Colistimethate sodium contains colistimethate sodium. It is an antibiotic that belongs to a group of antibiotics called polymyxins. It fights serious bacterial infections.

Colistimethate sodium is given by injection to treat some types of serious infections caused by certain bacteria. Colistimethate sodium is used when other antibiotics are not suitable.

In certain circumstances your doctor may decide not to prescribe Colistimethate sodium.

Do not use Colistimethate sodium

- If you are allergic (hypersensitive) to colistimethate sodium, colistin or to other polymyxins

If this applies to you, tell your doctor before you are given Colistimethate sodium.

Warnings and precautions

Talk to your doctor, pharmacist or nurse before using Colistimethate sodium:

- If you have or have had kidney problems

- If you suffer from myasthenia gravis

- If you suffer from porphyria

- If you suffer from asthma

If any of these apply to you, tell your doctor.

Children

In premature and new-born babies, special care should be taken when usin

Colistimethate sodium as the kidneys are not yet fully developed

Other medicines and Colistimethate sodium

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including non-prescription medicines.

If you are taking any of the following medicines, you may or may not be able to

take Colistimethate sodium. Sometimes the other medicines must be stopped (if only for a while) or you may need a lower dose of Colistimethate sodium or you may need to be monitored while you are taking Colistimethate sodium. In some cases, the level of colistimethate sodium in your blood may have to be measured from time to time to make sure that you are having the right dose.

These medicines may interfere with the effects of Colistimethate sodium.

-        medicines which can affect how your kidneys function. These include the aminoglycoside antibiotics (such as gentamicin, amikacin, netilmicin and tobramycin) and cephalosporins. Taking such medicines at the same time as Colistimethate sodium can increase the risk of damage to the kidneys (see section 4 of this leaflet).

-        medicines which can affect your nervous system. These include the aminoglycoside antibiotics (such as gentamicin, amikacin, netilmicin and tobramycin). Taking such medicines at the same time as Colistimethate sodium can increase the risk of side effects in the ears and other parts of your nervous system (see section 4 of this leaflet).

-        medicines called muscle relaxants, often used during general anaesthesia. Colistimethate sodium can increase the effects of these medicines. If you have a general anaesthetic, let your anaesthetist know that you are having Colistimethate sodium.

If you suffer from myasthenia gravis and are also taking other antibiotics called macrolides (such as azithromycin, clarithromycin or erythromycin) or antibiotics called fluoroquinolones (such as ofloxacin, norfloxacin and ciprofloxacin), taking Colistimethate sodium further increases the risk of muscle weakness and breathing difficulties.

Having Colistimethate sodium as an infusion at the same time as receiving Colistime- thate sodium as an inhalation can increase your risk of side effects

Pregnancy, breast-feeding and fertility

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking Colistimethate sodium.

You may be given Colistimethate sodium if you are pregnant or trying to get pregnant if your doctor considers the benefits are greater than the possible risks. It is unknown if having Colistimethate sodium may harm your unborn baby.

Colistimethate sodium is excreted in breast milk. Colistimethate sodium should be administered to breastfeeding women only when clearly needed.

Driving and using machines

Colistimethate sodium 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.

Your treatment with Colistimethate sodium has been prescribed by and will be given to you under the supervision of a doctor or nurse.

Depending on the reason (see section 1 of this leaflet), Colistimethate sodium 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. Colistimethate sodium may occasionally be given by injection into the brain or the spine.

The dose of Colistimethate sodium is dependent on how ill you are, how well your kidneys are working and your weight.

Colistimethate sodium is given to you by your 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 you are quite unwell, you will be given a higher dose of 9 million units once at the start of treatment.

In some cases, your 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.

Your doctor will monitor your kidney function regularly while you receive Colistimetha- te sodium.

Method of administration

Colistimethate sodium is given by injection mainly in hospitals.

Duration of treatment

Your doctor will decide how long your 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.

If you have problems with your kidneys you will usually be given a lower dose of Colistimethate sodium fewer times a day. Your doctor will work out the correct dose for you.

-        You will be given Colistimethate sodium 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 Colistimethate sodium over a shorter time.

-        Before Colistimethate sodium can be given it must be dissolved in sterile saline (salt volume (usually 50 ml).

-        Usually you will be treated for at least 5 days.

 If you are given too much Colistimethate sodium

As a doctor or nurse will be giving you Colistimethate sodium, 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 Colistimethate sodium 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 Colistimethate sodium when expected

If you think that you have missed a dose of Colistimethate sodium 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 Colistimethate sodium

Your doctor will decide how long you should be given Colistimethate sodium. 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 medicine, ask your doctor.

Like all medicines, Colistimethate sodium can cause side effects, although not everybody gets them.

Colistimethate sodium can sometimes cause allergic reactions like skin rash or red and lumpy skin rash, swollen eyelids, face, lips, mouth, neck or tongue, itching, difficulty breathing or swallowing and loss of consciousness. If this happens, your

Colistimethate sodium treatment will be stopped immediately.

Less severe allergic reactions include skin rashes that appear later during treatment.

Colistimethate sodium can also affect your kidneys, especially if the dose is high, if you already have kidney problems or you are taking other medicines that may affect your kidneys. These problems will normally get better if treatment is stopped or the dose of Colistimethate sodium is reduced.

Side effects that affect the nervous system are more likely to occur when the dose of Colistimethate sodium 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 you experience any difficulty breathing you should seek urgent medical attention.

Very common side effects (may affect more than 1 in 10 people):

-        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 (may affect up to 1 in 1 000 people):

-        kidney failure

Other side effects can include:

-        dizziness

-        difficulty in controlling movements

-        soreness at the site of injection

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report any side effects directly via:

·        The National Pharmacovigilance and Drug Safety Centre (NPC)

·        Fax: +966-11-205-7662

·        Call NPC at +966-11-2038222, Ext’s: 2317-2356-2353-2354-2334-2340.

·        Toll free phone: 8002490000

·        E-mail: npc.drug@sfda.gov.sa

·        Website: www.sfda.gov.sa/npc

By reporting side effects you can help provide more information on the safety of this medicine

Store below 30°C

Keep Colistimethate sodium out of the sight and reach of children.

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.

Do not use Colistimethate sodium after the expiry date which is stated on the vial or carton as “EXP”. The expiry date refers to the last day of that month.

This medicine does not require any special storage conditions.

Colistimethate sodium contains no preservatives. Once prepared, Colistimethate sodium should be used immediately.

Your doctor or nurse will dispose of any unused medicine safely. These measures will help to protect the environment.