Canada - English - Health Canada
Sterile Vancomycin Hydrochloride, USP
Vancomycin Hydrochloride for Injection, USP
Pharmaceutical Partners of Canada Inc.
Date of Preparation:
45 Vogell Road, Suite 200
January 17, 2008
Richmond Hill, ON
Control No.: 119199
NAME OF DRUG
Sterile Vancomycin Hydrochloride, USP
Vancomycin Hydrochloride for Injection, USP
In vitro studies indicate that the bactericidal action of vancomycin hydrochloride against
many gram-positive bacteria results from the inhibition of cell-wall synthesis. There is
also evidence that vancomycin alters the permeability of the cell membrane and
selectively inhibits RNA synthesis.
INDICATIONS AND CLINICAL USES
VANCOMYCIN HYDROCHLORIDE IV may be indicated in the therapy of severe or life-
threatening staphylococcal infections in patients who cannot receive or who have failed
staphylococci resistant to other antibiotics, including methicillin.
treatment of staphylococcal endocarditis.
VANCOMYCIN HYDROCHLORIDE IV 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 IV has been reported to be effective only in combination with an
treatment of diphtheroid endocarditis. VANCOMYCIN HYDROCHLORIDE IV 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
staphylococcal infections are localized and purulent, antibiotics are used as adjuncts to
appropriate surgical measures.
Although no controlled clinical efficacy trials have been conducted, VANCOMYCIN
HYDROCHLORIDE IV, has been suggested by the American Heart Association and the
American Dental Association for prophylaxis against bacterial endocarditis in patients
allergic to penicillin who have congenital and/or rheumatic or other acquired valvular
heart disease when they undergo dental procedures or surgical procedures of the upper
respiratory tract. (Note: When selecting antibiotics for the prevention of bacterial
endocarditis, the physician or dentist should read the full joint statement of the American
Heart Association and the American Dental Association).
hypersensitivity to this antibiotic.
exaggerated hypotension, including shock, and, rarely, cardiac arrest.
When given intravenously, toxic serum levels can occur. Vancomycin is excreted fairly
clearance.During parenteral therapy, the risk of toxicity appears appreciably increased
HYDROCHLORIDE is poorly absorbed orally. Toxic serum levels are therefore not
attained from oral dosage.
Clinically significant serum concentrations have been reported in some patients who
pseudomembranous colitis; therefore, monitoring of serum concentrations may be
appropriate in these patients.
Ototoxicity has occurred when serum levels exceeded 80
g/mL. Deafness may be
preceded by tinnitus. The elderly are more susceptible to auditory damage. Experience
with other antibiotics suggests that deafness may be progressive despite cessation of
particularly ethacrynic acid, neuromuscular blocking agents, aminoglycoside antibiotics,
polymixin B, colistin, viomycin, and cisplatin, requires careful monitoring.
If parenteral and oral vancomycin are administered concomitantly an additive effect can
occur. This should be taken into consideration when calculating the total dose. In this
situation serum levels of the antibiotic should be monitored.
VANCOMYCIN HYDROCHLORIDE IV should be administered in a dilute solution 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 (See Dosage and
Administration and Adverse Reactions).
Because of its ototoxicity and nephrotoxicity, VANCOMYCIN HYDROCHLORIDE should
be used with care in patients with renal insufficiency. If it is necessary to use
VANCOMYCIN HYDROCHLORIDE parenterally in patients with renal impairment, the
dose and/or dose intervals should be adjusted carefully and blood levels monitored.
VANCOMYCIN HYDROCHLORIDE should be avoided (if possible) in patients with
previous hearing loss. If it is used in such patients, the dose of VANCOMYCIN
HYDROCHLORIDE should be regulated by periodic determination of drug levels in the
blood. Patients with renal insufficiency and individuals over the age of 60 should be
given serial tests of auditory function and of vancomycin blood levels. All patients
receiving the drug should have periodic hematologic studies, urinalyses, and liver and
renal function tests.
