Warnings and precautions
- Risk of hypotension, bradycardia, and cardiac failure: Monitor for signs and symptoms of cardiovascular adverse effects. Reduce dose or discontinue use ( 5.1 , 5.2 , 5.3 , 5.8 )
- Risk of exacerbating reactive airway disease ( 5.4 )
- Diabetes mellitus: May mask symptoms of hypoglycemia and alter glucose levels; monitor ( 5.5 )
- Risk of unopposed alpha-agonism and severe hypertension in untreated pheochromocytoma ( 5.7 )
- Risk of myocardial ischemia when abruptly discontinued in patients with coronary artery disease ( 5.10 , 5.11 )
5.1Hypotension
Hypotension can occur at any dose but is dose-related. Patients with hemodynamic compromise or on interacting medications are at particular risk. Severe reactions may include loss of consciousness, cardiac arrest, and death. For control of ventricular heart rate, maintenance doses greater than 200 mcg/kg/min are not recommended. Monitor patients closely, especially if pretreatment blood pressure is low. In case of an unacceptable drop in blood pressure, reduce or stop esmolol hydrochloride.
Reduction of dose or termination of infusion reverses hypotension, usually within 30 minutes.
5.2Bradycardia
Bradycardia, including sinus pause, heart block, severe bradycardia, and cardiac arrest have occurred with the use of esmolol hydrochloride. Patients with first-degree atrioventricular block, sinus node dysfunction, or conduction disorders may be at increased risk. Monitor heart rate and rhythm in patients receiving esmolol hydrochloride [see Contraindications ( 4 )] . If severe bradycardia develops, reduce or stop esmolol hydrochloride.
5.3Cardiac Failure
Beta-blockers, like esmolol hydrochloride, can cause depression of myocardial contractility and may precipitate heart failure and cardiogenic shock. If the patient develops signs or symptoms of cardiac failure, stop esmolol hydrochloride and start supportive therapy.
5.4Reactive Airways Disease Patients
with reactive airways disease should, in general, not receive beta-blockers. Because of its relative beta 1 selectivity and titratability, titrate esmolol to the lowest possible effective dose. In the event of bronchospasm, stop the infusion immediately; a beta 2 stimulating agent may be administered with appropriate monitoring of ventricular rate.
5.5Hypoglycemia
Beta-blockers may prevent early warning signs of hypoglycemia, such as tachycardia, and increase the risk for severe or prolonged hypoglycemia at any time during treatment, especially in patients with diabetes mellitus or children and patients who are fasting (i.e., surgery, not eating regularly, or are vomiting). If severe hypoglycemia occurs, patients should be instructed to seek emergency treatment.
5.6Use in Patients with Prinzmetal’s Angina
Beta-blockers may exacerbate anginal attacks in patients with Prinzmetal’s angina because of unopposed alpha receptor–mediated coronary artery vasoconstriction. Do not use nonselective beta-blockers.
5.7Use in Patients with Pheochromocytoma
If esmolol hydrochloride is used in the setting of pheochromocytoma, give it in combination with an alpha-blocker, and only after the alpha-blocker has been initiated. Administration of beta-blockers alone in the setting of pheochromocytoma has been associated with a paradoxical increase in blood pressure from the attenuation of beta-mediated vasodilation in skeletal muscle.
5.8Use in Hypovolemic Patients
In hypovolemic patients, esmolol hydrochloride can attenuate reflex tachycardia and increase the risk of hypotension.
5.9Use in Patients with Peripheral Circulatory Disorders
In patients with peripheral circulatory disorders (including Raynaud’s disease or syndrome, and peripheral occlusive vascular disease), esmolol hydrochloride may aggravate peripheral circulatory disorders.
5.10Abrupt Discontinuation of Esmolol Hydrochloride
Severe exacerbations of angina, myocardial infarction, and ventricular arrhythmias have been reported in patients with coronary artery disease upon abrupt discontinuation of beta-blocker therapy. Observe patients for signs of myocardial ischemia when discontinuing esmolol hydrochloride. Heart rate increases moderately above pre-treatment levels 30 minutes after esmolol hydrochloride discontinuation.
5.11Use in Patients with Hyperthyroidism
Beta-adrenergic blockade may mask certain clinical signs (e.g., tachycardia) of hyperthyroidism. Abrupt withdrawal of beta-blockade might precipitate a thyroid storm; therefore, monitor patients for signs of thyrotoxicosis when withdrawing beta-blocking therapy.
5.12Use in Patients at Risk of Severe Acute Hypersensitivity Reactions
When using beta-blockers, patients at risk of anaphylactic reactions may be more reactive to allergen exposure (accidental, diagnostic, or therapeutic). Patients using beta-blockers may be unresponsive to the usual doses of epinephrine used to treat anaphylactic or anaphylactoid reactions [see Drug Interactions ( 7 )].