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ESMOLOL HYDROCHLORIDE 2500 MG POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION

Active substance(s): ESMOLOL HYDROCHLORIDE

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Esmolol hydrochloride 2500 mg
UK
PIL
04.04.2014

Art.Nr:
Pharma-Code:
Format:
Colors:

GI25519GB 0513
xxx
148 x 297 mm
black

adaption to approved var 14 (RS)

PACKAGE LEAFLET: INFORMATION FOR THE USER
ESMOLOL HYDROCHLORIDE 2500 mg powder for concentrate for solution
for infusion
Esmolol hydrochloride
Read all of this leaflet carefully before you start using this medicine.
- Keep this leaflet. You may need to read it again.
- If you have any further questions, ask your doctor or nurse.
- This medicine has been prescribed for you. Do not pass it on to others. It may
harm them, even if their symptoms are the same as yours.
- If any of the side effects gets serious, or if you notice any side effects not listed
in this leaflet, please tell your doctor or nurse.
In this leaflet:
1. What ESMOLOL HYDROCHLORIDE is and what it is used for
2. Before you use ESMOLOL HYDROCHLORIDE
3. How to use ESMOLOL HYDROCHLORIDE
4. Possible side effects
5. How to store ESMOLOL HYDROCHLORIDE
6. Further information
1. WHAT ESMOLOL HYDROCHLORIDE
IS AND WHAT IT IS USED FOR
Esmolol belongs to the group of beta
blockers these medicines slow down the
heart beat and reduce blood pressure.
Esmolol is used for short term treatment
if your heart beats too fast.
Esmolol is also used during or straight
after surgery if your blood pressure gets
too high and/or your heart beats too fast.
2. BEFORE
YOU
USE
ESMOLOL
HYDROCHLORIDE
Do not use ESMOLOL HYDROCHLORIDE if you
- are allergic (hypersensitive) to esmolol
or any of the other ingredients of
esmolol
- have a very slow heart beat have a
problem with the electrical messages
that control your heartbeat (a problem
called “heart block”).
- have a serious heart failure
- have a fast or alternating fast and slow
heartbeat (a problem called the “Sick
Sinus” syndrome)
- have a phaeochromocytoma not yet
treated. (A phaeochromocytoma is a
condition of the adrenal gland that may
be accompanied by a sudden increase
of blood pressure, severe headache,
sweating and increased heartbeat)
- have a problem with the blood supply
to your heart (a problem called
cardiogenic shock)
- have low blood pressure
- have increased pressure in the vessels
of the lung (pulmonary hypertension)
have an acute asthmatic attack
- have increased level of acids in your
body (a problem called metabolic
acidosis)
Take special care with ESMOLOL
HYDROCHLORIDE
- Esmolol hydrochloride MUST BE
RECONSTITUTED/DILUTED BY YOUR
DOCTOR OR NURSE
- The most frequently observed side
effect is hypotension (low blood
pressure). The signs of this may be
feeling dizzy or light headed, especially
when standing up. This is rapidly
reversible with dosage reduction or
discontinuation. Usually, your blood
pressure and ECG will be continuously
monitored if you are treated with
esmolol.
Your doctor will take special care if you
- have diabetes or low blood sugar
(hypoglycaemia). You require special
monitoring because esmolol can mask
the symptoms of a low blood sugar.
- have had heart problems in the past
Your doctor will monitor you very closely
for any heart symptoms. If necessary,
the treatment will be stopped, the
dosage lowered or special treatment
initiated.
- have a skin reaction at the injection
site, another injection site should be
used.
- have narrowing of your airways or
wheezing, such as with asthma.
- have psoriasis or healed psoriasis
(where your skin produces scaly
patches)
- have any allergies. Esmolol may
increase both your sensitivity toward
the cause of your allergy and the
seriousness of allergic reactions.
- have circulatory problems, such as
paleness of your fingers (Raynaud’s
disease) or aching, tired and sometimes
burning pains in your legs.
- have kidney problems.

