Esmolol hydrochloride 10 mg / mL – patient leaflet, side effects, dosage

1. What Esmolol hydrochloride is and what it is used for

Esmolol hydrochloride contains an active substance 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 are given Esmolol hydrochloride

Esmolol hydrochloride must not be given 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 hydrochloride 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 hydrochloride if any of the above applies to you. If you are not sure if you have any of these conditions, talk to your doctor, pharmacist or nurse before being given Esmolol hydrochloride.

Warnings and precautions

Talk to your doctor, pharmacist or nurse before you are given Esmolol hydrochloride. 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 hydrochloride 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 hydrochloride 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 hydrochloride

• 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 hydrochloride 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

• 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 hydrochloride 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, nurse or pharmacist before you are given this medicine. You may need to be checked carefully and your treatment may be changed.

Doping tests

The use of Esmolol hydrochloride can lead to positive results in doping controls. The health consequences of the use of Esmolol hydrochloride as a doping agent cannot be ignored, serious health hazards cannot be ruled out.

Other medicines and Esmolol hydrochloride

Tell your doctor, pharmacist, or nurse if you are taking, have recently taken or might take 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 hydrochloride works.

In particular, tell your doctor pharmacist 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 hydrochloride 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 medicines 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 medicines 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 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, pharmacist or nurse before having Esmolol hydrochloride.

Tests you may have while Esmolol hydrochloride is used

The use of medicines such as Esmolol hydrochloride over a long period of time can cause a reduction in the force of your heartbeat.

Since Esmolol hydrochloride is only used for a limited time, this is unlikely to happen to you. During treatment you will be carefully monitored and Esmolol hydrochloride 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 hydrochloride.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before having this medicine.

You should not be given Esmolol hydrochloride if you are pregnant, or if you think you may be pregnant.

Tell your doctor if you are breast-feeding. Esmolol hydrochloride may pass into breast milk, so you should not be given Esmolol hydrochloride if you are breast-feeding.

Esmolol hydrochloride contains sodium

This medicine contains 698.52 mg or 30.38 mmol sodium (main component of cooking salt / table salt) per bottle. This is equivalent to 34.9 % of the recommended maximum daily dietary intake of sodium for an adult.

3. How Esmolol hydrochloride is given

Dosage

Your doctor will decide how much of the medicine you will need and for how long it will be given to you. Esmolol hydrochloride will not normally be given for longer than 24 hours.

How Esmolol hydrochloride is given

Esmolol hydrochloride is ready to use. You will be given this medicine by a slow injection (infusion) through a needle inserted into a vein in your arm.

Esmolol hydrochloride must not be mixed with sodium bicarbonate or other medicines.

The following information is intended for healthcare professionals only:

This section contains practical information regarding administration. Read the SPC for full information on posology and method of administration, contraindications, warnings etc.

Esmolol hydrochloride10 mg / mL Solution for infusion is a ready-to-use 10 mg / mL solution, recommended for intravenous administration.

Posology is summarised in the following tables.

Table 1

Volume of Esmolol hydrochloride 10 mg / mL required for an INITIAL LOADING DOSE of 500 mcg / kg / minute

Table 2

Volume of Esmolol hydrochloride 10 mg / mL required to provide MAINTENANCE DOSES at infusion rates between 12.5 and 300 mcg / kg / minute

1 mL of Esmolol hydrochloride is equivalent to 10 mg of esmolol.

PERIOPERATIVE TACHYCARDIA AND HYPERTENSION

For perioperative tachycardia and/or 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.

Recommended maximum dose:

For adequate control of blood pressure, higher dosages (250 – 300 mcg / kg / min) may be required. The safety of dosages above 300 mcg / kg / min has not been adequately studied.

Incompatibilities

In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products or sodium bicarbonate solutions.

Arial 9 pt 160x840 mm

• 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 medicine, while your dose of Esmolol hydrochloride 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 hydrochloride for a short time.

Use in elderly

Your doctor will start your treatment with a lower dose.

Use in children and adolescents

Children up to the age of 18 years should not receive Esmolol hydrochloride.

