision of 5/98
  1. Opinions of respected authorities on the basis of clinical experience, 2/99.
  1. American Academy of Pediatrics, Committee on Infectious Diseases. Therapy for children with invasive pneumococcal infections. Pediatrics 1997; 99(2): 289-99.
  1. Reviewers' consensus on monograph revision of 3/99.
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