COLOMYCIN 1 International Unit Pdr for Soln Inj/Inf
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Patient Information leaflet
(PIL)
24-03-2016
Summary of Product characteristics
(SPC)
14-09-2017
Active ingredient:
COLISTIN MESILATE SODIUM
Available from:
Forest Laboratories UK Ltd
ATC code:
J01XB01
INN (International Name):
COLISTIN MESILATE SODIUM
Dosage:
1 International Unit
Pharmaceutical form:
Pdr for Soln Inj/Inf
Prescription type:
Product subject to prescription which may not be renewed (A)
Therapeutic area:
Polymixins
Authorization status:
Authorised
Authorization date:
2005-06-07
Patient Information leaflet
Page 1 of 6
PACKAGE LEAFLET: INFORMATION FOR THE USER
COLOMYCIN INJECTION 1 MILLION OR 2 MILLION INTERNATIONAL UNITS
POWDER FOR SOLUTION FOR INJECTION, INFUSION OR INHALATION
Colistimethate Sodium
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
Keep this leaflet. You may need to read it again.
If you have any further questions, ask your doctor.
This medicine has been prescribed for you only. Do not pass
it on to others. It may harm them,
even if their signs of illness are the same as yours.
If you get any side effects, talk to your doctor. This
includes any possible side effects not listed
in this leaflet.
WHAT IS IN THIS LEAFLET
1.
What Colomycin is and what it is used for
2.
What you need to know before you use Colomycin
3.
How to use Colomycin
4.
Possible side effects
5.
How to store Colomycin
6.
Contents of the pack and other information
1.
WHAT COLOMYCIN IS AND WHAT IT IS USED FOR
Colomycin contains the active substance colistimethate sodium.
Colistimethate sodium is an
antibiotic. It belongs to a group of antibiotics that are called
polymyxins.
Colomycin is given by injection to treat some
types of serious infections caused by certain bacteria.
Colomycin is used when other antibiotics are not suitable.
Colomycin is given as an inhalation to treat chronic
chest infections in patients with cystic fibrosis.
Colomycin is used when these infections are caused by specific
bacteria called _Pseudomonas _
_aeruginosa. _
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE COLOMYCIN
DO NOT USE COLOMYCIN:
- If you are allergic (hypersensitive) to colistimethate sodium,
colistin or to other polymyxins.
WARNINGS AND PRECAUTIONS
Talk to your doctor, pharmacist or nurse
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Summary of Product characteristics
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Colomycin Injection 1 million International Units.
Powder for solution for injection, infusion or inhalation.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial contains 1 million International Units Colistimethate
Sodium.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Powder for solution for injection, infusion or inhalation.
Sterile white powder in a 10ml colourless glass vial with a red
‘flip-off’ cap.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Colomycin by intravenous administration 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).
Colomycin by inhalation is also indicated for the management of adult
and paediatric chronic pulmonary infections due
to_ Pseudomonas aeruginosa_ in patients with cystic fibrosis (see
section 5.1).
Consideration should be given to official guidance on the appropriate
use of antibacterial agents.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
SYSTEMIC TREATMENT
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.
Posology
The following dose recommendations are made based on limited
population-pharmacokinetic data in critically ill patients
(see section 4.4):
_Adults and adolescents_
Maintenance dose 9 million IU/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.
Modelling suggests that loading and maintenance doses of up
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