Promixin (Colistimethate Sodium)
Promixin 1 million International Units (IU)
Powder for nebuliser solution
Colistimethate Sodium
1. WHAT PROMIXIN IS AND WHAT IT IS USED FOR
Promixin contains colistimethate sodium, an antibiotic that fights infections caused by
Pseudomonas aeruginosa.
This is a very common bacterium that infects the lungs of nearly all patients with cystic fibrosis at some time during their lives. If the infection is not properly controlled it will continue to damage the lungs, causing further problems.
Promixin is used to treat chest infections caused by Pseudomonas in people with cystic fibrosis. Promixin is breathed into the lungs (inhaled) so that more of the antibiotic can work against the bacteria causing the infection.
2. BEFORE YOU TAKE PROMIXIN
In certain circumstances your doctor may decide not to prescribe Promixin.
Do not use Promixin and tell your doctor if:
• you are pregnant or could get pregnant (please read the section ‘Pregnancy and breastfeeding’ below);
• you are breast-feeding (please read the section ‘Pregnancy and breast-feeding’ below).
• you are allergic (hypersensitive) to colistimethate sodium;
• you suffer from myasthenia gravis (a rare disease where your muscles are extremely weak and get tired very quickly).
If any of these apply to you, see your doctor before you start taking Promixin.
Take special care with Promixin and tell your doctor if:
• you have or have had kidney problems;
• you suffer from porphyria (a rare metabolic disease that some people are born with);
• you suffer from asthma.
If any of these apply to you, tell your doctor.
Using other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines you bought without a prescription. These medicines may interfere with the effect of Promixin.
• If you are taking antibiotics such as cephalothin sodium, gentamicin, amikacin, netilmicin and tobramycin, please tell your doctor. Taking Promixin at the same time as these other antibiotics could increase your risk of kidney problems.
• Promixin could prolong the effects of muscle relaxing medicines, which may be used as part of a general anaesthetic if you have an operation. If you need to have a general anaesthetic, tell the anaesthetist that you are taking Promixin.
Pregnancy and breast-feeding
You must not take Promixin if you are pregnant or trying to get pregnant. Promixin may harm your unborn baby.
Do not breast-feed while you are taking this medicine. Promixin can pass into breast milk.
Driving and using machines
Promixin may make you feel dizzy, confused or have problems with your sight, such as blurred vision. If this happens to you, do not drive or use any tools or machines.
3. HOW TO TAKE PROMIXIN
Always take Promixin exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.
The usual dose for adults and children over the age of two years is 1-2 vials two or three times a day. Your doctor will work out the best dose for you.
Tell your doctor if you have problems with your kidneys as you may need to take a lower dose of Promixin.
You should take your first dose of Promixin when you are with your doctor or nurse.
Take your Promixin after physiotherapy (if you have physiotherapy) and after taking any other nebulised medicines that you have been prescribed.
Promixin has to be breathed in from a nebuliser. Promixin can be taken using any nebuliser system that can be used to deliver antibiotics to the lungs. Promixin comes with a Promixin Disc so that it can be used with the I-neb® AAD® System. To find out how to use Promixin with I-neb, see the detailed instructions which come with the device. If you use a different nebuliser you should make sure the room is well ventilated.
How to prepare Promixin
Your doctor or nurse will show you how to use Promixin with your nebuliser.
Before Promixin can be taken it must be dissolved in sterile water or a half and half mixture of sterile water and sterile saline (salt water).
The following are general instructions on how to dissolve Promixin.
• Flip open the Promixin plastic cap.
• Carefully rip the foil seal from the top of the vial and remove it completely.
• Take out the rubber bung carefully.
• Slowly add sterile water or sterile water and sterile saline to the vial (the instructions with the nebuliser will tell you the correct volume of liquid to add to the Promixin vial.)
• Roll the vial gently between both hands to dissolve the Promixin in the liquid. This will reduce foaming.
• Avoid shaking the vial too hard.
• Pour the solution into the nebuliser.
• Any unused solution should be disposed of .
Once prepared Promixin should be used immediately.
If you take more Promixin than you should
If you realise that you have taken more Promixin than your doctor has recommended (or if someone else has taken some of your Promixin), contact your doctor straight away.
The symptoms of taking too much Promixin can include:
• tingling or numbness around the lips and face
• dizziness and spinning sensation (vertigo)
• slurred speech
• visual disturbance
• confusion
• mental disturbance
• flushing (reddening of the face)
If you forget to take Promixin
Take the dose as soon as you remember, unless it is near the time for your next dose. You do not need to make up for the dose you have missed.
If you stop taking Promixin
Do not stop your treatment early unless your doctor says that you can. Your doctor will tell you how long your treatment will last.
4. POSSIBLE SIDE EFFECTS
Like all medicines Promixin can cause side effects, although not everybody gets them.
Promixin can sometimes cause allergic reactions like skin rash. If this happens you should stop taking Promixin and tell your doctor immediately.
Breathing in Promixin through a nebuliser can make some people notice tightness in their chest, feel wheezy, cough or become breathless. For this reason the first dose should be taken when you are with your doctor or nurse. Your doctor may also advise you to take a medicine to help prevent any breathlessness. Your doctor may check your breathing at your clinic visits.
Promixin might also affect your kidneys, usually if the dose is high or you are taking other medicines that may affect your kidneys.
Promixin may sometimes cause you to have a sore mouth or sore throat.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
5. HOW TO STORE PROMIXIN
Keep Promixin out of the reach and sight of children.
Do not use Promixin after the expiry date which is stated on the vial or carton. The expiry date refers to the last day of that month.
Promixin does not require any special storage conditions.
Promixin contains no preservatives. Once prepared, Promixin should be used immediately.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer require. These measures will help to protect the environment.
6. FURTHER INFORMATION
- What Promixin contains
The active substance is colistimethate sodium (also known as colistin).
Each vial contains 1 million International Units (IU) of colistimethate sodium, which weighs about 80 milligrams (mg). There are no other ingredients.
- What Promixin looks like and contents of the pack
Promixin is a powder for nebuliser solution, supplied as a sterile powder in a glass vial.
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