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1 million International Units (IU)
Powder for Solution for Infusion
colistimethate sodium



PL393 Issue 6 UK



1 million International Units (IU)
Powder for Solution for Infusion
colistimethate sodium


Pregnancy and breast-feeding

If you were not given Promixin when expected

Promixin contains colistimethate sodium. It is an antibiotic that
is given by injection to treat some types of serious infections caused
by certain bacteria.

In certain circumstances your doctor may decide not to prescribe

You may be given Promixin 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 Promixin may harm
your unborn baby.

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.

Promixin is used when other antibiotics are not suitable.

Do not have Promixin and tell your doctor if:
l you

are allergic (hypersensitive) to colistimethate sodium,
colistin or to other polymyxins;
If this applies to you, tell your doctor before you are given

Take special care with Promixin and tell your doctor,
pharmacist or nurse if:
l you

have or have had kidney problems;

l you

suffer from myasthenia gravis (a rare disease where your
muscles are extremely weak and get tired very quickly);
l you

Read all of this leaflet carefully before you are given
this medicine
l Keep

this leaflet. You may need to read it again.

l If

you have further questions, please ask your doctor, nurse or
l 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

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

suffer from porphyria (a rare metabolic disease that some
people are born with).
In premature and new-born babies, special care should be taken
when using Promixin as the kidneys are not yet fully developed.

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
l Medicines

which can affect how your kidneys function. Taking
such medicines at the same time as Promixin can increase the
risk of damage to the kidneys.
l Medicines

which can affect your nervous system. Taking such
medicines at the same time as Promixin can increase the risk of
side effects in your nervous system.
l Medicines

called muscle relaxants, often used during general
anaesthetia. Promixin can increase the effects of these medicines.
If you have a general anaesthetic, let your anaesthetist know that
you are having Promixin.
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 Promixin further
increases the risk of muscle weakness and breathing difficulties.
Having Promixin as an infusion at the same time as receiving
colistimethate sodium as an inhalation can increase your risk of
side effects.

It is not recommended that you breast-feed while you are taking
this medicine as 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.

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.

Your treatment with Promixin will be 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 international units,
divided into two or three doses. If you are quite unwell, you will
be given a higher dose of 9 million international 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 international 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 Promixin.

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
The symptoms of having too much Promixin can include:
l dizziness
l slurred
l visual

and spinning sensation (vertigo)



l confusion
l mental


l flushing
l kidney


l muscle
l feeling

(reddening of the face)

as though you cannot breathe

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

Keep Promixin out of the sight and reach of children.

What Promixin contains

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.

The active substance is colistimethate sodium.

Promixin can sometimes cause allergic reactions like skin rash
or red and lumpy skin rash, swollen eyelids, face, lips, mouth or
tongue, itching, difficulty breathing or swallowing. 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)
l blood

tests may show changes in the way the kidneys are
l headache
l tingling

or numbness around the mouth, lips and face

l itching
l muscle


Rare side effects (affecting less than 1 person
in 1,000)
l kidney


Do not store above 25ºC
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.

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
Profile Pharma Limited
Bicentennial Building
Southern Gate
West Sussex
PO19 8EZ
Tel: +44 (0) 800 1300 855
Fax: +44 (0) 800 1300 856

Other side effects can include:


l dizziness

Xellia Pharmaceuticals ApS
Dalslandsgade 11
Copenhagen S

l difficulty

in controlling movements

l 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 side effects directly (see details below). By reporting
side effects you can help provide more information on the safety of
this medicine.

United Kingdom

This medicinal product is authorised in the Member
States of the EEA under the following names:
Austria, The Netherlands, Sweden: Tadim
Germany, Denmark, Norway, United Kingdom: Promixin
This leaflet was last approved in April 2015.