The prolonged use of VANCOMYCIN HYDROCHLORIDE may result in overgrowth of
non-susceptible organisms. If new infections due to bacteria or fungi appear during
therapy with this product, appropriate measures should be taken, including withdrawal
of VANCOMYCIN HYDROCHLORIDE. In rare instances, there have been reports of
Since VANCOMYCIN HYDROCHLORIDE IV is irritating to tissue and causes drug
fever, pain and possibly necrosis it should never be injected intramuscularly; it must be
administered intravenously. Pain and thrombophlebitis occur in many patients receiving
VANCOMYCIN HYDROCHLORIDE IV and are occasionally severe. The frequency and
severity of thrombophlebitis can be minimized if the drug is administered in a volume of
at least 200 mL of glucose or saline solution and if the sites of injection are rotated.
hypotension, flushing, erythema, urticaria, and pruritus) increases with concomitant
administration of anesthetic agents. Infusion-related events may be minimized by the
administration of VANCOMYCIN HYDROCHLORIDE IV as a 60-minute infusion prior to
The safety and efficacy of VANCOMYCIN HYDROCHLORIDE IV administration by the
intrathecal (intralumbar or intraventricular) route have not been assessed.
Some patients with inflammatory disorders of the intestinal mucosa may have significant
development of adverse reactions associated with the parenteral administration of
vancomycin. The risk is greater if renal impairment is present. It should be noted that
the total systemic and renal clearances of vancomycin are reduced in the elderly.
When patients with underlying renal dysfunction or those receiving concomitant therapy
with an aminoglycoside are being treated, serial monitoring of renal function should be
In vitro resistance to Vancomycin has been reported among some enterococcal and
Usage in Pregnancy: VANCOMYCIN HYDROCHLORIDE should be given to a
pregnant woman only if clearly needed. In a controlled clinical study, VANCOMYCIN
HYDROCHLORIDE was administered to 10 pregnant women for serious staphylococcal
nephrotoxic effects on the infant. VANCOMYCIN HYDROCHLORIDE levels of 13.2 and
g/mL were measured in cord blood of two patients. No sensorineural hearing loss
or nephrotoxicity attributable to VANCOMYCIN HYDROCHLORIDE was noted. One
infant whose mother received VANCOMYCIN HYDROCHLORIDE in the third trimester
experienced conductive hearing loss that was not attributed to the administration of
VANCOMYCIN HYDROCHLORIDE. Because the number of patients treated in this
study was limited and VANCOMYCIN HYDROCHLORIDE was administered only in the
second and third trimesters, it is not known whether VANCOMYCIN HYDROCHLORIDE
causes fetal harm.
Nursing Mothers: VANCOMYCIN HYDROCHLORIDE is excreted in human milk.
Caution should be exercised if 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 administration of the drug, taking
into account the importance of the drug to the mother.
Usage in Pediatrics: In premature neonates and young infants, it may be appropriate
to confirm desired vancomycin serum concentrations. Concomitant administration of
vancomycin and anesthetic agents has been associated with erythema and histamine-
like flushing in children.
Geriatrics: The natural decrease of glomerular filtration with increasing age may lead
to elevated vancomycin serum concentrations if dosage is not adjusted. Vancomycin
dosage schedules should be adjusted in elderly patients.
hypotension, wheezing, dyspnea, urticaria, or pruritis. 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 IV is given by
slow infusion over 60 minutes. In studies in normal volunteers, infusion-related events
did not occur when VANCOMYCIN HYDROCHLORIDE IV was administered at a rate of
10 mg/min or less.
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 pre-existing kidney dysfunction. When
Ototoxicity: A few dozen cases of hearing loss associated with VANCOMYCIN
dysfunction, pre-existing hearing loss, or concomitant treatment with an ototoxic drug.
Vertigo, dizziness, and tinnitus have been reported rarely.