If you are given more Esmolol hydrochloride than you should

As you are being given Esmolol hydrochloride by a trained and qualified person, it is unlikely that you will have too much. However, if this happens the doctor will stop Esmolol hydrochloride and give you additional treatment, if necessary.

If you think that a dose of Esmolol hydrochloride has been forgotten

As you are being given Esmolol hydrochloride 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 hydrochloride

Suddenly stopping Esmolol hydrochloride 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 hydrochloride.

If you have any further questions on the use of this product, ask your doctor, pharmacist 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 hydrochloride. The following side effects have been reported with this medicine:

Tell your doctor, nurse or pharmacist straight away if you notice any of the following side effects, which can be serious. The infusion may also need to be stopped.

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 hydrochloride 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 hydrochloride 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

• shortness of breath or tightness of the

  chest making it difficult to breathe

• wheezing
• blocked nose

• abnormal 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 hydrochloride was injected

• burning feeling or bruising at the site of

  injection

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 (frequency cannot be estimated from the available data):

  • 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, pharmacist 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 or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Esmolol hydrochloride

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 bottle and carton box after EXP. The expiry date refers to the last day of that month.

Do not remove the overpouch until ready to use.

Store below 25°C.

After first opening, chemical and physical in-use stability has been demonstrated for 24 hours at 2 to 8°C. From a microbiological point of view, unless the method of opening precludes the risk of microbial contamination, the product should be used immediately. If not used immediately, in-use storage times and conditions are the responsibility of the user.

Do not use Esmolol hydrochloride if you notice particles or discolouration of the solution.

Do not throw any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information

What Esmolol hydrochloride contains

• The active substance is esmolol hydrochloride. One mL contains 10 mg of esmolol hydrochloride. Each 250 mL bottle contains 2500 mg of esmolol hydrochloride.
• The other ingredients are sodium chloride, sodium acetate trihydrate, acetic acid glacial, hydrochloric acid / sodium hydroxide 1N (for pH adjustment), water for injections.

What Esmolol hydrochloride looks like and contents of the pack

Esmolol hydrochloride is clear and practically free from particles solution for intravenous infusion. It is available in 250 mL blow-fill-sealed polypropylene bottles with a molded plastic cap with an embedded rubber gasket in the inside and a pull ring in the outside. The above mentioned are packed in an aluminum overpouch. Pack sizes of 1 and 10 bottles.

Marketing Authorization Holder and Manufacturer

Marketing Authorisation Holder: Noridem Enterprises Ltd.,

Evagorou & Makariou, Mitsi Building 3, Office 115, 1065 Nicosia, Cyprus

Manufacturer: DEMO S.A.

PHARMACEUTICAL INDUSTRY,

21^st Km National Road Athens-Lamia, 14568 Krioneri, Attiki, Greece,

T: +30 210 8161802, F: +30 210 8161587

This leaflet was last revised in 09/2025.

Special precautions for disposal and other handling

Esmolol hydrochloride 10 mg / mL Solution for infusion is provided in 250 mL PP bottles. Do not add any additional medications to Esmolol hydrochloride

10 mg / mL Solution for infusion.

Each bottle is for single-patient use only. Any unused solution and the containers should be disposed of in accordance with local requirements. Do not reconnect partially used bottles.

CAUTION

Do not use plastic containers in series connections. Such use could result in an embolism due to residual air being drawn from the primary container before administration of the fluid from the secondary container is completed.

TO OPEN

Do not remove unit from overwrap until ready to use. Do not use if overwrap has been previously opened or damaged.

Visually inspect the solution for particulate matter and discolouration prior to

administration.

Only a clear and practically free from particles solution should be used.

Do not introduce additives to Esmolol hydrochloride 10 mg / mL Solution for infusion.

After first opening, chemical and physical in-use stability has been demonstrated for 24 hours at 2 to 8°C. From a microbiological point of view, unless the method of opening precludes the risk of microbial contamination, the product should be used immediately. If not used immediately, in-use storage times and conditions are the responsibility of the user.

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