Source:http://www4.wiwiss.fu-berlin.de/dailymed/resource/drugs/2214
| Predicate | Object |
|---|---|
| rdf:type | |
| rdfs:label |
Vancomycin Hydrochloride (Injection, Powder, Lyophilized, For Solution)
|
| dailymed-instance:dosage |
Infusion-related events are related to both concentration
and rate of administration of vancomycin. Concentrations of no more than 5
mg/mL and rates of no more than 10 mg/min are recommended in adults (see also
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 the risk of infusion-related events. Infusion-related events
may occur, however, at any rate or concentration. Patients with Normal Renal Function Adults: The usual daily intravenous dose is 2 g
divided either as 500 mg every six hours or 1 g every 12 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 daily dose. Pediatric Patients: The usual intravenous dosage
of vancomycin is 10 mg/kg per dose given every six hours. Each dose should
be administered over a period of at least 60 minutes. Infants and Neonates: In neonates and young infants,
the total daily intravenous dosage may be lower. In both neonates and infants,
an initial dose of 15 mg/kg is suggested, followed by 10 mg/kg every 12 hours
for neonates in the first week of life and every eight hours thereafter up
to the age of one month. Each dose should be administered over 60 minutes.
Close monitoring of serum concentrations of vancomycin may be warranted in
these patients. Patients with
Impaired Renal Function and Elderly Patients Dosage
adjustment must be made in patients with impaired renal function. In premature
infants and the elderly, greater dosage reductions than expected may be necessary
because of decreased renal function. Measurement of vancomycin serum concentrations
can be helpful in optimizing therapy, especially in seriously ill patients
with changing renal function. Vancomycin serum concentrations can be determined
by use of microbiologic assay, radioimmunoassay, fluorescence polarization
immunoassay, fluorescence immunoassay, or high-pressure liquid chromatography. If
creatinine clearance can be measured or estimated accurately, the dosage for
most patients with renal impairment can be calculated using the following
table. The dosage of vancomycin hydrochloride per day in mg is about 15 times
the glomerular filtration rate in mL/min: The initial dose should be no less than 15 mg/kg, even
in patients with mild to moderate renal insufficiency. The
table is not valid for functionally anephric patients. For such patients,
an initial dose of 15 mg/kg of body weight should be given to achieve prompt
therapeutic serum concentrations. The dose required to maintain stable concentrations
is 1.9 mg/kg/24 h. In patients with marked renal impairment, it may be more
convenient to give maintenance doses of 250 to 1000 mg once every several
days rather than administering the drug on a daily basis. In anuria, a dose
of 1000 mg every 7 to 10 days has been recommended. When
only serum creatinine concentration is known, the following formula (based
on sex, weight, and age of the patient) may be used to calculate creatinine
clearance. Calculated creatinine clearances (mL/min) are only estimates. The
creatinine clearance should be measured promptly. The serum creatinine must represent a steady state of renal
function. Otherwise, the estimated value for creatinine clearance is not valid.
Such a calculated clearance is an overestimate of actual clearance in patients
with conditions: (1) characterized by decreasing renal function, such as shock,
severe heart failure, or oliguria; (2) in which a normal relationship betweenmuscle mass and total body weight is not present, such as in obese patients
or those with liver disease, edema, or ascites; and (3) accompanied by debilitation,
malnutrition, or inactivity. The safety and efficacy
of vancomycin administration by the intrathecal (intralumbar or intraventricular)
route have not been assessed. Intermittent infusion
is the recommended method of administration.
|
| dailymed-instance:descripti... |
Sterile Vancomycin Hydrochloride, USP, intravenous, is a
chromatographically purified tricyclic glycopeptide antibiotic derived from Amycolatopsis orientalis (formerly Nocardia orientalis) and has the molecular formula
CHClNO���HCl. The molecular weight is 1485.74; 500 mg of the base is equivalent to
0.34 mmol and 1 g of the base is equivalent to 0.67 mmol. Vancomycin
HCl has the following structural formula: The
pharmacy bulk package contains sterile vancomycin hydrochloride equivalent
of 5 g vancomycin activity. Vancomycin Hydrochloride is an off-white lyophilized
powder. May contain hydrochloric acid and/or sodium hydroxide for pH adjustment.
