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VANCOCIN 500 MG POWDER FOR SOLUTION FOR INFUSION AND ORAL SOLUTION

Active substance(s): VANCOMYCIN HYDROCHLORIDE

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and 1000mg
Powder for
Solution for
Infusion and
Oral Solution

Vancomycin
The name of your medicine is Vancocin
500mg & 1000mg Powder for Solution
for Infusion and Oral Solution, which
will be referred to as Vancocin
throughout the rest of this document.
Read all of this leaflet carefully
before you start taking this medicine
because it contains important
information for you.
n Keep this leaflet. You may need to
read it again.
n If you have any further questions,
ask your doctor or pharmacist.
n If you get any side effects, talk to
your doctor or pharmacist. This
includes any possible side effects not
listed in this leaflet. See section 4.
What is in this leaflet:
1. What Vancocin is and what it is
used for
2. What you need to know before you
are given Vancocin
3. How you are given Vancocin
4. Possible side effects
5. How to store Vancocin
6. Contents of the pack and other
information

Vancocin contains the active ingredient
vancomycin hydrochloride, which is an
antibiotic. Vancocin powder is made into
a solution for infusion or oral solution.
Vancocin infusion is used to treat:
n very serious infections that cannot
be treated with other, better
tolerated, antibiotics such as
penicillins and cephalosporins.
n severe staphylococcal (a type of
bacteria) infections in patients who
cannot be given or do not respond to
penicillins and cephalosporins, or
who have staphylococcal infections
that are resistant to other
antibiotics.
n endocarditis (infection of the inside
lining of the heart) and to prevent
endocarditis in patients at risk from
dental or surgical procedures.
n other infections caused by the
staphylococcal bacteria such as bone
infection (osteomyelitis), lung tissue
infection (pneumonia), blood
poisoning (septicaemia) and skin
and muscle (soft tissue) infections
Vancomycin can be given orally for the
treatment of two specific bacterial gut
infections, namely, staphylococcal
enterocolitis and pseudomembranous
colitis (caused by Clostridium difficile)

2 What you need to know
before you are given Vancocin
Do not take Vancocin:
n If you are allergic to vancomycin.
An allergic reaction may include rash,
itching, difficulty breathing or swelling
of the face, lips, throat or tongue.

Warnings and precautions
Talk to your doctor or pharmacist
before being given Vancocin if you
n have an inflammatory disorder of
the digestive tract (you may be at
risk of side effects, especially if you
also have a kidney disorder)
n have a kidney disorder (you will need
to have your blood and kidneys
tested during treatment)
n are elderly (you may need your
blood and hearing monitored)
n have a hearing disorder, especially if
you are elderly (you may need
hearing tests during treatment)
n are receiving Vancocin for a long
time (you may develop another type
of infection)
Other medicines and Vancocin
Tell your doctor or pharmacist if you
are taking, have recently taken or
might take any other medicines,
including medicines obtained without a
prescription. This is especially
important of the following, as they
may interact with your Vancocin:
n anaesthetics – these may cause
redness, flushing, fainting, collapse
or even heart attacks. You should,
therefore, tell your doctor that you
are taking Vancocin if you are going
to have an operation.
n any drug that affects your nerves or
kidneys such as amphotericin B
(treats fungal infections),
aminoglycosides, bacitracin,
polymixin B, colistin, viomycin
(antibiotics) or cisplatin
(a chemotherapy drug).
n Potent diuretics (strong medicines
which are given to encourage the
production of urine) such as
furosemide.

It may still be all right for you to be
given Vancocin and your doctor will be
able to decide what is suitable for you.

Information for the Health Care Professional

Vancocin

1. NAME OF THE MEDICINAL PRODUCT
Vancocin 500mg powder for solution for infusion and
oral solution.
Vancocin 1000mg powder for solution for infusion and
oral solution.

Pregnancy and breast-feeding
If you are pregnant or breast-feeding,
think you may be pregnant or are
planning to have a baby, ask your
doctor or pharmacist for advice before
taking this medicine.

