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Tracrium

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Tracrium

Discontinued Warning IconPlease Note: This Brand Name drug is no longer available in the US.
(Generic versions may still be available.)

Tracrium

Tracrium Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Tracrium (atracurium besylate) is a muscle relaxant used as an adjunct to general anesthesia, to facilitate endotracheal intubation and to provide skeletal muscle relaxation during surgery or mechanical ventilation. The brand name of this medication is discontinued, but generic versions may be available. Common side effects include allergic reactions such as skin flushing, redness, itching, and hives.

A dose of Tracrium of 0.4 to 0.5 mg/kg (1.7 to 2.2 times the ED95), given as an intravenous bolus injection, is the recommended initial dose for most patients. Tracrium may interact with enflurane, isoflurane, halothane, antibiotics, lithium, magnesium salts, procainamide, quinidine, other muscle relaxants used during the same procedure, or succinylcholine. Tell your doctor all medications and supplements you use. During pregnancy, Tracrium should be administered only if prescribed. It is unknown if this drug passes into breast milk. Consult your doctor before breastfeeding.

Our Tracrium (atracurium besylate) 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 Prescribing information?

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

Tracrium FDA Prescribing Information: Side Effects
(Adverse Reactions)

SIDE EFFECTS

Observed in Controlled Clinical Studies

TRACRIUM (atracurium besylate) was well tolerated and produced few adverse reactions during extensive clinical trials. Most adverse reactions were suggestive of histamine release. In studies including 875 patients, TRACRIUM (atracurium besylate) was discontinued in only one patient (who required treatment for bronchial secretions), and six other patients required treatment for adverse reactions attributable to TRACRIUM (atracurium besylate) (wheezing in one, hypotension in five). Of the five patients who required treatment for hypotension, three had a history of significant cardiovascular disease. The overall incidence rate for clinically important adverse reactions, therefore, was 7/ 875 or 0.8%. Table 1 includes all adverse reactions reported attributable to TRACRIUM (atracurium besylate) during clinical trials with 875 patients.

Table 1: Percent of Patients Reporting Adverse Reactions Initial Dose of TRACRIUM (atracurium besylate) (mg/kg)

 

Adverse Reaction

Initial Dose of TRACRIUM (atracurium besylate) (mg/ kg)

0.00-0.30

(n = 485)

0.31-0.50*

(n = 366)

³ 0.60

(n = 24)

Total

(n = 875)

Skin Flush

Erythema

Itching

Wheezing/Bronchial Secretions

Hives

1.0%

0.6%

0.4%

0.2%

0.2%

8.7%

0.5%

0%

0.3%

0%

29.2%

0%

0%

0%

0%

5.0%

0.6%

0.2%

0.2%

0.1%

* Includes the recommended initial dosage range for most patients.


Most adverse reactions were of little clinical significance unless they were associated with significant hemodynamic changes. Table 2 summarizes the incidences of substantial vital sign changes noted during clinical trials of TRACRIUM (atracurium besylate) with 530 patients, without cardiovascular disease, in whom these parameters were assessed.

Table 2: Percent of Patients Showing >30% Vital Sign Changes Following Administration of TRACRIUM (atracurium besylate)

 

Vital Sign Change

Initial Dose of TRACRIUM (atracurium besylate) (mg/ kg)

0.00-0.30

(n = 365)

0.31-0.50*

(n = 144)

³ 0.60

(n = 21)

Total

(n = 530)

Mean Arterial Pressure

Increase

Decrease

1.9%

1.1%

2.8%

2.1%

0%

14.3%

2.1%

1.9%

Heart Rate

Increase

Decrease

1.6%

0.8%

2.8%

0%

4.8%

0%

2.1%

0.6%

* Includes the recommended initial dosage range for most patients.


Observed in Clinical Practice

Based on initial clinical practice experience in approximately 3 million patients who received TRACRIUM (atracurium besylate) in the US and in the United Kingdom, spontaneously reported adverse reactions were uncommon (approximately 0.01% to 0.02%). The following adverse reactions are among the most frequently reported, but there are insufficient data to support an estimate of their incidence:

General: Allergic reactions (anaphylactic or anaphylactoid responses) which, in rare instances, were severe (e.g., cardiac arrest).

Musculoskeletal: Inadequate block, prolonged block.

Cardiovascular: Hypotension, vasodilatation (flushing), tachycardia, bradycardia.

Respiratory: Dyspnea, bronchospasm, laryngospasm.

Integumentary: Rash, urticaria, reaction at injection site.

There have been rare spontaneous reports of seizures in ICU patients following long-term infusion of atracurium to support mechanical ventilation. There are insufficient data to define the contribution, if any, of atracurium and/or its metabolite laudanosine. (See PRECAUTIONS: Long-Term Use in Intensive Care Unit [ICU]).

Read the entire FDA prescribing information for Tracrium (Atracurium Besylate) »

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Additional Tracrium Information

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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