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COLISTIMETHATE SODIUM 1 MIU POWDER FOR SOLUTION FOR INJECTION

Active substance(s): COLISTIMETHATE SODIUM / COLISTIMETHATE SODIUM

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Package leaflet: Information for the patient

Colistimethate sodium

1 MIU

powder for solution for injection

Colistimethate sodium
Other medicines and Colistimethate sodium
Read all of this leaflet carefully before you are given this
Tell your doctor or pharmacist if you are taking, have recently taken or
medicine because it contains important information for you.
might take any other medicines, including non-prescription medicines.
• Keep this leaflet. You may need to read it again.
• Medicines which can affect your kidney function. Taking such
• If you have any further questions, ask your doctor, pharmacist or
medicines at the same time as Colistimethate sodium can increase
nurse.
the risk of kidney failure.
• If you get any side effects, talk to your doctor, pharmacist or
• Medicines which can affect your nervous system. Taking such
nurse. This includes any possible side effects not listed in this
medicines at the same time as Colistimethate sodium can increase
leaflet. See section 4.
the risk of side effects in your nervous system.
What is in this leaflet
• Medicines called muscle relaxants, often used during general
1. What Colistimethate sodium is and what it is used for
anaesthesia. Colistimethate sodium can increase the effects
2. What you need to know before you are given Colistimethate sodium
of these medicines. If you have a general anaesthetic, let your
3. How Colistimethate sodium is given
anaesthetist know that you are using Colistimethate sodium.
4. Possible side effects
If you suffer from myasthenia gravis and are also taking other
5. How to store Colistimethate sodium
antibiotics called macrolides (such as azithromycin, clarithromycin or
6. Contents of the pack and other information
erythromycin) or antibiotics called fluoroquinolones (such as ofloxacin,
1. What Colistimethate sodium is and what it is used for
Colistimethate sodium is an antibiotic. It belongs to a group of
antibiotics that are called polymyxins. This medicine works by killing
some types of bacteria that can cause various sorts of infections in
people.
Colistimethate sodium is given by injection to treat some types of
serious infections caused by certain bacteria. It is used when other
antibiotics are not suitable.
It is recommended that this antibiotic be used in combination with
others.
2. What you need to know before you are given Colistimethate
sodium
Colistimethate sodium must not be given:
• If you are allergic (hypersensitive) to colistimethate sodium, colistin,
or to other polymyxins.
Warnings and precautions
Talk to your doctor, pharmacist or nurse before receiving
Colistimethate sodium:
• if you have or have had kidney problems;
• if you suffer from myasthenia gravis (muscle weakness);
• if you suffer from porphyria (group of disorders that can cause nerve
or skin problems).
Tell your doctor or other healthcare professional immediately if a
severe allergic reaction occurs during treatment with Colistimethate
sodium, as treatment with this medicine must be stopped.
Using Colistimethate sodium systematically requires monitoring of
kidney function by laboratory tests, starting from the first days of
treatment and throughout the entire duration of treatment.

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 Colistimethate as an inhalation can increase your risk of
side effects.
Pregnancy and breast-feeding
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 this
medicine is given to you.
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.
It is not recommended that you breast-feed while you are taking this
medicine as Colistimethate sodium can pass into breast milk.
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.
Colistimethate sodium contains sodium
This medicine contains less than 1 mmol sodium (23 mg) per vial of
reconstituted solution for injection, i.e. essentially ‘sodium- free’.
3. How Colistimethate sodium is given
Your doctor will explain precisely how much Colistimethate sodium
you will be given, how often and for how long. This will depend on the
type of infection and its severity.
Tell your doctor if you have kidney problems, as the dose of medicine
to be taken may have to be adjusted.

Recommended dose in adults and adolescents
Colistimethate sodium is given to you by your doctor as an infusion
into a vein over 30 – 60 minutes.
Tell your doctor if you experience tingling around the mouth or
extremities (fingers and toes) or if you experienced diarrhoea during or 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
after treatment with Colistimethate sodium.
9 million units once at the start of treatment.
Children
In some cases, your doctor may decide to give a higher daily dose of
In premature and new-born babies, special care should be taken
up to 12 million units.
when using Colistimethate sodium as the kidneys are not yet fully
Use in children
developed.
The usual daily dose in children weighing up to 40 kg is 75.000 to
If you have kidney failure, the dosage of Colistimethate sodium may
be adjusted by your doctor.

