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ISOFLURANE 100% INHALATION VAPOUR LIQUID

Active substance(s): ISOFLURANE

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DNI 4067/6

The following information is intended for healthcare professionals only:
PROFESSIONAL USER LEAFLET

ISOFLURANE
100% Inhalation Vapour, Liquid
Compostion and Description
Isoflurane is a colourless non-flammable general inhalation anaesthetic which contains no
additive or stabiliser. It is 1-chloro-2,2,2-trichloroethyl difluoromethyl ether.
Indications
General inhalation anaesthetic for use in induction and maintenance.
Contraindications
Isoflurane is contraindicated in patients with known sensitivity to Isoflurane or to other
halogenated anaesthetics.
It is also contraindicated in patients with known or suspected genetic susceptibility to
malignant hyperthermia.
Precautions:
Vaporisers specially calibrated for isoflurane should be used so that the concentration of
anaesthetic delivered can be accurately controlled. Hypotension and respiratory depression
increase as anaesthesia is deepened.
Reports of QT prolongation, associated with torsade de pointes (in exceptional cases, fatal),
have been received.
Caution should be exercised when administering isoflurane to patients at risk of QT
prolongation.
Caution should be exercised in administering general anaesthesia, including isoflurane, to
patients with mitochondrial disorders.
Isoflurane, like other inhalational agents, has relaxant effects on the uterus with the potential
risk for uterine bleeding.
Clinical judgement should be observed when using isoflurane during obstetric anaesthesia.
Consideration should be taken to use the lowest possible concentration of isoflurane in
obstetrical operations (see 'Use in pregnancy').
Isolated cases of increased carboxyhaemoglobin have been reported with the use of
halogenated inhalation agents with a –CF2H moiety (i.e., desflurane, enflurane and
isoflurane). No clinically significant concentrations of carbon monoxide are produced in the
presence of normally hydrated absorbents. Care should be taken to follow manufacturer's
instructions for CO2 absorbents.
Isoflurane has been reported to interact with dry carbon dioxide absorbents during closed
circuit anaesthesia, to form carbon monoxide. In order to minimize the risk of formation of
carbon monoxide in rebreathing circuits and the possibility of elevated carboxyhaemoglobin
levels, carbon dioxide adsorbents should not be allowed to dry out.
Rare cases of extreme heat, smoke and/or spontaneous fire in the anaesthesia machine
have been reported during the administration of general anaesthesia with drugs in this class
when used in conjunction with desiccated CO2 absorbents, specifically those containing
potassium hydroxide (e.g. Baralyme). When a clinician suspects that the CO2 absorbent may
be desiccated, it should be replaced before administration of isoflurane. The colour indicator
of most CO2 absorbents does not necessarily change as a result of desiccation. Therefore, the
lack of significant colour change should not be taken as an assurance of adequate hydration.
CO2 absorbents should be replaced routinely regardless of the state of the colour indicator.
Because levels of anaesthesia can be altered easily and quickly with Isoflurane, only
vaporisers which produce a predictable concentration with a good degree of accuracy or
techniques during which inspired or expired concentrations can be monitored, should be
used.
The degree of hypotension and respiratory depression may provide some indication of
anaesthetic depth.
As with any potent general anaesthetic, isoflurane should only be administered in an
adequately equipped anaesthetising environment by those who are familiar with the
pharmacology of the drug and qualified by training and experience to manage the
anaesthetised patient.
Reports demonstrate that Isoflurane can produce hepatic injury ranging from mild transient
increases of liver enzymes to fatal hepatic necrosis in very rare instances.
It has been reported that previous exposure to halogenated hydrocarbon anaesthetics,
especially if the interval is less than 3 months, may increase the potential for hepatic injury.
Cirrhosis, viral hepatitis or other pre-existing liver disease can be a reason to select an
anaesthetic other than a halogenated anaesthetic.
Regardless of the anaesthetics employed, maintenance of normal haemodynamics is
important to the avoidance of myocardial ischaemia in patients with coronary artery disease.
Isoflurane markedly increases cerebral blood flow at deeper levels of anaesthesia. There
may be a transient rise in cerebral spinal fluid pressure which is fully reversible with
hyperventilation.
Isoflurane must be used with caution in patients with increased intracranial pressure. In such
cases hyperventilation may be necessary.
Use of isoflurane in hypovolaemic, hypotensive and debilitated patients has not been
extensively investigated. A lower concentration of isoflurane is recommended for use in these
patients.
The action of non-depolarising relaxants is markedly potentiated with isoflurane.
Isoflurane may cause a slight decrease in intellectual function for 2-4 days following
anaesthesia. Small changes in moods and symptoms may persist for up to 6 days after
administration. This must be taken into account when patients resume normal daily activities,
including driving or operating heavy machinery (see 'Effects on Ability to Drive and Use
Machines').
A potentiation of neuromuscular fatigue can be seen in patients with neuromuscular
diseases, such as myasthenia gravis. Isoflurane should be used with caution in these
patients.
Isoflurane should be administered with caution to patients who can develop

