COLOMYCIN INJECTION 1 MILLION INTERNATIONAL UNITS. POWDER FOR SOLN FOR INJ INFUSION OR INHALATION

Active substance: COLISTIMETHATE SODIUM

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PACKAGE LEAFLET:
INFORMATION FOR THE USER
COLOMYCIN INJECTION
1 million or 2 million International Units
Powder for solution for injection,
infusion or inhalation
Colistimethate Sodium

Read all of this leaflet carefully before you
start using 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.
• 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. This includes any possible side
effects not listed in this leaflet.
What is in this leaflet
1. What Colomycin is and what it is used for
2. What you need to know before you use
Colomycin
3. How to use Colomycin
4. Possible side effects
5. How to store Colomycin
6. Contents of the pack and other information
1. WHAT COLOMYCIN IS AND
WHAT IT IS USED FOR

Colomycin contains the active substance
colistimethate sodium. Colistimethate sodium is
an antibiotic. It belongs to a group of
antibiotics that are called polymyxins.
Colomycin works by killing some types of
bacteria that can cause various sorts of
infections in people. Like all antibiotics,
Colomycin is only able to kill some types of
bacteria so it is only suitable for treating some
types of infection.
• Colomycin can be used to treat chest
infections in adults and children who have
cystic fibrosis when these infections are due
to a bacterium called Pseudomonas
aeruginosa. Colomycin is usually given to
these patients by inhalation (nebulisation).
That is, they breathe in droplets of
Colomycin solution as a fine spray and the
droplets enter the lungs to reach the places
where the bacteria are causing infection.
• Colomycin is sometimes given to adults and
children as a solution into a vein in order to

treat serious infections due to certain types
of bacteria. These infections include some
pneumonias and some infections of the
bladder and kidneys. Colomycin is not often
used to treat these types of infections but
may be used when other antibiotics are not
suitable for some reason. For example, if the
person who is infected is allergic to the
other types of antibiotics or if the bacteria
are resistant to these other antibiotics.
2. WHAT YOU NEED TO KNOW
BEFORE YOU USE COLOMYCIN

Do not use Colomycin:
• If you are allergic to Colomycin (also known
as colistin or colistimethate sodium) or to
another antibiotic called polymyxin B.
• If you have myasthenia gravis (a disease
causing weakened muscles and excessive
tiredness)
Warnings and precautions
• Talk to your doctor before using Colomycin
if you have porphyria (a rare, often inherited
disorder),
• Talk to your doctor before using Colomycin
if you have kidney problems.
• Some people may experience a feeling of
tightness in the chest due to narrowing of
the airways when inhaling Colomycin. Your
doctor may prescribe other medicines for
inhalation directly before or after using
Colomycin; in order to prevent or treat this.
Other medicines and Colomycin
Tell your doctor if you are taking, have recently
taken or might take any other medicines.
If you are taking any of the following
medicines, you may or may not be able to take
Colomycin. Sometimes the other medicines
must be stopped (if only for a while) or you may
need a lower dose of Colomycin or you may
need to be monitored while you are taking
Colomycin. In some cases, the level of
Colomycin in your blood may have to be
measured from time to time to make sure that
you are having the right dose.
• Are you taking other antibiotics called
aminoglycosides (which include gentamicin,
tobramycin, amikacin and netilmicin)?
Having Colomycin at the same time as an
aminoglycoside antibiotic can increase the
risk of kidney problems or cause side effects
in the ears and other parts of the nervous
system (see section 4 of this leaflet).
• Are you taking other antibiotics called
cephalosporins? Taking cephalosporin
antibiotics at the same time as Colomycin
can increase the risk of kidney problems.
• Are you receiving muscle relaxant
medicines? These are most usually used
during a general anaesthetic so you should
make sure that you tell the anaesthetist that
you are having Colomycin before you have
an operation. Having a muscle relaxing drug
and Colomycin together can increase and
prolong the muscle relaxing effects.
• If you are likely to be given ether (a
substance sometimes used as an
anaesthetic) for any reason, please tell your
doctor that you are also being treated with
Colomycin.
Pregnancy and breast-feeding
Colomycin is not known to harm the unborn
child but, like all medicines, it will only be given
to a pregnant woman if it is really needed. If
you are pregnant, think you may be pregnant

or are planning to have a baby ask your doctor
for advice before taking this medicine.
Are you breast-feeding? Small amounts of
Colomycin enter the milk. If you cannot stop
breast-feeding while you take Colomycin, you
should watch your baby carefully for any signs
of illness and tell your doctor if you notice
anything wrong.
Driving and using machines
When Colomycin is given into a vein there may
be side effects such as dizziness, confusion or
problems with vision. If these occur, you should
not drive or operate machinery.
3. HOW TO USE COLOMYCIN