Taking other medicines
Please tell your doctor or nurse if you are
taking or have recently taken any other
medicines, including medicines obtained
without a prescription, herbal medicines,
or natural products. Your doctor will check
that any medicines you are taking will not
alter the way that Esmolol hydrochloride
works.
In particular, tell your doctor, nurse or
pharmacist if you are taking any of the
following:
• Medicines used to treat heart rhythm
problems, chest pain (angina) and high
blood pressure such as verapamil and
diltiazem
• Medicines used to treat both heart
rhythm problems and heart failure,
such as digoxin, digitoxin, digitalis,
quinidine, disopyramide or amiodarone
• Medicines used to treat diabetes,
including insulin and medicines taken
by mouth
• Medicines known as ganglion blocking
agents (such as trimetaphan)
• Medicines used to treat colds or a blocked
nose, called nasal ‘decongestants’
• Medicines used as pain killers, such as
non-steroidal anti-inflammatory drugs
known as NSAIDs
• Medicines used to treat depression,
such as ‘tricyclic’ antidepressants
or any other drugs for mental health
problems
• Clonidine, which is used to treat high
blood pressure and migraine
• Nifedipine, which is used to treat chest
pain (angina), high blood pressure and
Raynaud’s disease
• Warfarin, which is used to thin your
blood
• Reserpine, which is used to treat high
blood pressure
• Morphine, which is a strong pain killer
• Floctafenine, which is a pain killer
• Amisulpride, a medicine that is used to
treat mental problems
• Suxamethonium chloride (also known
as succinylcholine or scoline), which
is used to relax your muscles, usually
during an operation. Your doctor
will also take special care when
using Esmolol hydrochloride 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
or pharmacist before having Esmolol
hydrochloride.
Pregnancy and breast-feeding
Insufficient data are available about
the use of esmolol during pregnancy in
humans to prove safety. However, there
are no indicators of increased risk of birth
defects in humans.
Because of the lack of experience the use
of ESMOLOL HYDROCHLORIDE during
pregnancy is not recommended.
Ask your doctor or nurse for advice before
taking any medicine.
It is not known whether esmolol is
excreted in the breast milk. Therefore
breast-feeding is not recommended
during administration of esmolol.
Ask your doctor or nurse for advice before
taking any medicine.
3. HOW TO USE ESMOLOL HYDROCHLORIDE
ESMOLOL HYDROCHLORIDE MUST BE
RECONSTITUTED / DILUTED BEFORE
ADMINISTRATION
The dosage must be individually
adapted. A starting dosage followed
by a maintenance dosage should be

administered. Your doctor will determine
the dosage scheme and adapt the dosage
as needed based on the side effects.
ESMOLOL HYDROCHLORIDE is administered as an infusion. It is administered into a vein by a doctor or a nurse. The administration of the 50 mg/ml
solution using a perfusor pump should be
strictly done in a large vein or in a central
catheter.
The duration of use depends on the effect
and possibly occurring side effects. Your
doctor will determine the duration of
treatment.
Changing the dose of esmolol is not
usually necessary if you:
- have liver problems
- are elderly
If you have kidney problems then your
doctor will take appropriate caution.
Children and adolescents
The safety and efficacy of esmolol have
not been established in children and
adolescents.
If you have received more ESMOLOL
HYDROCHLORIDE than you should
If you have the feeling that you have
received too much esmolol, inform your
doctor or nurse who will then take further
measures.
The following symptoms may occur, if
there is an overdosage:
severe drop in blood pressure, slow heart
beat, reduced heart function, shock
occurring because of decreased heart
function, reduced breathing (respiratory
insufficiency), loss of consciousness
ranging to coma, convulsions (cramps),
nausea, vomiting, low blood sugar
(hypoglycaemia).
When
the
use
of
ESMOLOL
HYDROCHLORIDE is stopped
If you suffer from a heart disease caused
by coronary artery problems (such as
angina pectoris), caution is required when
interrupting treatment with ESMOLOL
HYDROCHLORIDE.
The infusion will be terminated gradually.
If you have any further questions on the
use of this product, ask your doctor or
nurse.
4. POSSIBLE SIDE EFFECTS
Like all medicines, ESMOLOL HYDROCHLORIDE can cause side effects,
although not everybody gets them.
Most side effects disappear within 30
minutes of stopping treatment with
ESMOLOL HYDROCHLORIDE.
Tell your doctor or nurse straight away
if you notice any of the following side
effects, which can be serious. The
infusion may need to be stopped.
Side effects are
frequency:
very common:

common:

uncommon:

rare:


very rare:

not known:



ranked according to their
affects more than 1 user
in 10
affects 1 to 10 users in
100
affects 1 to 10 users in
1,000
affects 1 to 10 users in
10,000
affects less than 1 user
in 10,000
Frequency cannot be
estimated from the
available data

