pharmacopeia
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/api/v1/drug/atracurium

Mechanism of action

Sourced from openFDA

Mechanism-of-action classes: Cholinergic Neuromuscular Nicotinic Antagonists; Competitive Cholinergic Nicotinic Antagonists.

Cholinergic Neuromuscular NicotinicCompetitive Cholinergic Nicotinic

Indications

Sourced from openFDA
  • Atracurium Besylate Injection, USP is indicated, as an adjunct to general anesthesia, to facilitate endotracheal intubation and to provide skeletal muscle relaxation during surgery or mechanical ventilation.

Contraindications

Sourced from openFDA
  • Atracurium besylate is contraindicated in patients known to have a hypersensitivity to it. Use of atracurium besylate from multiple dose vials containing benzyl alcohol as a preservative is contraindicated in patients with a known hypersensitivity to benzyl alcohol.contraindicated

Dosage & administration

Sourced from openFDA

To avoid distress to the patient, atracurium should not be administered before unconsciousness has been induced. Atracurium should not be mixed in the same syringe, or administered simultaneously through the same needle, with alkaline solutions (e.g., barbiturate solutions). Atracurium besylate should be administered intravenously. DO NOT GIVE ATRACURIUM BESYLATE BY INTRAMUSCULAR ADMINISTRATION. Intramuscular administration of atracurium besylate may result in tissue irritation and there are no clinical data to support this route of administration. As with other neuromuscular blocking agents, the use of a peripheral nerve stimulator will permit the most advantageous use of atracurium besylate, minimizing the possibility of overdosage or underdosage, and assist in the evaluation of recovery. Bolus Doses for Intubation and Maintenance of Neuromuscular Block Adults An atracurium besylate dose of 0.4 to 0.5 mg/kg (1.7 to 2.2 times the ED 95 ), given as an intravenous bolus injection, is the recommended initial dose for most patients. With this dose, good or excellent conditions for nonemergency intubation can be expected in 2 to 2.5 minutes in most patients, with maximum neuromuscular block achieved approximately 3 to 5 minutes after injection. Clinically required neuromuscular block generally lasts 20 to 35 minutes under balanced anesthesia. Under balanced anesthesia, recovery to 25% of control is achieved approximately 35 to 45 minutes after injection, and recovery is usually 95% complete approximately 60 minutes after injection.

Warnings & precautions

Sourced from openFDA

ATRACURIUM SHOULD BE USED ONLY BY THOSE SKILLED IN AIRWAY MANAGEMENT AND RESPIRATORY SUPPORT. EQUIPMENT AND PERSONNEL MUST BE IMMEDIATELY AVAILABLE FOR ENDOTRACHEAL INTUBATION AND SUPPORT OF VENTILATION, INCLUDING ADMINISTRATION OF POSITIVE PRESSURE OXYGEN. ADEQUACY OF RESPIRATION MUST BE ASSURED THROUGH ASSISTED OR CONTROLLED VENTILATION. ANTICHOLINESTERASE REVERSAL AGENTS SHOULD BE IMMEDIATELY AVAILABLE. DO NOT GIVE ATRACURIUM BESYLATE BY INTRAMUSCULAR ADMINISTRATION. Atracurium has no known effect on consciousness, pain threshold, or cerebration. It should be used only with adequate anesthesia. Atracurium besylate injection, which has an acid pH, should not be mixed with alkaline solutions (e.g., barbiturate solutions) in the same syringe or administered simultaneously during intravenous infusion through the same needle. Depending on the resultant pH of such mixtures, atracurium may be inactivated and a free acid may be precipitated. Atracurium besylate injection 10 mL multiple dose vials contain benzyl alcohol. In neonates, benzyl alcohol has been associated with an increased incidence of neurological and other complications which are sometimes fatal. Atracurium besylate 5 mL single-dose vials do not contain benzyl alcohol (see PRECAUTIONS: Pediatric Use ). Anaphylaxis Severe anaphylactic reactions to neuromuscular blocking agents, including atracurium besylate, have been reported. These reactions have in some cases been life-threatening and fatal.

Adverse reactions

Sourced from openFDA

Observed in Controlled Clinical Studies Atracurium 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, atracurium was discontinued in only one patient (who required treatment for bronchial secretions) and six other patients required treatment for adverse reactions attributable to atracurium (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 atracurium during clinical trials with 875 patients. Table 1: Percent of Patients Reporting Adverse Reactions * Includes the recommended initial dosage range for most patients. Adverse Reaction Initial Atracurium Dose (mg/kg) 0.00 to 0.30 (n = 485) 0.31 to 0.50 * (n = 366) > 0.60 (n = 24) Total (n = 875) Skin Flush 1% 8.7% 29.2% 5% Erythema 0.6% 0.5% 0% 0.6% Itching 0.4% 0% 0% 0.2% Wheezing/Bronchial Secretions 0.2% 0.3% 0% 0.2% Hives 0.2% 0% 0% 0.1% 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 atracurium clinical trials with 530 patients, without cardiovascular disease, in whom these parameters were assessed.

