Skip to Content

ESMOLOL 10 MG/ML SOLUTION FOR INJECTION

Active substance(s): ESMOLOL HYDROCHLORIDE

View full screen / Print PDF » Download PDF ⇩
Transcript
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT

Esmolol 10 mg/ml
solution for injection
esmolol hydrochloride
Read all of this leaflet carefully before you start using 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 or nurse. This includes any
possible side effects not listed in this leaflet. See section 4.
What is in this leaflet
1. What Esmolol is and what it is used for
2. What you need to know before you take Esmolol
3. How to take Esmolol
4. Possible side effects
5. How to store Esmolol
6. Contents of the pack and other information

• You

have kidney problems. If you have kidney disease or you need kidney
dialysis you could develop high blood potassium levels (hyperkalemia). This can
cause serious heart problems.
• You have any allergies or are at risk of anaphylactic reactions (severe allergic
reactions). Esmolol can make allergies more severe and more difficult to treat.
• You or any of your family have a history of psoriasis (where your skin produces
scaly patches).
• You have a disease called hyperthyroidism (an overactive thyroid gland).
Changing the dose is not usually necessary if you have liver problems.
If any of the above apply to you (or you are not sure), talk to your doctor or nurse
before being given this medicine. You may need to be checked carefully and your
treatment may be changed.

1. WHAT ESMOLOL IS AND WHAT IT IS USED FOR
Esmolol contains a medicine called esmolol. It belongs to a group of medicines
called ‘beta-blockers’. It works by controlling the rate and force of your heartbeat.
It can also help to reduce your blood pressure.
It is used to treat:
• Heartbeat problems, when your heart beats too fast.
• Heartbeat problems and an increase in your blood pressure if this happens
during or straight after an operation.

2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE ESMOLOL
Do not take Esmolol if:
• You are allergic to esmolol, to other beta-blocker medicines, or any of the
other ingredients of this medicine (listed in section 6). The signs of an allergic
reaction include shortness of breath, wheezing, rash, itching or swelling of your
face and lips.
• You have a very slow heartbeat (less than 50 beats per minute).
• You have a fast or alternating fast and slow heartbeat.
• You have something called “severe heart block”. Heart block is a problem with
the electrical messages that control your heartbeat.
• You have low blood pressure.
• You have a problem with the blood supply to your heart.
• You have serious heart failure symptoms.
• You are receiving or have recently received verapamil. You must not be given
Esmolol within 48 hours of when you stop receiving verapamil.
• You have a gland disease called phaeochromocytoma which has not been
treated. Phaeochromocytoma arises from the adrenal gland and may cause
a sudden increase in blood pressure, severe headache, sweating and
increased heartbeat.
• You have increased blood pressure in the lungs (pulmonary hypertension).
• You have asthma symptoms that are worsening rapidly.
• You have increased levels of acids in your body (metabolic acidosis).
You will not be given Esmolol if any of the above applies to you. If you are not
sure if you have any of these conditions, talk to your doctor or nurse before
having Esmolol.
Warnings and precautions
Talk to your doctor or nurse before taking Esmolol.
Your doctor will take special care with this medicine if:
• You are being treated for certain heart rhythm disorders called supraventricular
arrhythmias and you:
– Have other heart problems or
– Are taking other heart medicines
Use of Esmolol in this way can lead to severe reactions which may be fatal
including:
– Loss of consciousness
– Shock (when your heart does not pump enough blood)
– Heart attack (cardiac arrest)
• You develop low blood pressure (hypotension). The signs of this may be feeling
dizzy or light headed, especially when standing up. Low blood pressure usually
gets better within 30 minutes of the end of your Esmolol treatment.
• You have a low heart rate before treatment.
• Your heart rate decreases to less than 50 to 55 beats per minute. If this
happens your doctor may give you a lower dose or stop treatment with Esmolol.
• You have heart failure.
• You have problems with the electrical messages that control your heartbeat
(heart block).
• You have a gland disease called phaeochromocytoma which has been treated
with medicines called alpha-receptor blockers.
• You are being treated for high blood pressure (hypertension) which has been
caused by low body temperature (hypothermia).
• You have narrowing of your airways or wheezing, such as with asthma.
• You have diabetes or low blood sugar. Esmolol can increase the effects of your
diabetes medicines.
• You develop skin problems. These can be caused by the solution leaking around
the site of the injection. If this happens your doctor will use a different vein for
your injection.
• You have a particular type of angina (chest pain) called ‘Prinzmetal’s angina’.
• You have low blood volume (with low blood pressure). You could develop
circulatory collapse more easily.
• You have circulation problems, such as paleness of your fingers (Raynaud’s
disease) or aching, tired and sometimes burning pains in your legs.

