COLOMYCIN®
PATIENT INFORMATION LEAFLET
COLOMYCIN INJECTION
(COLISTIMETHATE SODIUM
POWDER FOR SOLUTION FOR
INJECTION, INFUSION OR INHALATION)
500,000 International Units/vial
1 million International Units/vial
and 2 million International Units/vial
• Keep this leaflet. You may need to read it again.
• If you have further questions, please ask your doctor, nurse or pharmacist.
• Remember this medicine is for YOU. Only a doctor can prescribe it for you. Never give it
to someone else. It may harm them even if their symptoms are the same as yours.
In this leaflet:
1. What Colomycin is and what it is used for
2. Before you take Colomycin
3. How Colomycin is given
4. Possible side effects
5. Storing Colomycin
The name of your medicine is Colomycin Injection.
Each vial contains the active ingredient colistimethate sodium (also called colistin) as an
amount of powder equivalent to 500,000, one million or two million units. There are no
inactive ingredients.
The sodium content for each vial strength is 0.114mMol, 0.228mMol and 0.456mMol
respectively.
Once made up as a solution with sterile water or sterile salt water, Colomycin can be given
by fast or slow injection into a vein or by inhalation (breathing in droplets as a fine spray).
See sections 1 and 3 of this leaflet for more information on how Colomycin can be given.
Marketing Authorisation holder and Manufacturer Responsible for Batch Release
Forest Laboratories UK Limited
Bourne Road
Bexley
Kent DA5 1NX
UK
1. What Colomycin is and what it is used for
Colomycin is supplied as a creamy white powder in single dose vials of either:
y 500,000 units of colistimethate sodium per vial: blue cap (0.5 MIU)
y 1 million units of colistimethate sodium per vial: red cap (1.0 MIU)
y 2 million units of colistimethate sodium per vial: lilac cap (2.0 MIU)
Each box contains ten vials.
Colomycin 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 people who have cystic fibrosis
when these are due to a bacterium called Pseudomonas aeruginosa. Colomycin is
usually given to these patients by inhalation. 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 (see section 3 of this leaflet).
- Colomycin is sometimes given 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 that are commonly
used for these infections are not suitable for some reason. For example, if the person
who is infected is allergic to many other types of antibiotics or if the bacteria are
resistant to many of these other antibiotics.
2. Before you take Colomycin
Colomycin is not suitable for everyone.
Colomycin should not be given if the answer to any of the following questions is “YES” for the
person who is to be treated. If you are unsure about anything, ask your doctor before
Colomycin is given.
y Are you allergic to Colomycin (also known as colistin or colistimethate sodium) or to
another antibiotic called polymyxin B?
y Do you have myasthenia gravis?
Colomycin may or may not be suitable if the answer to any of the following questions is
“YES” for the person who is to be treated. If you are unsure speak to your doctor.
y Do you have porphyria?
y Do you have kidney problems?
Pregnancy and breast-feeding
y Are you or do you think you might be pregnant? 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.
y 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 operating machinery
When Colomycin is given into a vein there may be side effects such as dizziness, confusion
or problems with vision (see also section 4 of this leaflet). If these occur, you should not
drive or operate machinery.
Taking other medicines
Please tell your doctor or pharmacist about any other medicines that you are taking,
including medicines that you obtained without a prescription.
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 blood levels of Colomycin may have to be measured from time
to time to make sure that you are having the right dose.
y Are you taking other antibiotics called aminoglycosides (which include gentamicin,
tobramycin, amikacin and netilmicin) or cephalosporins? 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). Taking cephalosporin antibiotics at the same time as Colomycin can
increase the risk of kidney problems.
y 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.
y If you are likely to be given ether for any reason, please tell your doctor that you are
also being treated with Colomycin.
3. How Colomycin is given
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 by 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.
Your doctor will decide on how Colomycin should be given and how long your treatment
should last. When treating bacterial infections it is important to complete the full course of
treatment.
y When Colomycin is to be given by inhalation using a nebuliser, the usual dose for
children under two years of age is half to one million units given twice a day.
y 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.
For use in a nebuliser: 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 this 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:
500,000 unit vial: 1 - 2ml
1 million unit vial: 2ml
2 million unit vial: 4ml
The solution is then poured into the nebuliser.
IMPORTANT: Do not mix Colomycin Injection with any other product for nebulisation at the
same time.
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.
Colomycin is given by injection mainly in hospitals. If you treat yourself at home, your doctor
or nurse will show you how to dissolve the powder and inject the right dose of solution.
• The usual dose in children and adults weighing up to 60 kg is 50,000 to 75,000 units for
each kilogram 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 and about 8 hours apart. The maximum dose is 6 million units in one day.
Lower doses are usually needed for persons who have kidneys that do not work very well
because blood levels after the usual recommended doses can be higher with a risk of
particular side effects.
Your doctor may take some blood samples and do some tests to make sure the Colomycin
dose is correct.
Sometimes it may also be necessary to measure blood levels of Colomycin in newborns and
in people with cystic fibrosis.
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 or 12 hours later and carry on from
there as instructed.
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.
4. Possible side effects
Like all medicines, Colomycin can cause side effects. 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.
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. Urgent medical attention is needed.
Less severe allergic reactions include skin rashes that appear later during treatment.
After injection of Colomycin into a vein:
Possible side effects include inability to breathe due to paralysis of the chest muscles,
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.
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. Urgent medical attention is needed.
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.
After inhalation of Colomycin:
Possible side effects include coughing, a feeling of tightness in the chest due to narrowing of
the airways (may not always be a true allergic reaction), sore mouth or throat and thrush
(Candida) infections of the mouth or throat.
If any of these side effects become troublesome or persist, or if you notice any side
effects not listed in this leaflet, you should tell your doctor as soon as possible.
5. Storing Colomycin
Keep out of the reach and sight of children.
Vials must not be stored above 25°C.
The vials must be protected from light by storing in the outer carton.
The vials must not be used after the expiry date printed on the vial label.
Colomycin solutions for injection should be used immediately after preparation.
Solutions for inhalation should preferably be given immediately. If this is not possible,
solutions should be stored for not longer than 24 hours in a refrigerator.
Any remaining solution should be discarded.
Date of preparation of this leaflet: November 2004 3496