Yellow Card Scheme

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1 million International Units (IU)
Powder for Solution for Infusion


Summary of Product Characteristics for

1061604 Issue 5 UK


Summary of Product Characteristics for


1 million International Units (IU)
Powder for Solution for Infusion

Paediatric population

4.3 Contraindications

The following dose recommendations are made based on limited
population-pharmacokinetic data in critically ill patients (see section 4.4):

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.

Hypersensitivity to the active substance colistimethate sodium or other

Adults and adolescents
Maintenance dose 9 MIU/day in 2-3 divided doses.
In patients who are critically ill, a loading dose of 9 MIU should be
The most appropriate time interval to the first maintenance dose has
not been established.
Modelling suggests that loading and maintenance doses of up to
12 MIU may be required in patients with good renal function in some
cases. Clinical experience with such doses is however extremely
limited and safety has not been established.

Children ≤ 40kg: 75,000 - 150,000 IU/kg/day divided into 3 doses.
For children with a body weight above 40 kg, use 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.
There are no data regarding the use or magnitude of a loading dose in
critically ill children.
No dose recommendations have been established in children with
impaired renal function.
Intrathecal and intraventricular administration

Renal impairment


The loading dose applies to patients with normal and impaired renal
functions including those on renal replacement therapy.

Intraventricular route: 125,000 IU/day

Dose adjustments in renal impairment are necessary, but
pharmacokinetic data available for patients with impaired renal function
is very limited.

Intrathecally administered doses should not exceed those
recommended for intraventricular use.

The following dose adjustments are suggested as guidance.
Promixin, 1 million International Units (IU), Powder for Solution for

Dose reductions are recommended for patients with creatinine
clearance < 50 mL/min: Twice daily dosing is recommended.

Creatinine clearance

Daily dose

< 50 - 30

5.5 - 7.5 MIU

< 30 - 10

4.5 - 5.5 MIU

< 10


3.5 MIU

Each vial contains 1 million International Units (IU) which is
approximately equivalent to 80 mg of colistimethate sodium.

Powder for solution for infusion
The powder is white to off white

4.1 Therapeutic indications
Promixin is indicated in adults and children including neonates for the
treatment of serious infections due to selected aerobic Gram-negative
pathogens in patients with limited treatment options (see sections 4.2,
4.4, 4.8 and 5.1).

MIU = million IU

Based on limited data, the following dose is recommended in adults:

No specific dosing recommendation can be made in children for
intrathecal and intraventricular routes of administration.
Method of administration
Promixin is administered intravenously as a slow infusion over
30 - 60 minutes.
Patients fitted with a totally implantable venous access device (TIVAD)
may tolerate an injection of up to 2 MIU in 10 mL given over a minimum
of 5 minutes.
Colistimethate sodium undergoes hydrolysis to the active substance
colistin in aqueous solution. For dose preparation, particularly where
combination of multiple vials is needed, reconstitution of the required
dose must be performed using strict aseptic technique (see section 6.6).

Haemodialysis and continuous haemo(dia)filtration:

Dose conversion table:

Colistin appears to be dialyzable through conventional haemodialysis
and continuous venovenous haemo(dia)filtration (CVVHF, CVVHDF).
There are extremely limited data from population PK studies from very
small numbers of patients on renal replacement therapy. Firm dose
recommendations cannot be made. The following regimes could be

In the EU, the dose of colistimethate sodium (CMS) must be prescribed
and administered only as International Units (IU). The product label
states the number of IU per vial.

No-HD days: 2.25 MIU/day (2.2 - 2.3 MIU/day).
HD days: 3 MIU/day on haemodialysis days, to be given after the
HD session.

Consideration should be given to official guidance on the appropriate
use of antibacterial agents.

The following conversion table is prepared for information and the
values must be considered nominal and approximate only.

CMS conversion table

Twice daily dosing is recommended.

4.2 Posology and method of administration

Confusion and medication errors have occurred because of the
different expressions of dose in terms of potency. The dose is
expressed in the US, and other parts of the world, as milligrams of
colistin base activity (mg CBA).