Hematopoietic: Reversible neutropenia, usually starting one week or more after onset
of therapy with VANCOMYCIN HYDROCHLORIDE or after a total dose of more than 25
g, has been reported in several dozen patients. Neutropenia appears to be promptly
Thrombocytopenia has rarely been reported. Although a causal relationship has not
been established, reversible agranulocytosis (granulocyte count less than 500/mm
has been reported rarely.
Phlebitis: Inflammation at the injection site has been reported.
Miscellaneous: Anaphylaxis, drug fever, nausea, chills, eosinophilia, hypotension,
wheezing, dyspnea, urticaria, pruritus flushing of the upper body (“red neck”), pain and
muscle spasm of the chest and back, rashes, including exfoliative dermatitis, Stevens-
Johnson syndrome, linear IgA bullous dermatosis and rare cases of vasculitis have
been associated with the administration of VANCOMYCIN HYDROCHLORIDE.
TREATMENT OF OVERDOSAGE
Other than general supportive treatment, no specific antidote is known. Dialysis does
not remove significant amounts of vancomycin. Hemofiltration and hemoperfusion with
polysulfone resin have been reported to result in increased vancomycin clearance.
In managing overdosage, consider the possibility of multiple drug overdoses, interaction
among drugs, and unusual drug kinetics in your patient.
DOSAGE AND ADMINISTRATION
The usual intravenous dose is 500 mg every six hours or 1 g every twelve hours.
Each dose should be administered at no more than 10 mg/min or over a period of at
least 60 minutes, whichever is longer. Other patient factors, such as age or obesity,
may call for modification of the usual intravenous daily dose.
Adults with Impaired Renal Function:
Dosage adjustment must be made in patients with impaired renal function to avoid toxic
serum levels. Serum levels should be checked regularly, since accumulation in such
patients has been reported to occur over several weeks of treatment.
For most patients with renal impairment or the elderly, the dosage calculation may be
made by using the following nomogram
if the creatinine clearance value is known.
Nomogram Relating Vancomycin Clearance, Creatinine Clearance
and Vancomycin Dose
Moellering, R.C., et al.: Vancomycin Therapy in Patients with Impaired Renal
Function: A Nomogram for Dosage, Ann. Int. Med., 1981, 94:343.
The nomogram is not valid for functionally anephric patients on dialysis. For such
patients, a loading dose of 15 mg/kg of body weight should be given in order to achieve
therapeutic serum levels promptly, and the dose required to maintain stable levels is 1.9
When only serum creatinine is available, the following formula (based on sex, weight,
and age of the patient) may be used to convert this value into estimated creatinine
clearance. The serum creatinine should represent a steady state of renal function.
Males: Weight (kg) x (140 - age)
72 x serum creatinine (mg/dL)
Females: 0.85 x above value
In anuria, a dose of 1 g every 7 to 10 days has been recommended.
Neonates, Infants and Children
The following dosage schedule has been used. Infusions should be over
Infants and Neonates
In both neonates and infants it is suggested that an initial dose of 15 mg/kg be given
followed by 10 mg/kg every 12 hours for neonates in the first week of life and every 8
hours thereafter up to the age of one month. Each dose should be administered over
warranted in these patients.
The usual intravenous dosage of VANCOMYCIN HYDROCHLORIDE is 10 mg/kg per
dose given every 6 hours. The majority of patients with infections caused by organisms
susceptible to the antibiotic show a therapeutic response by 48 to 72 hours. The total
duration of therapy is determined by the type and severity of the infection and the
clinical response of the patient. In staphylococcal endocarditis, therapy for 3 weeks or
longer is recommended.
Intermittent Intravenous Infusion: The reconstituted solution must be FURTHER
DILUTED with 100-200 mL Normal Saline or 5% Dextrose in Sterile Water for Injection.
This should be infused over a period of at least 60 minutes.
See instructions in the Reconstitution section.
Continuous Intravenous Infusion: Should be used only when intermittent infusion is
administration of vancomycin. Concentration of no more than 5 mg/mL and rates of no
more than 10 mg/min are recommended in adults (see age-specific recommendations).
