EPHEDRINE HYDROCHLORIDE 30MG IN 1ML SOLUTION FOR INJECTION

Active substance: EPHEDRINE HYDROCHLORIDE

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PIL

PATIENT INFORMATION LEAFLET

EPHEDRINE HYDROCHLORIDE 30mg in 1ml Solution for injection
This leaflet contains important information about Ephedrine Hydrochloride Injection. Read all of
this leaflet carefully before you start your treatment with this medicine.
1. Keep this leaflet. You may need to read it again.
2. If you have further questions, please ask your doctor.
3. 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.
In this leaflet
1. What is Ephedrine Hydrochloride Injection and what is it for
2. Before you are given Ephedrine Hydrochloride Injection
3. How Ephedrine Hydrochloride Injection is used
4. Possible side effects
5. How Ephedrine Hydrochloride Injection is stored
6. Further information

1. What is Ephedrine Hydrochloride
Injection and what is it for
Ephedrine Hydrochloride belongs to a group of
medicines called sympathomimetic drugs.
This group of drugs affect the part of your nervous
system that works automatically.
Ephedrine Hydrochloride is used when blood
pressure has dropped during spinal or epidural
anaesthesia. It helps raise the blood pressure by
temporarily reducing the blood supply to small blood
vessels.

2. Before you are given Ephedrine
Hydrochloride Injection
Your doctor will not give you Ephedrine
Hydrochloride Injection if you:
* are breast feeding as Ephedrine passes into
breast milk (see below for Pregnancy and Breast
Feeding)
* are a child who is taking the medicine theophylline
(used to treat asthma and breathing
difficulties).
Your doctor will take special care with Ephedrine
Hydrochloride Injection:
* if you suffer from any:
* heart disease
* thyroid disease as Ephedrine can affect the
control of your thyroid hormone
* diabetes as Ephedrine may increase in your
blood sugar
* glaucoma or high blood pressure as Ephedrine
may make this worse
* kidney problems
* if you are elderly or pregnant
* if you are a man who has difficulty in passing
urine because of prostate problems. Ephedrine
may make it more difficult to pass urine.

Taking other medicines
Tell your doctor if you are taking or have recently
taken any medicines including medicines obtained
without a prescription. Ephedrine can interfere with
the action of some other drugs and some drugs can
have an effect on ephedrine. The following drugs
can cause some problems when taken together with
Ephedrine Injection:
* Medicines for depression called mono amine
oxidase inhibitors (MAOIs). If Ephedrine Injection
is given to you while you are taking MAOIs or even
up to two weeks after you have stopped taking the
MAOIs it can cause a sudden decrease in blood
pressure which can make you very ill.
* Other Medicines for depression such as
Amitriptyline, Dosulepin
* Medicines for the heart such as digoxin and
quinidine
* Steroid medicines such as dexamethasone
* Theophylline, a medicine used to treat asthma
* Medicines used to treat Parkinson's disease called
COMT inhibitors (e.g. entacapone, tolcapone)
* Certain gases used in anaesthesia during surgery
* Medicines for high blood pressure such as
prazosin, clonidine, beta blockers such as Atenolol
or Propanolol and calcium channel blockers like
verapamil or diltiazem
Pregnancy and breast-feeding
* Tell your doctor before you are given Ephedrine
Injection if you are pregnant or planning to
become pregnant.
* If you are breast feeding you should tell your
doctor before you are given this medicine.
Ephedrine passes into the breast milk and can affect
your baby.
Driving and using machines
* Your medicine is unlikely to affect your ability to drive
or to operate machinery. However, some people may
feel dizzy when given Ephedrine Hydrochloride
injection. If this happens to you, do not drive or
operate machinery.

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3. How Ephedrine Hydrochloride
Injection is used
Ephedrine Hydrochloride Injection is always given
to you by a doctor or nurse. It is given into a vein.
If you are an adult: 3 - 7.5mg (maximum 9mg) by
slow injection into a vein repeated every 3 - 4 minutes
to a maximum of 30 mg.
If you are a child, the amount of ephedrine you are
given will depend on your body weight or skin area
0.5 - 0.75mg per kg of body weight or 17 - 25mg per
square metre of body surface.
If more Ephedrine is used than should be:
Tell the doctor if you hallucinate or experience delusions
or any of the side-effects described below so that
he/she can give appropriate treatment.
If you have already left the medical premises, contact
your nearest hospital, doctor or nurse.
If you miss a dose of Ephedrine:
It is unlikely that you will miss a dose as your doctor
or nurse will be giving it to you. However, it is important
not to have a double dose if you have missed one.
Ask your doctor or nurse when you should have the
next dose.
If you have any further questions on the use of this
product, ask your doctor or nurse.

