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The following information is intended for medical
or healthcare professionals only
Anectine® 50 mg/ml
1. Trade Name of the Medicinal Product
Anectine 50 mg/ml Injection.
2. Qualitative and Quantitative Composition
Suxamethonium chloride Injection BP 100 mg in 2 ml.
For a full list of excipients, see section 6.1.
3. Pharmaceutical Form
Solution for injection.
4.1 Therapeutic Indications
Used in anaesthesia as a muscle relaxant to facilitate
endotracheal intubation, mechanical ventilation and a wide
range of surgical and obstetric procedures.
It is also used to reduce the intensity of muscular contractions
associated with pharmacologically or electrically‑induced
4.2 Posology and Method of Administration
Usually by bolus intravenous injection.
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 Anectine is usually
administered intravenously in a dose of 1 mg/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 Anectine of 50% to 100%
of the initial dose administered at 5 to 10 minute intervals will
maintain muscle relaxation during short surgical procedures
performed under general anaesthesia.
For prolonged surgical procedures Anectine may be given by
intravenous infusion as a 0.1% to 0.2% solution, diluted in
5% glucose solution or sterile isotonic saline solution, at a rate
of 2.5 to 4 mg per minute. The infusion rate should be adjusted
according to the response of individual patients.
The total dose of Anectine given by repeated intravenous injection
or continuous infusion should not exceed 500 mg per hour.
Children: Infants and young children are more resistant to
Anectine compared with adults.
The recommended intravenous dose of Anectine for neonates
and infants is 2 mg/kg. A dose of 1 mg/kg in older children is
When Anectine is given as intravenous infusion in children,
the dosage is as for adults with a proportionately lower initial
infusion rate based on body weight.
Anectine may be given intramuscularly to infants at
doses up to 4 to 5mg/kg and in older children up to
4 mg/kg. These doses produce muscular relaxation
within about 3 minutes. A total dose of 150 mg should
not be exceeded.
Use in the elderly: Dosage requirements of Anectine in
the elderly are comparable to those for younger adults.
The elderly may be more susceptible to cardiac
arrhythmias, especially if digitalis‑like drugs are
also being taken. See also ‘Special Warnings and
Precautions for Use’.
Instructions to open the ampoule
See Section 6.6 Special precautions for disposal and
other handling for further information.
Anectine has no effect on the level of consciousness and should
not be administered to a patient who is not fully anaesthetised.
Hypersensitivity to suxamethonium may exist in rare instances,
and Anectine should not be administered to patients known to
be hypersensitive to the drug.
As suxamethonium can act as a trigger of sustained
myofibrillar contraction in susceptible individuals, Anectine
is contra‑indicated in patients with a personal or family
history of malignant hyperthermia. If this condition occurs
unexpectedly, all anaesthetic agents known to be associated
with its development (including Anectine) must be immediately
discontinued, and full supportive measures must be immediately
instituted. Intravenous dantrolene sodium is the primary specific
therapeutic drug and is recommended as soon as possible after
the diagnosis is made.
Anectine is contra‑indicated in patients known to have an
inherited atypical plasma cholinesterase activity.
An acute transient rise in serum potassium often occurs
following the administration of Anectine in normal individuals;
the magnitude of this rise is of the order of 0.5 mmol/litre. In
certain pathological states or conditions this increase in serum
potassium following Anectine administration may be excessive
and cause serious cardiac arrhythmias and cardiac arrest. For this
reason the use of Anectine is contra‑indicated in:
In patients recovering from major trauma or severe burns; the
period of greatest risk of hyperkalaemia is from about 5 to
70 days after the injury and may be further prolonged if there is
delayed healing due to persistent infection.
Patients with neurological deficits involving acute major muscle
wasting (upper and/or lower motor neurone lesions); the potential
for potassium release occurs within the first 6 months after the
acute onset of the neurological deficit and correlates with the
degree and extent of muscle paralysis. Patients who have been
immobilised for prolonged periods of time may be at similar risk.
