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ESMOLOL HYDROCHLORIDE is a brand name for Esmolol. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: ESMOLOL HYDROCHLORIDE 2500 mg powder is indicated for supraventricular tachycardia (except for pre- excitation syndromes), and for the rapid control of ventricular rate in patients with atrial fibrillation or atrial flutter in perioperative, postoperative, or other circumstances where short-term control of the…
Verbatim from this product's MHRA label. Tap a section to expand.
ESMOLOL HYDROCHLORIDE 2500 mg powder for concentrate for solution for infusion MUST NOT BE ADMINISTERED WITHOUT RECONSTITUTION/DILUTION. 4 and 6). 4). Posology SUPRAVENTRICULAR TACHYARRHYTHMIA The dosage of ESMOLOL HYDROCHLORIDE 2500 mg powder should be titrated individually.
A starting dose is required, followed by a maintenance dosage. The effective dose of ESMOLOL HYDROCHLORIDE 2500 mg powder is within the range of 50 to 200 micrograms/kg/min, although doses as high as 300 micrograms/kg/min have been used.
In a few patients the average effective dosage of 25 micrograms/kg/min has been adequate. g. lowered blood pressure) is approached, OMIT the loading infusion and reduce the incremental dose in the maintenance infusion from 50 micrograms/kg/min to 25 micrograms/kg/min or lower.
If necessary, the interval between the titration steps may be increased from 5 to 10 minutes. NB: Maintenance doses above 200 micrograms/kg/min have not been shown to have significantly increased benefits, and the safety of doses above 300 micrograms /kg/min has not been studied.
In the event of an adverse reaction, the dosage of ESMOLOL HYDROCHLORIDE 2500 mg powder may be reduced or discontinued. Pharmacological adverse reactions should resolve within 30 minutes. If a local infusion site reaction develops, an alternative infusion site should be used and caution should be taken to prevent extravasation.
The administration of ESMOLOL HYDROCHLORIDE 2500 mg powder infusions for longer than 24 hours has not been thoroughly evaluated. Infusion durations greater than 24 hours should only be used with caution. Abrupt discontinuation of ESMOLOL HYDROCHLORIDE 2500 mg powder in patients has not been reported to produce the withdrawal effects which may occur with abrupt withdrawal of beta-blockers following chronic use in coronary artery disease (CAD) patients.
However, caution should still be used in discontinuing ESMOLOL HYDROCHLORIDE 2500 mg powder infusions abruptly in CAD patients. PERIOPERATIVE TACHYCARDIA AND HYPERTENSION For perioperative tachycardia and hypertension the dosing regimen may vary as follows: a) For the 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/min infusion.
In case of undesirable effects, the dose of ESMOLOL HYDROCHLORIDE 2500 mg powder can be reduced or discontinued. Most of the undersirable effects observed have been mild and transient. The most important one has been hypotension. The following undesirable effects are ranked according to MedDRA System Organ Class (SOC) and to their frequency.
Note:
The frequency of occurrence of adverse events is classified as follows: Very common (≥ 1/10) Common (≥1/100 to < 1/10) Uncommon (≥1/1,000 to < 1/100) Rare (≥ 1/10,000 to < 1/1,000) Very rare (< 1/10,000) Not known (cannot be estimated from the available data) Frequency System Organ Class Very common Common Uncommon Very rare Not known Metabolism and nutrition disorders Anorexia Hyperkalemia Metabolic acidosis Psychiatric disorders Depression Anxiety Thinking abnormal Nervous system disorders Dizziness 1 Somnolence Headache Paraesthesiae Disturbance in attention Confusional state Agitation Syncope Convulsion Speech disorder Eye disorders Visual impairment Cardiac disorders Bradycardia Atrioventricular block Pulmonary arterial pressure increased Cardiac Failure Ventricular extrasystoles Nodal rhythm Angina pectoris Sinus arrest Asystole Accelerated idioventricular rhythm Coronary arteriospasm Cardiac arrest.
