Consumer medicine information

1. Why am I using Esmolol Hydrochloride Medsurge?

Esmolol Hydrochloride Medsurge contains the active ingredient esmolol hydrochloride. Esmolol Hydrochloride Injection is used as a short-term treatment for irregular heartbeat before, during or after surgery. It is also used in emergency situations. For more information, see Section 1. Why am I using Esmolol Hydrochloride Medsurge? in the full CMI.

2. What should I know before I use Esmolol Hydrochloride Medsurge?

Do not use if you have ever had an allergic reaction to esmolol hydrochloride or any of the ingredients listed at the end of this leaflet.
Tell your doctor if you have or have had any other medical conditions, are pregnant or plan to become pregnant or are breastfeeding.
For more information, see Section 2. What should I know before I use Esmolol Hydrochloride Medsurge? in the full CMI.

3. What if I am taking other medicines?

Some medicines may interfere with Esmolol Hydrochloride Medsurge and affect how it works.
A list of these medicines is in Section 3. What if I am taking other medicines? in the full CMI.

4. How do I use Esmolol Hydrochloride Medsurge?

Esmolol Hydrochloride Medsurge is given as a slow injection into a vein by a doctor or nurse. Your doctor will decide what dose and how long you will receive Esmolol Hydrochloride Medsurge Injection. This depends on your condition and other factors, such as your weight.
More instructions can be found in Section 4. How do I use Esmolol Hydrochloride Medsurge? in the full CMI.

5. What should I know while using Esmolol Hydrochloride Medsurge?

6. Are there any side effects?

Tell your doctor or nurse if you notice any of the following - tiredness, drowsiness, sweating, decreased alertness, dizziness or light-headedness (sometimes with fainting), especially on standing up, abnormal thinking or hallucinations (seeing, feeling or hearing things that are not there). Other side effects not listed above may also occur in some people. For more information, including what to do if you have any side effects, see Section 6. Are there any side effects? in the full CMI.

Notes

Distributed by Medsurge Healthcare Pty Ltd

1 Name of Medicine

Esmolol hydrochloride.

2 Qualitative and Quantitative Composition

Esmolol Hydrochloride Medsurge Injection is supplied as 100 mg/10 mL vial containing 100 mg esmolol hydrochloride.
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

100 mg/10 mL vial. Esmolol Hydrochloride Medsurge Injection is a clear, colourless to light yellow, sterile, nonpyrogenic solution of esmolol hydrochloride for intravenous infusion. The single dose vial has a pH range of 4.5 to 5.5.

4 Clinical Particulars

4.9 Overdose

Acute toxicity. Overdoses of esmolol hydrochloride can cause cardiac arrest. In addition, overdoses can produce bradycardia, hypotension, electro-mechanical dissociation and loss of consciousness. Cases of massive accidental overdoses of esmolol hydrochloride have occurred due to dilution errors. Some of these overdoses have been fatal while others resulted in permanent disability. Bolus doses in the range of 625 to 2500 mg (12.5-50 mg/kg) have been fatal. Patients have recovered completely from overdoses as high as 1.75 g given over one minute or doses of 7.5 g given over one hour for cardiovascular surgery. The patients who survived appear to be those whose circulation could be supported until the effects of esmolol hydrochloride resolved.
Because of its approximately 9-minute elimination half-life, the first step in the event of toxicity should be to discontinue the esmolol hydrochloride infusion. Then, based on the observed clinical effects, the following general measures should also be considered.
Bradycardia. Intravenous administration of atropine or another anticholinergic drug.
Bronchospasm. Nebulised beta₂-stimulating agent should be given. If this is not sufficient, intravenous administration of a beta₂-stimulating agent and/or a theophylline derivative can be considered.
Cardiac failure. Intravenous administration of a diuretic and/or digitalis glycoside. In shock resulting from inadequate cardiac contractility, intravenous administration of dopamine, dobutamine or isoprenaline may be considered. In case further treatment is necessary, the following agents can be given intravenously: atropine, inotropic agents, calcium ions.
Symptomatic hypotension. Intravenous administration of fluids and/or pressor agents.
For information on the management of overdose, contact the Poisons Information Centre on 131126 (Australia).

5 Pharmacological Properties

5.3 Preclinical Safety Data

Genotoxicity. Because of its short term usage no carcinogenicity, mutagenicity or reproductive performance studies have been conducted with esmolol hydrochloride.
Carcinogenicity. Because of its short term usage no carcinogenicity, mutagenicity or reproductive performance studies have been conducted with esmolol hydrochloride.

6 Pharmaceutical Particulars

6.7 Physicochemical Properties

Esmolol hydrochloride is ± methyl 3-[4-[2-hydroxy- 3-(isopropylamino) propoxy]phenyl] propionate hydrochloride. Esmolol hydrochloride has the empirical formula C₁₆H₂₅NO₄.HCl and a molecular weight of 331.8. It has one asymmetric centre and exists as a racemic mixture. It is a relatively hydrophilic compound which is very soluble in water and freely soluble in alcohol. Its partition coefficient (octanol/water) at pH 7.0 is 0.42 compared to 17.0 for propranolol.
Chemical structure.
https://stagingapi.mims.com/au/public/v2/images/fullchemgif/CSESMHYD.gif CAS number. 81161-17-3.

7 Medicine Schedule (Poisons Standard)

Prescription only medicine (Schedule 4).

Summary Table of Changes

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