Patients with pre‑existing hyperkalaemia. In the absence
of hyperkalaemia and neuropathy, renal failure is not a
contra‑indication to the administration of a normal single dose
of Anectine Injection, but multiple or large doses may cause
clinically significant rises in serum potassium and should not be
Suxamethonium causes a significant transient rise in intra‑ocular
pressure, and should therefore not be used in the presence of
open eye injuries or where an increase in intra‑ocular pressure is
undesirable unless the potential benefit of its use outweighs the
potential risk to the eye.
Anectine should be avoided in patients with a personal or
family history of congenital myotonic diseases such as myotonia
congenita and dystrophia myotonica since its administration
may on occasion be associated with severe myotonic spasms and
Anectine should not be used in patients with skeletal muscle
myopathies e.g. Duchenne muscular dystrophy since its
administration may be associated with malignant hyperthermia,
ventricular dysrhythmias and cardiac arrest secondary to acute
rhabdomyolysis with hyperkalaemia.
4.4 Special Warnings and Precautions for Use
Anectine paralyses the respiratory muscles as well as other
skeletal muscles but has no effect on consciousness.
Anectine should be administered only by or under close
supervision of an anaesthetist familiar with its action,
characteristics and hazards, who is skilled in the management of
artificial respiration and only where there are adequate facilities
for immediate endotracheal intubation with administration of
oxygen by intermittent positive pressure ventilation.
High rates of cross‑sensitivity (greater than 50%) between
neuromuscular blocking agents have been reported. Therefore,
where possible, before administering suxamethonium,
hypersensitivity to other neuromuscular blocking agents
should be excluded. Suxamethonium, should only be used
when absolutely essential in susceptible patients. Patients who
experience a hypersensitivity reaction under general anaesthesia
should be tested subsequently for hypersensitivity to other
Anectine should not be mixed in the same syringe with any
other agent, especially thiopental.
During prolonged administration of Anectine, it is recommended
that the patient is fully monitored with a peripheral nerve
stimulator in order to avoid overdosage.
Anectine is rapidly hydrolysed by plasma cholinesterase which
thereby limits the intensity and duration of the neuromuscular
Individuals with decreased plasma cholinesterase activity exhibit
a prolonged response to suxamethonium. Approximately
0.05% of the population has an inherited cause of reduced
Prolonged and intensified neuromuscular blockade following
Anectine Injection may occur secondary to reduced plasma
cholinesterase activity in the following states or pathological
• physiological variation as in pregnancy and the puerperium
(see section 4.6 Fertility, Pregnancy and Lactation)
• genetically determined abnormal plasma cholinesterase (see
section 4.3 Contraindications)
• severe generalised tetanus, tuberculosis, other severe or
• following severe burns (see section 4.3 Contraindications)
• chronic debilitating disease, malignancy, chronic anaemia and
• end-stage hepatic failure, acute or chronic renal failure (see
section 4.2 Posology and Method of Administration)
• auto-immune diseases: myxoedema, collagen diseases
• iatrogenic: following plasma exchange, plasmapheresis,
cardiopulmonary bypass, and as a result of concomitant drug
therapy (see section 4.5 Interactions).
If Anectine is given over a prolonged period, the characteristic
depolarising neuromuscular (or Phase I) block may change
to one with characteristics of a non‑depolarising (or Phase
II) block. Although the characteristics of a developing Phase
II block resemble those of a true non‑depolarising block,
the former cannot always be fully or permanently reversed
by anticholinesterase agents. When a Phase II block is fully
established, its effects will then usually be fully reversible
with standard doses of neostigmine accompanied by an
Tachyphylaxis occurs after repeated administration of Anectine.
Muscle pains are frequently experienced after administration
of suxamethonium and most commonly occur in ambulatory
patients undergoing short surgical procedures under general
anaesthesia. There appears to be no direct connection between
the degree of visible muscle fasciculation after Anectine
administration and the incidence or severity of pain. The use
of small doses of non‑depolarising muscle relaxants given
minutes before suxamethonium administration has been
advocated for the reduction of incidence and severity of
suxamethonium‑associated muscle pains. This technique may
require the use of doses of suxamethonium in excess of 1mg/kg
to achieve satisfactory conditions for endotracheal intubation.
