Warnings and precautions
Risk of hypotension, bradycardia, and cardiac failure: Reduce or discontinue use ( 5.1 , 5.2 , 5.3 , 5.10 ) Risk of exacerbating reactive airway disease ( 5.5 ) Diabetes mellitus: Increases the effect of hypoglycemic agents and masks hypoglycemic tachycardia ( 5.6 ) Risk of unopposed alpha-agonism and severe hypertension in untreated pheochromocytoma ( 5.9 ) Risk of myocardial ischemia when abruptly discontinued in patients with coronary artery disease ( 5.12 , 5.15 )
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 per kg per 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 injection.
Decrease 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 injection. 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 injection, can cause depression of myocardial contractility and may precipitate heart failure and cardiogenic shock. At the first sign or symptom of impending cardiac failure, stop esmolol hydrochloride and start supportive therapy [see Overdosage ( 10 )] .
5.4Intraoperative and Postoperative
Tachycardia and/or Hypertension Monitor vital signs closely and titrate esmolol hydrochloride slowly in the treatment of patients whose blood pressure is primarily driven by vasoconstriction associated with hypothermia.
5.5Reactive 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 hydrochloride 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 rates.
5.6Use in Patients with Diabetes Mellitus and Hypoglycemia
In patients with hypoglycemia, or diabetic patients (especially those with labile diabetes) who are receiving insulin or other hypoglycemic agents, beta blockers may mask tachycardia occurring with hypoglycemia, but other manifestations such as dizziness and sweating may not be masked. Concomitant use of beta blockers and antidiabetic agents can enhance the effect of antidiabetic agents (blood glucose–lowering).
5.7Infusion Site Reactions
Infusion site reactions have occurred with the use of esmolol hydrochloride injection. They include irritation, inflammation, and severe reactions (thrombophlebitis, necrosis, and blistering), in particular when associated with extravasation [see Adverse Reactions ( 6 )]. Avoid infusions into small veins or through a butterfly catheter. If a local infusion site reaction develops, use an alternative infusion site and avoid extravasation.
5.8Use 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.
5.9Use 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.
5.10Use in Hypovolemic Patients
In hypovolemic patients, esmolol hydrochloride injection can attenuate reflex tachycardia and increase the risk of hypotension.
5.11Use 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.
5.12Abrupt Discontinuation of Esmolol Hydrochloride Injection
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 pretreatment levels 30 minutes after esmolol hydrochloride discontinuation.
5.13Hyperkalemia
Beta blockers, including esmolol hydrochloride, have been associated with increases in serum potassium levels and hyperkalemia. The risk is increased in patients with risk factors such as renal impairment. Intravenous administration of beta blockers has been reported to cause potentially life-threatening hyperkalemia in hemodialysis patients. Monitor serum electrolytes during therapy with esmolol hydrochloride.
5.14Use in Patients with Metabolic Acidosis
Beta blockers, including esmolol hydrochloride, have been reported to cause hyperkalemic renal tubular acidosis. Acidosis in general may be associated with reduced cardiac contractility.
5.15Use 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.
5.16Use 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 )] .
