Colistimethate Sodium
COLISTIMETHATE SODIUM 1 MILLION I.U. POWDER FOR SOLUTION FOR INJECTION
1 million international units/vial
1. WHAT COLISTIMETHATE IS AND WHAT IT IS USED FOR
Colistimethate is an antibiotic. It belongs to a group of antibiotics called polymyxins. Like all antibiotics, Colistimethate is only active against some bacteria, so it is only suitable for treating some types of infection. Colistimethate is given by injection to treat
• Some serious infections where other antibiotics are not suitable. These infections include some types of pneumonia and some bladder or kidney infections.
• Certain chest infections in patients with cystic fibrosis.
2. BEFORE YOU ARE GIVEN COLISTIMETHATE
Colistimethate is not suitable for everyone. Some people must not have this injection. Do not have the injection if:
• you are allergic to Colistimethate (also known as colistin) or to another antibiotic called polymyxin B
• you have a condition called myasthenia gravis. If you are unsure about anything, ask your doctor before you have the injection.
Your doctor must be especially careful if:
• You have porphyria
• You have kidney problems
• You are pregnant or breastfeeding.
If you are unsure about anything speak to your doctor.
Taking other medicines
You must tell your doctor if you are taking any of the following medicines:
• Other antibiotics called aminoglycosides (such as gentamicin, tobramycin or kanamycin). Having Colistimethate at the same time as one of these antibiotics can increase the risk of damage to the kidneys or cause side effects in the ears and parts of the nervous system.
• Muscle relaxant medicines called curariform drugs that are often used during general anaesthesia. Colistimethate can increase the effects of these drugs.
If you need to have a general anaesthetic, make sure that the anaesthetist knows that you are having Colistimethate.
Make sure the doctor knows about any other medicines that you are taking, including medicines that you obtained without a prescription.
Each vial of Colistimethate contains about 5mg of sodium. This means that you could receive up to 30mg sodium each day if you are having the maximum adult dose. Please take this into account if you are on a low sodium (salt) diet and let your doctor or pharmacist know about this.
Pregnancy and breastfeeding
• Colistimethate 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.
• Small amounts of Colistimethate enter the milk. If you cannot stop breastfeeding while you have the injections, you should watch your baby carefully for any signs of illness and tell your doctor if you notice anything wrong.
Driving and operating machinery
Some people have reported side effects such as dizziness, confusion or problems with vision. If you are affected do not drive or operate machinery.
3. HOW COLISTIMETHATE IS GIVEN
The Colistimethate powder is made up into a solution and will be given to you either as an injection or infusion (drip) into a vein. Your doctor will decide how Colistimethate should be given and how long your treatment should last. This will usually be at least 5 days. When treating bacterial infections it is important to complete the full course of treatment.
The doctor will calculate the dose depending on the infection you have and how severe it is. It will also depend on your age, weight and how well your kidneys work.
Sometimes, particularly in people with kidney problems, people with cystic fibrosis or in newborn babies, the doctor may measure the level of Colistimethate in the blood and adjust the dose accordingly.
The usual dose for adults is between 1 and 2 million units three times a day. The maximum dose is 6 million units in 24 hours.
The usual daily dose for children weighing up to 60 kg is 50,000 to 75,000 units/kg.
People who have moderate or severe kidney problems will probably be given a lower dose.
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, please speak to your doctor or nurse. Too much Colistimethate can cause serious side effects.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Colistimethate can cause side effects although not everybody gets them.
Some side effects can be serious
Tell the doctor or nurse immediately if you notice any of the following symptoms:
• Wheezing or breathing difficulties which can lead to collapse, a rash, itching or hives on the skin, or sudden swelling of the face, throat or lips.
These can be signs of a severe allergic reaction.
The following side effects have also been reported:
• Reactions, such as irritation, at the injection site.
• Kidney problems. These are more likely in patients who already have poor kidneys, or who are given Colistimethate at the same time as other medicines that can affect 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 is reduced.
• Neurological problems such as inability to breathe because of 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). Side effects that affect the nervous system are more likely to occur when the dose of Colistimethate is too high, in people who have poor kidneys or in those who are also having curariform drugs or other medicines with a similar effect on how the nerves work.
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 COLISTIMETHATE
Keep out of the reach and sight of children. The vials of powder 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 carton and vial label. Do not freeze.
The solution of Colistimethate should be used immediately, or within 8 hours when stored at temperatures not exceeding 25°C or 24 hours in the refrigerator (2 to 8°C). The vials are for single use. Any unused solution should be discarded. Colistimethate should not be used if there is any discoloration or cloudiness of the solution
6. FURTHER INFORMATION
Colistimethate is a creamy white powder for solution for injection in single dose 10ml glass vials. Each carton contains 1 or 10 vials. Each vial contains the active ingredient, Colistimethate (also called colistin) as an amount of powder equivalent to one million international units. There are no other ingredients. The sodium content is 0.228 mMol per vial.
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