In selected patients in need of fluid restriction, a concentration up to 10 mg/mL may be
used; use of such higher concentrations may increase risk of infusion-related events.
Infusion related events may occur, however, at any rate or concentration.
Note: VANCOMYCIN HYDROCHLORIDE capsules are formulated in a matrix gel that
prevents administration by a nasogastric tube; if this route of administration is being
considered, the IV dosage form should be used.
STERILE VANCOMYCIN HYDROCHLORIDE
-tetracosine-26, carboxylic acid, monohydrochloride
Vancomycin hydrochloride, is a chromatographically purified tricyclic
orientalis). It is an off-white free flowing powder, having essentially no odor. It is
soluble in water and insoluble in organic solvents.
STERILE VANCOMYCIN HYDROCHLORIDE vials for IV use, contain vancomycin
reconstituted in water, it forms a clear, colourless solution with a pH range of 2.5 to 4.5.
Solution for Reconstitution
Sterile Water for Injection USP
Reconstitute as follows:
Shake well until dissolved.
Further Dilution is Required.
Note: Prior to administration, parenteral drug products should be inspected visually for
particulate matter and discoloration whenever solution or container permits.
For Intermittent Intravenous Infusion
500 mg vial: Reconstituted solutions must be diluted with at least 100 mL of 0.9%
Sodium Chloride Injection or 5% Dextrose in Sterile Water for Injection.
1 g vial: Reconstituted solutions must be diluted with at least 200 mL of 0.9% Sodium
Chloride Injection or 5% Dextrose in Sterile Water for Injection.
For Continuous Intravenous Infusion
The vials reconstituted according to the above table should be further diluted to the
desired volume with any of the solutions for IV infusion listed below.
Solutions for IV Infusion
5% Dextrose Injection
5% Dextrose Injection and 0.9% Sodium Chloride Injection
Lactated Ringer's Injection
Lactated Ringer's in 5% Dextrose Injection
-M in D5-W
0.9% Sodium Chloride Injection
Acetated Ringer's Injection
Pharmacy Bulk Vial
HOSPITALS WITH A RECOGNIZED INTRAVENOUS ADMIXTURE PROGRAM.
intravenous use only, employing a single puncture.
Reconstitute with Sterile Water for Injection.
Use reconstituted stock solution within 8 hours, and further diluted solutions within 24
hours if kept at room temperature and 96 hours if refrigerated from time of initial
STABILITY AND STORAGE RECOMMENDATIONS
Store between 15 and 25° C.
Reconstituted stock solution for Pharmacy Bulk vials should be used within 8 hours. All
other reconstituted solutions and further diluted infusion mixtures should be used within
24 hours if kept at room temperature or 96 hours when refrigerated.
Vancomycin solution has a low pH that may cause physical or chemical instability when it is
mixed with other compounds. Mixing with alkaline solutions should be avoided.
Mixtures of solutions of vancomycin and beta-lactam antibiotics have been shown to be
physically incompatible. The likelihood of precipitation increases with higher concentrations of
administration of these antibiotics. It is also recommended to dilute solutions of vancomycin to 5
mg/mL or less.
Although intravitreal injection is not an approved route of administration for vancomycin,
precipitation has been reported after intravitreal injection of vancomycin and ceftazidime for
endophthalmitis using different syringes and needles. The precipitates dissolved gradually, with
complete clearing of the vitreous cavity over two months and with improvement of visual acuity.
Some of the specific substances found incompatible are aminophylline, chloramphenicol
sodium succinate, dexamethasone phosphate, diphenylhydantoin
sodium, methicillin, vitamin B
complex with C, sulfisoxazole diethanolamine, heparin
sodium, potassium penicillin G,
pentobarbital sodium, phenobarbital sodium, secobarbital sodium, sodium bicarbonate,
and sulfadiazine sodium.
