Bretylium Tosylate

Ventricular Fibrillation, Ventricular Tachycardia

Treatment

2 FDA approvals

15 Active Studies for Bretylium Tosylate

What is Bretylium Tosylate

Bretylium

The Generic name of this drug

Treatment Summary

Bretylium is a drug used to treat abnormally fast heart rhythms, such as ventricular tachycardia and ventricular fibrillation. It works by blocking the release of a neurotransmitter called noradrenaline from the peripheral nervous system. Bretylium also interferes with the electrical signals in the heart by blocking potassium channels and inhibiting the enzyme Na,K-ATPase.

Bretylium Tosylate

is the brand name

Bretylium Tosylate Overview & Background

Brand Name

Generic Name

First FDA Approval

How many FDA approvals?

Bretylium Tosylate

Bretylium

2019

2

Approved as Treatment by the FDA

Bretylium, also known as Bretylium Tosylate, is approved by the FDA for 2 uses such as Ventricular Fibrillation and Ventricular Tachycardia .

Ventricular Fibrillation

Ventricular Tachycardia

Effectiveness

How Bretylium Tosylate Affects Patients

Bretylium is a medication that is attracted to the nerves in the body responsible for controlling blood pressure. It helps to reduce the amount of norepinephrine released, which helps prevent irregular heart rhythms and ventricular fibrillation.

How Bretylium Tosylate works in the body

Bretylium helps prevent irregular heartbeats, like ventricular fibrillation. It does this by making it harder for the heart to send out electrical signals. Bretylium also increases the time it takes the heart's electrical signals to reach the ventricles, which helps the heart beat more regularly. It can also help restore the natural rhythm of pacemaker tissue and increase the speed at which electrical signals travel through the heart.

When to interrupt dosage

The preferred dose of Bretylium Tosylate is contingent upon the specified condition. The measure of dosage fluctuates as per the technique of delivery (e.g. Solution - Intravenous or Intramuscular; Intravenous) featured in the table beneath.

Condition

Dosage

Administration

Ventricular Fibrillation

, 50.0 mg/mL, 4.0 mg/mL, 2.0 mg/mL

Intramuscular; Intravenous, , Solution, Solution - Intramuscular; Intravenous, Liquid, Liquid - Intramuscular; Intravenous, Intravenous, Solution - Intravenous, Injection, Injection - Intramuscular; Intravenous

Ventricular Tachycardia

, 50.0 mg/mL, 4.0 mg/mL, 2.0 mg/mL

Intramuscular; Intravenous, , Solution, Solution - Intramuscular; Intravenous, Liquid, Liquid - Intramuscular; Intravenous, Intravenous, Solution - Intravenous, Injection, Injection - Intramuscular; Intravenous

Warnings

There are 20 known major drug interactions with Bretylium Tosylate.

Common Bretylium Tosylate Drug Interactions

Drug Name

Risk Level

Description

Amifostine

Major

Bretylium may increase the hypotensive activities of Amifostine.

Dronedarone

Major

Bretylium may increase the QTc-prolonging activities of Dronedarone.

Hydroxyzine

Major

The risk or severity of QTc prolongation can be increased when Bretylium is combined with Hydroxyzine.

Mobocertinib

Major

The risk or severity of QTc prolongation can be increased when Bretylium is combined with Mobocertinib.

Ziprasidone

Major

The risk or severity of QTc prolongation can be increased when Bretylium is combined with Ziprasidone.

Bretylium Tosylate Toxicity & Overdose Risk

In mice, the fatal dose of bretylium is 400 mg/kg. Accidental overdosing has been reported, in which a patient was given 30 mg/kg instead of the intended 10 mg/kg dose. This caused a rapid increase in blood pressure, followed by dangerously low blood pressure, and the patient died 18 hours later due to renal failure and pneumonia. The bretylium levels in the patient's blood were 8000 ng/mL.

image of a doctor in a lab doing drug, clinical research

Bretylium Tosylate Novel Uses: Which Conditions Have a Clinical Trial Featuring Bretylium Tosylate?

19 active trials are exploring the potential of Bretylium Tosylate to address Ventricular Fibrillation.

Condition

Clinical Trials

Trial Phases

Ventricular Fibrillation

4 Actively Recruiting

Phase 4, Not Applicable, Phase 3

Ventricular Tachycardia

13 Actively Recruiting

Not Applicable, Phase 3, Phase 2, Early Phase 1

Patient Q&A Section about bretylium tosylate

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What class is procainamide?

"Procainamide is an anti-arrhythmic medication that affects the speed of electrical conduction in the heart. It also prolongs the heart's electrical activity and reduces the speed of impulse conduction."

Answered by AI

What is bretylium tosylate injection used for?

"Bretylium is an antiarrhythmic drug used to treat ventricular fibrillation (a type of irregular heart beat) and tachycardia (a fast heart rate). It is given as an injection and is used in emergency medicine and other medical specialty areas."

Answered by AI

Is bretylium still used?

"Since the drug bretylium has not been available since 1999, it has been forgotten because of shortages in supplies of the chemical substance."

Answered by AI

What kind of drug is bretylium?

"Bretylium is a drug that prevents or treats ventricular fibrillation, a life-threatening type of irregular heart rhythm."

Answered by AI

Clinical Trials for Bretylium Tosylate

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Image of Medical University of Michigan in Ann Arbor, United States.