Caution should be exercised when using suxamethonium in
children, since paediatric patients are more likely to have
an undiagnosed myopathy or an unknown predisposition to
malignant hyperthermia and rhabdomyolysis, which places
them at increased risk of serious adverse events following
suxamethonium (see section 4.3 Contraindications and
section 4.8 Adverse Reactions).
In patients with severe sepsis, the potential for
hyperkalaemia seems to be related to the severity and
duration of infection.
It is inadvisable to administer Anectine to patients with
advanced myasthenia gravis. Although these patients
are resistant to suxamethonium they develop a state
of Phase II block which can result in delayed recovery.
Patients with myasthenic Eaton‑Lambert syndrome are
more sensitive than normal to Anectine, necessitating
2. What you need to know before
you are given Anectine
Package Leaflet: Information for the
Anectine® 50 mg / ml
Read all of this leaflet carefully before
you are given this medicine because it
contains important information for you.
• eep this leaflet. You may need to read it
• f you have any further questions, ask
your doctor, nurse or member of the
operating theatre staff.
• f you get any side effects, talk to your
doctor, nurse, or member of the operating
theatre staff. This includes any possible
side effects not listed in this leaflet. See
What is in this leaflet:
1. What Anectine is and what it is used for
2. hat you need to know before you are
3. ow Anectine is given
4. ossible side effects
5. ow to store Anectine
6. ontents of the pack and other
1. What Anectine is and what it
is used for
Anectine contains a medicine called
suxamethonium chloride. This belongs to a
group of medicines called muscle relaxants.
Anectine is used:
• o relax muscles during operations on
adults and children
• o help insert a tube into the windpipe
(endotracheal intubation), if a person
needs help to breathe
• o reduce how strongly your muscles
Ask your doctor if you would like more
explanation about this medicine.
You should not be given Anectine if:
• ou are allergic to suxamethonium
chloride, any other muscle relaxants or
any of the other ingredients of Anectine
Injection (listed in section 6)
• ou or your family have reacted badly to an
anaesthetic before such as a very high body
temperature (malignant hyperthermia)
• ou have had a major accident, operation
or severe burns within the last three
• ou have not been able to move for a
long time such as to allow a broken bone
to mend or a long period of bed rest
• ou have high levels of potassium in your
• ou have recently had an eye injury
• ou suffer from a problem caused by too
much pressure in your eye called ‘glaucoma’
• ou or any of your family have a disease
of the muscles or nerves, such as a
muscle wasting disease, paralysis, motor
neurone disease, muscular dystrophy or
If any of the above apply to you or if you
are not sure, talk to your doctor, nurse
or member of the operating theatre staff
before you are given Anectine.
Warnings and precautions
Talk to your doctor, nurse or member of the
operating theatre staff before having this
medicine if you have:
• etanus, an infection which occurs
through wound contamination
• uberculosis or other severe or long
• ad any long standing illness which has
left you weak
• iver or kidney problems
• uto-immune diseases, for example,
• n underactive thyroid gland, a condition
known as myxoedema
• uscle disease, for example, myasthenia
• ecently had a blood transfusion or a
heart-lung by pass
• een in contact with insecticides
• ver had an allergic reaction to any
muscle relaxant which was given as part
of an operation.
Other medicines and Anectine
Tell your doctor, nurse or other relevant
hospital staff member if you are taking or
have recently taken any other medicines. This
includes any herbal products or medicines
bought without a prescription. This is because
these medicines can affect how well Anectine
works or can cause side effects.
