Skip to Content

VANCOMYCIN 500 MG POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION

Active substance(s): VANCOMYCIN HYDROCHLORIDE / VANCOMYCIN HYDROCHLORIDE

View full screen / Print PDF » Download PDF ⇩
Transcript
PACKAGE LEAFLET: INFORMATION FOR THE USER

Vancomycin 500 mg
Vancomycin 1000 mg

powder for concentrate for solution for infusion
Vancomycin
Read all of this leaflet carefully before
you start taking this medicine because it
contains important information for you.
• Keep this leaflet. You may need to read it
again.
• If you have any further questions, ask your
doctor or nurse.
• This medicine has been prescribed for you
only. Do not pass it on to others. It may harm
them, even if their signs of illness are the
same as yours.
• If you get any side effects, talk to your
doctor or nurse. This includes any possible
side effects not listed in this leaflet. See
section 4.
What is in this leaflet
1. What is Vancomycin and what it is used for
2. What you need to know before you use
Vancomycin
3. How to use Vancomycin
4. Possible side effects
5. How to store Vancomycin
6. Contents of the pack and other information

1. WHAT VANCOMYCIN IS AND WHAT
IT IS USED FOR
Vancomycin belongs to a group of glycopeptide
antibiotics which eliminate bacteria that cause
many kinds of infections, including pneumonia
and skin, bone and heart valve infections.
It is used to treat:
• serious infections caused by vancomycinsensitive bacteria which are resistant
(insensitive) to many other antibiotics;
• patients allergic to penicillins and
cephalosporins.
It can also be given to you before some surgical
procedures to prevent infections.
Your medicine is in the form of a powder for
solution. Before use, it will be dissolved and
diluted with an intravenous fluid that will be
given to you slowly by a drip into your vein by a
doctor or nurse.

2. WHAT YOU NEED TO KNOW BEFORE
YOU USE VANCOMYCIN
Do not use Vancomycin
if you are allergic to vancomycin
Warning and precautions
Talk to your doctor or pharmacist before using
Vancomicin.
Before treatment with vancomycin, make sure
that your doctor knows about your medical
history, especially if you:
• have low blood count
• have kidney problems
• have ear problems such as deafness
• are pregnant, or planning to become pregnant
• are breastfeeding
• are elderly and over 60 years of age
• are a premature infant or a child
• are going to have surgery
In case you develop severe allergic reaction,
your doctor will stop treatment with vancomycin
and give you other appropriate teratment. If you
will be given the infusion too fast, you can get
some side effects like low blood pressure or
rash. Stopping the infusion usually results in a
prompt cessation of the reactions.
Vancomycin must be used with caution in
patients with kidney failure or in those who
receive concomitant treatment with other
substances toxic to kidney as the possibility of
developing toxic effects is much higher. Serial
tests of kidney function should be performed
and the appropriate dose regimens adhered to
in order to reduce this risk.
Deafness, transitory or permanent, which may
be preceeded by noises in ears, can occur in
patients with prior deafness, who have received
excessive doses, or who receive concomitant
treatment with another substance toxic to
hearing. To reduce this risk, blood levels should
be determined periodically and periodic testing
of hearing function is recommended.
If you will receive vancomycin over a longerterm period, your blood will be tested at regular
intervals. You should also be monitored because
of possible superinfection (new infection
occurring over the existing one) or severe,
sometimes bloody diarrhoea (condition called
pseudomembranous colitis).

&

Other medicines and Vancomycin
Tell your doctor or pharmacist if you are taking,
have recently taken or might take any other
medicines, including medicines obtained
without a prescription, herbal remedies or
vitamins and minerals, because some of them
could have an interaction with vancomycin.
Furthermore, do not take any new medicine
without consulting your doctor.
The following medicines can react with
vancomycin if you take them at the same time,
such as medicines for the treatment of:
• infections caused by bacteria
(streptomycin, neomycin, gentamicin,
kanamycin, amikacin, bacitracin, tobramycin,
polymixin B, colistin),
• tuberculosis (viomycin),
• fungal infections (amphotericin B),
• cancer (cisplatin)
and
• medicines for muscle relaxation during
anaesthesia,
• anaesthetic agents (if you are going to have
general anaesthesia).
Your doctor may need to monitor your blood
and adjust the dosage if vancomycin is given at
the same time with other medicines.
Pregnancy and breast-feeding
Pregnancy
If you are, or think you may be, pregnant, tell
your doctor. Vancomycin should be given during
pregnancy only if clearly needed.
Breast-feeding
Tell your doctor if you are breast-feeding as
Vancomycin passes into breast milk. Your
doctor will decide, if vancomycin is clearly
needed or if you must stop breast-feeding.
Ask your doctor or pharmacist for advice before
taking this medicine.
Driving and using machines
Vancomycin has no or very little effect on your
ability to drive and operate machines.