Use in specific populations

Sourced from openFDA

Pregnancy Teratogenic Effects: Atracurium besylate has been shown to be potentially teratogenic in rabbits when given in doses up to approximately one-half the human dose. There are no adequate and well-controlled studies in pregnant women. Atracurium should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Atracurium besylate was administered subcutaneously on days 6 through 18 of gestation to non-ventilated Dutch rabbits. Treatment groups were given either 0.15 mg/kg once daily or 0.10 mg/kg twice daily. Lethal respiratory distress occurred in two 0.15 mg/kg animals and in one 0.10 mg/kg animal, with transient respiratory distress or other evidence of neuromuscular block occurring in 10 of 19 and in 4 of 20 of the 0.15 mg/kg and 0.10 mg/kg animals, respectively. There was an increased incidence of certain spontaneously occurring visceral and skeletal anomalies or variations in one or both treated groups when compared to non-treated controls. The percentage of male fetuses was lower (41% vs. 51%) and the post-implantation losses were increased (15% vs. 8%) in the group given 0.15 mg/kg once daily when compared to the controls; the mean numbers of implants (6.5 vs. 4.4) and normal live fetuses (5.4 vs. 3.8) were greater in this group when compared to the control group.

Overdosage

Sourced from openFDA

There has been limited experience with overdosage of atracurium besylate. The possibility of iatrogenic overdosage can be minimized by carefully monitoring muscle twitch response to peripheral nerve stimulation. Excessive doses of atracurium can be expected to produce enhanced pharmacological effects. Overdosage may increase the risk of histamine release and cardiovascular effects, especially hypotension. If cardiovascular support is necessary, this should include proper positioning, fluid administration, and the use of vasopressor agents if necessary. The patient’s airway should be assured, with manual or mechanical ventilation maintained as necessary. A longer duration of neuromuscular block may result from overdosage and a peripheral nerve stimulator should be used to monitor recovery. Recovery may be facilitated by administration of an anticholinesterase reversing agent such as neostigmine, edrophonium, or pyridostigmine, in conjunction with an anticholinergic agent such as atropine or glycopyrrolate. The appropriate package inserts should be consulted for prescribing information.

Approval history

Sourced from openFDA
  • Feb 17, 2012ANDAANDA091488Meitheal
  • Feb 17, 2012ANDAANDA091489Meitheal
  • Oct 18, 2012ANDAANDA090761Hospira Inc
  • Oct 18, 2012ANDAANDA090782Hospira Inc
  • Apr 8, 2015ANDAANDA206010Eugia Pharma
  • Apr 8, 2015ANDAANDA206011Eugia Pharma

FAERS reports

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Reference statistics only. FAERS reports are voluntarily submitted and are not incidence rates, safety signals, or causal evidence. Counts reflect reporting volume — how often a reaction was reported, not how often it occurs. For decision-grade use, consult openFDA and the FAERS Public Dashboard directly.
696 total reports matchedLatest report Share = reports listing the reaction ÷ total matched reports. Rows can sum to >100% because a single report often lists multiple reactions.
  1. 1Hypotension7411%
  2. 2Anaphylactic Reaction669.5%
  3. 3Anaphylactic Shock659.3%
  4. 4Bradycardia405.7%
  5. 5Bronchospasm355.0%
  6. 6Drug Interaction355.0%
  7. 7Cardiac Arrest334.7%
  8. 8Thrombocytopenia304.3%
  9. 9Drug Ineffective263.7%
  10. 10Oxygen Saturation Decreased263.7%
  11. 11Condition Aggravated223.2%
  12. 12Respiratory Failure223.2%
  13. 13Leukocytosis213.0%
  14. 14Rash Maculo-papular213.0%
  15. 15Tachycardia213.0%

Literature

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Recent PubMed references pinned to Atracurium as a MeSH major topic. Citations link to pubmed.ncbi.nlm.nih.gov.

Clinical trials

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The 10 most recently updated of 164 ClinicalTrials.gov registrations naming Atracurium as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

Frequently asked questions

How does Atracurium work?
Mechanism-of-action classes: Cholinergic Neuromuscular Nicotinic Antagonists; Competitive Cholinergic Nicotinic Antagonists.
What is Atracurium used for?
According to FDA labeling, Atracurium carries indications including: Atracurium Besylate Injection, USP is indicated, as an adjunct to general anesthesia, to facilitate endotracheal intubation and to provide skeletal muscle relaxation during surgery or mechanical ventilation.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.
What class of drug is Atracurium?
Atracurium is classified as Other quaternary ammonium compounds, Nondepolarizing Neuromuscular Blocker, Cholinergic Neuromuscular Nicotinic Antagonists, Competitive Cholinergic Nicotinic Antagonists, Decreased Striated Muscle Contraction, Neuromuscular Nondepolarizing Blockade.
What are the contraindications for Atracurium?
Atracurium labeling lists contraindications including: Atracurium besylate is contraindicated in patients known to have a hypersensitivity to it. Use of atracurium besylate from multiple dose vials containing benzyl alcohol as a preservative is contraindicated in patients with a known hypersensitivity to benzyl alcohol.. Always consult the full prescribing information and a clinician.
Note. Data for atracurium is illustrative MVP content compiled from public sources. pharmacopeia is for educational and informational use only and is not a substitute for professional medical advice.

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