When reconstituted with Sterile Water for Injection, USP, it forms a clear
solution with a pH of 4.0 (2.5 to 4.5). This product is oxygen sensitive. The
vancomycin hydrochloride pharmacy bulk package is a sterile preparation for
parenteral use that contains many single doses. The contents are intended
for use in a pharmacy admixture service and restricted to the preparation
of admixtures for intravenous infusion. Further dilution
is required before use.
|
| dailymed-instance:clinicalP... |
Vancomycin is poorly absorbed after oral administration;
it is given intravenously for therapy of systemic infections. Intramuscular
injection is painful. In subjects with normal kidney
function, multiple intravenous dosing of 1 g of vancomycin (15 mg/kg) infused
over 60 minutes produces mean plasma concentrations of approximately 63 mcg/mL
immediately after the completion of infusion, mean plasma concentrations of
approximately 23 mcg/mL two hours after infusion, and mean plasma concentrations
of approximately 8 mcg/mL eleven hours after the end of the infusion. Multiple
dosing of 500 mg infused over 30 minutes produces mean plasma concentrations
of about 49 mcg/mL at the completion of infusion, mean plasma concentrations
of about 19 mcg/mL two hours after infusion, and mean plasma concentrations
of about 10 mcg/mL six hours after infusion. The plasma concentrations during
multiple dosing are similar to those after a single dose. The
mean elimination half-life of vancomycin from plasma is 4 to 6 hours in subjects
with normal renal function. In the first 24 hours, about 75% of an administered
dose of vancomycin is excreted in urine by glomerular filtration. Mean plasma
clearance is about 0.058 L/kg/hr, and mean renal clearance is about 0.048
L/kg/hr. Renal dysfunction slows excretion of vancomycin. In anephric patients,
the average half-life of elimination is 7.5 days. The distribution coefficient
is from 0.3 to 0.43 L/kg. There is no apparent metabolism of the drug. About
60% of an intraperitoneal dose of vancomycin administered during peritoneal
dialysis is absorbed systemically in six hours. Serum concentrations of about
10 mcg/mL are achieved by intraperitoneal injection of 30 mg/kg of vancomycin.
Although vancomycin is not effectively removed by either hemodialysis or peritoneal
dialysis, there have been reports of increased vancomycin clearance with hemoperfusion
and hemofiltration. Total systemic and renal clearance
of vancomycin may be reduced in the elderly. Vancomycin
is approximately 55% serum protein bound as measured by ultrafiltration at
vancomycin serum concentrations of 10 to 100 mcg/mL. After I.V. administration
of vancomycin hydrochloride, inhibitory concentrations are present in pleural,
pericardial, ascitic, and synovial fluids; in urine; in peritoneal dialysis
fluid: and in atrial appendage tissue. Vancomycin hydrochloride does not readily
diffuse across normal meninges into the spinal fluid; but, when the meninges
are inflamed, penetration into the spinal fluid occurs.
|
| dailymed-instance:activeIng... | |
| dailymed-instance:contraind... |
Sterile vancomycin hydrochloride, USP is contraindicated
in patients with known hypersensitivity to this antibiotic.
|
| dailymed-instance:supply |
Sterile Vancomycin Hydrochloride, USP is supplied as a sterile
powder in a Pharmacy Bulk Package (100 mL) that contains 5 g List No. 6509. Prior
to reconstitution, store at controlled room temperature 15��to 30��C
(59��to 86��F). [See USP.]
|
| dailymed-instance:boxedWarn... |
Pharmacy Bulk Package���Not For Direct Infusion
|
| dailymed-instance:activeMoi... | |
| dailymed-instance:inactiveI... | |
| dailymed-instance:precautio... |
General: Clinically significant serum concentrations have been reported
in some patients who have taken multiple oral doses of vancomycin for active C. difficile-induced pseudomembranous colitis. Prolonged
use of vancomycin may result in the overgrowth of nonsusceptible organisms.
