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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.)

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 Tracrium (atracurium besylate) Side Effects Center for a complete guide to possible side effects

DRUG INTERACTIONS

Drugs which may enhance the neuromuscular blocking action of TRACRIUM (atracurium besylate) include: enflurane; isoflurane; halothane; certain antibiotics, especially the aminoglycosides and polymyxins; lithium; magnesium salts; procainamide; and quinidine.

If other muscle relaxants are used during the same procedure, the possibility of a synergistic or antagonist effect should be considered.

The prior administration of succinylcholine does not enhance the duration, but quickens the onset and may increase the depth, of neuromuscular block induced by TRACRIUM (atracurium besylate) . TRACRIUM (atracurium besylate) should not be administered until a patient has recovered from succinylcholine-induced neuromuscular block.

Read the Tracrium Drug Interactions Center for a complete guide to possible interactions

Last reviewed on RxList: 12/8/2004
This monograph has been modified to include the generic and brand name in many instances.

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Additional Tracrium Information

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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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