bronchoconstriction since bronchospasm can occur (see 'Undesirable Effects').
Isoflurane may cause respiratory depression which may be augmented by narcotic
premedication or other agents causing respiratory depression. Respiration should be
supervised and if necessary, assisted (see 'Undesirable Effects').
During the induction of anaesthesia, saliva flow and tracheobronchial secretion can increase
and can be the cause of laryngospasm, particularly in children.
Children under two years of age
Caution should be exercised when Isoflurane is used in small children due to limited
experience with this patient group.
During the induction of anaesthesia, saliva flow and tracheobronchial secretion can increase
and can be the cause of laryngospasm, particularly in children.
Malignant Hyperthermia
In susceptible individuals, isoflurane anaesthesia may trigger a skeletal muscle
hypermetabolic state leading to high oxygen demand and the clinical syndrome known as
malignant hyperthermia. The syndrome includes nonspecific features such as muscle rigidity,
tachycardia, tachypnoea, cyanosis, arrhythmias, and unstable blood pressures. (It should
also be noted that many of these nonspecific signs may appear with light anaesthesia, acute
hypoxia, etc.) An increase in overall metabolism may be reflected in an elevated temperature
(which may rise rapidly early or late in the case, but usually is not the first sign of augmented
metabolism) and an increased usage of the CO2 absorption system (hot canister). PaO2 and
pH may decrease, and hyperkalaemia and a base deficit may appear. Treatment includes
discontinuance of triggering agents (e.g. isoflurane), intravenous administration of dantrolene
sodium, and application of supportive therapy. Such therapy includes vigorous efforts to
restore body temperature to normal, respiratory and circulatory support as indicated, and
management of electrolyte-fluid-acid-base derangements. (Consult prescribing information
for dantrolene sodium intravenous for additional information on patient management.) Renal
failure may appear later.
Perioperative hyperkalaemia
Use of inhaled anaesthetic agents has been associated with rare increases in serum
potassium levels that have resulted in cardiac arrhythmias and death in paediatric age group
during the postoperative period. Patients with latent as well as overt neuromuscular disease,
particularly Duchenne muscular dystrophy appear to be most vulnerable. Concomitant use of
succinylcholine has been associated with most, but not all of these cases. These patients also
experienced significant elevations in serum creatine kinase levels and, in some cases,
changes in urine consistent with myoglobinuria. Despite the similarity in presentation to
malignant hyperthermia, these patients did NOT have classical signs or symptoms of
malignant hyperthermia such as muscle rigidity or hypermetabolic state. Prompt and vigorous
treatment for hyperkalaemia and resistant arrhythmias is recommended as is subsequent
evaluation for latent neuromuscular disease.
Drug Interactions:
Combinations advised against:
Beta- sympathomimetic agents like isoprenaline and alpha- and beta- sympathomimetic
agents like adrenaline and noradrenaline should be used with caution during isoflurane
narcosis, due to a potential risk of ventricular arrhythmia.
Non-selective MAO-inhibitors: Risk of crisis during the operation. Treatment should be
stopped 15 days prior to surgery.
Combinations requiring precautions in using:
Indirect-acting sympathomimetics (amphetamines and their derivatives, psychostimulants,
appetite suppressants, ephedrine and its derivatives): Risk of peri-operative hypertension. In
patients undergoing elective surgery, treatment should ideally be discontinued several days
before surgery.
Adrenaline, by subcutaneous or gingival injections: risk of serious ventricular arrhythmia as a
consequence of increased heart rate, although the myocardial sensitivity with respect to
adrenaline is lower with the use of Isoflurane than in the case of Halothane.
Calcium antagonists, in particular dihydropyridine derivatives:
Isoflurane may lead to marked hypotension in patients treated with calcium antagonists.
Caution should be exercised when calcium antagonists are used concomitantly with
inhalation anaesthetics due to risk of additive negative inotropic effect.
Beta-blockers: Cardiovascular compensation reactions may be impaired by beta-blockers.
Use of Isoflurane and Isoniazid can increase the risk of potentiation of the hepatotoxic effects.
Opioids, benzodiazepines and other sedative agents are associated with respiratory
depression, and caution should be exercised when concomitantly administered with
Isoflurane.
Muscle relaxants are markedly potentiated by Isoflurane. Neostigmine has an effect on the
non-depolarising relaxants, but has no effect on the relaxing action of Isoflurane itself.
MAC (minimum alveolar concentration) is reduced by concomitant administration of N2O in
adults.
Use in pregnancy
There are no or limited amount of data from the use of isoflurane in pregnant women. Studies
in animals have shown reproductive toxicity. Isoflurane should only be used during pregnancy
if the benefit outweighs the potential risk.
Isoflurane, like other inhalational agents, has relaxant effects on the uterus with the potential
risk for uterine bleeding. Clinical judgement should be observed when using isoflurane during
obstetric anaesthesia. Consideration should be taken to use the lowest possible
concentration of isoflurane in obstetrical operations.
Use in Caesarean Section
Isoflurane, in concentrations up to 0.75%, has been shown to be safe for the maintenance of
anaesthesia for caesarean section.
Nursing Mothers
It is not known whether isoflurane/metabolites are excreted in human milk. Because many
drugs are excreted in human milk, caution should be exercised when isoflurane is
administered to a nursing woman.
Effects on Ability to Drive and Use Machines
Patients should be advised that performance of activities requiring mental alertness, such as
operating a motor vehicle or hazardous machinery, may be impaired for 2-4 days after
anaesthesia with isoflurane. As with other anaesthetics, small changes in moods and
symptoms may persist for up to 6 days after administration.
Dosage and administration
Administer by inhalation. The use of Isoflurane - specific vaporisers will facilitate accurate