Common flavouring syrups have been added to the solution to improve
the taste for oral administration. There is no information to indicate that
the potency or efficacy of the drug is affected by the addition of these
AVAILABILITY OF DOSAGE FORMS
powder in vials containing vancomycin hydrochloride equivalent to 500 mg and 1 g
VANCOMYCIN HYDROCHLORIDE FOR INJECTION Pharmacy Bulk Vial 7355 is
available in vials containing vancomycin hydrochloride equivalent to 10 g vancomycin
base, edetate calcium disodium equivalent to 0.2 mg edetate/g vancomycin, and
ethanol equivalent to up to 30 mg/g vancomycin.
HYDROCHLORIDE and other classes of antibiotics. Laboratory-induced resistance has
been reported to occur in a slow stepwise fashion. The development of resistance to
vancomycin by staphylococci has not been reported in clinical use. Its activity is not
significantly altered by changes in pH or by the presence of serum. Vancomycin is
active against most strains of the following organisms in vitro and in clinical infections:
Staphylococcus aureus (including heterogeneous methicillin-resistant strains)
S. epidermidis (including heterogeneous methicillin-resistant strains)
Streptococcus pneumoniae (including multiple-resistant strains)
S. pyogenes (group A beta-hemolytic)
S. agalactiae (group B beta-hemolytic)
Alpha-hemolytic streptococci (viridans groups)
Enterococci (e.g., E. faecalis)
Many strains of streptococci, staphylococci, C. difficile, and other gram-
positive bacteria are susceptible in vitro to concentrations of 0.5 to 5
Staphylococci are generally susceptible to less than 5
g/mL of vancomycin
hydrochloride, but a small proportion of S. aureus strains requires 10 to
g/mL for inhibition.
In vitro resistance to Vancomycin has been reported among some enterococcal and
Vancomycin is not effective in vitro against gram-negative bacilli, mycobacteria, or fungi.
In Vitro Activity of Vancomycin
No. of Strains
1.0 - 2.0
0.78 - 12.5
0.25 - 1.0
0.5 - 4.0
0.3 - 12.0
0.2 - 3.12
1.56 - 6.25
0.4 - 3.1
0.2 - 6.25
0.125 - 0.5
0.8 - 3.1
0.39 - 1.56
0.8 -> 100.0
0.4 - 1.6
3.1 - 12.5
1.0 - 4.0
Methods of Susceptibility Testing
When the standardized method of disc susceptibility testing is used, a 30
g disc of
"susceptible" organisms. A zone size of 10-11 mm indicates intermediate susceptibility,
while a zone size of 9 mm or less indicates resistance.
With the WHO-ICS agar dilution and broth dilution methods, an MIC of < 5
indicates susceptibility to vancomycin.
diffusion method. This test can quantitatively measure vancomycin concentrations from
0.5 to 8
Two disc-diffusion assay methods are available for vancomycin. Both use Bacillus
subtilis as the test organism. The first method, which uses antibiotic medium No. 5, is
capable of measuring vancomycin levels from approximately 5 to 40
second uses minimal salt agar and is capable of detecting vancomycin concentrations
from about 0.8 to 25
g/mL. A modification of this assay permits reliable bioassay for
vancomycin (in concentrations of 0.78 to 50.0
g/mL) in the presence of rifampin or
aminoglycosides. Two commercially prepared assay methods are now available and
Vancomycin is 55% protein bound as measured by ultrafiltration at Vancomycin serum
levels of 10 to 100 mg/L.