The following side effects may
appear:
Very common: fall in blood pressure,
sweating
Common: Feeling sleepy, Headache,
Difficulty
concentrating,
Dizziness,
Feeling lightheaded, Tingling or “pins and
needles”, Feeling or being sick (nausea
and vomiting), Loss of appetite, Irritation
and hardening of your skin where Esmolol
hydrochloride was injected, Feeling weak,
Feeling tired (fatigue), Feeling anxious or
depressed, Feeling confused or agitated
Uncommon: Slow heart rate, Sudden loss
of consciousness, Feeling faint of fainting,
Fits (seizures or convulsions), Changes in
your sense of taste, Problems with speech,
Problems with eyesight, Shortness of
breath or difficulty breathing, Fluids on
your lungs, Wheezing, Blocked nose,
Abnormal breath sounds, Dry mouth,
Pain in your stomach area, Indigestion,
Constipation, Problems passing urine,
Discoloured skin, Reddening of the skin,

Pain in your muscles or tendons, Poor
circulation in your arms or legs, Looking
pale or flushed, Chest pain, Feeling cold
or high temperature (fever), Pain and
swelling (oedema) of your vein where
Esmolol hydrochloride was injected,
Burning feeling at the site of injection,
Abnormal thoughts
Very rare: Severe reduction in heart rate,
Cardiac arrest, Tender blood vessels with
an area of hot red skin (thrombophlebitis),
Skin problems caused by the solution
leaking around the site of injection
Not known (the number of people affected
is unknown): Psoriasis (where your skin
produces scaly patches).
If any of the side effects gets serious, or
if you notice any side effects not listed
in this leaflet, please tell your doctor or
nurse.
5. HOW TO STORE Esmolol hydrochloride
Keep out of the reach and sight of
children.
Do not use ESMOLOL HYDROCHLORIDE
after the expiry date which is stated on
the label after EXP. The expiry date refers
to the last day of that month.
This medicinal product does not require
any special storage conditions.
The in-use storage condition is 25°C.
The opened, reconstituted and diluted
product is physicochemically stable during
24 hours at 25 °C. From microbiological
point of view the product must be used
immediately after opening and dilution.
In case this is not done, the user is
responsible for use and administration.
Normally, the period of use is not more
than 24 hours at 2-8 °C, unless opening,
reconstitution/dilution has taken place
in controlled and validated aseptic
conditions.
Medicines should not be disposed of 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
What ESMOLOL HYDROCHLORIDE
contains
The
active
substance
is
esmolol
hydrochloride.
One 50 ml vial contains 2500 mg esmolol
hydrochloride. The product contains no
other ingredients.
Each ml of reconstituted concentrate
for solution for infusion contains 50 mg
esmolol hydrochloride (50 mg/ml).
Each ml of the diluted solution for infusion
contains 10 mg esmolol hydrochloride
(10 mg/ml).
What Esmolol hydrochloride looks
like and contents of the pack
One vial contains 2500 mg white to
almost white powder.
The vial consists of colourless glass (type I).
One pack ESMOLOL HYDROCHLORIDE
2500 mg powder for solution for infusion
contains 1 vial.
Marketing Authorisation Holder and
Manufacturer
Marketing Authorisation Holder
Orpha-Devel Handels und Vertriebs GmbH
Wintergasse 85/1B
A-3002 Purkersdorf
Austria
Manufacturer
HIKMA Italia S.P.A.
Viale Certosa 10
Pavia (PV) 27100
Italy
This leaflet was last approved in
April 2014.
The information for the use of this
product for medical or healthcare
professionals is available in the SPC.

GI25519GB 0513

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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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