&

Other medicines and Esmolol
Tell your doctor if you are using, have recently used or might use any other
medicines. This includes medicines that you have obtained yourself, without a
prescription, including herbal medicines and natural products. Your doctor will
check that any other medicines you are taking will not alter the way that
Esmolol works.
In particular, tell your doctor or nurse if you are taking any of the following:
• Medicines that can lower the blood pressure or slow the heart rate.
• Medicines used to treat heart rhythm problems or chest pain (angina) such
as verapamil and diltiazem. You should not receive Esmolol within 48 hours of
stopping verapamil.
• Nifedipine, which is used to treat chest pain (angina), high blood pressure and
Raynaud’s disease.
• Medicines used to treat heart rhythm problems (such as quinidine,
disopyramide, amiodarone) and heart failure (such as digoxin, digitoxin,
digitalis).
• Medicines used to treat diabetes, including insulin and medicines taken by
mouth.
• Medicines known as ganglion blocking agents (such as trimetaphan).
• Medicines used as pain killers, such as non-steroidal anti-inflammatory drugs
known as NSAIDs.
• Floctafenine, which is a pain killer.
• Amisulpride, a medicine that is used to treat mental problems.
• ‘Tricyclic’ antidepressant medicines (such as imipramine and amitriptyline) or
any other drugs for mental health problems.
• Barbiturates (such as phenobarbital, used to treat epilepsy) or phenothiazines
(such as chlorpromazine, used to treat mental disorders).
• Clozapine which is used to treat mental disorders.
• Epinephrine, which is used to treat allergic reactions.
• Medicines used to treat asthma.
• Medicines used to treat colds or a blocked nose, called ‘nasal decongestants’.
• Reserpine, which is used to treat high blood pressure.
• Clonidine, which is used to treat high blood pressure and migraine.
• Moxonidine, which is used to treat high blood pressure.
• Ergot derivates, medicines mainly used to treat Parkinson’s disease.
• Warfarin, which is used to thin your blood.
• Morphine, which is a strong pain killer.
• Suxamethonium chloride (also known as succinylcholine or scoline) or
mivacurium, which are used to relax your muscles, usually during an operation.
Your doctor will also take special care when using Esmolol during operations,
when you will be having anaesthetics and other treatments.
If you are not sure if any of the above applies to you talk to your doctor, nurse or
pharmacist before having Esmolol.
Tests you may have while Esmolol is used
The use of medicines such as Esmolol over a long period of time can cause a
reduction in the force of your heartbeat.
Since Esmolol is only used for a limited time, this is unlikely to happen to you.
During treatment you will be carefully monitored and Esmolol treatment will be
reduced or stopped if the force of your heartbeat is reduced.
Your doctor will also check your blood pressure while you are being treated
with Esmolol.
Pregnancy and breast-feeding
Ask your doctor or pharmacist for advice before taking any medicine.
You should not be given Esmolol if you are pregnant, or if you think you may be
pregnant.
Tell your doctor if you are breast-feeding. Esmolol may pass into breast milk, so
you should not be given Esmolol if you are breast-feeding.
Esmolol contains sodium
This medicinal product contains less than 1 mmol sodium (23 mg) per vial, i.e.
essentially ‘sodium-free’.

3. HOW TO TAKE ESMOLOL
The recommended dose
Your doctor will decide how much of the medicine you will need and for how long
it will be given to you. Esmolol will not normally be given for longer than 24 hours.

Esmolol 10 mg/ml
Solution for injection
esmolol hydrochloride

The following information is intended for medical or healthcare professionals only:
Posology and method of administration
Esmolol is a ready-to-use 10 mg/ml solution recommended for intravenous administration.
This dosage form is used to administer the appropriate Esmolol loading dose or bolus dose by hand held syringe.
Posology is summarised in the following tables.
Table 1: Volume of Esmolol 10 mg/ml required for an INITIAL LOADING DOSE of 500 mcg/kg/minute

Patient weight (kg)


40 50 60 70 80 90 100 110
120

Volume (ml) 2 2.5 3 3.5 4 4.5 5 5.5 6
Table 2: Volume of Esmolol 10 mg/ml required to provide MAINTENANCE DOSES at infusion rates between 12.5 and 300 mcg/kg/minute




Infusion Dose Rate

12.5 25 50 100 150 200 300
mcg/kg/min mcg/kg/min mcg/kg/min mcg/kg/min mcg/kg/min mcg/kg/min mcg/kg/min

Patient weight (kg) Amount to administer per hour to achieve the dose rate (ml / hr)


