Tracrium
- Generic Name: atracurium besylate
- Brand Name: Tracrium
Tracrium (Atracurium Besylate) side effects drug center
Tracrium Side Effects Center
What Is Tracrium?
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 Tracrium is discontinued, but generic versions may be available.
What Are Side Effects of Tracrium?
Common side effects of Tracrium (atracurium besylate) include:
- allergic reactions (such as skin flushing [skin redness or warmth], redness, itching, wheezing, and hives),
- low blood pressure,
- fast or slow heart rate,
- shortness of breath, or
- injection site reactions.
Dosage for Tracrium
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.
What Drugs, Substances, or Supplements Interact with Tracrium?
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.
Tracrium During Pregnancy or Breastfeeding
During pregnancy, Tracrium should be administered only if prescribed. It is unknown if this drug passes into breast milk. Consult your doctor before breastfeeding.
Additional Information
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.
Tracrium Professional Information
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)
&Copy; Tracrium Patient Information is supplied by Cerner Multum, Inc. and Tracrium Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.