2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Vancomycin hydrochloride equivalent to 500mg
vancomycin (525,000 IU). When reconstituted with 10ml
water for injections, the solution contains vancomycin
50mg/ml.
Vancomycin hydrochloride equivalent to 1000mg
vancomycin (1,050,000 IU). When reconstituted with 20ml
water for injections, the solution contains vancomycin
50mg/ml.

Driving and using machines
Vancocin should not affect your ability
to drive or use machines.

3. PHARMACEUTICAL FORM
Powder for solution for infusion and oral solution.
An off-white lyophilised plug, when reconstituted in water,
it forms a clear solution.

3 How you are given Vancocin
Dosage
The dose of Vancocin will depend on
your age, the type of infection you
have, and other conditions. Infusions
should be given over at least 60
minutes and the solution you are given
should not contain more than 5mg/ml
of Vancomycin.
The usual adult infusion dose is
500mg every six hours or 1000mg
every twelve hours. Before it is given
to you, this medicine will initially be
dissolved in water and then added to
an infusion bag containing sodium
chloride (salt) or dextrose (a sugar)
solution. It will then be given as a slow
infusion through a drip into a vein.
The usual infusion dose for children is
10 mg/kg (body weight) given every
6 hours (total daily dose 40mg/kg of
body weight).
The elderly, pregnant mothers,
premature infants, and patients with
a kidney disorder may need a
different dose.

4 CLINICAL PARTICULARS
4.1 Therapeutic indications
Vancomycin is indicated in potentially life threatening
infections which cannot be treated with other effective,
less toxic antimicrobial drugs, including the penicillins and
cephalosporins.
Vancomycin is useful in the therapy of severe
staphylococcal infections in patients who cannot receive or
who have failed to respond to the penicillins and
cephalosporins, or who have infections with staphylococci
resistant to other antibiotics.
Vancomycin is used in the treatment of endocarditis and as
prophylaxis against endocarditis in patients at risk from
dental or surgical procedures.
Its effectiveness has been documented in other infections
due to staphylococci, including osteomyelitis, pneumonia,
septicaemia and soft tissue infections.
Vancomycin may be used orally for the treatment of
staphylococcal enterocolitis and pseudomembranous colitis
due to Clostridium difficile. Parenteral administration of
vancomycin is not effective for these indications.
Intravenous administration may be used concomitantly
if required.
Consideration should be given to official guidance on the
appropriate use of antibacterial agents.
4.2. Posology and method of administration
For intravenous infusion and oral use only and not for
intramuscular administration.
Infusion related adverse events are related to both
concentration and rate of administration of vancomycin.
Concentrations of no more than 5mg/ml are recommended.
In selected patients in need of fluid restriction, a
concentration up to 10mg/ml may be used; use of such
higher concentrations may increase the risk of infusion
related events. Infusions should be given over at least 60
minutes. In adults, if doses exceeding 500mg are used, a
rate of infusion of no more than 10mg/min is

recommended. Infusion related events may occur, however,
at any rate or concentration.
Intravenous Infusion in Patients with Normal Renal
Function
Adults: The usual intravenous dose is 500mg every six hours
or 1g every 12 hours, in Sodium Chloride Intravenous Infusion
BP or 5% Dextrose Intravenous Infusion BP. Each dose should
be administered at no more than 10mg/min. Other patient
factors, such as age, obesity or pregnancy, may call for
modification of the usual daily dose. The majority of patients
with infections caused by organisms sensitive to the
antibiotic show a therapeutic response within 48-72 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, treatment for three
weeks or longer is recommended.
Pregnancy: It has been reported that significantly
increased doses may be required to achieve therapeutic
serum concentrations in pregnant patients (see section 4.6
‘Fertility, pregnancy and lactation’)
The elderly: Dosage reduction may be necessary to a
greater extent than expected because of decreasing renal
function (see below). Monitor auditory function (see
section 4.4 ‘Special warning and precautions for use’).
Paediatric population
The usual intravenous dosage is 10mg/kg per dose given
every 6 hours (total daily dosage 40mg/kg of body
weight). Each dose should be administered over a period of
at least 60 minutes.
Neonates have a larger volume of distribution and
incompletely developed renal function; therefore dosing
guidelines differ from those recommended for children and
adults. In neonates and young infants, the total daily
dosage may be lower. An initial dose of 15mg/kg is
suggested, followed by 10mg/kg every 12 hours in the first
week of life and every 8 hours thereafter until one month
of age. Each dose should be administered over 60 minutes.
Close monitoring of serum vancomycin concentrations may
be warranted in these patients. One dosing nomogram for
dosing vancomycin in neonates is illustrated in the
following table.
Vancomycin Dosage Guideline for Neonates
aPCA
Chronological Serum Creatinine Dosage
(Weeks) Age
Concentration (mg/kg)