4. Possible side effects
Like all medicines, Ephedrine Injection can cause
side effects although not everyone gets them.
The most common side effects are:
* an inability to sleep
* anxiety, restlessness and
* a rapid heart beat
Other Side effects
Nervous system:
Shaking and difficulty in breathing; feeling sick (nausea),
being sick (vomiting), Loss of appetite; headache,
confusion and Feeling, seeing or hearing things which
do not exist.
Dry mouth or over-production of saliva, sweating, and
difficulties in passing urine and urine retention.

Very rarely an eye disorder can occur
(angle closure glaucoma). If you experience eye pain,
nausea and vomiting and blurring of your vision, go to
the Accident and Emergency department of your
hospital immediately.
Do not be concerned by this list of side effects.
You may not get any of them.
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.

5. How Ephedrine Hydrochloride Injection
is stored
* Keep out of the reach and sight of children
* Do not use Ephedrine Hydrochloride Injection after
the expiry date which is stated on the ampoule and
carton after Exp:. The expiry date refers to the last
day of that month.
* Medicines should not be disposed via wastewater
or household waste. Ask your pharmacist how to
dispose of medicines no longer required. These
measures will help to protect the environment.

6. Further information
Ephedrine Hydrochloride Injection is a sterile solution
for injection.
Each 1 ml of Injection contains 30mg of Ephedrine
Hydrochloride as active ingredient.
It also contains water for injections.
Each ampoule contains 1ml of sterile solution and is
available in packs of 10 ampoules.
The Marketing Authorisation for Ephedrine
Hydrochloride Injection is held by Auden Mckenzie
(Pharma Division) Ltd., Mckenzie House, Bury Street,
Ruislip, Middlesex, HA4 7TL, UK.
Ephedrine Hydrochloride Injection is manufactured by
SNS Pharmaceuticals Ltd., Mckenzie House, Bury Street,
Ruislip, Middlesex, HA4 7TL, UK.
This leaflet was updated in November 2010

Heart problems:
Increase in heart rate is one of the most common side
effects but decrease in heart beat can also sometimes
occur; cold fingers and toes, high blood pressure,
irregular heart beat, chest pain, dizziness and flushing.
Other undesirable effects:
If you are diabetic, ephedrine may cause your blood
sugar to rise.

P0016-10-01/1

Auden Mckenzie

Booklet
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Page 2

SPC
SUMMARY OF PRODUCT CHARACTERISTICS
(Please detach prior to giving the leaflet to the patient)

1. Trade Name of the Medicinal Product
Ephedrine Hydrochloride 30mg in 1ml, solution for injection
2. Qualitative and Quantitative Composition
Ephedrine hydrochloride 30mg/ml
For excipients, see Section 6.1.

given ephedrine and adrenergic neurone-blocking drugs
concurrently.
Cardiac glycosides, quinidine, tricyclic antidepressants
An increased risk of arrhythmias may occur.
Corticosteroids
Ephedrine accelerates the metabolism of dexamethasone.

4. Clinical Particulars

COMT inhibitors:
A single case report describes severe hypertension in a patient given
entacapone and intravenous ephedrine. In one study, tocapone did
not alter the effect of ephedrine (route of administration not stated).
Therefore, caution should be taken when COMT inhibitors are
co-administered with intravenous ephedrine.

4.1. Therapeutic Indications
Reversal of low blood pressure resulting from spinal or epidural
anaesthesia.

Clonidine:
Experimental studies in patients show that pre-treatment with
clonidine can increase the blood pressure response to ephedrine.

4.2. Posology and Method of Administration
Method of administration: slow intravenous injection.

Volatile anaesthetics:
Ephedrine should be avoided or used with care in patients
undergoing anaesthesia with cyclopropane, halothane or other
volatile anaesthetics.