Vascular disorders Hypotension Peripheral ischaemia Pallor Flushing Thrombophlebitis 2 1 Dizziness and diaphoresis are in association with symptomatic hypotension. 2 In association with Injection and Infusion site reactions. Frequency System Organ Class Very common Common Uncommon Very rare Not known Respiratory, thoracic and mediastinal disorders Dyspnoea Pulmonary oedema Bronchospasm Wheezing Nasal congestion Rhonchi Rales Gastrointestinal disorders Nausea Vomiting Dysgeusia Dyspepsia Constipation Dry mouth Abdominal pain Skin and subcutaneous tissue disorders Diaphoresis 1 Skin discolouration 2 Erythema 2 Skin necrosis 2 (due to extravasation) Psoriasis 3 Angioedem a Urticaria Musculoskeletal and connective tissue disorders Musculoskeletal pain 4 Renal and urinary disorders Urinary retention General disorders and administration site conditions Asthenia Fatigue Injection site reaction Infusion site reaction Infusion site inflammation Infusion site induration Chills Pyrexia Oedema 2 Pain 2 Infusion site burning Infusion site ecchymosis Chest Pain Infusion site phlebitis Infusion site vesicles Blistering 2 1 Dizziness and diaphoresis are in association with symptomatic hypotension.
Warnings ESMOLOL HYDROCHLORIDE 2500 mg powder for concentrate for solution for infusion must be reconstituted/diluted and used immediately after opening (see section 6). Incorrect dilutions of ESMOLOL HYDROCHLORIDE 2500 mg powder may result in severe overdoses.
9). It is advised to terminate the infusion gradually because of the risk of rebound tachycardia. It is recommended to continuously monitor the blood pressure and the ECG in all patients treated with ESMOLOL HYDROCHLORIDE 2500 mg powder.
In the event of a hypotensive episode, the infusion rate should be reduced or, when necessary, be discontinued. The use of ESMOLOL HYDROCHLORIDE 2500 mg powder for control of ventricular response in patients with supraventricular arrhythmias should be undertaken with caution when the patient is compromised hemodynamically or is taking other drugs that decrease any or all of the following: peripheral resistance, myocardial filling, myocardial contractility, or electrical impulse propagation in the myocardium.
Despite the rapid onset and offset of the effects of ESMOLOL HYDROCHLORIDE 2500 mg powder, severe reactions may occur, including loss of consciousness, cardiogenic shock, cardiac arrest. Several deaths have been reported in complex clinical states where ESMOLOL HYDROCHLORIDE 2500 mg powder was presumably being used to control the ventricular rate.
The most frequently observed side effect is hypotension, which is dose related but can occur at any dose. This can be severe. In the event of a hypotensive episode the infusion rate should be lowered or, if necessary, be discontinued.
Hypotension is usually reversible (within 30 minutes after discontinuation of administration of HYDROCHLORIDE 2500 mg powder). In some cases, additional interventions may be necessary to restore blood pressure. In patients with a low systolic blood pressure, extra caution is needed when adjusting the dosage and during the maintenance infusion.
Hypersensitivity to the active substance; - Severe sinus bradycardia (less than 50 beats per minute); - “Sick sinus” -syndrome; severe AV-nodal conductance disorders (without pacemaker); 2nd or 3rd degree AV-block; - Cardiogenic shock; - Severe hypotension; - Decompensated heart failure; - Concomitant or recent intravenous administration of verapamil.
5); - Non-treated phaeochromocytoma; - Pulmonary hypertension; - Acute asthmatic attack; - Metabolic acidosis;
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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Titrate the infusion rate as required up to 300 micrograms/kg/min. b) Upon awakening from anaesthesia administer an infusion of 500 micrograms/kg/min for up to 4 minutes followed by an infusion of 300 micrograms/kg/min. c) For postoperative situations when time for titration is available give the 500 micrograms/kg/min loading dose over one 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/min given over four minutes, stopping at the desired therapeutic effect. Replacement of ESMOLOL HYDROCHLORIDE 2500 mg powder therapy by alternative drugs After patients achieve an adequate control of the heart rate and a stable clinical status, transition to alternative drugs (such as antiarrhytmics or calcium antagonists) may be accomplished.
Reducing the dosage:
When ESMOLOL HYDROCHLORIDE 2500 mg powder is to be replaced by alternative drugs, the physician should carefully consider the labelling of the alternative drug selected and reduce the dosage of ESMOLOL HYDROCHLORIDE 2500 mg powder as follows: 1) Within the first hour after the first dose of the alternative drug, reduce the ESMOLOL HYDROCHLORIDE 2500 mg powder infusion rate by one-half (50%).