In particular tell your doctor, nurse or
member of the operating theatre staff if
you are taking any of the following:
• naesthetics, or other medicines used
during surgery such as pain killers
• edicines for raised pressure in the eye
(glaucoma) such as ecothiophate eye drops
• edicines for coughs, cold, sleeping or
tablets for allergies
• edicines used to treat malaria,
containing chloroquine or quinine
• ral contraceptives
• edicines for treating asthma and other
• edicines containing metoclopramide,
used to treat and prevent feeling or being
• edicines for treating cancer (cytotoxic
• edicines for mental problems
• edicines containing magnesium
• edicines containing oestrogens
• edicines containing steroids
• edicines used to treat
disturbances in heartbeat rhythm
• edicines used to treat myasthenia gravis
• edicines used to control your heart
• edicines used to control your blood
pressure during surgery
• edicines that can affect the
way your body fights disease
(immunosuppressants) such as
azathioprine. These can be used to stop
your body rejecting a transplanted organ
or for ‘auto-immune’ diseases such as
• medicines used to treat depression and/
or anxiety SSRIs (selective serotonin
reuptake inhibitors) including fluoxetine,
paroxetine, sertraline, fluvoxamine,
In healthy adults, Anectine occasionally causes a mild
transient slowing of the heart rate on initial administration.
Bradycardias are more commonly observed in children and on
repeated administration of suxamethonium in both children
and adults. Pre‑treatment with intravenous atropine or
glycopyrrolate significantly reduces the incidence and severity of
In the absence of pre‑existing or evoked hyperkalaemia,
ventricular arrhythmias are rarely seen following
suxamethonium administration. Patients taking digitalis‑like
drugs are however more susceptible to such arrhythmias. The
action of suxamethonium on the heart may cause changes in
cardiac rhythm including cardiac arrest.
4.5 Interactions with Other Medicaments and Other Forms of
Certain drugs or chemicals are known to reduce normal
plasma cholinesterase activity and may therefore prolong the
neuromuscular blocking effects of Anectine. These include:
• organophosphorous insecticides and metriphonate
• ecothiopate eye drops
• specific anticholinesterase agents: neostigmine, pyridostigmine,
physostigmine, edrophonium; tacrine hydrochloride
• cytotoxic compounds: cyclophosphamide, mechlorethamine,
triethylene‑melamine, and thiotepa
• psychiatric drugs: phenelzine, promazine and chlorpromazine
• anaesthetic agents and drugs: ketamine, morphine and
morphine antagonists, pethidine, pancuronium, propanidid
• selective serotonin reuptake inhibitors (SSRI).
Other drugs with potentially deleterious effects on plasma
cholinesterase activity include aprotinin, diphenhydramine,
promethazine, oestrogens, oxytocin, high-dose steroids, and oral
contraceptives, terbutaline and metoclopramide.
Certain drugs or substances may enhance or prolong the
neuromuscular effects of Anectine by mechanisms unrelated to
plasma cholinesterase activity. These include:
• magnesium salts
• lithium carbonate
• quinine and chloroquine
• antibiotics such as the aminoglycosides, clindamycin and
• antiarrhythmic drugs: quinidine, procainamide, verapamil,
beta‑blockers, lidocaine and procaine
• volatile inhalational anaesthetic agents: halothane, enflurane,
desflurane, isoflurane, diethylether and methoxyflurane have
little effect on the Phase I block of Anectine Injection but will
accelerate the onset and enhance the intensity of a Phase II
Patients receiving digitalis‑like drugs are more susceptible to the
effects of suxamethonium‑exacerbated hyperkalaemia.
4.6 Fertility, Pregnancy and Lactation
No studies of the effect of suxamethonium on female fertility or
pregnancy have been performed.
Suxamethonium has no direct action on the uterus or other
smooth muscle structures. In normal therapeutic doses it does
not cross the placental barrier in sufficient amounts to affect the
respiration of the infant.
The benefits of the use of suxamethonium as part of a rapid
sequence induction for general anaesthesia normally outweigh
the possible risk to the foetus.
Plasma cholinesterase levels fall during the first trimester of
pregnancy to about 70 to 80% of their pre‑pregnancy values;
a further fall to about 60 to 70% of the pre‑pregnancy levels
occurs within 2 to 4 days after delivery. Plasma cholinesterase
levels then increase to reach normal over the next 6 weeks.
Consequently, a high proportion of pregnant and puerperal
patients may exhibit mildly prolonged neuromuscular blockade
following Anectine Injection.
It is not known whether suxamethonium or its metabolites are
excreted in human milk.