(Days)
(mg/dl)b
<30
≤7 ------c
15 every 24 hr

>7
≤1.2
10 every 12 hr
30-36 ≤14
------
10 every 12 hr

>14
≤0.6
10 every 8 hr

0.7 – 1.2
10 every 12 hr
>36
≤7
------
10 every 12 hr

>7
≤0.6
10 every 8 hr

0.7 – 1.2
10 every 12 hr
PCA = postconceptual age (gestational age at birth plus
chronological age)
If the serum creatinine concentration is >1.2mg/dl, use an
initial dosage of 15mg/kg every 24 hours
c 
Serum creatinine concentration is not used to determine
the dosage for this type of patient because of its lack of
reliability or because of the lack of information.
a 

b 

Patients with impaired renal function:
Dosage adjustments must be made to avoid toxic serum
levels. In premature infants and the elderly, greater dosage
reductions than expected may be necessary because of
decreased renal function.
Regular monitoring of serum levels is advised in such
patients, as accumulation has been reported, especially
after prolonged therapy. Vancomycin serum concentrations
may be determined by use of a microbiological assay,
radioimmunoassay, fluorescence polarisation
immunoassay, fluorescence immunoassay or high pressure
liquid chromatography.
The following nomogram, based on creatinine clearance
values, is provided:
Dosage nomogram for vancomycin in patients with
impaired renal function
30.9
27.8

1.25

24.7
21.6

1.00

18.5
0.75

15.4
12.4

0.50

09.3
06.2

0.25

03.1
0

0.2

0.4

0.6 0.8 1.0 1.2 1.4 1.6
Creatinine Clearance (ml/min/kg)

1.8

29.3
26.3
23.2
20.1
17.0
13.9
10.8
07.7
04.6

Vancomycin Dose (mg/kg/24hr)

Vancocin 500mg

1 What Vancocin is and what it
is used for

Vancomycin Clearance (ml/min/kg)

Package leaflet:
Information for the user






01.5

2.0

The nomogram is not valid for functionally anephric
patients on dialysis. For such patients, a loading dose of
15mg/kg body weight should be given to achieve
therapeutic serum levels promptly, and the dose required
to maintain stable levels is 1.9mg/kg/24 hours. Since
individual maintenance doses of 250mg to 1g are
convenient, in patients with marked renal impairment a
dose may be given every several days rather than on a
daily basis. In anuria a dose of 1g every 7 to 10 days has
been recommended.
Measurement of serum concentrations: Following multiple
intravenous doses, peak serum concentrations, measured
2 hours after infusion is complete, range from 18-26mg/l.
Trough levels measured immediately prior to the next dose
should be 5-10mg/l. Ototoxicity has been associated with
serum drug levels of 80-100mg/l, but this is rarely seen
when serum levels are kept at or below 30mg/l.
Oral Administration
The contents of vials for parenteral administration may
be used.
Adults and the elderly: The usual daily dose given is
500mg in divided doses for 7 to 10 days, although up to
2g/day have been used in severe cases. The total daily
dosage should not exceed 2g. Each dose may be
reconstituted in 30ml water and either given to the patient
to drink, or administered by nasogastric tube.
Paediatric population
The usual daily dose is 40mg/kg in three or four divided
doses for 7 to 10 days. The total daily dosage should not
exceed 2g.

