Patient leaflet - Colistimethate Sodium 1 million International units (IU) powder for solution for injection/infusion
1. What Colistimethate sodium is and what it is used for
Colistimethate sodium contains the active substance colistimethate sodium. Colistimethate sodium is an antibiotic. It belongs to a group of antibiotics that are called polymyxins.
Colistimethate sodium is given by injection to treat some types of serious infections caused by certain bacteria. Colistimethate sodium is used when other antibiotics are not suitable.
2. What you need to know before you use Colistimethate sodium
Do not use Colistimethate sodium
- If you are allergic (hypersensitive) to colistimethate sodium, colistin or to other polymyxins.
Warnings and precautions
Talk to your doctor, pharmacist or nurse before using Colistimethate sodium if you:
- have or have had kidney problems
- suffer from myasthenia gravis
- suffer from porphyria
- suffer from asthma.
Children
In premature and newborn babies, special care should be taken when using Colistimethate sodium as the kidneys are not yet fully developed.
Other medicines and Colistimethate sodium
Tell your doctor or pharmacist 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 Colistimethate sodium. Sometimes the other medicines must be stopped (if only for a while) or you may need a lower dose of Colistimethate sodium or you may need to be monitored while you are taking Colistimethate sodium. In some cases, the level of Colistimethate sodium in your blood may have to be measured from time to time to make sure that you are having the right dose.
- Medicines like antibiotics called aminoglycosides (which include gentamicin, tobramycin, amikacin and netilmicin) and cephalosporins which can affect how your kidneys function. Taking such medicines at the same time as Colistimethate sodium can increase the risk of damage to the kidneys (see section 4 of this leaflet)
- Medicines like antibiotics called aminoglycosides (which include gentamicin, tobramycin, amikacin and netilmicin) which can affect your nervous system. Taking such medicines at the same time as Colistimethate sodium can increase the risk of side effects in the ears and other parts of your nervous system (see section 4 of this leaflet)
- Medicines called muscle relaxants, often used during general anaesthesia. Colistimethate sodium can increase the effects of these medicines. If you have a general anaesthetic, let your anaesthetist know that you are having Colistimethate sodium.
If you suffer from myasthenia gravis and are also taking other antibiotics called macrolides (such as azithromycin, clarithromycin or erythromycin) or antibiotics called fluoroquinolones (such as ofloxacin, norfloxacin and ciprofloxacin), taking Colistimethate sodium further increases the risk of muscle weakness and breathing difficulties.
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.
Colistimethate sodium 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.
Are you breast-feeding? Small amounts of colistimethate sodium enter the milk. If you cannot stop breast-feeding while you take Colistimethate sodium, 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 Colistimethate sodium 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.
Colistimethate sodium contains sodium
This medicine contains less than 1mmol sodium (23mg) per vial, that is to say essentially ‘sodium-free’.
3. How to use Colistimethate sodium
Depending on the reason (see section 1 of this leaflet), Colistimethate sodium 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 to 60 minutes) into a vein. Colistimethate sodium may occasionally be given by injection into the brain or the spine.
Always use Colistimethate sodium exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
For use by infusion or injection:
Colistimethate sodium is given to you by your doctor as an infusion into a vein over 30–60 minutes.
The usual daily dose in adults is 9 million units, divided into two or three doses. If you are quite unwell, you will be given a higher dose of 9 million units once at the start of treatment.
In some cases, your doctor may decide to give a higher daily dose of up to 12 million units.
The usual daily dose in children weighing up to 40kg is 75,000 to 150,000 units per kilogram body weight, divided into three doses. Higher doses have occasionally been given in cystic fibrosis.
Children and adults with kidney problems, including those on dialysis, are usually given lower doses. Your doctor will monitor your kidney function regularly while you receive Colistimethate sodium.
Method of administration
Colistimethate sodium is given by injection mainly in hospitals. If you are to treat yourself at home, your doctor, pharmacist 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 depending on the severity of the infection. 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 Colistimethate sodium than you should
If you think that you have given yourself too much Colistimethate sodium 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 Colistimethate sodium 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 Colistimethate sodium, please ask your doctor, nurse or pharmacist about this.
If you forget to use Colistimethate sodium
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 Colistimethate sodium three times a day, or 12 hours later if using Colistimethate sodium twice a day. Carry on from there as instructed. Do not take a double dose to make up for a forgotten dose.
If you stop using Colistimethate sodium
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 or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Allergic reactions
When Colistimethate sodium is given into a vein, 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 Colistimethate sodium into a vein
Side effects that affect the nervous system are more likely to occur when the dose of Colistimethate sodium 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 Colistimethate sodium 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 Colistimethate sodium is reduced.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. 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 or search for MHRA Yellow Card in the Goodle Play or Apple Store. By reporting side effects you can help provide more information on the safety of this medicine.
5. How to store Colistimethate sodium
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 the carton after EXP. The expiry date refers to the last day of that month.
Do not store above 25°C.
Keep the vials in the outer carton in order to protect from light.
Colistimethate sodium should be used immediately after preparation. 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 Colistimethate sodium contains
The active substance is colistimethate sodium.
Each vial contains either 1 million or 2 million IU colistimethate sodium.
There are no other ingredients.
What Colistimethate sodium looks like and contents of the pack
Colistimethate sodium 1 million international units is a white lyophilised powder available in 10ml clear glass vials.
Colistimethate sodium 2 million international units is a white lyophilised powder available in 10ml clear glass vials.
Pack sizes
1 x 1 vial
1 x 10 vials
Not all pack sizes may be marketed
Marketing Authorisation Holder
Accord, Barnstaple, EX32 8NS, UK
Manufacturer
Accord Healthcare Limited Sage House, 319 Pinner Road North Harrow, Middlesex
HA1 4HF, United Kingdom
This leaflet was last revised in April 2023
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01271 385257