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The following information is intended for healthcare professionals only. Intravenous administration - bolus:
This medicinal product must be reconstituted, under aseptic
This medicinal product is for single use only and any remaining
conditions, with not more than 10 ml of a solution of sodium chloride
solution should be discarded.
solution 0.9% or water for injections (WFI). During reconstitution swirl
Method of administration
gently to avoid frothing.
This medicinal product can be administered by intravenous
Intravenous administration - infusion:
administration or intrathecal and intraventricular administration.
After reconstitution, the solution may be diluted usually with 50 ml of
a solution of sodium chloride 0.9% for administration by infusion over

150.000 units per kilogram body weight, divided into three doses.
Higher doses have occasionally been given in cystic fibrosis.
Patients with kidney impairment
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 sodium.
Colistimethate sodium may occasionally be given directly
into the fluid surrounding the brain (called “intrathecal” or
“intraventricular” routes) in the treatment of meningitis.
Intraventricular route in adults: 125,000 IU/day.
The doses administered via the intrathecal route must not exceed
those recommended for intraventricular administration.
No specific dosing recommendation can be made in children for
intrathecal and intraventricular routes of administration.
If you are given more Colistimethate sodium than you should
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), tingling around
the mouth and extremities (fingers and toes), slurred speech, visual
disturbance, confusion, mental disturbance, flushing (reddening of
the face), kidney problems, muscle weakness, feeling as though you
cannot breathe.
If you missed your dose of Colistimethate sodium
If you think a dose has been missed, talk to your doctor or other
healthcare professional immediately. You must not be given a double
dose to make up for a forgotten dose.
If you stop using 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.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not
everybody gets them.
Allergic reactions
Colistimethate sodium can sometimes cause allergic reactions like
skin rash, swelling of the face, lips, mouth or tongue. Breathing
difficulties have also been observed. If this happens, your
Colistimethate sodium treatment will be stopped immediately.
If you experience signs of an allergic reaction you should seek
urgent medical attention.
Neurological problems
The most serious 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.
Other possible side effects:
–– headache,
–– tingling or numbness around the mouth, lips, face or extremities
(fingers and toes),
–– slurred speech,
–– itching, muscle weakness,
–– dizziness,
–– difficulty in controlling movements,
–– soreness at the site of injection.
Colistimethate sodium can affect your kidneys, especially if the dose
is high, in case of long-term treatment with this medicine or you are
taking other medicines that may affect your kidneys. Blood tests may

show changes in the way the kidneys are working. Kidney failure
may occur from the first days of treatment onwards, and is usually
reversible on discontinuation of therapy.
With intrathecal or intraventricular administration, meningeal irritation
can be observed.
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 side effects directly via Yellow Card Scheme Website:
www.mhra.gov.uk/yellowcard. By reporting side effects you can help
provide more information on the safety of this medicine.
5. How to store Colistimethate sodium
Keep this medicine out of the sight and reach of children.
Do not use this medicine 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.
The chemical and physical in-use stability of reconstituted solution
with a concentration ≥ 80,000 IU/mL, has been demonstrated for
24 hours at 2 to 8°C.
From a microbiological point of view, the product should be used
immediately. If not used immediately, in-use storage times and
conditions following reconstitution/dilution are the sole responsibility
of the user.
For solutions for infusion, which have been diluted beyond the
original vial volume and / or with a concentration < 80,000 IU/mL and
for intrathecal and intraventricular routes should be used immediately.
Do not throw away any medicines via wastewater or household
waste. Ask your pharmacist how to throw away medicines you no
longer use. These measures will help protect the environment.
6. Contents of the pack and other information
What Colistimethate sodium contains
The active substance is Colistimethate sodium (Colistin
methasulfonate sodium salt) 1 million international units (IU)
(equivalent to approximately 80 mg)
What Colistimethate sodium looks like and contents of the pack
Colistimethate sodium is a white powder supplied in a glass vial.
Box of 1 vial with powder
Box of 10 vials with powder
Box of 30 vials with powder
Box of 50 vials with powder
Not all pack sizes may be marketed.
Marketing Authorisation Holder
PANMEDICA
69/71, avenue Pierre Grenier
92100 Boulogne-Billancourt
FRANCE
Manufacturer
XELLIA PHARMACEUTICAL APS
Dalslandsgade 11,
2300 Copenhagen S,
DENMARK
This medicinal product is authorised in the Member States of the
EEA under the following names:
France:

COLISTIMETHATE SODIQUE PANPHARMA 1.000.000 U.I.,
poudre pour solution injectable

United
Colistimethate sodium 1 MIU, powder for solution for
Kingdom: injection
This leaflet was last revised in 05/2017.

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30-60 minutes. During reconstitution swirl gently to avoid frothing.

After reconstitution

Intrathecal and intraventricular administration:
This medicinal product must be reconstituted, under aseptic
conditions, with 8 ml of sodium chloride solution 0.9%.
During reconstitution swirl gently to avoid frothing.
The concentration of the reconstituted solution is 125,000 IU/mL.
The volume administered should not exceed 1 mL.

Hydrolysis of colistimethate is significantly increased when
reconstituted and diluted below its critical micelle concentration of
about 80,000 IU per ml. Solutions below this concentration should be
used immediately.

The pH of the reconstituted or diluted solution is 6.5-8.5.

Any unused product or waste material should be disposed of in
accordance with local requirements.

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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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