DNI 4067/6

INFORMATION FOR THE PATIENT.

ISOFLURANE
100% Inhalation Vapour, Liquid
Read all of this leaflet carefully before you are
given this medicine.
- Keep this leaflet. You many need to read it
again.
- If you have any further questions, ask your
doctor or nurse
- If any of the side effects get serious or if you
notice any side effects not listed in this leaflet,
please tell your doctor or nurse. See section 4
In this leaflet:
1. What Isoflurane is and what it is used for
2. What you need to know before you are given
Isoflurane
3. How Isoflurane will be given
4. Possible side effects
5. How to store Isoflurane
6. Contents of the pack and other information
1. WHAT ISOFLURANE IS AND WHAT IT IS
USED FOR
Isoflurane is a general anaesthetic used for surgical
operations and other procedures.
It is an inhaled anaesthetic that is given as a vapour
for you to breathe in. It causes you to fall into a deep,
painless sleep (induction of anaesthesia). It also
maintains a deep, painless sleep during which you
can undergo surgery (maintenance of anaesthesia).
2. WHAT YOU NEED TO KNOW BEFORE YOU
ARE GIVEN ISOFLURANE
You should NOT be given isoflurane
Tell your doctor if any of the following applies to you:
• You are hypersensitive to Isoflurane or other
similar anaesthetics
• You, or anyone in your family, are susceptible to a
condition known as malignant hyperthermia (rapid
rise in body temperature) during anaesthesia.
Warnings and Precautions
Tell your doctor before you are given Isoflurane if:
• You have previously been given an inhaled
anaesthetic, particularly if this was more than
once over a short period
• You have reacted badly after previous
administration of lsoflurane or other similar
anaesthetics, e.g. you developed jaundice, fever,
liver or blood problems.
• You have a disease of your liver
• You have heart disease
• You have raised intracranial pressure. Isoflurane
may raise pressure inside your skull. This could be









a problem if you have a head injury, brain tumour or
another condition that already raises pressure inside
your head
You have low blood pressure, low blood volume or are
debilitated. You may need a lower dose of Isoflurane.
You have a condition that affects muscles (a
neuromuscular disease e.g. Duchenne muscular
dystrophy or myasthenia gravis)
You suffer from bronchoconstriction (tightening of the
lungs and airways leading to coughing, wheezing or
shortness of breath
You are suffering from any other illness other than
those connected with your operation
You are pregnant or breastfeeding.

