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COLISTIMETHATE SODIUM 1 MILLION I.U. POWDER FOR SOLUTION FOR INJECTION

Active substance(s): COLISTIMETHATE SODIUM

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PATIENT INFORMATION LEAFLET

COLISTIMETHATE SODIUM 1 MILLION I.U. POWDER FOR SOLUTION FOR INJECTION
1 million international units/vial

The name of your medicine is Colistimethate
sodium 1 Million I.U. Powder for Solution for
Injection.
It is referred to as Colistimethate in this leaflet.
 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 if you
notice any side effects not listed in this leaflet,
please tell the doctor, nurse or pharmacist.
In this leaflet:
1. What Colistimethate is and what it is used for
2. What you need to know before you are given
Colistimethate
3. How Colistimethate is given
4. Possible side-effects
5. Storing Colistimethate
6. Further information

Colistimethate can increase the risk of damage to
the kidneys
- medicines which can affect your nervous system.
Taking such medicines at the same time as
Colistimethate can increase the risk of side effects in
your nervous system
- medicines called muscle relaxants, often used
during general anaesthesia. Colistimethate can
increase the effects of these medicines. If you have
a general anaesthetic, let your anaesthetist know
that you are having Colistimethate.
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 further increases the risk of muscle
weakness and breathing difficulties.

1. WHAT COLISTIMETHATE IS AND WHAT IT IS USED FOR

Having Colistimethate as an infusion at the same
time as receiving colistimethate as an inhalation can
increase your risk of side effects.

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

Make sure the doctor knows about any other
medicines that you are taking, including medicines
that you obtained without a prescription.

2. WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN
COLISTIMETHATE
Colistimethate is not suitable for everyone. Some
people must not have this injection. Do not have the
injection:
If you are allergic (hypersensitive) to colistimethate,
colistin or to other polymyxins.
If you are unsure about anything, ask your doctor
before you have the injection.
Warnings and precautions
Talk to your doctor, pharmacist or nurse before
using Colistimethate
- If you have or have had kidney problems.
- If you suffer from myasthenia gravis
- If you suffer from porphyria
In premature and new-born babies, special care
should be taken when using Colistimethate as the
kidneys are not yet fully developed.

Each vial of Colistimethate contains about 5mg of
sodium. This means that you could receive up to
60mg sodium each day if you are having the
maximum adult dose. Please take this into account
if you are on a low sodium (salt) diet and let your
doctor or pharmacist know about this.
Pregnancy and breastfeeding
 Colistimethate 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 Colistimethate 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.

Other medicines and Colistimethate
- medicines which can affect how your kidneys
function. Taking such medicines at the same time as
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Information for the Healthcare Professional
COLISTIMETHATE SODIUM 1 MILLION I.U. POWDER FOR SOLUTION FOR INJECTION
Please read this information carefully before using Colistimethate Sodium. Further information is
contained in the Summary of Product Characteristics.
PRESENTATION
Colistimethate Sodium is a white lyophilised powder in
a 10ml glass vial. Each vial contains 1 Million I.U.
(International Units) of Colistimethate Sodium.
DOSAGE AND METHOD OF ADMINISTRATION
Colistimethate Sodium is administered intravenously
as a slow infusion over 30 – 60 minutes.
Dilution/flush solution:
For bolus injection:
Reconstitute the contents of the vial with not more
than 10ml water for injection or 0.9% sodium chloride.
For infusion:
The contents of the reconstituted vial may be diluted,
usually with 50ml 0.9% sodium chloride. During
reconstitution swirl gently to avoid frothing.
Reconstituted Colistimethate Sodium is a clear
solution.
Dosage (adjustment required in renal impairment):
Adults and adolescents
Maintenance dose 9MIU/day in 2-3 divided doses
In patients who are critically ill, a loading dose of 9
MIU should be administered.