3. Pharmaceutical Form
Solution for injection
(Colourless solution)

Adults:
3 – 7.5mg (maximum 9 mg) slowly into a vein, repeated every 3 - 4
minutes to a maximum of 30 mg.
Children:
0.5 – 0.75mg per kg of body weight or 17 – 25mg per square metre
of body surface.
4.3 Contraindications
Do not use:In patients who are breastfeeding.
In children who are also taking theophylline
(see section 4.5).
4.4. Special Warnings and Precautions for Use
Ephedrine should be used with caution in patients suffering from
hyperthyroidism (patients may be hypersusceptible), diabetes
mellitus (ephedrine may cause hyperglycaemia), ischaemic heart
disease (because of positive inotropic and chronotropic effects on the
heart), hypertension (ephedrine increases blood pressure), renal
impairment, angle-closure glaucoma, and in elderly (more sensitive
to the cardiovascular effects of sympathomimetic agents) or pregnant
patients.
It may precipitate acute urinary retention in prostatic hypertrophy.
4.5 Interaction with other medicinal products and other forms of
interaction
Monoamine Oxidase Inhibitors (MAOIs)
The administration of ephedrine to patients concurrently using an
MAOI (including reversible inhibitors of monoamine oxidase A [RIMA]
such as moclobemide) may cause an acute hypertensive crisis.
Co-adminstration of ephedrine and a non-selective MAOI may result
in an acute hypertensive crisis with marked headache, severe
hypertension and subarachnoid haemorrhage. The interaction may
occur up to two weeks after stopping MAOI therapy.
Doxapram, oxytocin, ergot alkaloids, beta blockers
There is a risk of hypertension if ephedrine is used in combination
with any of these drugs.
Antihypertensive drugs
Ephedrine may counteract the effects of some antihypertensive
drugs. Loss of blood pressure control has been detected in patients

Theophylline
In children, co-administration of ephedrine with theophylline should
be avoided or used with caution.
4.6. Pregnancy and Lactation
Drugs should be prescribed in pregnancy only if the expected benefit
to the mother is thought to be greater than the risk to the foetus, and
all drugs should be avoided if possible during the first trimester.
Ephedrine should be avoided or used with caution in pregnancy as
increased foetal heart rate has been reported following parenteral
administration, particularly during labour.
Lactation: Administration of ephedrine to nursing mothers should be
avoided as ephedrine is excreted in breast milk and irritability and
disturbed sleep in the infant have been reported.
4.7. Effects on Ability to Drive and Use Machines
None known.
4.8 Undesirable effects
Ephedrine is associated with the following undesirable effects:
CNS effects
Insomnia, anxiety and restlessness are common. CNS excitatory
effects such as tremor and respiratory depression have been
reported.
Nausea, vomiting, anorexia; headache, confusion and paranoid
psychosis can occur.
Effects on the peripheral nervous system
Dry mouth or hypersalivation, sweating, and difficulties in micturition
including urinary retention, particularly in men with prostatic
hypertrophy, are observed.
Cardiovascular effects
Tachycardia is one of the most common adverse effects but
bradycardia sometimes occurs as can impaired circulation to the
extremities, hypertension, cardiac arrhythmias, anginal pain,
vasodilation with low blood pressure, dizziness and flushing.

Back

Other undesirable effects
Changes in blood-glucose concentration (hyperglycaemia).
Prolonged administration has no cumulative effect but tachyphylaxis
may occur with repetitive dosing because of depletion of
neurotransmitter from storage sites. Tolerance – probably as a result
of pharmacodynamic rather than pharmacokinetic factors - with
dependence, has been reported.
Very rarely, angle closure glaucoma.
4.9. Overdose
Signs:
The potentially life-threatening effects of ephedrine are its acute
cardiovascular and central stimulant effects in excessive dosage or in
hypersusceptible subjects. The effects of ephedrine in overdose
include nausea, vomiting, fever, palpitations, tachycardia,
hypertension, paranoid psychosis as evidenced by hallucinations and
delusions, respiratory depression, convulsions and coma.

resistant to metabolism by monoamine oxidase and is largely
excreted unchanged in the urine, together with small amounts of
metabolites produced by hepatic metabolism. Ephedrine is
metabolised by N-demethylation to phenylpropanolamine
(norephedrine), the major metabolite. This is pharmacologically
active (half-life 1.5 – 4 hours), producing central stimulant effects.
Ephedrine is also deaminated, yielding benzoic acid, hippuric acid
and 1-phenylpropane-1,2-diol. Up to 95% of the dose can be
recovered in 24 hours with 55 – 75% as unchanged drug. The mean
plasma half-life is about 6 hours (range:3 – 11 hours). Clearance is
13.6 – 44.3 l/hour. The urinary excretion is pH dependent;
elimination is enhanced and half-life accordingly shorter in acid urine.
In alkaline urine, excretion is reduced to 20 – 35% of the dose.
Renal disease is likely to impair the elimination of ephedrine with a
corresponding increase in half-life.
Ephedrine crosses the placenta and is excreted in breast milk.
5.3. Preclinical Safety Data
None stated.