About 75% of an administered dose of vancomycin is excreted in urine by glomerular
filtration in the first 24 hours. Mean plasma clearance is about 0.058 L/kg/h, and mean
renal clearance is about 0.048 L/kg/h. Renal Vancomycin clearance is fairly constant
and accounts for 70% to 80% of Vancomycin elimination. When a single intravenous
injection of 500 mg of vancomycin was administered over 30 minutes to healthy
volunteers, the mean serum peak concentration was 51
g/mL at 1 hour
g/mL at 6 hours post infusion. After a 1 g single dose I.V. over 30 minutes, the
mean peak level was 85
g/mL at 1 hour, 11
g/mL at 6 hours, and 5.1
g/mL at 12 hours post infusion. Following multiple dosages of 500 mg every 6 hours
infused over 30 minutes, the mean peak ranged from 41-57
g/mL. Following multiple
60 minute 1 g I.V. infusions of vancomycin in healthy volunteers, mean peak plasma
concentrations were 64
g/mL at 6 hours, and 7
g/mL at 12 hours post
infusion. The plasma half-life ranged from 3 to 8 hours with an overall mean of 4.5
There is no apparent metabolism of the drug.
Infusions of 1 g vancomycin in 250 mL D5-W were given over 30 minutes to 29 anephric
patients. After 18 days with intermittent dialysis at three-day
intervals, the serum concentration was still 3.5
g/mL. The elimination half-life was
about 7.5 days.
Tissue Penetration and Distribution:
Central Nervous System: Vancomycin does not readily diffuse across normal meninges
into the spinal fluid; but, when the meninges are inflamed, penetration into the spinal
Other Tissues and Fluids: Vancomycin concentration in human pericardial, pleural, bile,
ascitic and synovial fluids reaches approximately one third of the equivalent serum level
after single intravenous doses. A level of 7.6
g/mL was achieved in the brain cyst of
one infant following intravenous infusion of 40 mg/kg daily for 4 days.
Vancomycin was administered to mice, rats and dogs by various routes.
SE (mg/kg) following Vancomycin
Rats died quickly from CNS-mediated effects, while dogs died, generally from kidney
failure, several days after the intravenous administration.
Vancomycin, when administered intravenously in a 5 percent solution to dogs at a rate
of 0.6 mL/minute, caused a slight dose-related drop in blood pressure. When the same
dogs were given the same doses at a rate of 15 mL/minute, blood pressure dropped
dramatically, as much as 40 percent. Whether the response is due to a direct effect on
histamine receptors or to release of histamine, possibly from mast cells, is not known.
Dogs were given daily i.v. doses of vancomycin at 12.5 mg and 50 mg/kg for 21-311
days. Renal damage was seen in 4/22 dogs receiving 50 mg/kg/day.
Monkeys tolerated i.v. doses of 25 and 50 mg/kg/day for 16-187 days, with irritation at
the injection site as the only toxic effect.
Cats received i.v. doses of 25 and 50 mg/kg/day for three months with no systemic
Anaphylaxis could not be induced in 9 guinea pigs that received 100 mg vancomycin
subcutaneously when challenged by a 25 mg i.v. dose, 25 days later.
Intraperitoneal doses of 150 mg vancomycin or 60 mg tobramycin given subcutaneously
to rats, resulted in no nephrotoxicity; however, when administered together, significant
renal toxicity occurred.
Vancomycin 1000 mg/kg administered subcutaneously concurrently with ethacrynic acid
40 mg/kg intravenously, did not produce ototoxicity in a guinea pig model.
Neuromuscular blocking has not been demonstrated in vancomycin-treated rabbits.
Vancomycin, a new antibiotic. I. Chemical and biologic properties. Antibiotics
Annual. P. 606, 1955-56.
Ziegler DW, Wolfe RN, McGuire JM. Vancomycin, a new antibiotic. II.
vitro antibacterial studies. Antibiotics Annual. P. 612, 1955-56.
Wallace JF, Smith RH, Petersdorf RG. Oral administration of vancomycin in the
treatment of staphylococcal enterocolitis. New Eng J Med. 1965, 272:1014-
Geraci JE, Heilman FR, Nichols DR, Wellmann WE, Ross GT. Some laboratory
and clinical experiences with a new antibiotic, vancomycin. Mayo Clinic Proc.
vancomycin. Ann Intern Med. 1966, 65(1).
Geraci JE et al. Antibiotic therapy of bacterial endocarditis. VII. Vancomycin for
acute micrococcal endocarditis: Preliminary report. Proc Staff Meet Mayo Clinic.