3. HOW TO USE VANCOMYCIN
You will be given Vancomycin by medical staff
while you are in hospital.
Your doctor will decide how much of this
medicine you should receive each day and how
long the treatment will last.
Dosage
The dose given to you will depend on:
• your age,
• the infection you have,
• how well your kidneys are working,
• your hearing ability
• any other medicines you may be taking.
Adults and children above 12 years:
the usual dose is 2000 mg daily in two or four
doses.
Use in children under 12 years:
will be given smaller doses, depending on their
body weight.
Patients with impaired kidney function,
the elderly and pre-term new-born infants:
the doctor will reduce the dose or extend the
interval between two doses.
During treatment you might have blood tests,
be asked to provide urine samples and possibly
have hearing tests to look for signs of possible
side effects.
How the treatment will be given
Intravenous infusion means that the medicinal
product flows from an infusion bottle or bag
through a tube to one of your blood vessels and
into your body. Your doctor, or nurse, will always
give vancomycin into your blood, never in a
muscle. Vancomycin will be diluted before being
given to you, and will slowly flow into your vein
for at least 60 minutes.
Duration of treatment
The length of treatment depends on the
infection you have and may last a number of
weeks.
If you take more Vancomycin than you
should
As this medicine will be given to you while you
are in the hospital, it is unlikely that you will be
given too much vancomycin. However, tell your
doctor or nurse immediately if you have any
concerns.

Vancomycin 500 mg powder for concentrate for solution for infusion
Vancomycin 1000 mg powder for concentrate for solution for infusion
Vancomycin

The following information is intended for medical or healthcare professionals only:
This is an extract from the Summary of Product Characteristics to assist in the administration of
Vancomycin. When determining appropriateness of use in a particular patient, the prescriber should be
familiar with the Summary of Product Characteristics of the medicinal product.