Depending on the reason it is being given (see
section 1 of this leaflet) Colomycin may be
given by fast injection (over 5 minutes into a
special kind of tube in a vein) or slow injection
(infusion over about 30 minutes) into a vein.
Colomycin can also be breathed into the lungs
as a fine spray made using a machine called a
nebuliser. The droplets of the spray produced
by the nebuliser are small enough to enter the
lungs so that Colomycin can reach the site of
the bacterial infection.
Always use Colomycin exactly as your doctor
has told you. Check with your doctor if you are
not sure.
For use in a nebuliser:
Dose
• When Colomycin is to be given by
inhalation using a nebuliser, the usual dose
for children under two years of age is
500,000 to one million units given twice a
day.
• In most older children and adults, the dose
is one or two million units twice a day, with
a maximum of two million units three times
a day.
Method of administration
If you are treating yourself at home, your
doctor or nurse will show you how to use
Colomycin in your nebuliser when you first
start the treatment. The following are general
instructions.
The plastic cap is flipped open and the foil seal
carefully ripped from around the top of the vial
to remove it completely. The rubber bung is
taken out carefully and sterile water or sterile
salt water (saline) is added to each vial to
dissolve the powder as follows:
1 million unit vial: 2ml sterile water / saline
2 million unit vial: 4ml sterile water / saline
The solution is then poured into the nebuliser.
IMPORTANT: Do not mix Colomycin with any
other product for nebulisation at the same
time.
For use by infusion or injection:
Dose
When Colomycin is being given into a vein to
treat serious infections (see section 1 of this
leaflet), the dose is chosen according to the
age of the person to be treated, their body
weight, how well their kidneys are working
and the type of infection that is being treated.
• The usual dose in children and adults
weighing up to 60 kg is 50,000 to 75,000
units for each kilogram of their body weight
each day. This dose is divided into three
doses given about 8 hours apart.
• The usual dose in people who weigh more
than 60 kg is 1 to 2 million units given three

times a day with doses about 8 hours apart.
The maximum dose is 6 million units in one
day.
Lower doses are usually needed for people with
kidney problems. This is because the usual
recommended dose can lead to high levels of
Colomycin in their blood which increases the
risk of some side effects.
Your doctor may take some blood samples and
do some tests to make sure your Colomycin
dose is correct.
Sometimes it may also be necessary to measure
blood levels of Colomycin in newborn babies
and in people with cystic fibrosis.
Method of administration
Colomycin is given by injection mainly in
hospitals. If you are to treat yourself at home,
your doctor or nurse will show you how to
dissolve the powder and inject the right dose of
solution.
Duration of treatment
Your doctor will decide how long your
treatment should last. For use by infusion or
injection, a minimum of 5 days treatment is
recommended. For treatment by infusion or
injection of infections in patients with cystic
fibrosis, treatment should be continued for up
to 12 days. For nebulised use your doctor will
advise on the course of the treatment.
When treating bacterial infections it is important
to complete the full course of treatment so as to
prevent worsening of the existing infection.
If you use more Colomycin than you should
If you think that you have given yourself too
much Colomycin, you should contact your
doctor or nurse immediately for advice or, if
they are not available, contact or go to your
nearest hospital accident and emergency
department. If too much Colomycin is
accidentally given, the side effects can be
serious and can include kidney problems,
muscle weakness and difficulty (or even
stopping) breathing.
If you are being treated in hospital or at home
by a doctor or nurse and think that you may
have missed a dose or been given too much
Colomycin, please ask your doctor, nurse or
pharmacist about this.
If you forget to use Colomycin
If you are treating yourself and have missed any
doses, you should give the missed dose as soon
as you remember and then give the next dose
8 hours later if using Colomycin three times a
day, or 12 hours later if using Colomycin twice a
day. Carry on from there as instructed. Do not
take a double dose to make up forgotten dose.
If you stop using Colomycin
Do not stop your treatment early unless your
doctor says you can. Your doctor will decide
how long your treatment should last. If you
have any further questions on the use of this
medicine, ask your doctor.
4. POSSIBLE SIDE EFFECTS

