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Description:
Sterile Vancomycin Hydrochloride, USP is a glycopeptide antibiotic derived from Nocardia
orientalis and is active against many gram-positive bacteria including Staphylococcus
aureus, Staph. Epidermidis, alpha and beta hemolytic streptococci, group D. streptococci,
cornybacteria and clostridia.
Mode of action:
The bactericidal action of vancomycin results primarily from inhibition of cell-wall
biosynthesis. In addition, vancomycin alters bacterial-cell-membrane permeability and
RNA synthesis. There is no cross-resistance between vancomycin and other antibiotics.
Indications and Usage
Vancomycin is indicated for the treatment of serious or severe infections caused by
susceptible strains of methicillin-resistant staphylococci. Sterile Vancomycin
Hydrochloride, USP is indicated for initial therapy when methicillin-resistant staphylococci
are suspected, but after susceptibility data are available, therapy should be adjusted
accordingly. Vancomycin is effective in the treatment of staphylococcal endocarditis. Its
effectiveness has been documented in other infections due to staphylococci, including
septicemia, bone infections, lower respiratory tract infections, and skin and skin structure
infections. When staphylococcal infections are localized and purulent, antibiotics are used
as adjuncts to appropriate surgical measures.
Contraindications
Sterile Vancomycin Hydrochloride, USP is contraindicated in patients with known
hypersensitivity to this antibiotic.
Dosage And Administration
Patients with Normal Renal Function
Adults
The usual daily dose intravenous dose is 2 g divided either as 500 mg every six hours or 1 g every
12 hours.
Pediatric Patients
The usual intravenous dosage of vancomycin is 10 mg/kg per dose given every 6 hours.
Neonates
In pediatric patients 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.
Patients with Impaired Renal Function and Elderly Patients
Dosage adjustment must be made in patients with impaired renal function Vancomycin
Hydrochloride, USP per day in mg is about 15 times the glomerular filtration rate in mL/min:
Dosage table for vancomycin in patients with impaired renal function :
Creatinine Clearance
mL/min
100
90
80
70
60
50
40
30
20
10
Vancomycin Dose
mg/24 hr
1,545
1,390
1,235
1,080
925
770
620
465
310
155
Size: 108 x 224mm
mqmyJrKmKi (Administration procedure) Î
1
Diluent
for
Covan
KxKr† KhP~
TokPã 10 Ko.Ku.
cJAuMP~≤
nJ~JPur oJgJ ßgPT
dJTjJKa fáPu
10 Ko.Ku. cJAuMP~≤ nJ~Ju
­Fr oPiq k´Pmv TrJj FmÄ
xKuCvj ‰frL Tr∆j
2
(NaCl Solution 0.9%)
ßaPj Kjj
4
QfrLTíf kMPrJ xKuCvj
nJ~Ju ßgPT KxKr†­F
ßaPj Kjj
Diluted
for
Covan
KxKr† ßgPT kMPrJ xKuCvj
cJAuMP~≤
(NaCl Solution 0.9%)
­Fr nJ~Ju­F
k´Pmv TrJj
3
Covan®
Presentation:
Covan® 500mg Injection: Each vial contains sterile Vancomycin Hydrochloride USP powder
equivalent to Vancomycin 500mg.
Covan® 1gm Injection: Each vial contains sterile Vancomycin Hydrochloride USP powder
equivalent to Vancomycin 1gm.
Covan®
Vancomycin 500mg & 1g IV Infusion
Precaution:
Prolonged use of vancomycin may result in the overgrowth of nonsusceptible
microorganisms. Careful observation of the patient is essential. If superinfection occurs
during therapy, appropriate measures should be taken. In rare instances, there have been
reports of pseudomembranous colitis due to C. difficile developing in patients who received
intravenous vancomycin.
Covan®
Covan®
5
Diluent
for
Covan
500 Ko.V´J. TokPã 1 W≤J FmÄ
1 V´Jo TokPã 2 W≤J xo~ iPr
AjKlCvj KyxJPm Khj
Side-effects:
During or soon after rapid infusion of vancomycin, few patients may develop anaphylactic
reactions, including hypotension, wheezing, dyspnea, urticaria, or pruritus.
Use in pregnancy and lactation:
Pregnancy Category C.
Vancomcyin should be given to a pregnant woman only if clearly needed.
Vancomycin is excreted in human milk. Caution should be exercised when vancomycin is
administered to a nursing woman.
Overdosage
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.
Commercial pack:
Covan® 500mg Injection: Each box contains 1 vial of sterile Vancomycin Hydrochloride USP
equivalent to Vancomycin 500mg.
Covan® 1gm Injection: Each box contains 1 vial of sterile Vancomycin Hydrochloride USP
equivalent to Vancomycin 1gm.
Manufactured by :
RENATA LIMITED
Section VII Milk Vita Road
Mirpur, Dhaka, Bangladesh
May, 2012
C-Code No. : 6147/V 01
Size: 108 x 224mm