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

Active substance: 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. Before you are given Colistimethate
3. How Colistimethate is given
4. Possible side-effects
5. Storing Colistimethate
6. Further information

1. WHAT COLISTIMETHATE IS AND WHAT IT IS USED FOR
Colistimethate is an antibiotic. It belongs to a group
of antibiotics called polymyxins.
Like all antibiotics, Colistimethate is only active
against some bacteria, so it is only suitable for
treating some types of infection.
Colistimethate is given by injection to treat
• Some serious infections where other antibiotics
are not suitable. These infections include some
types of pneumonia and some bladder or kidney
infections.
• Certain chest infections in patients with cystic
fibrosis.
2. 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 to Colistimethate (also known as
colistin) or to another antibiotic called polymyxin
B
• you have a condition called myasthenia gravis.
If you are unsure about anything, ask your doctor
before you have the injection.
Your doctor must be especially careful if:
• You have porphyria
• You have kidney problems
• You are pregnant or breastfeeding.
If you are unsure about anything speak to your
doctor.

Taking other medicines
You must tell your doctor if you are taking any of the
following medicines:
• Other antibiotics called aminoglycosides (such as
gentamicin, tobramycin, amikacin or netilmicin) or
cephalosporins. Having Colistimethate at the
same time as one of these antibiotics can
increase the risk of damage to the kidneys or
cause side effects in the ears and parts of the
nervous system.
• Muscle relaxant medicines that are often used
during general anaesthesia. Colistimethate can
increase the effects of these drugs.
• Ether, a substance sometimes used as an
anaesthetic.
If you need to have a general anaesthetic, make
sure that the anaesthetist knows that you are having
Colistimethate.
Make sure the doctor knows about any other
medicines that you are taking, including medicines
that you obtained without a prescription.
Each vial of Colistimethate contains about 5mg of
sodium. This means that you could receive up to
30mg 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.

3. HOW COLISTIMETHATE IS GIVEN
The Colistimethate powder is made up into a
solution and will be given to you either as an
injection or infusion (drip) into a vein. Your doctor
will decide how Colistimethate should be given and
how long your treatment should last. This will usually
be at least 5 days. When treating bacterial
infections it is important to complete the full course
of treatment.

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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

Dosage (adjustment required in renal
impairment):
Children and adults (including the elderly):
Over 60kg: I – 2 million units three times daily.
Maximum 6 million units in 24 hours.
Up to 60 kg: 50,000 units/kg/day, to a maximum of
75,000 units/kg/day. The total daily dose should be
divided into three doses given at approximately 8hour intervals.

To be given by IV bolus or IV infusion.
Dilution/flush solution: 0.9% sodium chloride or
water for injections.
Reconstituted Colistimethate Sodium is a clear
solution.
Administration rate:
IV infusion: 50ml over 30 minutes.
IV bolus (up to 2 million units) through a TIVAD:
10ml over a minimum 5 minutes.

Stability in solution: Up to 24 hours in a
refrigerator (2-8°C) or 8 hours below 25°C.
Incompatibilities with commonly used
mixtures: Do not mix reconstituted solution with
other medicinal products
Special handling information: For single use
only. Discard any remaining solution.
The outer surface of the primary container is nonsterile.

The doctor will calculate the dose depending on
the infection you have and how severe it is. It will
also depend on your age, weight and how well your
kidneys work.
Sometimes, particularly in people with kidney
problems, people with cystic fibrosis or in newborn
babies, the doctor may measure the level of
Colistimethate in the blood and adjust the dose
accordingly.
The usual dose for patients weighing more than
60kg is between 1 and 2 million units three times a
day. The maximum dose is 6 million units in 24
hours.
The usual daily dose for children and adults
weighing up to 60 kg is 50,000 to 75,000 units/kg
per day, given in 3 doses at approximately 8-hour
intervals.
People who have moderate or severe kidney
problems will probably be given a lower dose.
If you are being treated in hospital or at home
by a doctor or nurse and think that you may have
missed a dose or been given too much
Colistimethate, please speak to your doctor or
nurse. Too much Colistimethate can cause serious
side effects.
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.
If any of these side effects become
troublesome or persist, or if you notice any
side effects not listed in this leaflet, you should
tell your doctor as soon as possible.
5. STORING COLISTIMETHATE
Keep out of the reach and sight 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
Date of approval of this leaflet:
09/2009
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.

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CONTRAINDICATIONS
Do not use in patients with known hypersensitivity
to Colistimethate Sodium or polymyxin B or in
patients with myasthenia gravis.
INTERACTIONS WITH OTHER MEDICINAL PRODUCTS
AND OTHER FORMS OF INTERACTION
Colistimethate Sodium may interact with
aminoglycoside and cephalosporin antibiotics,
neuromuscular blocking drugs or ether.
PHARMACEUTICAL INFORMATION
Excipients: There are no other excipients
Shelf-life: 2 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, the reconstituted product should be used
immediately. If not used immediately, in-house
storage times and conditions prior to use are the
responsibility of the user and should not be longer
than 24 hours in the refrigerator (2 to 8°C) or up to
8 hours when stored at temperatures not
exceeding 25°C.
Nature of Container
10ml Type III glass vials with rubber stoppers and
aluminium crimp seals. Each carton contains 1 or
10 vials.

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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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