The dose to be administered and the treatment duration should take
into account the severity of the infection as well as the clinical response.
Therapeutic guidelines should be adhered to.
The dose is expressed in international units (IU) of colistimethate sodium
(CMS). A conversion table from CMS in IU to mg of CMS as well as to
mg of colistin base activity (CBA) is included at the end of this section.

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As in patients with normal renal function. Three times daily dosing is


≈ mg CBA

≈ mass of CMS




Hepatic impairment














There are no data in patients with hepatic impairment. Caution is
advised when administering colistimethate sodium in these patients.
Older people
No dose adjustments in older patients with normal renal function are
considered necessary.

* Nominal potency of the drug substance = 12,500 IU/mg

4.4 Special warnings and precautions for use

severity. It is important to consider this diagnosis in patients who
develop diarrhoea during or after the use of colistimethate sodium
(see section 4.8). Discontinuation of therapy and the administration
of specific treatment for Clostridium difficile should be considered.
Medicinal products that inhibit peristalsis should not be given.

Consideration should be given to co-administering intravenous
colistimethate sodium with another antibacterial agent whenever this
is possible, taking into account the remaining susceptibilities of the
pathogen(s) under treatment. As the development of resistance to
intravenous colistin has been reported in particular when it is used as
a monotherapy, co- administration with other antibacterial should also
be considered in order to prevent the emergence of resistance.

Intravenous colistimethate sodium does not cross the blood brain
barrier to a clinically relevant extent. The use of intrathecal or
intraventricular administration of colistimethate sodium in the treatment
of meningitis was not systematically investigated in clinical trials and is
supported by case reports only. Data supporting the posology are very
limited. The most commonly observed adverse effect of CMS
administration was aseptic meningitis (see section 4.8).

There are limited clinical data on the efficacy and safety of intravenous
colistimethate sodium. The recommended doses in all subpopulations
are equally based on limited data (clinical and pharmacokinetic/
pharmacodynamics data). In particular there are limited safety data for
the use of high doses (> 6 MIU/day) and the use of a loading dose, and
for special populations (patients with renal impairment and the paediatric
population). Colistimethate sodium should only be used when other,
more commonly prescribed antibiotics are not effective or not

4.5 Interaction with other medicinal products and other
forms of interaction

Renal function monitoring should be performed at the start of treatment
and regularly during treatment in all patients. The dose of colistimethate
sodium should be adjusted according to creatinine clearance (see
section 4.2). Patients who are hypovolaemic or those receiving other
potentially nephrotoxic drugs are at increased risk of nephrotoxicity from
colistin (see sections 4.5 and 4.8). Nephrotoxicity has been reported to
be associated with cumulative dose and treatment duration in some
studies. The benefit of prolonged treatment duration should be
balanced against the potentially increased risk of renal toxicity.

No in vivo interaction studies have been performed. The mechanism of
conversion of colistimethate sodium to the active substance, colistin, is
not characterised. The mechanism of colistin clearance, including renal
handling, is equally unknown. Colistimethate sodium or colistin did not
induce the activity of any P 450 (CYP) enzyme tested (CYP1A2, 2B6,
2C8, 2C9, 2C19 and 3A4/5) in in vitro studies in human hepatocytes.