Posology and method of administration
Vancomycin powder for concentrate for solution for infusion must be administered intravenously. Each
dose should be administered at a rate not exceeding 10 mg/min or over a period of time of at least 60
minutes (whichever is longer).
The dose should be individually adapted according to weight, age and renal function.
The following dosage regimens are recommended:
Patients with normal renal function
Adults and adolescents above 12 years of age:
The recommended daily intravenous dose is 2000 mg, divided into doses of 500 mg every 6 hours or
1000 mg every 12 hours.
For bacterial endocarditis, the generally accepted regimen is 1000 mg vancomycin intravenously every
12 hours for 4 weeks either alone or in combination with other antibiotics (gentamicin plus rifampin,
gentamicin, streptomycin). Enterococcal endocarditis is treated for 6 weeks with vancomycin in
combination with an aminoglycoside – according to national recommendations.
Peri-operative prophylaxis against bacterial endocarditis: Adults receive 1000 mg vancomycin
intravenously prior to surgery (prior to induction of anaesthesia) and depending on time and type of
surgery, the dose of 1000 mg of vancomycin IV 12 hours postoperatively can be given.
Paediatric population
Children one month to 12 years of age:
The recommended intravenous dose is 10 mg/kg, every 6 hours or 20 mg/kg every 12 hours.
Infants and newborns:
The recommended initial dose is 15 mg/kg, followed by 10 mg/kg every 12 hours during the first week of
life and every 8 hours after that age and up to 1 month of age. Careful monitoring of serum concentration
of vancomycin is recommended (see below).
Special population
Elderly patients:
Lower maintenance doses may be required due to the
age-related reduction in renal function.
Obese patients:
Modification of the usual daily doses may be required.
Patients with hepatic insufficiency
There is no evidence that the dose has to be reduced
in patients with hepatic insufficiency.
Patients with impaired renal function
The dose must be adjusted in patients with impaired
renal function and the following nomogram can serve
as guidance. Careful monitoring of serum
concentration of vancomycin is recommended (see below).
In patients with mild or moderate renal failure, the starting dose must not be less than 15 mg/kg. In
patients with severe renal failure, it is preferable to administer a maintenance dose between 250 mg and
1000 mg at a spacing of several days rather than administer lower daily doses.
Patients with anuria (with practically no renal function) should receive doses of 15 mg/kg body weight
until the therapeutic serum concentration is reached. The maintenance doses are 1.9 mg/kg body weight
per 24 hours. In order to facilitate the procedure, adult patients with strongly impaired renal function may
obtain a maintenance dose of 250 - 1000 mg at intervals of several days instead of a daily dose.
Dosage in case of haemodialysis
For patients without any renal function, even under regular hemodialysis, the following dosage is also
possible:
Saturating dose 1000 mg, maintenance dose 1000 mg every 7 - 10 days.
If polysulfone membranes are used in haemodialysis (high flux dialysis), the half-life of vancomycin is
reduced.
An additional maintenance dose may be necessary in patients on regular haemodialysis.
Monitoring of vancomycin serum concentrations:
The serum concentration of vancomycin should be monitored at the second day of treatment immediately
prior to the next dose, and one hour post infusion. Therapeutic vancomycin blood levels should be
between 30 and 40 mg/l (maximum 50 mg/l) one hour after the end of the infusion, the minimum level
(short prior to the next administration) between 5 and 10 mg/l, or according to local recommendation.
The concentrations should normally be monitored twice or three times per week.
Method of administration:
Parenterally vancomycin shall only be administered as slow intravenous infusion (not more than 10 mg/
min – over at least 60 min) which is sufficiently diluted (at least 100 ml per 500 mg or at least 200 ml
per 1000 mg).
Patients requiring fluid restriction can receive a solution of 500 mg / 50 ml or 1000 mg / 100 ml. With
these higher concentrations the risk for infusion related side effects can be increased.
For information about the preparation of the solution, please refer to chapter 6.6.
Duration of treatment
The duration of the treatment depends on the severity of the infection as well as on the clinical and
bacteriological progress.

If you have any further questions on the use of
this medicine, ask your doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS
Like all medicines, this medicine can cause side
effects, although not everybody gets them.
Stop taking the medicine immediately and
seek medical attention if signs of an allergic
reaction occur:
hives; swelling of your face, lips, tongue, or
throat; difficulty breathing or swallowing or
dizziness.
If you think you have any of the following side
effects or symptoms, tell your doctor as soon
as possible:
Common side effects (affect 1 to 10 users in
100):
• decrease in blood pressure;
• swelling, redness and pain along a vein;
• breathlessness, a high pitched sound resulting
from turbulent air flow in the upper airway
• generalized rash and mucosal inflammation,
itching, itchy rash;
• redness of the upper body and the face,
pain and contraction of the chest and back
muscles;
• kidney problems which may be detected
primarily by increased creatinine or urea
concentrations in your blood.
Uncommon side effects (affect 1 to 10 users
in 1,000):
• temporary or permanent loss of hearing.
Rare side effects (affect 1 to 10 users in
10,000):
• anaphylactic reactions, allergic reactions;
• drug fever, chills;
• increased or reduced (sometimes severely
decreased) urine output, or traces of blood in
urine;
• increase or decrease in some of the cells in
the blood;
• noises (e.g. hissing) in ears;
• feeling faint;
• red or purple skin (possible signs of blood
vessel inflammation);
• nausea.
Very rare side effects (affect less than 1 out of
10,000 patients):
Skin disorders resulting from an allergic reaction
(multiple skin lesions, joint aches), cardiac
arrest, or inflammation of the bowel which
causes abdominal pain or bloody diarrhoea.
If you get any side effects, talk to your doctor or
pharmacist. This includes any side effects not
listed in this leaflet.
Reporting of side effects
If you get any side effects, talk to your doctor or
nurse. This includes any possible side effects
not listed in this leaflet. You can also report side
effects directly via the national reporting system
listed below:
Ireland
HPRA Pharmacovigilance, Earlsfort Terrace,
IRL - Dublin 2, Tel: +353 1 6764971,
Fax: +353 1 6762517, Website: www.hpra.ie,
e-mail: medsafety@hpra.ie.
United Kingdom
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 VANCOMYCIN
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 and carton, after
EXP: (month/year). The expiry date refers to the
last day of that month.
Do not store above 25 ºC.
Reconstituted concentrate:
After reconstitution, the reconstituted
concentrate should be diluted immediately.
Further diluted solution:
Chemical and physical in-use stability has been
demonstrated for 48 hours at 2-8 ºC and 25 ºC
with Sodium Chloride 9 mg/ml (0.9%) Injection
and Glucose 50 mg/ml (5%) Injection.
From a microbiological point of view, unless
the method of reconstitution/dilution precludes
the risk of microbial contamination, the product
should be used immediately.
If not used immediately, in-use storage times
and conditions are the responsibility of the user
and would normally not be longer than 24 hours
at 2 to 8 °C.