Common flavouring syrups may be added to the solution at
the time of administration to improve the taste.
Capsules are also available.
Preparation of solutions: see section 6.6 ‘Special
precautions for disposal and other handling’.
4.3 Contraindications
Hypersensitivity to the active substance.
4.4. Special warnings and precautions for use
Warnings
Rapid bolus administration (e.g. over several minutes) may
be associated with exaggerated hypotension, including
shock, and, rarely, cardiac arrest. Vancomycin should be
infused 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 ‘Posology and method of
administration’ and ‘Undesirable effects’ sections).
Some patients with inflammatory disorders of the
intestinal mucosa may have significant systemic absorption
of oral vancomycin and, therefore, may be at risk for the
development of adverse reactions associated with the
parenteral administration of vancomycin. The risk is greater
in patients with renal impairment. It should be noted that
the total systemic and renal clearances of vancomycin are
reduced in the elderly.
Due to its potential ototoxicity and nephrotoxicity,
vancomycin should be used with care in patients with renal
insufficiency and the dose should be reduced according to
the degree of renal impairment. The risk of toxicity is
appreciably increased by high blood concentrations or
prolonged therapy. Blood levels should be monitored and
renal function tests should be performed regularly.
Vancomycin should also be avoided in patients with
previous hearing loss. If it is used in such patients, the dose
should be regulated, if possible, by periodic determination
of the drug level in the blood. 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 treatment.
Vancomycin should be administered with caution in
patients allergic to teicoplanin, since allergic cross reactions
between vancomycin and teicoplanin have been reported.
Usage in the elderly: The natural decrement of glomerular
filtration with increasing age may lead to elevated
vancomycin serum concentrations if dosage is not adjusted
(see section 4.2 ‘Posology and method of administration’).
Paediatric population
In premature neonates and young infants, it may be
appropriate to confirm desired vancomycin serum
concentrations. Concomitant administration of vancomycin
and anaesthetic agents has been associated with erythema
and histamine like flushing in children.
Precautions
Clinically significant serum concentrations have been
reported in some patients being treated for active C.
difficile-induced pseudomembranous colitis after multiple
oral doses of vancomycin. Therefore, monitoring of serum
concentrations may be appropriate in these patients.
Patients with borderline renal function 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 haematological
studies, urine analysis and renal function tests.
Vancomycin is very irritating to tissue, and causes injection
site necrosis when injected intramuscularly; it must be
infused intravenously. Injection site pain and
thrombophlebitis occur in many patients receiving
vancomycin and are occasionally severe.
The frequency and severity of thrombophlebitis can be
minimised by administering the drug slowly as a dilute
solution (2.5 to 5.0g/l) and by rotating the sites of infusion.
Prolonged use of vancomycin may result in the overgrowth
of non susceptible organisms. 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.
4.5. Interaction with other medicinal products and
other forms of interaction
Concomitant administration of vancomycin and anaesthetic
agents has been associated with erythema, histamine-like
flushing and anaphylactoid reactions.
There have been reports that the frequency of
infusion-related events increases with the concomitant
administration of anaesthetic agents. Infusion-related
events may be mimmised by the administration of
vancomycin as a 60-minute infusion prior to anaesthetic
induction.
Concurrent or sequential systemic or topical use of other
potentially ototoxic or nephrotoxic drugs, such as
amphotericin B, aminoglycosides, bacitracin, polymixin B,
colistin, viomycin, cisplatin, and loop diuretics may increase
the toxicity of vancomycin and if they need to be given
should be used with caution and appropriate monitoring.
4.6. Fertility, pregnancy and lactation
Pregnancy
Teratology studies have been performed at 5 times the
human dose in rats and 3 times the human dose in rabbits,
and have revealed no evidence of harm to the foetus due
to vancomycin. In a controlled clinical study, the potential
ototoxic and nephrotoxic effects of vancomycin
hydrochloride on infants were evaluated when the drug
was administered to pregnant women for serious
staphylococcal infections complicating intravenous drug
abuse. Vancomycin hydrochloride 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 attributable to
vancomycin. Because vancomycin was administered only in
the second and third trimesters, it is not known whether it
causes foetal harm. Vancomycin should be given in
pregnancy only if clearly needed and blood levels should be
monitored carefully to minimise the risk of foetal toxicity. It
has been reported, however, that pregnant patients may
require significantly increased doses of vancomycin to
achieve therapeutic serum concentrations.
Breast-feeding
Vancomycin hydrochloride is excreted in human milk.
Caution should be exercised when vancomycin is
administered to a nursing woman. It is unlikely that a