Careful observation of the patient is essential. If superinfection occurs
during therapy, appropriate measures should be taken. In
order to minimize the risk of nephrotoxicity when treating patients with underlying
renal dysfunction or patients receiving concomitant therapy with an aminoglycoside,
serial monitoring of renal function should be performed and particular care
should be taken in following appropriate dosing schedules (see DOSAGE
AND ADMINISTRATION). Serial tests of auditory
function may be helpful in order to minimize the risk of ototoxicity. Reversible
neutropenia has been reported in patients receiving vancomycin hydrochloride
(see ADVERSE REACTIONS). Patients
who will undergo prolonged therapy with vancomycin hydrochloride or those
who are receiving concomitant drugs which may cause neutropenia should have
periodic monitoring of the leukocyte count. Vancomycin
hydrochloride is irritating to tissue and must be given by a secure intravenous
route of administration. Pain, tenderness, and necrosis occur with intramuscular
injection of vancomycin hydrochloride or with inadvertent extravasation. Thrombophlebitis
may occur, the frequency and severity ofwhich can be minimized by administering
the drug slowly as a dilute solution (2.5 to 5 g/L) and by rotating the sites
of infusion. There have been reports that the frequency
of infusion-related events (including hypotension, flushing, erythemia, urticaria,
and pruritus) increases with the concomitant administration of anesthetic
agents. Infusion-related events may be minimized by the administration of
vancomycin hydrochloride as a 60-minute infusion prior to anesthetic induction. The
safety and efficacy of vancomycin administration by the intrathecal (intralumbar
or intraventricular) routes have not been assessed. Reports
have revealed that administration of sterile vancomycin HCl by the intraperitoneal
route during continuous ambulatory peritoneal dialysis (CAPD) has resulted
in a syndrome of chemical peritonitis. To date, this syndrome has ranged from
a cloudy dialysate alone to a cloudy dialysate accompanied by variable degrees
of abdominal pain and fever. This syndrome appears to be short-lived after
discontinuation of intraperitoneal vancomycin. Prescribing
vancomycin in the absence of a proven or strongly suspected bacterial infection
or a prophylactic indication is unlikely to provide benefit to the patient
and increases the risk of the development of drug-resistant bacteria.<br/>Drug Interactions: Concomitant administration of vancomycin and anesthetic agents
has been associated with erythema and histamine-like flushing (see Pediatric Use) and anaphylactoid reactions (see ADVERSE REACTIONS). Concurrent
and/or sequential systemic or topical use of other potentially neurotoxic
and/or nephrotoxic drugs, such as amphotericin B, aminoglycosides, bacitracin,
polymyxin B, colistin, viomycin, or cisplatin, when indicated, requires careful
monitoring.<br/>Pregnancy:: Teratogenic Effects, Category C���Animal reproduction studies
have not been conducted with Vancomycin HCl. It is not known whether Vancomycin
HCl can affect reproduction capacity. In a controlled clinical study, the
potential ototoxic and nephrotoxic effects of Vancomycin HCl on infants were
evaluated when the drug was administered to pregnant women for serious staphylococcal
infections complicating intravenous drug abuse. Vancomycin HCl 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 patients 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. Vancomycin
hydrochloride should be given to a pregnant woman only if clearly needed.<br/>Nursing Mothers: Vancomycin is excreted in human milk. 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 to discontinue the drug, taking into account the importance
of the drug to the mother.<br/>Pediatric Use: 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 pediatric patients (see ADVERSE
REACTIONS).<br/>Geriatrics: The natural decrement 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
(see DOSAGE AND ADMINISTRATION).<br/>Information for Patients: Patients should be counseled that antibacterial drugs including
vancomycin should only be used to treat bacterial infections. They do not
treat viral infections (e.g., the common cold). When vancomycin is prescribed
to treat a bacterial infection, the patient should be told that although it
is common to feel better early in the course of therapy, the medication should
be taken exactly as directed. Skipping doses or not completing the full course
of therapy may (1) decrease the effectiveness of the immediate treatment and(2) increase the likelihood that bacteria will develop resistance and will
not be treatable by vancomycin or other antibacterial drugs in the future.
|
| dailymed-instance:overdosag... |
Supportive care is advised, with maintenance of glomerular
filtration. Vancomycin is poorly removed by dialysis. Hemofiltration and hemoperfusion
with polysulfone resin have been reported to result in increased vancomycin
clearance. The median lethal intravenous dose is 319 mg/kg in rats and 400
mg/kg in mice. To obtain up-to-date information about
the treatment of overdose, a good resource is your certified Regional Poison
Control Center. Telephone numbers of certified poison control centers are
listed in the Physicians' Desk Reference
(PDR). In managing overdosage, consider the possibility of multiple
drug overdoses, interaction among drugs, and unusual drug kinetics in your
patient.