The most appropriate time interval to the first
maintenance dose has not been established.
Loading and maintenance doses of up to 12 MIU may
be required in patients with good renal function in
some cases.
The loading dose applies to patients with normal and
impaired renal functions including those on renal
replacement therapy.
Renal impairment
Dose adjustments in renal impairment are necessary.
The following dose adjustments are suggested as
guidance.
Dose reductions are recommended for patients with
creatinine clearance < 50 ml/min:
Twice daily dosing is recommended.
Paediatric population
The data supporting the dose regimen in paediatric
patients are very limited. Renal maturity should be
taken into consideration when selecting the dose.
The dose should be based on lean body weight.
Children ≤ 40kg
75,000-150,000 IU/kg/day divided into 3 doses.
For children with a body weight above 40 kg, use

3. HOW COLISTIMETHATE IS GIVEN
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 Colistimethate
4. POSSIBLE SIDE EFFECTS
Like all medicines, Colistimethate 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 Colistimethate 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 Colistimethate 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 Colistimethate 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.
Reporting of side effects
If you get any side effects, talk to your doctor,
nurse or pharmacist. This includes any possible
side effects not listed in this leaflet. You can also
report side effects directly via the Yellow Card
Scheme at: www.mhra.gov.uk/yellowcard.
By reporting side effects you can help provide
more information on the safety of this medicine.
5. STORING COLISTIMETHATE
Keep this medicine out of the sight and reach 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 Colistimethate should be used
immediately, or within 8 hours when stored at
o
temperatures not exceeding 25 C or 24 hours in
o
the refrigerator (2 to 8 C). The vials are for single
use. Any unused solution should be discarded.
Colistimethate should not be used if there is any
discoloration or cloudiness of the solution
6. FURTHER INFORMATION
Colistimethate is a creamy white powder for
solution for injection in single dose 10ml glass
vials. Each carton contains 1 or 10 vials. Each vial
contains the active ingredient, Colistimethate (also
called colistin) as an amount of powder equivalent
to one million international units. There are no
other ingredients. The sodium content is 0.228
mMol per vial.
Manufacturer
Alfa Wassermann S.p.A.; Via Enrico Fermi, 1;
65020 Alanno (Pe); Italy.
Marketing Authorisation Holder
Beacon Pharmaceuticals Ltd., Tunbridge Wells,
Kent TN1 1YG
This leaflet was last revised in: 03/2016
If you find this leaflet difficult to read or understand,
please speak to the doctor or nurse or contact the
marketing authorisation holder at the above
address.
ALXP009BNC

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of the dosing recommendation for adults should be
considered.
The use of doses >150,000 IU/kg/day has been
reported in children with cystic fibrosis.

aminoglycoside and cephalosporin antibiotics,
neuromuscular blocking drugs or ether.

Incompatibilities with commonly used mixtures:
Do not mix reconstituted solution with other
medicinal products.
Special handling information:
Solutions below 80,000 IU/ml should be used
immediately. For solutions for bolus injection the
chemical and physical in-use stability of
reconstituted solution in the original vial, with a
concentration ≥ 80,000 IU/ml has been
demonstrated for 24 hours at 2 to 8°C.
Solutions for infusion, which have been diluted
beyond the original vial volume and/or with a
concentration < 80,000 IU/ml should be used
immediately.
For single use only. Discard any remaining solution.
The outer surface of the primary container is nonsterile.

Excipients: There are no other excipients

CONTRAINDICATIONS

PHARMACEUTICAL INFORMATION

Shelf-life: 3 years
STORAGE PRECAUTIONS
Do not store above 25°C. Store the vial in the outer
carton in order to protect from light.
Do not freeze.
From a microbiological point of view, unless the
method of opening/ reconstitution/ dilution precludes
the risk of microbial contamination, the product
should be used immediately.
If not used immediately, in-use storage times and
conditions are the responsibility of user.
Nature of Container
10ml Type III glass vials with rubber stoppers and
aluminium crimp seals. Each carton contains 1 or 10
vials.

Do not use in patients with known hypersensitivity to
Colistimethate Sodium or polymyxin B.
INTERACTIONS WITH OTHER MEDICINAL PRODUCTS AND
OTHER FORMS OF INTERACTION
ALXP009BNC
Colistimethate Sodium may interact with

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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