2) After administration of the second dose of the other alternative drug, monitor the patient’s response and if satisfactory control is maintained for the first hour, discontinue the ESMOLOL HYDROCHLORIDE 2500 mg powder infusion. g.
5 – 25 micrograms/kg/min. Also, if desired, increase the interval between titration steps from five to ten minutes. ESMOLOL HYDROCHLORIDE 2500 mg powder should be discontinued when heart rate or blood pressure rapidly approach or exceed a safety limit, and then restarted without a loading infusion at a lower dose after the heart rate or blood pressure has returned to an acceptable level.
Special populations Elderly The elderly should be treated with caution, starting with a lower dosage. Special studies in the elderly have not been conducted. However, analysis of data of 252 patients over 65 years indicated that no variations in pharmacodynamic effects occurred as compared with data of patients under 65.
Patients with kidney insufficiency In patients with renal insufficiency caution is needed when ESMOLOL HYDROCHLORIDE 2500 mg powder is administered by infusion, since the acid metabolite of ESMOLOL HYDROCHLORIDE 2500 mg powder is excreted through the kidneys.
Excretion of the acid […]
2 In association with Injection and Infusion site reactions. 3 Beta-blockers as a drug class can cause psoriasis in some situations, or worsen it. 4 Including midscapular pain and costochondritis 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. uk/yellowcard.
Bradycardia, including severe bradycardia, and cardiac arrest has occurred with the use of ESMOLOL HYDROCHLORIDE. ESMOLOL HYDROCHLORIDE 2500 mg powder should be used with special caution in patients with low pretreatment heart rates and only when the potential benefits are considered to outweigh the risk.
3). If the pulse rate decreases to less than 50- 55 beats per minute at rest and the patient experiences symptoms related to bradycardia, the dosage should be reduced or administration stopped. The elderly should be treated with caution, starting with a lower dosage, but tolerance is usually good in the elderly.
Sympathetic stimulation is necessary in supporting circulatory function in congestive heart failure, and Betablockade carries the potential hazard of further depressing myocardial contractility and precipitating more severe failure.
Continued depression of the myocardium with beta blocking agents over a period of time can, in some cases, lead to cardiac failure. Caution should be exercised when using HYDROCHLORIDE 2500 mg powder in patients with compromised cardiac function.
At the first sign or symptom of impending cardiac failure, ESMOLOL HYDROCHLORIDE 2500 mg powder should be withdrawn. 9). 3). 3). 3). Caution is required when ESMOLOL HYDROCHLORIDE 2500 mg powder is used to treat hypertension following induced hypothermia.
Patients with bronchospastic disease should, in general, not receive beta blockers. Because of its relative beta1 selectivity and titratability, ESMOLOL HYDROCHLORIDE 2500 mg powder should be used with caution in patients with bronchospastic diseases.
However, since beta1 selectivity is not absolute, ESMOLOL HYDROCHLORIDE 2500 mg powder should be carefully titrated to obtain the lowest possible effective dose. In the event of bronchospasm, the infusion should be terminated immediately and a beta2 agonist should be administered if necessary.
If the patient already uses a beta-2-receptorstimulating agent, it can be necessary to re-evaluate the dose of this agent. ESMOLOL HYDROCHLORIDE 2500 mg powder should be used with caution in patients with a history of wheezing and asthma.
Precautions ESMOLOL HYDROCHLORIDE 2500 mg powder should be used with caution in diabetics or in case of suspected of actual hypoglycaemia. The severity of hypoglycaemia is less than the one observed with less cardio-selective beta-blockers.
Beta-blockers may mask the prodromal symptoms of hypoglycaemia such as tachycardia. However, dizziness and sweating, however, may not be affected. 5). Infusions of concentrations of 20 mg/ml have been associated with significant venous irritation and thrombophlebitis in animals and man.
Extravasation of 20 mg/ml may lead to a serious local reaction and possible skin necrosis. Local reactions have also been reported following infusion of concentrations of 10 mg/ml. Infusion into small veins or through a butterfly catheter should therefore be avoided.
The administration of the 50 mg/ml solution should be strictly done in a large vein or in a central […]