Do not use this medicine if you notice an
unclear solution and extraneous particles.
The stability of reconstituted solution is stated
below in the additional information for health
professionals.
Do not throw away any medicines via
wastewater. 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 Vancomycin contains
• The active substance is vancomycin (as
hydrochloride).
• There are no other ingredients.
Vancomycin 500 mg powder for concentrate for
solution for infusion
Each vial contains:
500 mg vancomycin (as vancomycin
hydrochloride) equivalent to not less than
525,000 IU
When reconstituted with 10 ml of water for
injections, the resulting concentrate for solution
for infusion contains 50 mg/ml vancomycin.
Vancomycin 1000 mg powder for concentrate
for solution for infusion
Each vial contains:
1000 mg vancomycin (as vancomycin
hydrochloride) equivalent to not less than
1,050,000 IU.
When reconstituted with 20 ml of water for
injections, the resulting concentrate for solution
for infusion contains 50 mg/ml vancomycin.
What Vancomycin looks like and contents
of the pack
This medicine is a homogeneous, white to offwhite freeze-dried powder for concentrate for
solution for infusion. It must be first dissolved
in water for injection and further diluted in an
appropriate diluent prior to use.
This medicine is supplied in transparent glass
vials closed with rubber stopper and sealed
with aluminium and plastic flip-off caps.
This medicine is available in two strengths:
500 mg and 1000 mg
Vancomycin is packed in carton boxes. Each
box can contain 1 or 10 vials.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and
Manufacturers
Marketing Authorisation Holder:
Hikma Farmacêutica (Portugal), S.A.
Estrada do Rio da Mó n.º 8, 8A e 8B – Fervença
2705-906 Terrugem SNT, Portugal
Manufacturers:
Hikma Italia S.pA.
Viale Certosa, 10, 27100 Pavia, Italy
Hikma Farmacêutica (Portugal), S.A.
Estrada do Rio da Mó n.º 8, 8A e 8B – Fervença
2705-906 Terrugem SNT, Portugal
Distributor in Ireland
Consilient Health Limited
Block 2A, Richview Office Park
Clonskeagh, Dublin 14, Ireland
Distributor in UK
Consilient Health (UK) Ltd.
No.1 Church Road,
Richmond, Surrey, TW9 2QE.
This medicinal product is authorised in
the Member States of the EEA under the
following names:
Austria: Vancomycin Hikma, 500 mg und
1000 mg, Pulver für ein Konzentrat zur
Herstellung einer Infusionslösung
Czech Republic: Vancomycin Hikma, 500 mg
a 1000 mg, Prášek pro koncentrát pro
infuzní roztok
France: Vancomycin Hikma, 500 mg et
1000 mg, Poudre pour solution à diluer
pour solution pour perfusion
Ireland: Vancomycin, 500mg and 1000 mg,
Powder for concentrate for solution for
infusion
Nederland: Vancomycin Hikma, 500 mg en
1000 mg, Poeder voor concentraat voor
oplossing voor infusie
Portugal: Vancomicina Hikma, 500 mg e
1000 mg, Pó para concentrado para
solução para perfusão
United Kingdom: Vancomycin, 500 mg and
1000 mg, Powder for concentrate for
solution for infusion
This leaflet was last approved in September
2016.

Keep the vial in the outer carton in order to
protect from light.

