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Hypotension: 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 BREVIBLOC injection. Decrease of dose or termination of infusion reverses hypotension, usually within 30 minutes.
Bradycardia: Bradycardia, including sinus pause, heart block, severe bradycardia, and cardiac arrest have occurred with the use of BREVIBLOC 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 BREVIBLOC injection [see Contraindications].
If severe bradycardia develops, reduce or stop BREVIBLOC injection.
Cardiac Failure: Beta blockers, like BREVIBLOC 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 BREVIBLOC injection and start supportive therapy [see Overdosage].
Intraoperative and Postoperative Tachycardia and/or Hypertension: 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.
Reactive Airways Disease: Patients with reactive airways disease should, in general, not receive beta blockers. Because of its relative beta1 selectivity and titratability, titrate BREVIBLOC injection to the lowest possible effective dose. In the event of bronchospasm, stop the infusion immediately; a beta2 stimulating agent may be administered with appropriate monitoring of ventricular rates.
Use 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).
Infusion Site Reactions: Infusion site reactions have occurred with the use of BREVIBLOC injection. They include irritation, inflammation, and severe reactions (thrombophlebitis, necrosis, and blistering), in particular when associated with extravasation [see Adverse Reactions]. 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.
Use 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.
Use in Patients with Pheochromocytoma: If BREVIBLOC injection 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.
Use in Hypovolemic Patients: In hypovolemic patients, BREVIBLOC injection can attenuate reflex tachycardia and increase the risk of hypotension.
Use in Patients with Peripheral Circulatory Disorders: In patients with peripheral circulatory disorders (including Raynaud's disease or syndrome, and peripheral occlusive vascular disease), BREVIBLOC injection may aggravate peripheral circulatory disorders.
Abrupt Discontinuation of BREVIBLOC 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 BREVIBLOC injection.
Heart rate increases moderately above pretreatment levels 30 minutes after BREVIBLOC injection discontinuation.
Hyperkalemia: Beta blockers, including BREVIBLOC injection, 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 BREVIBLOC injection.
Use in Patients with Metabolic Acidosis: Beta blockers, including BREVIBLOC injection, have been reported to cause hyperkalemic renal tubular acidosis. Acidosis in general may be associated with reduced cardiac contractility.
Use 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.
Use 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 Interactions].
Hepatic Impairment: No special precautions are necessary in patients with hepatic impairment because BREVIBLOC injection is metabolized by red-blood cell esterases [see Pharmacology under Actions].
Renal Impairment: No dosage adjustment is required for esmolol in patients with renal impairment receiving a maintenance infusion of esmolol 150 mcg/kg for 4 hours. There is no information on the tolerability of maintenance infusions of esmolol using rates in excess of 150 mcg/kg or maintained longer than 4 hours [see Pharmacology under Actions].
Use in Children: The safety and effectiveness of BREVIBLOC injection in pediatric patients have not been established.
Use in the Elderly: Clinical studies of BREVIBLOC injection did not include sufficient numbers of subjects aged 65 and over to determine whether they responded differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should usually start at the low end of the dosing range, reflecting greater frequency of decreased renal or cardiac function and of concomitant disease or other drug therapy.
