Colistimethate sodium 1 million IU Powder for solution for injection/infusion

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Colistimethate sodium

Available from:

Noridem Enterprises Limited

ATC code:

J01XB01

INN (International Name):

Colistimethate sodium

Pharmaceutical form:

Powder for solution for injection/infusion

Therapeutic area:

colistin

Authorization status:

Not marketed

Authorization date:

2023-06-09

Patient Information leaflet

1
PACKAGE LEAFLET
2
PACKAGE LEAFLET: INFORMATION FOR THE USER
COLISTIMETHATE SODIUM_ _1 MILLION IU POWDER FOR SOLUTION FOR
INJECTION/INFUSION
COLISTIMETHATE SODIUM 2 MILLION IU POWDER FOR SOLUTION FOR
INJECTION/INFUSION
Colistimethate sodium
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU ARE GIVEN 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 or pharmacist.
-
If you get any side effects, talk to your doctor. This includes any
possible side effects not listed
in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Colistimethate sodium is and what it is used for
2.
What you need to know before you are given Colistimethate sodium
3.
How Colistimethate sodium
_ _
is given
4.
Possible side effects
5.
How to store Colistimethate sodium
6.
Contents of the pack and other information
1.
WHAT COLISTIMETHATE SODIUM IS AND WHAT IT IS USED FOR
This medicine
_ _
contains the active substance colistimethate sodium. Colistimethate
sodium is an
antibiotic. It belongs to a group of antibiotics that are called
polymyxins.
This medicine
_ _
is given by injection to treat some types of serious infections caused
by certain bacteria.
It is used when other antibiotics are not suitable.
2.
WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN COLISTIMETHATE SODIUM_ _
COLISTIMETHATE SODIUM_ _MUST NOT BE GIVEN
-
If you are allergic to colistimethate sodium, colistin or to other
polymyxins
.
WARNINGS AND PRECAUTIONS
Talk to your doctor, pharmacist or nurse before receiving
Colistimethate sodium
_ _
if:
- if you have or have had kidney problems
- if you suffer from myasthenia gravis
- if you suffer from porphyria
- if you suffer from asthma
If you experience muscle spasm, fatigue or increased urine output at
any time, tell your doctor
immediately as these events may be related to a condition known as
pseudo-Bartter syndrome.
CHILDREN
In premature and new-born babies, special care should be taken when
using Colistimethate s

Summary of Product characteristics

Health Products Regulatory Authority
20 June 2023
CRN00DKJQ
Page 1 of 9
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Colistimethate sodium 1 million IU Powder for solution for
injection/infusion
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial contains 1 million IU colistimethate sodium.
3 PHARMACEUTICAL FORM
Powder for solution for injection/infusion.
White to off white powder.
pH of 1 vial Colistimethate sodium 1 million IU powder in 10 ml: 6.5 -
8.5
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Colistimethate sodium 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).
Consideration should be given to official guidance on the appropriate
use of antibacterial agents.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
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.
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 million IU
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 to 12
million IU 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.
The loading dose applies to patients with normal and impai