Caution is advised when administering colistimethate sodium to infants
< 1 year of age as renal function is not fully mature in this age group.
Further, the effect of immature renal and metabolic function on the
conversion of colistimethate sodium to colistin is not known.
In case of an allergic reaction, treatment with colistimethate sodium
must be discontinued and appropriate measures implemented.
High serum concentrations of colistimethate sodium, which may be
associated with overdosage or failure to reduce the dosage in patients
with renal impairment, have been reported to lead to neurotoxic effects
such as facial paraesthesia, muscle weakness, vertigo, slurred speech,
vasomotor instability, visual disturbances, confusion, psychosis and
apnoea. Monitoring should be performed for perioral paraesthesia and
paraesthesia in the extremities, which are signs of overdose (see
section 4.9).
Colistimethate sodium is known to reduce the presynaptic release of
acetylcholine at the neuromuscular junction and should be used in
patients with myasthenia gravis with the greatest caution and only if
clearly needed.
Respiratory arrest has been reported following intramuscular
administration of colistimethate sodium. Impaired renal function
increases the possibility of apnoea and neuromuscular blockade
following administration of colistimethate sodium.
Colistimethate sodium should be used with extreme caution in patients
with porphyria.
Antibiotic-associated colitis and pseudomembranous colitis have
been reported with nearly all anti-bacterial agents and may occur with
colistimethate sodium. They may range from mild to life- threatening in

Concomitant use of intravenous colistimethate sodium with other
medications that are potentially nephrotoxic or neurotoxic should be
undertaken with the greatest caution.
Caution should be taken with concomitant use with other formulations
of colistimethate sodium as there is little experience and there is a
possibility of summative toxicity.

The potential for drug-drug interactions should be borne in mind when
Promixin is co-administered with drugs known to inhibit or induce drug
metabolising enzymes or drugs known to be substrates for renal carrier
Due to the effects of colistin on the release of acetylcholine,
non-depolarising muscle relaxants should be used with caution in
patients receiving colistimethate sodium as their effects could be
prolonged (see section 4.4).
Co-treatment with colistimethate sodium and macrolides such as
azithromycin and clarithromycin, or fluoroquinolones such as norfloxacin
and ciprofloxacin should be undertaken with caution in patients with
myasthenia gravis (see section 4.4).

4.6 Fertility, pregnancy and lactation
There are no data on the effects of colistimethate sodium on human
fertility. Effects on male and female fertility have not been evaluated in
animal studies.
Safety in human pregnancy has not been established. Animal studies
are insufficient with respect to effects on reproduction. There is
evidence that colistimethate sodium crosses the placenta and
consequently there is potential for foetal toxicity if administered during
pregnancy. Hence, Promixin should only be given during pregnancy if
the benefits outweigh any potential risk.
Colistimethate sodium is excreted
in breast milk; breast feeding is not
recommended during therapy.

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4.7 Effects on ability to drive and use machines

Reporting of suspected adverse reactions

Neurotoxicity, characterised by dizziness, confusion or visual
disturbances have been reported following parenteral administration of
colistimethate sodium. If these effects occur patients should be warned
against driving or operating machinery.

Reporting suspected adverse reactions after authorisation of the
medicinal product is important. It allows continued monitoring of the
benefit/risk balance of the medicinal product. Healthcare professionals
are asked to report any suspected adverse reactions via;

4.8 Undesirable effects

Yellow Card Scheme

The most commonly reported adverse reaction is renal function
impairment, and more rarely renal failure, usually following use of higher
than recommended doses in patients with normal renal function, or
failure to reduce the dosage in patients with renal impairment or when
used concomitantly with other nephrotoxic antibiotics. The effect is
usually reversible on discontinuation of therapy, but rarely intervention
(renal replacement therapy) may be required.
High serum concentrations of colistimethate sodium, which may be
associated with overdosage or failure to reduce the dosage in patients
with renal impairment, have been reported to lead to neurotoxic effects
such as facial paraesthesia, muscle weakness, vertigo, slurred speech,
vasomotor instability, visual disturbances, confusion, psychosis and
apnoea. Concomitant use with either non-depolarising muscle relaxants
or antibiotics with similar neurotoxic effects can also lead to neurotoxicity.
Dose reduction of colistimethate sodium may relieve symptoms.
Hypersensitivity reactions such as skin rash and angioedema have
been known to occur. In the event such reactions occur, treatment with
colistimethate sodium should be withdrawn.
Adverse reactions are tabulated below by system organ class and
frequency. Frequencies are defined as very common (≥1/10): common
(≥1/100 to <1/10): uncommon (≥1/1,000 to <1/100): rare (≥1/10,000
to <1/1,000) and very rare (<1/10,000), not known (cannot be
estimated from the available data).