Other medicines and Isoflurane
Tell your doctor if you are taking or have recently taken
any of the following:
• medicines that affect the heart such as adrenaline,
amphetamine or beta blockers
• strong painkillers such as morphine or codeine
• medicines for treating high blood pressure such as
nifedipine or diltiazem, or other drugs that relax your
veins such as captopril or enalapril, or alpha blockers
such as prazosin
• monoamine oxidase inhibitors (MAOIs) used to treat
depression. If you are taking MAOls, where possible,
your doctor should stop this medicine 14 days before
planned surgery muscle relaxants, as a lower dose
may be needed
• muscle relaxants such as Neostigmine
• isoniazid, used to treat infections.
Please tell your doctor or nurse if you are taking or have
recently taken any other medicines, including medicines
obtained without a prescription.
Pregnancy and Breast feeding
Tell your doctor or anaesthetist if you are or think you may
be pregnant. You should not receive lsoflurane if you are
pregnant unless it is essential.
Isoflurane may cause increased blood loss after
operations involving the womb
If you have been breast feeding before being given
lsoflurane, you should stop until the medicine is cleared
from your body. Your doctor will let you know when it is
safe for you to continue breast feeding.
Driving and using machines
You should not drive or use machines until your doctor
advises that you are safe to do so. Your mental alertness
may be affected for 2-4 days, do not drive or operate
machinery if you are affected after you have had a

general anaesthetic.
3. HOW ISOFLURANE WILL BE GIVEN
Isoflurane will be given by a trained anaesthetist in a
surgery or hospital. The anaesthetist will decide on
how much Isoflurane you need based on your age,
weight and type of operation, and when it is to be
given. Isoflurane liquid is changed to vapour (gas) in a
vapouriser. You will breathe it in as a vapour. It may be
used to put you to sleep before your operation or, if you
are put to sleep with an injection, it may be used to
maintain anaesthesia during the operation. If you
have any further questions on the use of this product,
ask your anaesthetist, doctor or nurse.
Inducing sleep at the start of anaesthesia
Isoflurane is not recommended in infants and children
for inducing sleep at the start of anaesthesia.
Medication before anaesthesia
Anaesthetist may decide to give your child medication
to counter act the possible reduction in breathing and
heart rate effects which may occur with the use of
Isoflurane.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Isoflurane can cause side effects,
although not everybody gets them. If you or your child
suffer from any unusual or unexpected symptoms
after an operation tell your doctor or anaesthetist
IMMEDIATELY
• After waking from lsoflurane anaesthesia, you may
feel shivery, sick or you may vomit.
• You may experience an allergic or hypersensitivity
reaction, rash or swelling of the face.
• Isoflurane may trigger malignant hyperthermia in
some people. This condition may run in families.
Affected patients develop a very high temperature
after receiving certain anaesthetic drugs. Intensive
care is usually needed and the condition may be
fatal.
• Your blood pressure may fall after being given
Isoflurane, especially if you are already taking
medicines to lower blood pressure.
• Use of inhaled anaesthetic agents such as
Isoflurane has been very rarely associated with
increase in potassium levels in the blood
(hyperkalaemia), resulting in abnormality of heart
rhythm and death in children during the
postoperative period. This event has been
described in patients with latent as well as overt
muscular disease, particularly Duchenne muscular
dystrophy.
• You may experience breathing problems or rarely
difficulty breathing (bronchospasm), increased
heart rate and irregular heart beats (arrhythmias).
• The number of white blood cells in the blood may
increase, levels of blood glucose may increase,
blood levels of certain enzymes and other blood
cells may be altered.

• Agitation, delirium, altered mood, mental
impairment, and convulsions have been reported.
• Effects on the liver have occurred after lsoflurane
anaesthesia. There have been rare reports of mild,
moderate and severe liver problems such as
jaundice (causing yellowing of the skin and white of
the eyes) and inflammation of the liver (hepatitis)
causing pain in the abdomen.
• Isoflurane may cause increased blood loss after
operations involving the womb.
• As with other anaesthetics, small changes in moods
and symptoms may persist for up to 6 days after
administration.
Reporting of side effects
If you get any side effects, talk to your doctor,
pharmacist or nurse. This includes any possible side
effects not listed in this leaflet. You can also report side
effects directly via the Yellow Card Scheme at:
www.mhra.gov.uk/yellowcard. By reporting side effects
you can help provide more information on the safety of
this medicine.
5. HOW TO STORE ISOFLURANE
Keep out of the reach and sight of children.
Expiry date:
Isoflurane should not be used after the expiry date
which is stated on the carton. The expiry date refers to
the last day of that month.
Storage conditions :
Do not store above 30oC.
6. CONTENTS OF THE PACK AND OTHER
INFORMATION
What Isoflurane contains:
Isoflurane 100% Inhalation Vapour, Liquid contains
100% of the active ingredient isoflurane. There are no
other ingredients.
What Isoflurane 100% Inhalation Vapour, Liquid looks
like and contents of the pack:
Isoflurane is a colourless liquid available in 100 ml and
250 ml amber coloured glass bottles.
Marketing Authorisation Holder
Piramal Healthcare UK Limited
Whalton Road, Morpeth,
Northumberland NE61 3YA, United Kingdom
Manufacturer
Piramal Healthcare UK Limited
Whalton Road, Morpeth,
Northumberland NE61 3YA, United Kingdom
This leaflet was last revised in 10/2015

