Each vial contains the active substance colistimethate sodium (also called colistin) as an amount of powder equivalent to one million units. There are no other ingredients. This medicinal product contains less than 1mmol sodium (23mg) per vial, i.e. essentially 'sodium free'.
Colomycin contains the active substance colistimethate sodium. Colistimethate sodium is an antibiotic. It belongs to a group of antibiotics that are called polymyxins.
Colomycin is given by injection to treat some types of serious infections caused by certain bacteria. Colomycin is used when other antibiotics are not suitable.
Colomycin is given as an inhalation to treat chronic chest infections in patients with cystic fibrosis. Colomycin is used when these infections are caused by specific bacteria called Pseudomonas aeruginosa.
Depending on the reason (see Indications/Uses), Colomycin 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. Colomycin may occasionally be given by injection into the brain or the spine. 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.
Always use Colomycin exactly as the doctor has told. Check with the doctor if unsure.
For use by infusion or injection: Colomycin is given to the patient by the 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 the patient is quite unwell, he/she will be given a higher dose of 9 million units once at the start of treatment.
In some cases, the doctor may decide to give a higher daily dose of up to 12 million units.
The usual daily dose in children weighing up to 40 kg 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.
The doctor will monitor the kidney function regularly while the patient receives Colomycin.
Method of administration: Colomycin is given by injection mainly in hospitals. If the patient is to treat him/herself at home, the doctor or nurse will show the patient how to dissolve the powder and inject the right dose of solution.
Duration of treatment: The doctor will decide how long the treatment should last depending of 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.
For use in a nebuliser: The usual dose for adults, adolescents and children aged 2 years or older is 1-2 million units two to three times per day (maximum 6 million units per day).
The usual dose for children less than 2 years old is 0.5-1 million units twice daily (maximum 2 million units per day).
The doctor may decide to adjust the dose depending on the circumstances. If the patient also takes other inhaled medicines, the doctor will tell the patient which order to taken them in.
Method of administration: If the patient is treating him/herself at home, the doctor or nurse will show the patient how to use Colomycin in the nebuliser when the patient first starts the 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: 1 million unit vial: 2ml sterile water / saline.
The solution is then poured into the nebuliser.
IMPORTANT: Do not mix Colomycin with any other product for nebulisation at the same time.
Duration of treatment: For nebulised use the doctor will advise on the course of the treatment.
If the patient forgets to use Colomycin: If the patient is treating him/herself and have missed any doses, he/she should give the missed dose as soon as he/she remembers and then give the next dose 8 hours later if using Colomycin three times a day, or 12 hours later if using Colomycin twice a day. Carry on from there as instructed. Do not take a double dose to make up forgotten dose.
If the patient stops using Colomycin: Do not stop the treatment early unless the doctor says the patient can. The doctor will decide how long the treatment should last. If the patient has any further questions on the use of this medicine, he/she should ask the doctor.
If the patient thinks that he/she has given him/herself too much Colomycin, he/she should contact the doctor or nurse immediately for advice or, if they are not available, contact or go to the 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 the patient is being treated in hospital or at home by a doctor or nurse and think that he/she may have missed a dose or been given too much Colomycin, please ask the doctor, nurse or pharmacist about this.
Do not use Colomycin if the patient is allergic (hypersensitive) to colistimethate sodium, colistin or to other polymyxins.
Talk to the doctor, pharmacist or nurse before using Colomycin: If the patient has or has had kidney problems; If the patient suffers from myasthenia gravis; If the patient suffers from porphyria; If the patient suffers from asthma.
Some people may experience a feeling of tightness in the chest due to narrowing of the airways when inhaling Colomycin. The doctor may prescribe other medicines for inhalation directly before or after using Colomycin; in order to prevent or treat this.
In premature and new-born babies, special care should be taken when using Colomycin as the kidneys are not yet fully developed.
Driving and using machines: When Colomycin is given into a vein there may be side effects such as dizziness, confusion or problems with vision. If these occur, the patient should not drive or operate machinery.
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. If the patient is pregnant, thinks she may be pregnant or is planning to have a baby ask the doctor for advice before taking this medicine.
If the patient is breast-feeding, small amounts of Colomycin enter the milk. If the patient cannot stop breast-feeding while she takes Colomycin, she should watch the baby carefully for any signs of illness and tell the doctor if she notices anything wrong.
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Allergic reactions: 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.
If the patient experiences signs of an allergic reaction he/she should seek urgent medical attention.
Less severe allergic reactions include skin rashes that appear later during treatment.
Side effects associated with injecting Colomycin into a vein: 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.
If the patient experiences any difficulty breathing he/she 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 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.
If the patient gets any side effects, he/she should talk to the doctor. This includes any possible side effects not listed.
Side effects associated with inhaling Colomycin (nebulisation): 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.
Possible side effects include coughing, a feeling of tightness in the chest due to narrowing of the airways, sore mouth or throat and thrush (Candida) infections of the mouth or throat.
Reporting of side effects: If the patient gets any side effects, he/she should talk to the doctor or pharmacist. This includes any possible side effects not listed.
By reporting side effects the patient can help provide more information on the safety of this medicine.
Tell the doctor if the patient is taking, has recently taken or might take any other medicines.
If the patient is taking any of the following medicines, he/she may or may not be able to take Colomycin. Sometimes the other medicines must be stopped (if only for a while) or the patient may need a lower dose of Colomycin or may need to be monitored while he/she is taking Colomycin. In some cases, the level of Colomycin in the blood may have to be measured from time to time to make sure that the patient is having the right dose.
Medicines like antibiotics called aminoglycosides (which include gentamicin, tobramycin, amikacin and netilmicin) and cephalosporins which can affect how the kidneys function. Taking such medicines at the same time as Colomycin can increase the risk of damage to the kidneys (see Side Effects).
Medicines like antibiotics called aminoglycosides (which include gentamicin, tobramycin, amikacin and netilmicin) which can affect the nervous system. Taking such medicines at the same time as Colomycin can increase the risk of side effects in the ears and other parts of the nervous system (see Side Effects).
Medicines called muscle relaxants, often used during general anaesthesia. Colomycin can increase the effects of these medicines. If the patient has a general anaesthetic, let the anaesthetist know that the patient is having Colomycin.
If the patient suffers from myasthenia gravis and is also taking other antibiotics called macrolides (such as azithromycin, clarithromycin or erythromycin) or antibiotics called fluoroquinolones (such as ofloxacin, norfloxacin and ciprofloxacin), taking Colomycin further increases the risk of muscle weakness and breathing difficulties.
Having Colomycin as an infusion at the same time as receiving Colomycin as an inhalation can increase the risk of side effects.
Do not store the vials above 25°C.
Keep the vials in the outer carton in order to protect from light.
Colomycin solutions for injection and for inhalation should be used immediately after preparation.
If this is not possible, talk first to the doctor or pharmacist as the solutions may be stored in a refrigerator for no longer than 24 hours. Any remaining solution should be discarded.
Do not throw away any medicines via wastewater or household waste. Ask the pharmacist how to throw away medicines no longer used. These measures will help protect the environment.
J01XB01 - colistin ; Belongs to the class of polymyxins. Used in the systemic treatment of infections.
Colomycin powd for inj, infusion or inhalation 1 MU
10 × 1's
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