4.9. Overdose
Supportive care is advised, with maintenance of
glomerular filtration. Vancomycin is poorly removed from
the blood by haemodialysis or peritoneal dialysis.
Haemoperfusion with Amberlite resin XAD-4 has been
reported to be of limited benefit.

5 PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
Pharmacotherapeutic group: glycopeptide antibacterials
ATC Code: J01 XA01 for intravenous use and A07 AA09
for oral use.
Vancomycin is a tricyclic glycopeptide antibiotic derived
from Amycolatopsis orientalis. The primary mode of action
of vancomycin is inhibition of cell-wall synthesis. In addition,
vancomycin may alter bacterial cell membrane permeability
and RNA synthesis. There is no cross-resistance between
vancomycin and other classes of antibiotics.
EUCAST Clinical MIC Breakpoints
EUCAST Clinical MIC (version 6.0, valid from 2016-01-01)
Microorganism
Breakpoints (mg/L)

Susceptible Resistant
Staphylococcus spp.
(S. aureus)
≤ 21
>2
Coagulase-negative
1
staphylococcus
≤4
>4
Enterococcus spp.
≤ 4
>4
1
Streptococcus ABCG
≤2
>2
1
Streptococcus pneumoniae ≤ 2
>2
Viridans group streptococci ≤ 21
>2
Gram-positive anaerobes ≤ 2
>2
Clostridium difficile
≤ 22
> 22
Corynebacterium spp.
≤ 2
>2
Non-susceptible isolates are rare or not yet reported. The
identification and antimicrobial susceptibility test result on
any such isolate must be confirmed and the isolate sent to
a reference laboratory.
2
The breakpoints are based on epidemiological cut off
values (ECOFFs), which distinguish wild type isolates from
those with reduced susceptibility.
The prevalence of acquired resistance may vary
geographically and with time for selected species and local
information on resistance is desirable, particularly when
treating severe infections. As necessary, expert advice
should be sought when the local prevalence of resistance is
such that the utility of the agent in at least some types of
infections is questionable.
Commonly susceptible species:
Gram-positive aerobes
Enterococcus faecalis
Staphylococcus aureus
Coagulase-negative staphyloccoci
Streptococcus group B
Streptococcus group C
Streptococcus group G
Streptococcus pneumoniae
1

Streptococcus pyogenes
Viridans streptococci
Species for which acquired resistance may be a problem:
Gram-positive aerobes
Enterococcus faecium
Clostridium difficile (e.g. toxigenic strains implicated in
pseudomembranous colitis) is a target species for oral use
where high intraluminal concentrations of vancomycin
are achieved.
5.2. Pharmacokinetic properties
Vancomycin is given intravenously for therapy of
systemic infections.
In subjects with normal renal function, multiple intravenous
dosing of 1g of vancomycin (15mg/kg) infused over
60 minutes produces mean plasma concentrations of
approximately 63mg/L immediately after the completion of
infusion, mean plasma concentrations of approximately
23mg/L 2 hours after infusion. Multiple dosing of 500mg
infused over 30 minutes produces mean plasma
concentrations of about 49mg/L at the completion of
infusion, mean plasma concentrations of about 19mg/L
2 hours after infusion, and mean plasma concentrations
of about 10mg/L 6 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 the
plasma is 4 to 6 hours in patients with normal renal
function. 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 0.048L/kg/h. Renal vancomycin
clearance is fairly constant and accounts for 70% to 80% of
vancomycin elimination. The volume of distribution ranges
from 0.39 to 0.97L/kg. There is no apparent metabolism of
the drug. Vancomycin is 55% protein bound as measured by
ultrafiltration at vancomycin serum levels of 10 to 100mg/L.
After IV administration of vancomycin hydrochloride,
inhibitory concentrations are present in pleural,
pericardial, ascitic, atrial appendage tissue and synovial
fluid, as well as urine and peritoneal fluid. Vancomycin
does not readily penetrate the cerebrospinal fluid unless
the meninges are inflamed.
Renal dysfunction slows excretion of vancomycin. In anephric
patients, the average half-life of elimination is 7.5 days.
The total systemic and renal clearance of vancomycin may
be reduced in the elderly due to the natural decrement of
glomerular filtration.
Vancomycin is not significantly absorbed from the normal
gastro intestinal tract and is therefore not effective by the
oral route for infections other than staphylococcal
enterocolitis and pseudomembranous colitis due to
Clostridium difficile.
Orally administered vancomycin does not usually enter the
systemic circulation even when inflammatory lesions are
present. Measurable serum concentrations may occur
infrequently in patients with active C. difficile-induced
pseudomembranous colitis and, in the presence of renal
impairment, the possibility of accumulation exists.
Administration of vancomycin oral solution, 2g daily for
16 days to anephric patients with no inflammatory bowel
disease, gave serum levels of <0.66μg/ml. With doses of