Body System


Reported adverse reaction

Immune system

Not known

Hypersensitivity reactions
such as skin rash and

Nervous system

Very Common

Not known
Skin and
tissue disorders

Very Common

Renal and urinary

Very Common

General disorders Not known
and administration
site conditions

Neurotoxicity such as,
facial, mouth and peri-oral
paraesthesia, headache, and
muscle weakness

Renal impairment
demonstrated by increased
blood creatinine and / or urea
and / or decreased creatinine
renal clearance
Renal failure
Injection site reaction

4.9 Overdose
Overdosage may cause renal insufficiency, renal failure, apnoea, muscle
weakness, vertigo, slurred speech, vasomotor instability, visual
disturbances, confusion and psychosis.
No antidote is available.
Management of overdose is by means of supportive treatment and
measures designed to increase clearance of colistimethate sodium such
as inducing an osmotic diuresis with mannitol, peritoneal dialysis or
prolonged haemodialysis.

5.1 Pharmacodynamic properties


EUCAST Breakpoints
Susceptible (S)
Acinetobacter S ≤ 2
Enterobacteriaceae S ≤ 2
Pseudomonas spp S ≤ 4

Resistant (R) a
R > 2 mg/L
R > 2 mg/L
R > 4 mg/L

Breakpoints apply to dosage of 2-3 MIU x 3. A loading dose (9 MIU) may be needed.

The prevalence of acquired resistance may vary geographically and
with time for selected species and local information on resistance is
desirable, particularly when treating severe infections. As necessary,
expert advice should be sought when the local prevalence of resistance
is such that the utility of the agent, in at least some types of infections,
is questionable.
Commonly susceptible species
Acinetobacter baumannii
Haemophilus influenzae
Klebsiella spp
Pseudomonas aeruginosa
Species for which acquired resistance may be a problem

Pharmacotherapeutic group: antibacterials for systemic use, other
antibacterials, polymyxins

Stenotrophomonas maltophilia
Achromobacter xylosoxidans (formerly Alcaligenes xylosoxidans)

ATC code: J01XB01

Inherently resistant organisms

General properties
Mechanism of action
Colistin is a cyclic polypeptide antibacterial agent belonging to the
polymyxin group. Polymyxins work by damaging the cell membrane
and the resulting physiological effects are lethal to the bacterium.
Polymyxins are selective for aerobic Gram-negative bacteria that have
a hydrophobic outer membrane.
Resistant bacteria are characterised by modification of the phosphate
groups of lipopolysaccharide, which become substituted with
ethanolamine or aminoarabinose. Naturally resistant Gram-negative
bacteria, such as Proteus mirabilis and Burkholderia cepacia, show
complete substitution of their lipid phosphate by ethanolamine or
Cross resistance between colistin (polymyxin E) and polymyxin B is
expected. Since the mechanism of action of the polymyxins is different
from that of other antibacterial agents, resistance to colistin and
polymyxin by the above mechanism alone would not be expected
to result in resistance to other drug classes.
PK/PD relationship
Polymyxins have been reported to have a concentration-dependent
bactericidal effect on susceptible bacteria. fAUC/ MIC is considered
to be correlated with clinical efficacy.

Burkholderia cepacia and related species
Proteus spp
Providencia spp
Serratia spp

5.2 Pharmacokinetic properties
The information on the pharmacokinetics of colistimethate
sodium (CMS) and colistin is limited. There are indications that
pharmacokinetics in critically ill patients differ from those in patients
with less severe physiological derangement and from those in healthy
volunteers. The following data are based on studies using HPLC to
determine CMS/colistin plasma concentrations.

