Promixin
1 million International Units (IU)
Powder for Solution for Injection
colistimethate sodium
Read all of this leaflet carefully before you are given this medicine
- Keep this leaflet. You may need to read it again.
- If you have further questions, please ask your doctor, nurse or pharmacist.
- If any of the side effects gets serious, or you notice any side effects not listed in this leaflet, please tell your doctor, nurse or pharmacist.
In this leaflet
- 1. What Promixin is and what it is used for
- 2. Before you are given Promixin
- 3. How you will be given Promixin
- 4. Possible side effects
- 5. How to store Promixin
- 6. Further information
What Promixin Is And What It Is Used For
Promixin contains colistimethate sodium. It is an antibiotic that fights serious bacterial infections, especially chest infections and infections of the urinary tract.
Promixin is used when other more common antibiotics no longer work or cannot be used.
Before You Are Given Promixin
In certain circumstances your doctor may decide not to prescribe Promixin.
Do not have Promixin and tell your doctor if:
- you are allergic (hypersensitive) to the active substance in Promixin (colistimethate sodium);
- you are pregnant or could get pregnant (please read the section ‘Pregnancy and breast-feeding’ below);
- you are breast-feeding (please read the section ‘Pregnancy and breast-feeding’ below);
- 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, tell your doctor before you are given 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).
If any of these apply to you, tell your doctor.
Taking other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including non-prescription medicines. These medicines may interfere with the effects 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 being given Promixin.
Pregnancy and breast-feeding
You must not be given 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.
How You Will Be Given Promixin
Your treatment with Promixin has been prescribed by and will be given to you under the supervision of a doctor or nurse.
The dose of Promixin is dependent on how ill you are, how well your kidneys are working and your weight.
The usual dose for people who weigh up to 60 Kg is 50,000 to 75,000 International Units (IU) for each kilogram of body weight each day. This will be divided into 3 equal doses and given at 8 hourly intervals.
The usual dose for people who weigh over 60 Kg is 1-2 million International Units given every 8 hours.
If you have problems with your kidneys you will usually be given a lower dose of Promixin fewer times a day. Your doctor will work out the correct dose for you.
- You will be given Promixin by a slow injection (infusion) into a vein over 30 minutes.
- If you have been fitted with a Totally Implantable Venous Access Device (TIVAD) you may be given a smaller volume of Promixin over a shorter time.
- Before Promixin can be given it must be dissolved in sterile water or sterile saline (salt water).
- The correct dose of Promixin will then be further diluted in a suitable volume (usually 50 mL).
- Usually you will be treated for at least 5 days.
If you are given too much Promixin
As a doctor or nurse will be giving you Promixin, it is unlikely that you will receive an incorrect dose. Tell your doctor or nurse if you have any concerns about the amount of medicine that you are given.
The symptoms of having too much Promixin can include:
- dizziness and spinning sensation (vertigo)
- slurred speech
- visual disturbance
- confusion
- mental disturbance
- flushing (reddening of the face)
- kidney problems
- muscle weakness
- feeling as though you cannot breathe
If you were not given Promixin when expected
If you think that you have missed a dose of Promixin and it is less than 3 hours since you should have been given the dose, tell your doctor or nurse.
If it is more than 3 hours after the missed dose the doctor or nurse will wait for your next dose.
Stopping Promixin
Your doctor will decide how long you should be given Promixin. It is important that your treatment is completed as advised by your doctor or your symptoms may get worse.
If you have any further questions on the use of this product, ask your doctor.
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, your Promixin treatment will be stopped immediately.
Promixin can also affect your kidneys, especially if the dose is high or you are taking other medicines that may affect your kidneys.
Very common side effects (affecting more than 1 person in 10)
- blood tests may show changes in the way the kidneys are working
- headache
- tingling or numbness around the mouth, lips and face
- itching
- muscle weakness
Rare side effects (affecting less than 1 person in 1 000)
- kidney failure
Other side effects can include:
- dizziness
- difficulty in controlling movements
- soreness at the site of injection
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor, nurse or pharmacist.
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.
Your doctor or nurse will dispose of any unused medicine safely. These measures will help to protect the environment.
Further Information
What Promixin contains
The active substance is colistimethate sodium.
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 supplied as a powder in a glass vial. The powder must be made into a solution for infusion.
Promixin is supplied in packs containing 10 vials.
Marketing Authorisation Holder
West Sussex
Manufacturer
This leaflet was last approved in JANUARY/2010
No comments:
Post a Comment