2g daily, concentration of 3,100mg/kg can be found in the
faeces and levels of <1μg/ml can be found in the serum
of patients with normal renal function who have
pseudomembranous colitis.
5.3. Pre-clinical Safety Data
Although no long-term studies in animals have been
performed to evaluate carcinogenic potential, no mutagenic
potential of vancomycin was found in standard laboratory
tests. No definitive fertility studies have been performed.

6 PHARMACEUTICAL PARTICULARS
6.1 List of excipients
None
(Vials of Vancocin contain only the active ingredient,
vancomycin hydrochloride).
6.2. Incompatibilities
Vancomycin solution has a low pH that may cause chemical
or physical 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 vancomycin. It is recommended to
adequately flush intravenous lines between administration
of these antibiotics. It is also recommended to dilute
solutions of vancomycin to 5mg/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.
6.3. Shelf Life
2 years
After reconstitution: May be stored in a refrigerator
(2°-8°C) for 24 hours.
Prior to administration, parenteral drug products should be
inspected visually for particulate matter and discolouration
whenever solution or container permits.
Solutions of the parenteral powder intended for oral
administration may be stored in a refrigerator (2°-8°C)
for 96 hours.
6.4. Special precautions for storage
Do not store above 25°C.
For storage conditions after reconstitution of the medicinal
product, see section 6.3.
6.5. Nature and contents of container
500mg presentation: Rubber stoppered 10ml vials each
containing chromatographically purified vancomycin
hydrochloride 525,000iu, equivalent to 500mg vancomycin
as an off-white lyophilised plug
One 10ml vial packaged in a cardboard carton.
1g presentation: Rubber stoppered 20ml vials containing
chromatographically purified vancomycin hydrochloride,
1,050,000IU, equivalent to 1 g vancomycin, as an off-white
lyophilised plug.
One 20ml vial packaged in a cardboard carton.

The usual adult oral dose is 500mg per
day in divided doses for 7 to 10 days.
The maximum daily dose is 2g/day for
severe infections. Each dose can be
added to 30ml water and either given
to the patient to drink, or given by
nasogastric tube (a tube passing
through the nose into the stomach).
The usual oral dose for children is
40mg/kg (body weight) in three or
four doses for 7 to 10 days. The
maximum daily dose is 2g.

