Product Description
COLISTIN® is an antibiotic. It belongs to a group of antibiotics called polymyxins.
It contains Colistimethate sodium as an active ingredient
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.
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BEFORE YOU ARE GIVEN COLISTIN ®
COLISTIN ® is not suitable for everyone. Some people must not have this injection. Do not have the injection if you:• are allergic to COLISTIN ® or to another antibiotic called polymyxin B
• 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
• have kidney problems
• 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, amikacin or netilmicin) or cephalosporins. Having COLISTIN ® 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 that are often used during general anaesthesia. COLISTIN ® can increase the effects of these drugs.
• Ether, a substance sometimes used as an anaesthetic.
If you need to have a general anaesthetic, make sure that the anaesthetist knows that you are having COLISTIN ®.
Make sure the doctor knows about any other medicines that you are taking, including medicines that you obtained without a prescription.
Pregnancy and breastfeeding• COLISTIN ® 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 COLISTIN ® 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.
HOW COLISTIN ® IS GIVEN
The COLISTIN ® 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 COLISTIN ® 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 COLISTIN ® in the blood and adjust the dose accordingly.
The usual dose for patients weighing more than 60kg 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 and adults weighing up to 60 kg is 50,000 to 75,000 units/kg per day, given in 3 doses at approximately 8-hour intervals
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 COLISTIN ®, please speak to your doctor or nurse. Too much COLISTIN ® can cause serious side effects.
POSSIBLE SIDE EFFECTS
Like all medicines, COLISTIN ® 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 COLISTIN ® 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 COLISTIN ® 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 COLISTIN ® is too high, in people who have poor kidneys or in those who are also receiving muscle relaxants 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.
HOW TO STORE COLISTIN
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 COLISTIN ® should be used immediately, or within 8 hours when stored at temperatures not exceeding 25oC or 24 hours in the refrigerator (2 to 8oC). The vials are for single use. Any unused solution should be discarded. COLISTIN ® should not be used if there is any discoloration or cloudiness of the solution
FURTHER INFORMATION
Each vial contains the active ingredient, Colistimethate sodium as an
amount of powder equivalent to one million international units. There
are no other ingredients.COLISTIN ® is a creamy white powder for solution for injection in single dose 10ml glass vials. Each carton contains 1 or 10 vials.
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