|
| dailymed-instance:genericMe... |
Vancomycin Hydrochloride
|
| dailymed-instance:fullName |
Vancomycin Hydrochloride (Injection, Powder, Lyophilized, For Solution)
|
| dailymed-instance:adverseRe... |
Infusion-Related Events: During
or soon after rapid infusion of vancomycin hydrochloride, 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 Man Syndrome���)
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 is given by a slow infusion over 60 minutes. In
studies of normal volunteers, infusion-related events did not occur when vancomycin
HCl was administered at a rate of 10 mg/min or less. Nephrotoxicity: Rarely, renal failure, principally
manifested by increased serum creatinine or BUN concentrations, especially
in patients given large doses of vancomycin, 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 preexisting
kidney dysfunction. When vancomycin hydrochloride was discontinued, azotemia
resolved in most patients. Ototoxicity: A few dozen cases of hearing loss associated with vancomycin hydrochloride
have been reported. Most of these patients had kidney dysfunction or a preexisting
hearing loss, or were receiving 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 dosage of more than 25 g, has been reported for several dozen
patients. Neutropenia appears to be promptly reversible when vancomycin hydrochloride
is discontinued. Thrombocytopenia has rarely been reported. Although
a causal relationship has not been established, reversible agranulocytosis
(granulocytes<500/mm) has been reported rarely. Phlebitis: Inflammation at the injection site has
been reported. Gastrointestinal: Onset of pseudomembranous colitis symptoms may occur during or
after antibiotic treatment (see WARNINGS). Miscellaneous: Infrequently, patients have been reported to have had anaphylaxis,
drug fever, nausea, chills, eosinophilia, rashes (including exfoliative dermatitis),
linear IgA bullous dermatosis, Stevens-Johnson syndrome, toxic epidermal necrolysis,
and rare cases of vasculitis in association with the administration of vancomycin. Chemical
peritonitis has been reported following intraperitoneal administration of
vancomycin (see PRECAUTIONS).
|
| dailymed-instance:warning |
Rapid bolus administration (e.g., over several minutes) may
be associated with exaggerated hypotension and, rarely, cardiac arrest. Vancomycin
hydrochloride 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. Ototoxicity
has occurred in patients receiving vancomycin hydrochloride. 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 hydrochloride must
be adjusted for patients with renal dysfunction (see PRECAUTIONS and DOSAGE AND ADMINISTRATION). Pseudomembranous
colitis has been reported with nearly all antibacterial agents including vancomycin,
and may range in severity from mild to life-threatening. Therefore, it is
important to consider this diagnosis in patients who present with diarrhea
subsequent to the administration of antibacterial agents. Treatment
with antibacterial agents alters the normal flora of the colon and may permit
overgrowth of clostridia. Studies indicate that a toxin produced by Clostridium difficile is one primary cause of
antibiotic-associated colitis. After the diagnosis of pseudomembranous colitis
has been established, therapeutic measures should be initiated. Mild cases
of pseudomembranous colitis usually respond to drug discontinuation alone.
In moderate to severe cases, consideration should be given to management with
fluids and electrolytes, protein supplementation and treatment with an antibacterial
drug effective against C. difficile colitis.
|
| dailymed-instance:indicatio... |
Vancomycin hydrochloride is indicated for the treatment of
serious or severe infections caused by susceptible strains of methicillin-resistant
(��-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 whenmethicillin-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, antibioticsare 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 S.
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 hydrochloride
is not effective by the oral route for other types of infection. Although
no controlled clinical efficacy studies have been conducted, intravenous vancomycin
has been suggested by the American Heart Association and the American Dental
Association as prophylaxis against bacterial endocarditis in penicillin-allergic
patients who have congenital heart disease or rheumatic or other acquired
valvular heart disease when these patients 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. 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.
|
| dailymed-instance:represent... | |
| dailymed-instance:routeOfAd... | |
| dailymed-instance:name |
Vancomycin Hydrochloride
|