6.6 Special precautions for disposal and
other handling
Preparation of solution: At the time of use, add 10ml of
Water for Injections PhEur to the 500mg vial, or 20ml Water
for Injections PhEur to the 1000mg vial. Vials reconstituted
in this manner will give a solution of 50mg/ml.
FURTHER DILUTION IS REQUIRED. Read instructions
which follow:
Intermittent infusion is the preferred method of
administration. Reconstituted solutions containing 500mg
vancomycin must be diluted with at least 100ml diluent.
Reconstituted solutions containing 1000mg vancomycin
must be diluted with at least 200ml diluent. Sodium
Chloride Intravenous Infusion BP or 5% Dextrose
Intravenous Infusion BP are suitable diluents. The desired
dose should be given by intravenous infusion over a period
of at least 60 minutes. If administered over a shorter period
of time or in higher concentrations, there is the possibility
of inducing marked hypotension in addition to
thrombophlebitis. Rapid administration may also produce
flushing and a transient rash over the neck and shoulders.
Continuous infusion (should be used only when intermittent
infusion is not feasible). 1000-2000mg can be added to a
sufficiently large volume of Sodium Chloride Intravenous
Infusion BP or 5% Dextrose Intravenous Infusion BP to
permit the desired daily dose to be administered slowly by
intravenous drip over a 24 hour period.
Oral Administration
The contents of vials for parenteral administration may
be used.
Common flavouring syrups may be added to the solution at
the time of administration to improve the taste.
Capsules are also available.
Any unused medicinal product or waste material should be
disposed of in accordance with local requirements.

If you are given more Vancocin than
you should receive
As Vancocin will be given to you whilst
you are in hospital is unlikely that you
will be given too little or too much,
however, tell your doctor or nurse if
you have any concerns.
If you have any further questions on
the use of this medicine, ask your
doctor or nurse.

4 Possible side effects

7. MARKETING AUTHORISATION HOLDER
Flynn Pharma Ltd
Alton House
4 Herbert Street
Dublin 2
Ireland

Like all medicines, this medicine can
cause side effects, although not
everybody gets them. All medicines
can cause allergic reactions, although
serious allergic reactions are very rare.
Tell your doctor immediately if you
get any sudden wheeziness, difficulty
in breathing, swelling of the eyelids,
face or lips, rash or itching (especially
affecting your whole body).

8. MARKETING AUTHORISATION NUMBER(S)
PL 13621/0033
9 DATE OF FIRST AUTHORISATION/RENEWAL OF
THE AUTHORISATION
Date of first authorisation: 18/04/1990
Date of latest renewal: 11/10/2005
10 DATE OF REVISION OF THE TEXT
04/05/2016

Serious side effects
The following side effects are serious.
You should stop taking this medicine
and tell your doctor immediately if you
experience them:
n serious peeling or blistering of
the skin



nursing infant can absorb a significant amount of
vancomycin from its gastro-intestinal tract.
4.7. Effects on ability to drive and use machines
Not relevant.
4.8 Undesirable effects
Infusion-related events: During or soon after rapid infusion
of vancomycin, patients may develop anaphylactoid
reactions including hypotension, wheezing, dyspnoea,
urticaria or pruritus. Rapid infusion may also cause flushing
of the upper-body (‘red-neck’syndrome) or pain and
muscle spasm of the chest and back. These reactions
usually resolve within 20 minutes but may persist for
several hours. In animal studies, hypotension and
bradycardia occurred in animals given large doses of
vancomycin at high concentrations and rates. Such events
are infrequent if vancomycin is given by slow infusion over
60 minutes. In studies of normal volunteers, infusionrelated events did not occur when vancomycin was
administered at a rate of 10mg/min or less.
Rapid bolus injection may give hypotension, bradycardia,
cardiogenic shock and rarely cardiac arrest.
Nephrotoxicity: Rarely, renal failure, principally manifested
by increased serum creatinine or blood urea concentrations,
have been observed, especially in patients given large
doses of intravenously administered vancomycin. Rare
cases of interstitial nephritis have been reported. Most
occurred in patients who were given aminoglycosides
concomitantly or who had pre-existing kidney dysfunction.
When vancomycin was discontinued, azotaemia resolved in
most patients.
Ototoxicity: Hearing loss associated with intravenously
administered vancomycin has been reported. Most of these
patients had kidney dysfunction, pre-existing hearing loss,
or concomitant treatment with an ototoxic drug. Vertigo,
dizziness and tinnitus have been reported rarely. Tinnitus,
possibly preceding onset of deafness, may occur and
should be regarded as an indication to discontinue
treatment.
Haematological: Reversible neutropenia, usually starting
one week or more after onset of intravenous therapy or
after a total dose of more than 25g. Neutropenia appears to
be promptly reversible when vancomycin is discontinued.
Thrombocytopenia has rarely been reported. Reversible
agranulocytosis (less than 500 granulocytes per mm3) has
been reported rarely, although causality has not been
established. Eosinophilia has been reported.
Miscellaneous: Phlebitis, hypersensitivity reactions
anaphylaxis, nausea, chills, drug fever, rashes (including
exfoliative dermatitis) and rare cases of vasculitis.
Vancomycin has been associated with the bullous eruption
disorders, Stevens-Johnson syndrome, toxic epidermal
necrolysis and linear IgA bullous dermatosis. If a bullous
disorder is suspected, the drug should be discontinued and
specialist dermatological assessment should be carried out.
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation
of the medicinal product is important. It allows continues
monitoring of the benefit/risk balance of the medicinal
product. Healthcare professionals are asked to report any
suspected adverse reactions via the Yellow Card Scheme
Website: www.mhra.gov.uk/yellowcard.