Goodman, Gilman: The pharmacological basis of therapeutics. Sixth Edition.
1980, P. 1230.
Griffith RS, Peck FB Jr. Vancomycin, a new antibiotic. III. Preliminary clinical
and laboratory studies. Antibiotics Annual. p. 619, 1955-56.
Woodley DW, Hall WH. The treatment of severe staphylococcal infections with
vancomycin. Ann Int Med. 1961, 55:235.
Finegold SM, Gaylor DW. Enterocolitis due to phage type 54 staphylococci
resistant to kanamycin, neomycin. New Eng J Med. 1960, 263:1110.
McHenry MC, Gavan TL. Vancomycin. Pediatric Clinics of North America.
Geraci JE, Hermans PE. Vancomycin. Mayo Clinic Proc. 1983, 58:88-91.
Shuttleworth R, Taylor M, Jones DM. Antimicrobial susceptibilities of clostridium
difficile. J Clin Pathol. 1980, 33:1002-1005.
Bartlett JG. Antibiotic-associated pseudomembranous colitis. Hospital Practice.
Thomas DFM et al. Association between clostridium difficile and
in Hirschsprung's Disease. Lancet. 1982, 78-79.
Welch DF, Marks MI. Is Clostridium difficile pathogenic in infants? The Journal
of Pediatrics. 1982, 100(3):393-395.
Keighley MRB. Pseudomembranous colitis. Schweiz Rundschar Med (PRAXIS).
Marrie TJ et al. Clostridium difficile: Epidemiology and clinical features. The
Canadian Journal of Surgery. 1982, 25(4):438-442.
Sabath LD. Antibiotics used in therapy of infections due to Staphylococcus
aureus. Proceedings of the 13th International Congress of Chemotherapy. 1983,
Matzke GR, McGory RW, Halstenson CE, Keane WF. Pharmacokinetics of
vancomycin in patients with various degrees of renal function. Antimicrobial
Agents and Chemotherapy. 1984, 25(4):433-437.
Reviews of Infectious Diseases. 1984, 6(1):S235-S241.
Cunha BA, Ristuccia AM. Clinical usefulness of vancomycin. Clin. Pharm.
Pfaller MA et al. Laboratory evaluation of five assay methods for vancomycin. J
Clin Micro. 1984, 20:311-316.
Kaplan EL. Vancomycin in infants and children: A review of pharmacology and
indications for therapy and prophylaxis. J Ant Chem. 1984, 14(Suppl. D):59-66.
Moellering RC Jr. Pharmacokinetics of vancomycin. J Ant Chem. 1984,
Kirby WMM. Vancomycin therapy of severe staphylococcal infections. J Ant
Chem. 1984, 14(Suppl. D):73-78.
Fekety R, Silva J, Buggy B, Deery WG. Treatment of antibiotic-associated colitis
with vancomycin. J Ant Chem. 1984, 14(Suppl. D):97-102.
Watanakunakorn C. Mode of action and in vitro activity of vancomycin. J Ant
Chem. 1984, 14(Suppl. D):7-18.
endocarditis: Microbiologic and clinical observations as guides to therapy. Ann
Int Med. 1983, 98:447-455.
Fekety R. Recent advances in management of bacterial diarrhea. Reviews of
Infectious Diseases, 1983, 5(2):246-257.
Griffith RS. Vancomycin use - an historical review. J Ant Chem. 1984, 14(Suppl.
Burdon DW. Treatment of pseudomembranous colitis and antibiotic-associated
diarrhea. J Ant Chem. 1984, 14(Suppl. D):103-109.
Dudley MN et al. Oral bacitracin vs, vancomycin therapy for Clostridium difficile-
induced diarrhea. Arch Intern Med. 1986, 146:1101-1104.
Cooper GL, Given DB. Vancomycin - a comprehensive review of 30 years of
clinical experience. Park Row Publishers Inc. 1986.