control of the administered concentration of anaesthetic.
MAC values for Isoflurane vary with age. The table below indicates average MAC values for
different age groups.
ADULTS*
AGE
Average MAC value
In 100% Oxygen
70% N2O
26 ± 4 years
1.28%
0.56%
44 ± 7 years
1.15%
0.50%
64 ± 5 years
1.05%
0.37%
PAEDIATRIC POPULATION
Age
Average MAC Value
in 100% Oxygen
Preterm neonates
< 32 weeks gestational age
1.28%
Preterm neonates
32-37 weeks gestational age
1.41%
0-1 month
1.60%
1-6 months
1.87%
6-12 months
1.80%
1-5 years
1.60%
Premedication:
Premedication drugs should be selected according to the needs of the patient. The respiratory
depressant effect of Isoflurane should be taken into account. The use of anticholinergic drugs is
a matter of choice, but may we advisable for inhalation induction in paediatrics.
Induction:
As Isoflurane has a mild pungency, inhalation should usually be preceded by the use of a short
acting barbiturate, or other intravenous induction agent, to prevent coughing. Alternatively,
Isoflurane with oxygen or with an oxygen/ nitrous oxide mixture may be administered.
It is recommended that induction with Isoflurane be initiated at a concentration of 0.5%.
Concentrations of 1.5-3.0% usually produce surgical anaesthesia in 7-10 minutes.
Induction of anaesthesia in children: Isoflurane is not recommended for use as an inhalation
induction agent in infants and children because of the occurrence of cough, breath-holding,
desaturation, increased secretions and laryngospasm.
Maintenance:
Adequate anaesthesia for surgery may be sustained with an inspired Isoflurane concentration of
1.0% to 2.5% in an oxygen/nitrous oxide mixture. Additional Isoflurane (0.5% to 1.0%) may be
required when Isoflurane is given with oxygen alone.
For caesarean section, 0.5-0.75% isoflurane in a mixture of oxygen/nitrous oxide is suitable to
maintain anaesthesia for this procedure.
Arterial pressure levels during maintenance tend to be inversely related to alveolar Isoflurane
concentration in the absence of other complicating factors. Provided there are no other
complicating factors this is probably due to peripheral vasodilation. Excessive falls in blood
pressure may be due to the depth of anaesthesia and, in such circumstances, can be corrected
by reducing the inspired Isoflurane concentration.
Elderly:
As with other agents, lesser concentrations of isoflurane are normally required to maintain
surgical anaesthesia in elderly patients. See above for MAC values related to age.
Undesirable Effects:
Adverse reactions encountered in the administration of Isoflurane are in general dose
dependent extensions of pharmaco-physiological effects and include hypotension, respiratory
depression and arrhythmias. Potential serious undesirable effects include malignant
hyperthermia, hyperkalaemia, elevated serum creatine kinase, myoglobinuria, anaphylactic
reactions and liver adverse reactions (see 'Precautions'). Shivering, nausea, vomiting, ileus,
agitation and delirium have been observed in the post-operative period.
Cardiac arrest, bradycardia and tachycardia have been observed with general inhalation
anaesthetic drugs including isoflurane.
Reports of QT prolongation, associated with torsade de pointes (in exceptional cases, fatal)
have been received.
b. Tabulated summary of adverse reactions
The following table displays adverse reactions reported in clinical trials and from post-marketing
experience. Frequency cannot be estimated from the available data, therefore it is "not known".
SUMMARY OF MOST FREQUENT ADVERSE DRUG REACTIONS
SOC
FREQUENCY ADVERSE REACTIONS
Blood and lymphatic
2
system disorders
Not known
Carboxyhaemoglobinaemia
1
Immune system disorders
Not known
Anaphylactic reaction
Not known
Hypersensitivity1
Metabolism and nutrition disorders
Not known
Hyperkalaemia2
Not known
Blood glucose increased1
Psychiatric disorders
Not known
Agitation
Not known
Delirium
Not known
Mood altered5
Nervous system disorders
Not known
Convulsion
Not known
Mental impairment4
Cardiac disorders
Not known
Arrhythmia
Vascular disorders
Not known
Hypotension2 3
Not known
Haemorrhage 2
Respiratory, thoracic and
Not known
Bronchospasm
mediastinal disorders
Not known
Dyspnoea11
Not known
Wheezing
2
Not known
Respiratory depression
Not known
Laryngospasm2
Gastrointestinal disorders
Not known
Ileus
Not known
Vomiting
Not known
Nausea
Hepatobiliary disorders
Not known
Hepatic necrosis2 2
Not known
Hepatocellular injury 1
Not known
Blood bilirubin increased