n severe

allergic reactions including
shortness of breath, wheezing,
fainting, collapse, very slow pulse
rate, swollen hands and face, and
hearing loss

The following side effects have
been reported:
n changes in blood counts, which will
show up as bruising or a very tired
feeling (a blood test carried out by a
doctor will detect these)
n chills
n fever
n rash (alone)
n itching
n inflammation of the vein where your
drip is inserted
n you may stop urinating or notice
that you are urinating much less
than usual (kidney failure) or that
your urine becomes cloudy
n spinning sensation (vertigo)
n dizziness
n ringing in the ears (tinnitus)
n hearing loss
n rarely it can cause cardiac arrest
(heart attack).
Other possible side effects:
If Vancocin is infused too quickly, or
given as a very concentrated solution,
patients may develop severe allergic
reactions as described above. Rapid
infusion may also cause flushing of the
upper body (‘red neck’syndrome) or
pain and muscle spasms in the chest
and back. Your doctor will ensure that
Vancocin is infused slowly and is given
at the correct concentration
Reporting of side effects
If you get any side effects, talk to your
doctor or pharmacist. This includes any

possible side effects not listed in this
leaflet. You can also report side effects
directly via the Yellow Card Scheme
Website: www.mhra.gov.uk/
yellowcard. By reporting side effects
you can help provide more information
on the safety of this medicine.

5 How to store Vancocin
Your doctor or pharmacist knows how
to store Vancocin.
Keep this medicine out of the sight and
reach of children.
Do not use this medicine after the
expiry date which is stated on the
label. The expiry date refers to the last
day of that month.
Before it is made up it should be stored
below 25°C.
After it is made up, Vancocin solution
for infusion may be stored in a
refrigerator (2°-8°C) for 24 hours.
Solutions intended for oral dosing may
be stored in a refrigerator (2°-8°C) for
96 hours.
Your doctor will ensure that the solution
is not discoloured or contains particles.
Do not throw away any medicines via
wastewater or household waste. Ask
your pharmacist how to throw away
medicines you no longer use. These
measures will help protect the
environment.

6 Contents of the pack and
other information
What Vancocin Powder contains:
The active substance is vancomycin
hydrochloride 500mg or 1000mg.
There are no other ingredients.

What Vancocin looks like and
contents of the pack
500mg presentation: Rubber
stoppered 10ml vials each containing
vancomycin hydrochloride equivalent
to 500 mg vancomycin as an offwhite powder.
One 10 ml vial packaged in a
cardboard carton.
1000mg presentation: Rubber
stoppered 20ml vials containing
vancomycin hydrochloride, equivalent
to 1000 mg vancomycin, as an
off-white powder.
One 20ml vial packaged in a
cardboard carton.
Marketing Authorisation Holder
Flynn Pharma Ltd
Alton House
4 Herbert Street
Dublin 2,
Ireland
Manufacturer
Xellia Pharmaceuticals ApS
Dalslandsgade 11
DK-2300 København S
Denmark
This leaflet was last revised in
May 2016

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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