Suxamethonium Chloride 50mg/ml Solution for Injection

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Suxamethonium chloride

Available from:

Mercury Pharmaceuticals (Ireland) Ltd

ATC code:

M03AB; M03AB01

INN (International Name):

Suxamethonium chloride

Dosage:

50 milligram(s)/millilitre

Pharmaceutical form:

Solution for injection

Prescription type:

Product subject to prescription which may not be renewed (A)

Therapeutic area:

Choline derivatives; suxamethonium

Authorization status:

Not marketed

Authorization date:

1988-12-20

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
SUXAMETHONIUM CHLORIDE 50MG/ML SOLUTION FOR INJECTION
suxamethonium chloride
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 nurse.
- If you get any side effects, talk to your doctor, nurse or
pharmacist. This includes any possible side effects
not listed in this leaflet. See section 4.
The name of your medicine is Suxamethonium Chloride 50mg/ml Solution
for Injection. It will be referred to
as Suxamethonium Chloride for ease hereafter.
WHAT IS IN THIS LEAFLET:
1. What Suxamethonium Chloride is and what it is used for
2. What you need to know before you are given Suxamethonium Chloride
3. How Suxamethonium Chloride
will be given to you
4. Possible side effects
5. How to store Suxamethonium Chloride
6. Contents of the pack and other information
1. WHAT SUXAMETHONIUM CHLORIDE IS AND WHAT IT IS USED FOR
Suxamethonium Chloride belongs to a group of medicines called muscle
relaxants. Their effect is to block
the connection between the nerves and certain muscles, which relaxes
these muscles by temporarily
paralysing them. This effect helps surgeons when performing
operations.
This medicine can also be used when a patient is put on a ventilator
to control breathing. During this
procedure, it is necessary for the muscles used for breathing to be
paralysed. Suxamethonium Chloride can
also
reduce
the
intensity
of
muscle
contractions
associated
with
drug-induced
convulsions
or
with
electroconvulsive therapy (ECT).
2. WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN SUXAMETHONIUM CHLORIDE
YOU SHOULD NOT BE GIVEN SUXAMETHONIUM CHLORIDE
• if you are allergic to Suxamethonium Chloride, any other muscle
relaxants or any of the other ingredients
of this medicine (listed in section 6)
• if you or your family have reacted badly to an anaesthetic before
such as a very high body temperature
(malignant hyperthermia)

Summary of Product characteristics

Health Products Regulatory Authority
16 September 2022
CRN00D3GG
Page 1 of 12
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Genotoxicity:No bacterial mutation assays have been conducted. There
are some data to suggest a weak clastogenic effect in
mice, but not in patients who had received suxamethonium chloride.
Carcinogenicity:Carcinogenicity studies have not been
performed. Embryo-foetal Development:Animal reproduction studies have
not been conducted with suxamethonium. It is also
not known whether suxamethonium can affect reproductive capacity or
cause foetal harm when administered to a pregnant
woman.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 2ml of solution contains Suxamethonium Chloride 100mg (50mg/ml)
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Solution for injection or infusion.
Clear colourless sterile solution.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Suxamethonium chloride Injection is an ultra-short acting,
depolarising, neuromuscular blocking agent. It is used in anaesthesia
as a skeletal muscle relaxant to facilitate tracheal intubation and
mechanical ventilation in surgical procedures.
Suxamethonium chloride injection is also used to reduce the intensity
of muscular contractions associated with
pharmacologically or electrically-induced convulsions.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Adults: _The dose is dependent on body weight, the degree of muscular
relaxation required, the route of administration, and the
response of individual patients.
To achieve endotracheal intubation, Suxamethonium is usually
administered intravenously in a dose of 1mg/kg. This dose will
usually produce muscular relaxation in about 30 to 60 seconds and has
a duration of action of about 2 to 6 minutes.
Larger doses will produce more prolonged muscular relaxation, but
doubling the dose does not necessarily double the
duration of relaxation.
Supplementary doses of Suxamethonium of 50% to 100% of the initial
dose administered at 5 to 10 minute in