Like all medicines, this medicine can cause side
effects, although not everybody gets them.
Allergic reactions
Whether Colomycin is given into a vein or by
inhalation, an allergic reaction is possible.
Serious allergic reactions can happen even with
the very first dose and can include rapid
development of rashes, swelling of the face,
tongue and neck, inability to breathe due to

narrowing of the airways and loss of
consciousness.
If you experience signs of an allergic
reaction you should seek urgent medical
attention.
Less severe allergic reactions include skin
rashes that appear later during treatment.
Side effects associated with injecting
Colomycin into a vein
Side effects that affect the nervous system are
more likely to occur when the dose of
Colomycin is too high, in people who have
poor kidneys or in those who are also taking
muscle relaxants or other medicines with a
similar effect on how the nerves work.
The most serious of these possible side effects
in the nervous system is inability to breathe
because of paralysis of the chest muscles.
If you experience any difficulty breathing
you should seek urgent medical attention.
Other possible side effects include numbness
or tingling (especially around the face),
dizziness or loss of balance, rapid changes in
blood pressure or blood flow (including
faintness and flushing), slurred speech,
problems with vision, confusion and mental
problems (including loss of sense of reality).
There can be reactions at the site of the
injection, such as irritation.
Kidney problems may also occur. These are
especially likely in people who already have
poor kidneys, or who are given Colomycin at
the same time as other medicines that can
cause side effects in the kidneys or who are
given a dose that is too high. These problems
will normally get better if treatment is stopped
or the dose of Colomycin is reduced.
If you get any side effects, talk to your doctor.
This includes any possible side effects not listed
in this leaflet.
Side effects associated with inhaling
Colomycin (nebulisation)
The risk of side effects is usually much less
when it is given by inhalation because very
little Colomycin usually reaches the
bloodstream when it is given this way.
Possible side effects include coughing, a
feeling of tightness in the chest due to
narrowing of the airways, sore mouth or
throat and thrush (Candida) infections of the
mouth or throat.
If you get any side effects, talk to your doctor.
This includes any possible side effects not listed
in this leaflet.
5. HOW TO STORE COLOMYCIN

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 vial label after EXP. The
expiry date refers to the last date of that month.
Do not store the vials above 25°C.
Keep the vials in the outer carton in order to
protect from light.
Colomycin solutions for injection should be
used immediately after preparation.
Colomycin solutions for inhalation should
preferably be given immediately. If this is not
possible, solutions should not be stored for
longer than 24 hours in a refrigerator. Any
remaining solution should be discarded.
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 Colomycin contains
Each vial contains the active substance
colistimethate sodium (also called colistin) as an
amount of powder equivalent to one million or
two million units. There are no other
ingredients. This medicinal product contains less
than 1mmol sodium (23mg) per vial, i.e.
essentially ‘sodium free’.
What Colomycin looks like and contents of
the pack
Colomycin, a powder for solution for injection,
infusion or inhalation, is supplied as a creamy
white powder in single dose vials of either:
• 1 million units of colistimethate sodium per
vial: red cap (1.0 MIU)
• 2 million units of colistimethate sodium per
vial: lilac cap (2.0 MIU)
Each box contains ten vials.
Marketing Authorisation Holder
Forest Laboratories UK Limited
Riverbridge House
Anchor Boulevard
Crossways Business Park
Dartford
Kent
DA2 6SL
UK
Manufacturer and site of batch release
Penn Pharmaceutical Services
Tredegar
Gwent
NP22 3AA
UK
This leaflet was last revised in Month

10/2012

Other sources of information:
Other formats:
To listen to or to request a copy of this leaflet in Braille, large print or audio please call
free of charge: 0800 198 5000 (UK only)
Please be ready to give the following information:
Product Name

Reference Number

Colomycin Injection 1 million International Units

0108/5006

Colomycin Injection 2 million International Units
0108/0122
This is a service provided by the Royal National Institute of Blind People.
Patients in Ireland should telephone Forest Laboratories UK Ltd. on +44 (0) 1322 421800
0000

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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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