&

P0509

Interaction with other medicinal products and other forms of interaction
Other potentially nephrotoxic or ototoxic medications
Concurrent or sequential administration of vancomycin with other potentially neurotoxic or/and
nephrotoxic active substances particularly gentamicin, amphotericin B, streptomycin, neomycin,
kanamycin, amikacin, tobramycin, viomycin, bacitracin, polymyxin B, colistin and cisplatin may potentiate
the nephrotoxicity and/or ototoxicity of vancomycin and consequently requires careful monitoring of the
patient.
Because of synergic action (e.g. with gentamicin) in these cases the maximum dose of vancomycin has to
be restricted to 500 mg every 8 hours.
Anaesthetics
Concurrent administration of vancomycin and anaesthetic agents has been associated with erythema,
histamine like flushing and anaphylactoid reactions. This may be reduced if the vancomycin is
administered over 60 minutes before anaesthetic induction.
Muscle relaxants
If vancomycin is administered during or directly after surgery, the effect (neuromuscular blockade) of
muscle relaxants (such as succinylcholine) concurrently used can be enhanced and prolonged.

Incompatibilities
Vancomycin has a low pH that may cause chemical or physical instability when it is mixed with other
substances. Therefore, each parenteral solution should be checked visually for precipitations and
discolouration prior to use.
This medicinal product must not be mixed with other medicinal products except those mentioned in
section 6.6.
Combination therapy
In case of combination therapy of vancomycin with other antibiotics/chemotherapeutics, the preparations
should be administered separately.
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 the intravenous lines between administration of these antibiotics. It is
also recommended to dilute solutions of vancomycin to 5 mg/ml or less.

Shelf life
Powder: 2 years
Reconstituted concentrate:
Chemical and physical in-use stability has been demonstrated for 48 hours at 2- 8ºC and 25 ºC.
After reconstitution, the reconstituted concentrate should be diluted immediately.
Further diluted solution:
Chemical and physical in-use stability has been demonstrated for 48 hours at 2-8 ºC and 25 ºC with
Sodium Chloride 9 mg/ml (0.9%) Injection and Glucose 50 mg/ml (5%) Injection.
From a microbiological point of view, unless the method of reconstitution/dilution precludes the risk of
microbial contamination, the product should be used immediately.
If not used immediately, in-use storage times and conditions are the responsibility of the user and would
normally not be longer than 24 hours at 2 to 8 °C.
Special precautions for disposal and other handling
The product must be reconstituted and the resulting concentrate must then be diluted immediately prior
to use.
Preparation of the reconstituted concentrate
Dissolve Vancomycin 500 mg Powder for concentrate for solution for infusion in 10 ml of sterile Water for
injection.
Dissolve Vancomycin 1000 mg Powder for concentrate for solution for infusion in 20 ml of sterile Water
for injection.
One ml of reconstituted concentrate contains 50 mg of vancomycin.
Appearance of reconstituted concentrate
After reconstitution the solution is clear and colourless to slightly yellowish brown without visible particles.
For storage conditions of the reconstituted medicinal product, see section 6.3.
Preparation of final diluted Solution for infusion
Reconstituted solutions containing 50 mg/ml of vancomycin should be further diluted.
Suitable diluents are:
Sodium Chloride 9 mg/ml (0.9%) Injection
Glucose 50 mg/ml (5%) Injection
Intermittent infusion:
Reconstituted solution containing 500 mg vancomycin (50 mg/ml) must be diluted further with at least
100 ml diluent (to 5 mg/ml).
Reconstituted solution containing 1000 mg vancomycin (50 mg/ml) must be diluted further with at least
200 ml diluent (to 5 mg/ml).
The concentration of vancomycin in Solution for infusion should not exceed 5 mg/ml.
The desired dose should be administered slowly by intravenous use at a rate of no more than 10 mg/
minute, for at least 60 minutes or even longer.
Continuous infusion:
This should be used only if treatment with an intermittent infusion is not possible. Dilute 1000 mg to
2000 mg of dissolved vancomycin in a sufficient amount of the above suitable diluent and administer it in
the form of a drip infusion, so that the patient will receive the prescribed daily dose in 24 hours.
Appearance of diluted solution
After dilution the solution is clear, free from extraneous particles.
For storage conditions of the diluted medicinal product, see section 6.3.
Before administration, the reconstituted and diluted solutions should be inspected visually for particulate
matter and discoloration. Only clear and colourless solution free from particles should be used.
Disposal
Vials are for single use only. Unused medicinal products must be discarded.
Any unused medicinal product or waste material should be disposed of in accordance with local
requirements.

Expand view ⇕

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.

Hide