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Hypotension

In clinical trials 20-50% of patients treated with BREVIBLOC (Esmolol Hydrochloride) have experienced hypotension, generally defined as systolic pressure less than 90 mmHg and/or diastolic pressure less than 50 mmHg. About 12% of the patients have been symptomatic (mainly diaphoresis or dizziness). Hypotension can occur at any dose but is dose-related so that doses beyond 200 mcg/kg/min (0.2 mg/kg/min) are not recommended. Patients should be closely monitored, especially if pretreatment blood pressure is low. Decrease of dose or termination of infusion reverses hypotension, usually within 30 minutes.

Cardiac Failure

Sympathetic stimulation is necessary in supporting circulatory function in congestive heart failure, and beta blockade carries the potential hazard of further depressing myocardial contractility and precipitating more severe failure. Continued depression of the myocardium with beta blocking agents over a period of time can, in some cases, lead to cardiac failure. At the first sign or symptom of impending cardiac failure, BREVIBLOC (Esmolol Hydrochloride) should be withdrawn. Although withdrawal may be sufficient because of the short elimination half-life of BREVIBLOC (esmolol) , specific treatment may also be considered (see OVERDOSE). The use of BREVIBLOC (esmolol) for control of ventricular response in patients with supraventricular arrhythmias should be undertaken with caution when the patient is compromised hemodynamically or is taking other drugs that decrease any or all of the following: peripheral resistance, myocardial filling, myocardial contractility, or electrical impulse propagation in the myocardium. Despite the rapid onset and offset of the effects of BREVIBLOC (esmolol) , several cases of death have been reported in complex clinical states where BREVIBLOC (esmolol) was presumably being used to control ventricular rate.

Intraoperative and Postoperative Tachycardia and/or Hypertension

BREVIBLOC (Esmolol Hydrochloride) should not be used as the treatment for hypertension in patients in whom the increased blood pressure is primarily due to the vasoconstriction associated with hypothermia.

Bronchospastic Diseases

PATIENTS WITH BRONCHOSPASTIC DISEASES SHOULD, IN GENERAL, NOT RECEIVE BETA BLOCKERS. Because of its relative beta₁ selectivity and titratability, BREVIBLOC (Esmolol Hydrochloride) may be used with caution in patients with bronchospastic diseases. However, since beta1 selectivity is not absolute, BREVIBLOC (esmolol) should be carefully titrated to obtain the lowest possible effective dose. In the event of bronchospasm, the infusion should be terminated immediately; a beta₂ stimulating agent may be administered if conditions warrant but should be used with particular caution as patients already have rapid ventricular rates.

Diabetes Mellitus and Hypoglycemia

BREVIBLOC (Esmolol Hydrochloride) should be used with caution in diabetic patients requiring a beta blocking agent. Beta blockers may mask tachycardia occurring with hypoglycemia, but other manifestations such as dizziness and sweating may not be significantly affected.

General

Because the acid metabolite of BREVIBLOC (esmolol) is primarily excreted unchanged by the kidney, BREVIBLOC (Esmolol Hydrochloride) should be administered with caution to patients with impaired renal function. The elimination half-life of the acid metabolite was prolonged ten-fold and the plasma level was considerably elevated in patients with end-stage renal disease.

Carcinogenesis, Mutagenesis, Impairment of Fertility

Because of its short term usage no carcinogenicity, mutagenicity or reproductive performance studies have been conducted with BREVIBLOC (Esmolol Hydrochloride).

Pregnancy Category C

Teratogenicity studies in rats at intravenous dosages of BREVIBLOC (Esmolol Hydrochloride) up to 3000 mcg/kg/min (3 mg/kg/min) (ten times the maximum human maintenance dosage) for 30 minutes daily produced no evidence of maternal toxicity, embryotoxicity or teratogenicity, while a dosage of 10,000 mcg/kg/min (10 mg/kg/min) produced maternal toxicity and lethality. In rabbits, intravenous dosages up to 1000 mcg/kg/min (1 mg/kg/min) for 30 minutes daily produced no evidence of maternal toxicity, embryotoxicity or teratogenicity, while 2500 mcg/kg/min (2.5 mg/kg/min) produced minimal maternal toxicity and increased fetal resorptions.

Although there are no adequate and well-controlled studies in pregnant women, use of esmolol in the last trimester of pregnancy or during labor or delivery has been reported to cause fetal bradycardia, which continued after termination of drug infusion. BREVIBLOC (esmolol) should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Nursing Mothers

It is not known whether BREVIBLOC (Esmolol Hydrochloride) is excreted in human milk; however, caution should be exercised when BREVIBLOC (esmolol) is administered to a nursing woman.

Pediatric Use

The safety and effectiveness of BREVIBLOC (Esmolol Hydrochloride) in pediatric patients have not been established.

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