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| Name: |
VANCOMYCIN |
| Classification: |
Tricyclic glycopeptide
derived from Amycolatopsis orientalis (formerly nocardia
orientalis) |
| Mechanism of Action: |
Inhibits the
cell wall biosynthesis, also alters bacterial cell
membrane permeability and RNA synthesis. There is
no cross sensitivity between Vancomycin and other
drugs. The drug is Bactericidal. It is Bacteriostatic
in some instances with enterococcal infections and
in some MRSA infections. |
| Spectrum of activity: |
Vancomycin
is active against staphylococci, including Staphylococcus
aureus and Staphylococcus epidermidis (including heterogeneous
methicillin-resistant strains); Streptococci, including
Streptococcus pyogenes, Streptococcus pneumoniae (including
penicillin-resistant strains), Streptococcus agalactiae,
the viridans group, Streptococcus bovis, and enterococci
(e.g., Enterococcus faecalis [formerly Streptococcus
faecalis]); Clostridium difficile (e.g., toxigenic
strains implicated in pseudomembranous enterocolitis);
and diphtheroids. Other organisms that are susceptible
to Vancomycin in vitro include Listeria monocytogenes,
Lactobacillus species, Actinomyces species, Clostridium
species, and Bacillus species.
In vitro resistance to Vancomycin has been reported
among some enterococcal and staphylococcal isolates.
Vancomycin is not active in vitro against Gram-negative
Bacilli, Mycobacteria, or Fungi.
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Approved Indications: |
Vancomycin
is active against staphylococci, including Staphylococcus
aureus and Staphylococcus epidermidis (including
heterogeneous methicillin-resistant strains);
Streptococci, including Streptococcus pyogenes,
Streptococcus pneumoniae (including penicillin-resistant
strains), Streptococcus agalactiae, the viridans
group, Streptococcus bovis, and enterococci
(e.g., Enterococcus faecalis [formerly Streptococcus
faecalis]); Clostridium difficile (e.g., toxigenic
strains implicated in pseudomembranous enterocolitis);
and diphtheroids. Other organisms that are susceptible
to Vancomycin in vitro include Listeria monocytogenes,
Lactobacillus species, Actinomyces species,
Clostridium species, and Bacillus species.
In vitro resistance to Vancomycin has been reported
among some enterococcal and staphylococcal isolates.
Vancomycin is not active in vitro against Gram-negative
Bacilli, Mycobacteria, or Fungi.
For the treatment of serious or severe infections
caused by susceptible strains of methicillin-resistant
(ß-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.
In the treatment of Staphylococcal endocarditis.
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.
It 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).
It has been reported to be effective for the
treatment of diphtdiphtheroid endocarditis.
It has been used successfully in combination
with rifampin, an aminoglycoside, or both in
early-onset prosthetic valve endocarditis caused
by S. 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.
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.
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| Dosage and
renal/hepatic Adjustment: |
Concentrations
of no more than 5 mg/ml and rates of no more than
10 mg/min are recommended in adults
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 hydrochloride 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:
rate in ml/min:
| DOSAGE TABLE FOR Vancomycin |
| IN PATIENTS WITH IMPAIRED RENAL
FUNCTION |
| (Adapted from Moellering et al)4 |
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|
Creatinine Clearance |
Vancomycin Dose |
mL/min |
mg/24 h |
100 |
1545 |
90 |
1390 |
80 |
1235 |
70 |
1080 |
60 |
925 |
50 |
770 |
40 |
620 |
30 |
465 |
20 |
310 |
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10 |
155 |
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The initial dose should be no less than 15 mg/kg,
even in patients with mild to moderate renal insufficiency.
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.
| Men: |
[Weight (kg) x (140 - age in years)] / [72
x serum creatinine concentration (mg/dL)] |
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| Women: |
0.85 x above value |
Intermittent infusion is the recommended method of
administration.
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| Oral bioavailability: |
Very poor. Can only
be given by the intravenous route |
| CSF penetration: |
The safety
and efficacy of Vancomycin administration by the Intrathecal
(Intralumbar or Intraventricular) route have not been
assessed. |
| Other important Pharmokinetics: |
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| Pregnancy
classification: |
Teratogenic Effects, Category C
Vancomycin should be given to a pregnant woman only
if clearly needed. |
| Common side effects: |
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.
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.
Serial tests of auditory function may be helpful in
order to minimize the risk of ototoxicity.
Reversible neutropenia has been reported.
Vancomycin hydrochloride is irritating to tissue and
must be given by a secure intravenous route of administration.
There have been reports that the frequency of infusion-related
events (including hypotension, flushing, erythema,
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.
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.
Drug Interactions
Concomitant administration of Vancomycin and anesthetic
agents has been associated with erythema and histamine-like
flushing.
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.
Nursing Mothers
Vancomycin is excreted in human milk. Caution should
be exercised when Vancomycin is administered to a
nursing woman.
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.
Geriatrics
Vancomycin dosage schedules should be adjusted in
elderly patients.
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.
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| Precautions: |
Sterile Vancomycin
hydrochloride, USP is contraindicated in patients with
known hypersensitivity to this antibiotic. |
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