6.5 Nature and contents of container

It is estimated that approximately 30% of colistimethate sodium is
converted to colistin in healthy subjects, its clearance is dependent on
creatinine clearance and as renal function decreases, a greater portion
of CMS is converted to colistin. In patients with very poor renal function
(creatinine clearance <30 mL/min), the extent of conversion could be
as high as 60 to 70%. CMS is eliminated predominantly by the kidneys
via glomerular filtration. In healthy subjects, 60% to 70% of CMS is
excreted unchanged in the urine within 24 hours.

The product is supplied in clear type I glass vials sealed with a
siliconised chlorobutyl type I rubber stopper and protected by a 20 mm
aluminium tear-off cap incorporating a red flip-up central plastic top.
The product is supplied in pack sizes of 10 vials.

The elimination of the active colistin is incompletely characterised.
Colistin undergoes extensive renal tubular reabsorption and may either
be cleared non-renally or undergo renal metabolism with the potential
for renal accumulation. Colistin clearance is decreased in renal
impairment, possibly due to increased conversion of CMS.
Half-life of colistin in healthy subjects and those with cystic fibrosis
is reported to be around 3h and 4h, respectively, with a total clearance
of around 3L/h. In critically ill patients, half-life has been reported to
be prolonged to around 9-18h.

5.3 Preclinical safety data
Animal studies are insufficient with respect to effects on reproduction.
Data on potential genotoxicity are limited and carcinogenicity data
for colistimethate sodium are lacking. Colistimethate sodium has been
shown to induce chromosomal aberrations in human lymphocytes,
in vitro. This effect may be related to a reduction in mitotic index,
which was also observed.

6.1 List of excipients

6.2 Incompatibilities
This medicinal product must not be mixed with other medicinal
products except those mentioned in section 6.6.

6.3 Shelf life



Absorption of colistimethate sodium from the gastrointestinal tract
does not occur to any appreciable extent in the normal individual.

Two years
After reconstitution:


Chemical and physical in-use stability has been demonstrated for up
to 8 hours at room temperature.

The volume of distribution of colistin in healthy subjects is low and
corresponds approximately to extracellular fluid (ECF). The volume of
distribution is relevantly enlarged in critically ill subjects. Protein binding
is moderate and decreases at higher concentrations. In the absence of
meningeal inflammation, penetration into the cerebrospinal fluid (CSF)
is minimal, but increases in the presence of meningeal inflammation.

From a microbiological point of view solutions should be used
immediately. If not used immediately in-use storage times and
conditions prior to use are the responsibility of the user and would
normally not be longer than 24 hours at 2 to 8ºC, unless reconstitution/
dilution has taken place in controlled and validated aseptic conditions.

Both CMS and colistin display linear PK in the clinically relevant dose

6.4 Special precautions for storage


For storage conditions of the reconstituted/diluted product see
section 6.3.

After infusion of colistimethate sodium the inactive pro-drug is
converted to the active colistin. Peak plasma concentrations of
colistin have been shown to occur with a delay of up to 7 hours
after administration of colistimethate sodium in critically ill patients.

Do not store above 25ºC

6.6 Special precautions for disposal and other handling
For single use only.
Promixin must be reconstituted, under aseptic conditions, with sodium
chloride solution 9 mg/mL (0.9%) to produce a clear colourless to pale
yellow solution. Following reconstitution, the solution should be diluted
to a suitable volume for infusion over 30 - 60 minutes with sodium
chloride solution 9 mg/mL (0.9%) for infusion. The solution should
be inspected visually for particulate matter and discoloration prior to
administration. The solution should only be used if the solution is clear
and free from particles.
Solutions should be used immediately after reconstitution (see
section 4.2).
Discard any unused solution. Waste material should be disposed of in
accordance with local requirements.

Profile Pharma Limited
Bicentennial Building
Southern Gate
West Sussex
PO19 8EZ
United Kingdom

PL 19419/0002


Date of first authorisation: 24th June 2003
Date of latest renewal: 13th March 2009

10th April 2015.


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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.