40

3 ml/hr

6 ml/hr

12 ml/hr

24 ml/hr

36 ml/hr

48 ml/hr

72 ml/hr



50

3.75 ml/hr

7.5 ml/hr

15 ml/hr

30 ml/hr

45 ml/hr

60 ml/hr

90 ml/hr



60

4.5 ml/hr

9 ml/hr

18 ml/hr

36 ml/hr

54 ml/hr

72 ml/hr

108 ml/hr



70

5.25 ml/hr

10.5 ml/hr

21 ml/hr

42 ml/hr

63 ml/hr

84 ml/hr

126 ml/hr



80

6 ml/hr

12 ml/hr

24 ml/hr

48 ml/hr

72 ml/hr

96 ml/hr

144 ml/hr



90

6.75 ml/hr

13.5 ml/hr

27 ml/hr

54 ml/hr

81 ml/hr

108 ml/hr

162 ml/hr



100

7.5 ml/hr

15 ml/hr

30 ml/hr

60 ml/hr

90 ml/hr

120 ml/hr

180 ml/hr



110

8.25 ml/hr

16.5 ml/hr

33 ml/hr

66 ml/hr

99 ml/hr

132 ml/hr

198 ml/hr



120

9 ml/hr

18 ml/hr

36 ml/hr

72 ml/hr

108 ml/hr

144 ml/hr

216 ml/hr

• Shortness

How Esmolol is given
Esmolol is ready to use. You will be given Esmolol by a slow injection (infusion)
through a needle inserted into a vein in your arm.
Esmolol must not be mixed with sodium bicarbonate or other medicinal products.
• The

treatment is given in two stages:
– Stage one: a large dose is given over one minute. This increases the levels
in your blood quickly.
– Stage two: a smaller dose is then given over four minutes.
– Stage one and two may then be repeated and adjusted according to your
heart’s response. As soon as an improvement has happened, stage one (the
large dose) will be stopped and stage two (the small dose) will be reduced
as necessary.
– After reaching a stable condition, you may be given another heart drug,
while your dose of Esmolol is gradually reduced.
• If your heart rate or blood pressure increases during an operation or straight
after recovering from it, you will be given larger doses of Esmolol for a
short time.
Use in elderly
Your doctor will start your treatment with a lower dose.
Use in children
Children up to the age of 18 years should not receive Esmolol .
If you have too much Esmolol
As you are being given Esmolol by a trained and qualified person, it is unlikely
that you will have too much. However, if this happens the doctor will stop Esmolol
and give you additional treatment, if necessary.
If you think that a dose of Esmolol has been forgotten
As you are being given Esmolol by a trained and qualified person, it is unlikely
that you will miss a dose. However, if you think that you have missed a dose, talk
to your doctor, nurse or pharmacist as soon as possible.
If you stop having Esmolol
Suddenly stopping Esmolol may cause symptoms of rapid heartbeat (tachycardia)
and high blood pressure (hypertension) to return. To avoid this your doctor should
stop your treatment gradually. If you are known to have coronary artery disease
(this may be associated with a history of angina or heart attack) your doctor will
take special care when stopping treatment with Esmolol .
If you have any further questions on the use of this medicine, ask your doctor
or nurse.

4. POSSIBLE SIDE EFFECTS
Like all medicines, this medicine can cause side effects, although not everybody
gets them.
Most side effects disappear within 30 minutes of stopping treatment with Esmolol.

of breath or tightness of the chest making it difficult to breathe

• Wheezing
• Blocked

nose
rattling/crackling sounds when breathing
• Changes in your sense of taste
• Indigestion
• Constipation
• Dry mouth
• Pain in your stomach area
• Discoloured skin
• Reddening of the skin
• Pain in your muscles or tendons, including around the shoulder blades and ribs
• Problems passing urine (urinary retention)
• Feeling cold or high temperature (fever)
• Pain and swelling (oedema) of your vein where Esmolol was injected.
• Burning feeling or bruising at the site of injection.
• Abnormal

Very rare (may affect less than 1 in 10,000 people)
• Severe reduction in heart rate (sinus arrest)
• No electrical activity in the heart (asystole)
• Tender blood vessels with an area of hot red skin (thrombophlebitis)
• Dead skin caused by the solution leaking around the site of the injection.
Not known (the number of people affected is unknown)
• Increased levels of potassium in the blood (hyperkalemia)
• Increased levels of acids in your body (metabolic acidosis)
• Increased rate of contraction of the heart (accelerated idioventricular rhythm)
• Spasm of the artery in the heart
• Failure of the normal circulation of the blood (cardiac arrest)
• Psoriasis (where your skin produces scaly patches)
• Swelling of the skin of the face, limbs, tongue or throat (angioedema)
• Hives (urticaria)
• Inflammation of a vein or blistering at the site of infusion.
Reporting of side effects
If you get any side effects, talk to your doctor or nurse. This includes any possible
side effects not listed in this leaflet. You can also report side effects directly via
Yellow Card Scheme, Website: 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 ESMOLOL
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the label and
carton after EXP.
Do not store above 25°C.
Chemical and physical in-use stability has been demonstrated for 24 hours at
2 to 8°C.
Keep the vial in the outer carton in order to protect from light.

