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Indications for BREVIBLOC (esmolol HCl) Injection
- BREVIBLOC Injection is indicated for the rapid control of ventricular rate in patients with atrial fibrillation or atrial flutter in perioperative, postoperative, or other emergent circumstances where short term control of ventricular rate with a short-acting agent is desirable.
- BREVIBLOC Injection is also indicated in noncompensatory sinus tachycardia where, in the physician’s judgment, the rapid heart rate requires specific intervention. BREVIBLOC Injection is intended for short-term use.
Intraoperative and Postoperative Tachycardia and Hypertension
- BREVIBLOC Injection is indicated for the short-term treatment of tachycardia and hypertension that occur during induction and tracheal intubation, during surgery, on emergence from anesthesia and in the postoperative period, when in the physician’s judgment such specific intervention is considered indicated.
- Use of BREVIBLOC Injection to prevent such events is not recommended.
Important Risk Information for BREVIBLOC (esmolol HCl) Injection
- BREVIBLOC Injection is contraindicated in patients with:
- Severe sinus bradycardia, heart block greater than first degree and sick sinus syndrome all of which may precipitate or worsen bradycardia
- Decompensated heart failure
- Cardiogenic shock
- IV administration of cardiodepressant calcium-channel antagonists (e.g. verapamil) and BREVIBLOC Injection in close proximity (i.e., while cardiac effects from the other drug are still present); fatal cardiac arrests have occurred in patients receiving BREVIBLOC Injection and IV verapamil
- Pulmonary hypertension
- Known hypersensitivity to esmolol or any inactive product ingredients
- Hypotension can occur at any dose but is dose-related. 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 BREVIBLOC Injection.
- Bradycardia, including sinus pause, heart block, severe bradycardia, and cardiac arrest have occurred. Monitor patient’s heart rate and rhythm. If severe bradycardia develops, reduce or stop BREVIBLOC Injection.
- Beta-blockers, like BREVIBLOC Injection, can cause depression of myocardial contractility and may precipitate heart failure and cardiogenic shock. Stop BREVIBLOC Injection and start support therapy at first sign of impending cardiac failure.
- Monitor vital signs closely and titrate BREVIBLOC Injection slowly in the treatment of patients whose blood pressure is primarily driven by vasoconstriction associated with hypothermia.
- Patients with reactive airways disease should, in general, not receive beta blockers. Titrate BREVIBLOC Injection to the lowest possible effective dose. Stop infusion immediately in the event of a bronchospasm.
- In patients with hypoglycemia or diabetes, beta blockers may mask tachycardia occurring with hypoglycemia.
- Avoid infusions into small veins or through a butterfly catheter.
- Risk of unopposed alpha-agonism and severe hypertension in untreated pheochromocytoma. If used in the setting of pheochromocytoma, give it in combination with an alpha-blocker, and only after the alpha-blocker has been initiated.
- Risk of myocardial ischemia when abruptly discontinued in patients with coronary artery disease.
- Concomitant use of BREVIBLOC Injection with other drugs that can lower blood pressure, reduce myocardial contractility, or interfere with sinus node function or electrical impulse propagation in the myocardium can exaggerate BREVIBLOC Injection’s effects on blood pressure, contractility, and impulse propagation. Severe interactions with such drugs can result in, for example, severe hypotension, cardiac failure, severe bradycardia, sinus pause, sinoatrial block, atrioventricular block, and/or cardiac arrest.
- Concomitant administration of digoxin and BREVIBLOC Injection leads to an approximate 10% to 20% increase of digoxin blood levels at some time points and increases the risk of bradycardia.
- BREVIBLOC Injection can prolong the duration of neuromuscular blockade.
- Beta blockers increase the risk of withdrawal rebound hypertension when used with antihypertensive agents, such as clonidine, guanfacine, or moxonidine.
- Calcium channel antagonists and BREVIBLOC Injection can cause fatal cardiac arrest in patients with depressed myocardial function.
- Sympathomimetic drugs having beta-adrenergic agonist activity will counteract the effects of BREVIBLOC Injection.
- Do not use BREVIBLOC Injection in patients receiving drugs that are vasoconstrictive and have positive inotropic effects, such as epinephrine, norepinephrine, and dopamine.
- Adverse reactions most commonly (≥3%) reported in clinical trials included asymptomatic (25%) and symptomatic (12%) hypotension, infusion site reaction (8%), nausea (7%), dizziness (3%), and somnolence (3%).