Treatment:
Emesis or lavage if the victim presents within four hours of the
overdose and intensive supportive treatment.

6. PHARMACEUTICAL PARTICULARS

In severe overdosage, diazepam may be required to control CNS
stimulation and severe hypertension will require specific therapy.

6.1. List of Excipients
Water for Injections

A slow intravenous injection of labetalol 50 – 200 mg may be given
with electrocardiographic monitoring for the treatment of
supraventricular tachycardia. Marked hypokalaemia (< 2.8 mmol/l)
owing to compartmental shift of potassium predisposes to cardiac
arrhythmias and may be corrected by infusing potassium chloride in
addition to propranolol and correcting respiratory alkalosis when
present.
5. Pharmacological Properties
5.1. Pharmacodynamic Properties
Ephedrine is an alkaloid and vasoconstrictor sympathomimetic with
direct and indirect effects on adrenergic receptors. It acts indirectly
by enhancing the release of the neurotransmitter, noradrenaline, from
storage sites in the sympathetic nerves to the effector organ. It
possesses weak α- as well as ß1- and ß2- adrenergic activities and
has pronounced stimulating effects on the central nervous system. It
has a more prolonged though less potent action than adrenaline.

6.2. Incompatibilities
Incompatible with anionic salts such as phosphates, carbonates and
acetates.
6.3. Shelf-Life
3 years
6.4. Special Precautions for Storage
Do not store above 25°C.
6.5. Nature and Content of Container
1ml clear glass (Ph. Eur. Type I) ampoules containing 1ml solution for
injection.
Pack size: 10 ampoules per carton.
6.6. Instructions for Use, Handling and Disposal
None stated.

Ephedrine is a cardiac stimulant; cardiac output is increased. The
drug stimulates heart rate by acting on ß receptors and, by acting on
α-adrenergic receptors to constrict peripheral vessels, variably
increases peripheral resistance; as a result, ephedrine usually
increases blood pressure, at least transiently. It can therefore be
used as an emergency method of elevating blood pressure such as
in hypotension resulting from sympathetic block in spinal or epidural
anaesthesia. The dual action is useful in managing associated
bradycardia.

7. MARKETING AUTHORISATION HOLDER
Auden Mckenzie Ltd (Pharma Division)
Mckenzie House
Bury Street
Ruislip
Middlesex
HA4 7TL

Although they raise blood pressure, such pressor drugs do so at the
expense of perfusion of vital organs such as the kidney.

8. MARKETING AUTHORISATION NUMBER(S)
PL 17507/0016

By activation of ß-adrenergic receptors in the lungs ephedrine
promotes bronchodilatation by relaxing bronchial smooth muscle.
Ephedrine reduces intestinal tone and motility. Stimulation of the
α-adrenergic receptors of smooth muscle cells in the bladder base
and relaxation of the bladder wall may increase the resistance to the
outflow of urine. Ephedrine contracts the sphincter muscle but
relaxes the detrusor muscle of the bladder and usually reduces the
activity of the uterus. It has a stimulant action on the respiratory
centre. It dilates the pupil but does not affect the light reflexes.
Ephedrine has been shown to stimulate oxygen uptake and
thermogenesis.
5.2. Pharmacokinetic Properties
Ephedrine is rapidly and extensively distributed throughout the body,
with accumulation in the liver, lungs, kidneys, spleen and brain. The
volume of distribution ranges from 122 to 320 l. Ephedrine is

9. DATE OF FIRST AUTHORISATION / RENEWAL OF THE
AUTHORISATION
12 December 2001
10 DATE OF REVISION OF THE TEXT
11-11-2009
Auden Mckenzie (Pharma Division) Ltd

P0016-10-01/1

Auden Mckenzie
Group

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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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