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The following adverse reaction rates are based on use of BREVIBLOC (Esmolol Hydrochloride) in clinical trials involving 369 patients with supraventricular tachycardia and over 600 intraoperative and postoperative patients enrolled in clinical trials. Most adverse effects observed in controlled clinical trial settings have been mild and transient. The most important adverse effect has been hypotension (see WARNINGS). Deaths have been reported in post-marketing experience occurring during complex clinical states where BREVIBLOC (esmolol) was presumably being used simply to control ventricular rate (see WARNINGS, Cardiac Failure).

Cardiovascular

Symptomatic hypotension (diaphoresis, dizziness) occurred in 12% of patients, and therapy was discontinued in about 11%, about half of whom were symptomatic. Asymptomatic hypotension occurred in about 25% of patients. Hypotension resolved during BREVIBLOC (Esmolol Hydrochloride) infusion in 63% of these patients and within 30 minutes after discontinuation of infusion in 80% of the remaining patients. Diaphoresis accompanied hypotension in 10% of patients. Peripheral ischemia occurred in approximately 1% of patients. Pallor, flushing, bradycardia (heart rate less than 50 beats per minute), chest pain, syncope, pulmonary edema and heart block have each been reported in less than 1% of patients. In two patients without supraventricular tachycardia but with serious coronary artery disease (post inferior myocardial infarction or unstable angina), severe bradycardia/sinus pause/asystole has developed, reversible in both cases with discontinuation of treatment.

Central Nervous System

Dizziness has occurred in 3% of patients; somnolence in 3%; confusion, headache, and agitation in about 2%; and fatigue in about 1% of patients. Paresthesia, asthenia, depression, abnormal thinking, anxiety, anorexia, and lightheadedness were reported in less than 1% of patients. Seizures were also reported in less than 1% of patients, with one death.

Respiratory

Bronchospasm, wheezing, dyspnea, nasal congestion, rhonchi, and rales have each been reported in less than 1% of patients.

Gastrointestinal

Nausea was reported in 7% of patients. Vomiting has occurred in about 1% of patients. Dyspepsia, constipation, dry mouth, and abdominal discomfort have each occurred in less than 1% of patients. Taste perversion has also been reported.

Skin (Infusion Site)

Infusion site reactions including inflammation and induration were reported in about 8% of patients. Edema, erythema, skin discoloration, burning at the infusion site, thrombophlebitis, and local skin necrosis from extravasation have each occurred in less than 1% of patients.

Miscellaneous

Each of the following has been reported in less than 1% of patients: Urinary retention, speech disorder, abnormal vision, midscapular pain, rigors, and fever.

Catecholamine-depleting drugs, e.g., reserpine, may have an additive effect when given with beta blocking agents. Patients treated concurrently with BREVIBLOC (Esmolol Hydrochloride) and a catecholamine depletor should therefore be closely observed for evidence of hypotension or marked bradycardia, which may result in vertigo, syncope, or postural hypotension.

A study of interaction between BREVIBLOC (esmolol) and warfarin showed that concomitant administration of BREVIBLOC (esmolol) and warfarin does not alter warfarin plasma levels. BREVIBLOC (esmolol) concentrations were equivocally higher when given with warfarin, but this is not likely to be clinically important.

When digoxin and BREVIBLOC (esmolol) were concomitantly administered intravenously to normal volunteers, there was a 10-20% increase in digoxin blood levels at some time points. Digoxin did not affect BREVIBLOC (esmolol) pharmacokinetics. When intravenous morphine and BREVIBLOC (esmolol) were concomitantly administered in normal subjects, no effect on morphine blood levels was seen, but BREVIBLOC (esmolol) steady-state blood levels were increased by 46% in the presence of morphine. No other pharmacokinetic parameters were changed.

The effect of BREVIBLOC (esmolol) on the duration of succinylcholine-induced neuromuscular blockade was studied in patients undergoing surgery. The onset of neuromuscular blockade by succinylcholine was unaffected by BREVIBLOC (esmolol) , but the duration of neuromuscular blockade was prolonged from 5 minutes to 8 minutes.

Although the interactions observed in these studies do not appear to be of major clinical importance, BREVIBLOC (esmolol) should be titrated with caution in patients being treated concurrently with digoxin, morphine, succinylcholine or warfarin.

While taking beta blockers, patients with a history of severe anaphylactic reaction to a variety of allergens may be more reactive to repeated challenge, either accidental, diagnostic, or therapeutic. Such patients may be unresponsive to the usual doses of epinephrine used to treat allergic reaction.

Caution should be exercised when considering the use of BREVIBLOC (esmolol) and verapamil in patients with depressed myocardial function. Fatal cardiac arrests have occurred in patients receiving both drugs. Additionally, BREVIBLOC (esmolol) should not be used to control supraventricular tachycardia in the presence of agents which are vasoconstrictive and inotropic such as dopamine, epinephrine, and norepinephrine because of the danger of blocking cardiac contractility when systemic vascular resistance is high.

Last reviewed on RxList: 12/3/2007
This monograph has been modified to include the generic and brand name in many instances.