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
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.

1. What Colomycin is and what it is used for

Colomycin is supplied as a creamy white powder in single dose vials of either:

• 500,000 units of colistimethate sodium per vial: blue cap (0.5 MIU)
• 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.

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.

• Are you allergic to Colomycin (also known as colistin or colistimethate sodium) or to another antibiotic called polymyxin B?
• 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.

• Do you have porphyria?
• Do you have kidney problems?

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.

• 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.
• 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 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.

• 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.
The 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 not be stored for longer than 24 hours in a refrigerator.
Any remaining solution should be discarded.