4.7 Effects on Ability to Drive and Use Machines
This precaution is not relevant to the use of suxamethonium
injection. Suxamethonium will always be used in combination with
a general anaesthetic and therefore the usual precautions relating
to performance of tasks following general anaesthesia apply.
4.8 Undesirable Effects
Adverse reactions are listed below by system organ class and
frequency. Estimated frequencies were determined from
published data. Frequencies are defined as follows: very common
(≥1/10); common (≥1/100 and <1/10), uncommon (≥1/1,000 and
<1/100); rare (≥1/10,000 and <1/1,000); very rare (<1/10,000).
Immune system disorders
Increased intraocular pressure.
Arrhythmias (including ventricular
arrhythmias), cardiac arrest.
There are case reports of hyperkalaemia‑related cardiac arrests
following the administration of suxamethonium to patients with
congenital cerebral palsy, tetanus, Duchenne muscular dystrophy,
and closed head injury. Such events have also been reported
rarely in children with hitherto undiagnosed muscular disorders.
Hypertension and hypotension have also been reported.
Respiratory, thoracic and mediastinal disorders
Bronchospasm, prolonged respiratory
† Individuals with decreased plasma cholinesterase
activity exhibit a prolonged response to suxamethonium.
Approximately 0.05% of the population has an inherited
cause of reduced cholinesterase activity. Please refer to
section 4.4 Special Warnings and Precautions for Use
Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think
you may be pregnant, are planning to have
a baby or have given birth in the last six
weeks, ask your doctor for advice before
taking this medicine.
Driving and using machines
It can be dangerous to drive or operate
machinery too soon after having had an
operation. Your doctor will tell you how
long to wait before you can drive and use
3. How Anectine is given
How your injection is given
You will never be expected to give yourself
this medicine. It will always be given to you
by a person who is qualified to do so.
Anectine can be given:
• s a single injection into your vein
(intravenous bolus injection)
• s a continuous infusion into your vein.
This is where the drug is slowly given to
you over a long period of time.
Your doctor will decide the way you are
given the drug and the dose you will
receive. It will depend on:
• our body weight
• he amount of muscle relaxation you
• our expected response to the medicine.
If you receive more Anectine than you
Anectine will always be given under carefully
controlled conditions. However, if you think
that you have been given more than you
should tell your doctor or nurse immediately.
If you have any further questions on the use
of this medicine, ask your doctor.
4. Possible side effects
Like all medicines, this medicine can cause side
effects, although not everybody gets them.
If you get any side effects, talk to your
doctor, nurse or other relevant hospital staff
member. This includes any possible side
effects not listed in this leaflet.
Very rarely, a sudden and severe allergic
reaction to Anectine can occur. If you get
any of the following symptoms tell your
doctor or nurse immediately:
• hortness of breath, wheezing or trouble
• welling of your eyelids, face, lips, tongue
or other parts of the body
• ash, itching or hives on the skin
• a collapse.
Very common Increased intragastric pressure.
Excessive salivation has also been reported
Skin and subcutaneous tissue disorders
Musculoskeletal and connective tissue disorders
Very common Muscle fasciculation, post‑operative muscle
pains (Please refer to section 4.4 Special
Warnings and Precautions for Use).
# Rhabdomyolysis has also been reported (see section
4.3 Contraindications and section 4.4 Special Warnings and
Precautions for Use)
General disorders and administration site conditions
Malignant hyperthermia (Please refer to section
4.4 Special Warnings and Precautions for Use).
Transient blood potassium increase
Reporting of suspected adverse reactions
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 the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.
Apnoea and prolonged muscle paralysis are the main serious
effects of overdosage. It is essential, therefore, to maintain the
airway and adequate ventilation until spontaneous respiration
The decision to use neostigmine to reverse a Phase II
suxamethonium‑induced block depends on the judgement of the
clinician in the individual case. Valuable information in regard
to this decision will be gained by monitoring neuromuscular
function. If neostigmine is used its administration should be
accompanied by appropriate doses of an anticholinergic agent
such as atropine.
5.1 Pharmacodynamic Properties
Pharmacotherapeutic group: Peripherally acting muscle
relaxants, choline derivatives, ATC code: M03AB01.
