CISATRACURIUM SXP cisatracurium (as besilate) 10mg/5mL injection solution in vial

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

cisatracurium besilate

Available from:

Southern Cross Pharma Pty Ltd

INN (International Name):

cisatracurium besilate

Patient Information leaflet

________________________________________________________________________________
C: Products/Cisatracurium/CMI SXP oct12 14/10/12 Page
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CISATRACURIUM SXP INJECTION SOLUTION
_cisatracurium (as besylate) _
CONSUMER MEDICINE INFORMATION
_ _
What is in this leaflet
This leaflet answers some common
questions about CISATRACURIUM
SXP. It does not contain all of the
available information.
Reading this leaflet does not take the
place of talking to your doctor or
pharmacist.
Taking any medicine involves some
risk. It is possible that all risks
associated with this medicine might not
have been detected, despite proper
testing. Only your doctor or pharmacist
is able to weigh up all of the relevant
facts, and you should consult them if
you have any queries.
If you have any concerns about the use
of CISATRACURIUM SXP ask your
doctor or pharmacist.
KEEP THIS INFORMATION.
You may want to read it again.
This leaflet provides information about
CISATRACURIUM SXP. The
statements that are made in this leaflet
cannot be applied to any other
medicine, even those that are similar or
appear to contain the same ingredients.
What CISATRACURIUM
SXP is used for
CISATRACURIUM SXP is used to
relax the body's muscles.
CISATRACURIUM SXP will
normally be given to you when you are
in surgery, or during other medical
procedures. CISATRACURIUM SXP
is only used in conjunction with an
anaesthetic, so you will be asleep
during the procedure.
If you have any questions about why
CISATRACURIUM SXP is used ask
your doctor.
How does
CISATRACURIUM SXP
work?
Cisatracurium besylate (the active
ingredient in CISATRACURIUM
SXP) belongs to a group of medicines
called "neuromuscular blockers".
CISATRACURIUM SXP works by
blocking the effects of one of the
body's chemical messengers called
acetylcholine. Acetylcholine is
involved in muscle contraction.
By relaxing your body's muscles
CISATRACURIUM SXP makes it
easier for you to be kept asleep (under
anaesthesia) or sedation.
Your doctor will be able to provide you
with more information.
Before you use it
CISAT

Summary of Product characteristics

C:Products/Cisatracurium/PI SXP June2017
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PRODUCT INFORMATION
CISATRACURIUM SXP INJECTION SOLUTION
NAME OF THE MEDICINE
Cisatracurium (as besilate)
Chemical name: (1
_R_
,1'
_R_
,2
_R_
,2'
_R_
)-2,2'-(3,11-Dioxo-4,10-dioxatridecamethylene) bis-
(1,2,3,4-tetrahydro-6,7-dimethoxy-2-methyl-1- veratrylisoquinolinium)
dibenzenesulfonate.
The chemical structure of cisatracurium besilate is:
Cisatracurium besilate
Molecular formula: C
65
H
82
N
2
O
18
S
2
MW: 1,243.5
CAS number: 96946-42-8
DESCRIPTION
Cis-atracurium besilate is a white to off white powder.
The injection solution contains benzenesulfonic acid, Water for
Injections and is
preservative free.
PHARMACOLOGY
Cisatracurium besilate, a stereoisomer of atracurium, is an
intermediate duration,
nondepolarising benzylisoquinolinium skeletal muscle relaxant.
PHARMACODYNAMICS
Cisatracurium besilate binds to cholinergic receptors on the motor
endplate to
antagonise the action of acetylcholine, resulting in a competitive
block of
neuromuscular transmission. This action is readily reversed by
anticholinesterase
agents such as neostigmine.
C:Products/Cisatracurium/PI SXP June2017
Page 2 of 16
The ED
95
(dose required to produce 95% depression of the twitch response of the
adductor pollicis muscle to stimulation of the ulnar nerve) of
cisatracurium besilate is
estimated to be 0.05 mg/kg bodyweight during opioid anaesthesia
(thiopentone,
fentanyl, midazolam). The recommended intubation dose for
cisatracurium in adults is
three times the ED
95
, which has a longer clinically effective duration than the
recommended intubation dose of atracurium (two times the ED
95
) (see Dosage and
Administration).
The ED
95
of cisatracurium besilate in children during halothane anaesthesia is
0.04
mg/kg bodyweight.
PHARMACOKINETICS
Cisatracurium besilate undergoes degradation in the body at
physiological pH and
temperature by Hofmann elimination to form laudanosine and the
monoquaternary
acrylate metabolite. The monoquaternary acrylate undergoes hydrolysis
by
nonspecific plasma