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Brevibloc

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Brevibloc

Brevibloc

Brevibloc Side Effects Center

Medical Editor: Charles Patrick Davis, MD, PhD

Brevibloc Premixed (esmolol hydrochloride) Injection is a beta blocker currently available in generic form and is indicated for the rapid control of ventricular rate in patients with atrial fibrillation, or atrial flutter in perioperative, postoperative, or other emergent circumstances. Brevibloc is also indicated in noncompensatory sinus tachycardia where the rapid heart rate requires specific intervention.

Dosage needs to be titrated, using ventricular rate as the guide. An initial loading dose of .5 milligrams/kg (500 micrograms/kg) infused over a minute duration followed by a maintenance infusion of .05 milligrams/kg/min (50 micrograms/kg/min) for the next 4 minutes is recommended. Use of esmolol in the last trimester of pregnancy or during labor or delivery has been reported to cause fetal bradycardia. Brevibloc should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Caution should be exercised when Brevibloc is administered to a nursing woman.

Our Brevibloc Premixed (esmolol hydrochloride) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is Patient Information in Detail?

Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.

Brevibloc in Detail - Patient Information: Side Effects

Esmolol use has been associated with low blood pressure and other serious side effects.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Brevibloc (Esmolol) »

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Brevibloc FDA Prescribing Information: Side Effects
(Adverse Reactions)

SIDE EFFECTS

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.

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 and common adverse effect has been hypotension [see WARNINGS AND PRECAUTIONS]. Deaths have been reported in post-marketing experience occurring during complex clinical states where BREVIBLOC was presumably being used simply to control ventricular rate [see WARNINGS AND PRECAUTIONS].

Table 2 : Clinical Trial Adverse Reactions (Frequency ≥ 3%)

System Organ Class (SOC) Preferred MedDRA Term Frequency
VASCULAR DISORDERS Hypotension*
Asymptomatic hypotension
25%
Symptomatic hypotension (hyperhidrosis, dizziness) 12%
GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Infusion site reactions (inflammation and induration) 8%
GASTROINTESTINAL DISORDERS Nausea 7%
NERVOUS SYSTEM DISORDERS Dizziness 3%
Somnolence 3%
* Hypotension resolved during BREVIBLOC (esmolol hydrochloride) infusion in 63% of patients. In 80% of the remaining patients, hypotension resolved within 30 minutes following discontinuation of infusion.

Clinical Trial Adverse Reactions (Frequency < 3%)

Psychiatric Disorders

Confusional state and agitation (~2%)

Anxiety, depression and abnormal thinking ( < 1%)

Nervous System Disorders

Headache (~ 2%)

Paresthesia, syncope, speech disorder, and lightheadedness ( < 1%)

Convulsions ( < 1%), with one death

Vascular Disorders

Peripheral ischemia (~1%)

Pallor and flushing ( < 1%)

Gastrointestinal Disorders

Vomiting (~1%)

Dyspepsia, constipation, dry mouth, and abdominal discomfort have ( < 1%)

Renal and Urinary Disorders

Urinary retention ( < 1%)

Post-Marketing Experience

In addition to the adverse reactions reported in clinical trials, the following adverse reactions have been reported in the post-marketing experience. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to estimate reliably their frequency or to establish a causal relationship to drug exposure.

Cardiac Disorders

Cardiac arrest, Coronary arteriospasm

Skin and Subcutaneous Tissue Disorders

Angioedema, Urticaria, Psoriasis

Read the entire FDA prescribing information for Brevibloc (Esmolol) »

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Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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