Short‑acting depolarising neuromuscular blocking agent.
5.2 Pharmacokinetic Properties
5.3 Preclinical Safety Data
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
Carcinogenicity studies have not been performed.
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.
6.1 List of Excipients
Water for Injections EP.
Suxamethonium injection should not be mixed with
any other drug prior to its administration.
6.3 Shelf Life
6.4 Special Precautions for Storage
Store between 2 and 8°C. Do not freeze. Keep in the
outer carton to protect from light.
6.5 Nature and Contents of Container
Neutral glass. 2ml ampoules.
6.6 Special precautions for disposal and other handling
For intravenous injection under medical direction.
Instructions to open the ampoule
Ampoules are equipped with the OPC (One Point Cut) opening
system and must be opened using the following instructions:
• old with the hand the bottom
part of the ampoule as indicated in
• ut the other hand on the top of
the ampoule positioning the thumb
above the coloured point and press
as indicated in picture 2
7. Marketing Authorisation Holder
The Wellcome Foundation Limited
980 Great West Road, Brentford, Middlesex TW8 9GS,
trading as GlaxoSmithKline UK,
Stockley Park West, Uxbridge, Middlesex UB11 1BT
8. Marketing Authorisation Number
9. Date of First Authorisation/Renewal of Authorisation
16 May 2008
This leaflet was last revised in March 2014.
There are other serious side effects that
you and your doctor must look out for. You
must tell your doctor or nurse straight
away if you have any of the following:
Common (may affect up to 1 in 10 people)
• aised pressure of fluid in the eye which
may cause headache or blurred vision
• peeding up or slowing down of your
• rotein in the blood or urine due to
• uscle damage which may make your
muscles ache or feel tender, stiff and
weak. Your urine may also look dark or
be red or cola coloured.
Rare (may affect up to 1 in 1,000 people)
• abnormal heart rhythm
• eart problems including changes in the
way in which your heart beats or your
heart stopping beating
• ifficulty in breathing or temporary loss
Very rare (may affect up to 1 in 10,000 people)
• high body temperature.
Other side effects include:
Very common (may affect more than 1 in
• bdominal cramps or pain and a feeling
of nausea or “fullness”
• isible twitching of muscle under the skin
• xcessive production of saliva
• uscle pain after the operation -
your doctor will monitor you for this.
Common (may affect up to 1 in 10 people)
• kin flushing
• kin rash
• igh level of potassium in your blood
• igh/low blood pressure
Rare (may affect up to 1 in 1,000 people)
• ifficulty in opening your mouth.
Reporting of side effects
If you get any side effects, talk to your
doctor, nurse or pharmacist. This includes
any possible side effects not listed in this
leaflet. You can also report side effects
directly via the Yellow Card Scheme at:
By reporting side effects you can help
provide more information on the safety of
5. How to store Anectine
• eep Anectine out of the sight and reach
• o not use Anectine after the expiry date
which is stated on the pack
• tore in a refrigerator, between 2 and
8°C. Do not freeze
• tore in the original package to protect
• o not throw away any medicines via
wastewater or household waste. Your
doctor or nurse will throw away any
medicine that is no longer required. This
will help protect the environment.
6. Contents of the pack and other
What Anectine contains
• he active substance is 50 mg / ml
• he other ingredient is water for
What Anectine looks like and contents
of the pack
Anectine Injection is supplied as a clear,
colourless solution in a neutral glass, 2 ml
Marketing Authorisation Holder and
Marketing Authorisation Holder:
The Wellcome Foundation Limited,
Stockley Park West, Uxbridge,
Middlesex UB11 1BT
GlaxoSmithKline Manufacturing S.p.A.,
Strada Provinciale Asolana 90,
43056 San Polo di Torrile, Parma, Italy
To listen to or request a copy of this leaflet
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The Information provided applies only to
This leaflet was last revised in May 2014
Anectine is a registered trademark of the
GlaxoSmithKline group of companies.
© 2014 GlaxoSmithKline group of
companies. All rights reserved.