Skin and subcutaneous
tissue disorders
Renal and urinary disorders
General disorders and
administration site conditions
Investigations

Not known
Not known
Not known
Not known
Not known
Not known
Not known
Not known
Not known
Not known
Not known
Not known
Not known
Not known

1

Swelling face1
Dermatitis
contact1
Rash1
1
Blood creatinine increased
Blood urea decreased1 2
Hyperthermia malignant
Chest discomfort1
Chills
White blood cell count
increased1
2
Hepatic enzyme increased
Fluoride increased1
Electroencephalogram
abnormal
Blood cholesterol decreased1
Blood alkaline phosphatase
decreased1

See 'c. Description of
selected adverse reactions' below
See 'Precautions'
3
In patients undergoing induced abortion.
4
May cause a slight decrease in intellectual function for 2-4 days after anaesthesia. See
'Precautions'.
5
Small changes in moods and symptoms may persist for up to 6 days. See 'Precautions'.
c. Description of selected adverse reactions
Transient increases in blood bilirubin, blood glucose and serum creatinine with decrease
in BUN, serum cholesterol and alkaline phosphatase have been observed. As with other
general anaesthetics, transient elevations in white blood count have been observed
even in the absence of surgical stress.
Rare reports of hypersensitivity (including dermatitis contact, rash, dyspnoea, wheezing,
chest discomfort, swelling face, or anaphylactic reaction) have been received, especially
in association with long-term occupational exposure to inhaled anaesthetic agents,
including isoflurane. These reactions have been confirmed by clinical testing (e.g.,
methacholine challenge). The etiology of anaphylactic reactions experienced during
inhalational anaesthetic exposure is, however, unclear because of the exposure to
multiple concomitant drugs, many of which are known to cause such reactions.
Minimally raised levels of serum inorganic fluoride occur during and after isoflurane
anaesthesia, due to biodegradation of the agent. It is unlikely that the low levels of serum
inorganic fluoride observed (mean 4.4 μmol/l in one study) could cause renal toxicity, as
these are well below the proposed threshold levels for kidney toxicity.
d. Paediatric population
Use of inhaled anaesthetic agents has been associated with rare increases in serum
potassium levels that have resulted in cardiac arrhythmias and death in paediatric
patients during the post-operative period.
During the induction of anaesthesia, saliva flow and tracheobronchial secretion can
increase and can be the cause of laryngospasm.
e. Other special populations
Neuromuscular disease:
Use of inhaled anaesthetic agents has been associated with rare increases in serum
potassium levels that have resulted in cardiac arrhythmias and death in paediatric
patients during the post-operative period. Patients with latent as well as overt
neuromuscular disease, particularly Duchenne muscular dystrophy, appear to be most
vulnerable. Early and aggressive intervention to treat the hyperkalaemia and resistant
arrhythmias is recommended, as is subsequent evaluation for latent neuromuscular
disease.
Elderly:
Lesser concentrations of isoflurane are normally required to maintain surgical
anaesthesia in elderly patients.
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.
Overdose
As with other halogenated anaesthetics, hypotension and respiratory depression have
been observed. Close monitoring of blood pressure and respiration is recommended.
Supportive measures may be necessary to correct hypotension and respiratory
depression resulting from excessively deep levels of anaesthesia.
Pharmaceutical Precautions:
Do not store above 30°C. Keep the container tightly closed. Keep out of the reach of
children.
Shelf Life:
5 years.
Legal Category: P
Package Information:
lsoflurane is supplied in bottles of 100 ml or 250 ml.
PL29595/0005
Text Revised: October 2015
2

MA Holder:
Piramal Healthcare UK Limited
Whalton Road, Northumberland, NE61 3YA, United Kingdom

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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