AI-Guided Ablation for Ventricular Tachycardia in Heart Disease

18+
All Sexes
Ann Arbor, MI

Over the last decade, radiofrequency catheter ablation (RFCA) has become an established treatment for ventricular arrhythmias (VA). Due to the challenging nature of visualizing lesion formation in real time and ensuring an effective transmural lesion, different surrogate measures of lesion quality have been used. The Ablation Index (AI) is a variable incorporating power delivery in its formula and combining it with CF and time in a weighted equation which aims at allowing for a more precise estimation of lesion depth and quality when ablating VAs. AI guidance has previously been shown to improve outcomes in atrial and ventricular ablation in patients with premature ventricular complexes (PVC). However research on outcomes following AI-guidance for VT ablation specifically in patients with structural disease and prior myocardial infarction remains sparse. The investigators aim at conducting the first randomized controlled trial testing for the superiority of an AI-guided approach regarding procedural duration.

Recruiting
Has No Placebo

Medical University of Michigan (+5 Sites)

Alexander Mazur, MD

Biosense Webster, Inc.

Image of CardioVascular Associates of Mesa in Mesa, United States.

CCM Device for Heart Failure

18+
All Sexes
Mesa, AZ

The goal of this clinical trial is to demonstrate that the OPTIMIZER® Integra CCM-D System (the "CCM-D System") can safely and effective convert induced ventricular fibrillation (VF) and spontaneous ventricular tachycardia and/or ventricular fibrillation (VT/VF) episodes in subjects with Stage C or D heart failure who remain symptomatic despite being on guideline-directed medical therapy (GDMT), are not indicated for cardiac resynchronization therapy (CRT), and have heart failure with reduced left ventricular ejection fraction (LVEF ≤40%). Eligible subjects will be implanted with the CCM-D System. A subset of subjects will be induced into ventricular fibrillation "on the table" in the implant procedure room. During the follow-up period, inappropriate shock rate and device-related complications will be evaluated. The follow-up period is expected to last at least two years.

Waitlist Available
Has No Placebo

CardioVascular Associates of Mesa (+66 Sites)

Niraj Varma, MD, PhD

Impulse Dynamics

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Image of Cedars Cancer Center, McGill University Health Centre in Montreal, Canada.

Ablative Radiation for Ventricular Tachycardia

18+
All Sexes
Montreal, Canada

In 2017 a novel treatment approach to a series of 5 patients with refractory VT was introduced, using ablative radiation with a stereotactic body radiation therapy (SBRT) technique to arrhythmogenic scar regions defined by noninvasive cardiac mapping. More recently, Robinson et al. reported on the results of their Electrophysiology-Guided Noninvasive Cardiac Radioablation for Ventricular Tachycardia (ENCORE-VT) trial, also using a similar SBRT technique in a series of 17 patients with refractory VT. Both studies report a marked reduction in VT burden, a decrease in antiarrhythmic drug use, and an improvement in quality of life. Since then, numerous other centres have detailed their initial experience with this technique. These initial results suggest that this new treatment paradigm has the potential to improve morbidity and mortality for patients suffering from treatment-refractory VT by means of a minimally invasive technique, but requires further validation for widespread use. The appropriate dose for therapeutic effect of this new treatment is not well established as only a single dose prescription of 25 Gy in 1 fraction has been described with benefit. In this phase 2 trial, the investigators plan on expanding the experience with this technique but also by contributing to understanding the relationship between dose-effect relationship through a dose de-escalation stratification, to 20 Gy in 1 fraction, with the goal of minimizing possible adverse events and radiation dose to surrounding healthy tissue while maintaining a clinical benefit.

Phase 2
Waitlist Available

Cedars Cancer Center, McGill University Health Centre

Martin L Bernier, MD

Image of Nova Scotia Health Authority in Halifax, Canada.

SBRT for Ventricular Tachycardia

Any Age
All Sexes
Halifax, Canada

Ventricular tachycardia (VT) contributes to over 350,000 sudden deaths each year in the US. Malignant VTs involve an electrical "short circuit" in the heart, formed by narrow channels of surviving tissue inside myocardial scar. Current treatment for VT consists of either implantable defibrillators (ICDs), suppressive drug therapy, catheter ablation or a combination of all 3. Implantable Defibrillators (ICDs) reduce sudden death and can terminate some ventricular tachycardia (VT) without shocks, but they don't prevent VT. The occurrence of ≥1 ICD shock is associated with reductions in mental well-being and physical functioning, and increases in anxiety and sometimes depression. Further, ICD shocks have been consistently associated with adverse outcomes, including heart failure and death. Furthermore, the most important predictor of ICD shocks is a history of prior ICD shocks. Therapies to suppress VT include antiarrhythmic drug therapy and catheter ablation, neither however is universally effective. When VT recurs despite antiarrhythmic drug therapy and catheter ablation, novel yet invasive, approaches may be required. Such invasive procedures carry consequent risks of cardiac and extra-cardiac injury. Stereotactic body radiotherapy (SBRT) is a non-invasive technique that delivers high doses of radiation precisely to specified regions in the body, while minimizing exposure to adjacent tissue. This technique is currently, and commonly used in the treatment of cancer. Conventional application of SBRT has made use of its ability to spare non-target tissue, including for treatment of tumors near the heart. More recently, clinicians have changed the paradigm, by focusing radioablative energy on ventricular scar responsible for ventricular tachycardia. Pre-clinical studies have supported the concept and were followed by first-in-human VT therapeutic experience in 2017. Subsequent studies have had encouraging results for patients who failed or were unable to tolerate conventional treatment.

Recruiting
Has No Placebo

Nova Scotia Health Authority

John Sapp, MD FRCPC

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