Tell your doctor or nurse straight away if you notice any of the following side
effects, which can be serious. The infusion may also need to be stopped.
The following side effects have been reported with Esmolol :
Very common (may affect more than 1 in 10 people)
• Fall in blood pressure. This can be rapidly corrected by reducing the dose of
Esmolol or stopping the treatment. Your blood pressure will be measured often
during treatment.
• Excessive sweating
Common (may affect less than 1 in 10 people)
• Loss of appetite
• Feeling anxious or depressed
• Dizziness
• Feeling sleepy
• Headache
• Tingling or ‘pins and needles’.
• Difficulty concentrating
• Feeling confused or agitated
• Feeling or being sick (nausea and vomiting)
• Feeling weak
• Feeling tired (fatigue)
• Irritation and hardening of your skin where Esmolol was injected.
Uncommon (may affect less than 1 in 100 people)
• Abnormal thoughts
• Sudden loss of consciousness
• Feeling faint or fainting
• Fits (seizures or convulsions)
• Problems with speech
• Problems with eyesight
• Slow heart rate
• Problems with the electrical messages that control your heartbeat
• Increased pressure in the arteries of the lungs
• Inability of the heart to pump enough blood (heart failure)
• A disruption in the rhythm of the heart sometimes known as palpitations
(ventricular extrasystoles)
• A heartbeat disorder (nodal rhythm)
• Chest discomfort caused by poor blood flow through the blood vessels of the
heart muscle (angina pectoris)
• Poor circulation in your arms or legs
• Looking pale or flushed
• Fluid on your lungs

6. CONTENTS OF THE PACK AND OTHER INFORMATION
What Esmolol contains
• The

active substance is esmolol hydrochloride.
other ingredients are sodium acetate trihydrate, glacial acetic acid, sodium
hydroxide and/or hydrochloric acid for pH adjustment and water for injections.
• The

Each ml of solution contains 10 mg esmolol hydrochloride, equivalent to
8.9 mg esmolol.
Each 10 ml vial of solution contains 100 mg esmolol hydrochloride, equivalent to
89 mg esmolol.
What Esmolol looks like and contents of the pack
Esmolol is a clear colourless to light yellow solution packed in 10 ml amber, type I
glass vials, packed in cardboard cartons.
Pack size : 10 vials.
Marketing Authorisation Holder and Manufacturer
Hikma Farmacêutica (Portugal) S.A.
Estrada do Rio da Mó, nº8, 8A e 8B
Fervença
2705-906 Terrugem SNT
Portugal
Distributed by:
Consilient Health (UK) Ltd.,
No.1 Church Road, Richmond upon Thames,
Surrey. TW9 2QE.
This medicinal product is authorised in the Member States of the EEA
under the following names:
Austria:
Germany:
Italy:
Portugal:
The Netherlands:
United Kingdom:

Esmolol Hikma 10 mg/ml, Injektionslösung
Esmolol Hikma 10 mg/ml, Injektionslösung
Esmololo cloridrato Hikma
Esmolol Hikma
Esmolol HCl Hikma 10 mg/ml, oplossing voor injectie
Esmolol 10 mg/ml, Solution for injection

This leaflet was last revised in May 2016.

P0470

&

Perioperative tachycardia and hypertension
For perioperative tachycardia and hypertension the dosing regimen may vary
as follows:
For intraoperative treatment - during anaesthesia when immediate control
is required:
• A bolus injection of 80 mg is given over 15 to 30 seconds followed by a
150 micrograms/kg/minute infusion. Titrate the infusion rate as required up
to 300 micrograms/kg/minute. The volume of infusion required for different
patient weights is provided in Table 2.
Upon awakening from anaesthesia
• An infusion of 500 micrograms/kg/minute is given for 4 minutes followed by
a 300 micrograms/kg/minute infusion. The volume of infusion required for
different patient weights is provided in Table 2.
For post-operative situations when time for titration is available
• A loading dose of 500 micrograms/kg/minute is given over 1 minute before
each titration step to produce a rapid onset of action. Use titration steps of
50, 100, 150, 200, 250 and 300 micrograms/kg/minute given over 4
minutes and stopping at the desired therapeutic effect. The volume of
infusion required for different patient weights is provided in Table 2.

Incompatibilities
In the absence of compatibility studies, this medicinal product must not be
mixed with other medicinal products or sodium bicarbonate solutions.
Special precautions for disposal and other handling
For single use only.
Avoid contact with alkali.
The solution should be visually inspected for particulate matter and
discolouration prior to administration. Only a clear and colourless or slightly
coloured solution should be used. Any unused medicinal product or waste
material should be disposed of in accordance with local requirements.

Expand view ⇕

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.

Hide