Vecuronium

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Vecuronium
Black Box Warning
Adult Indications & Dosage
Pediatric Indications & Dosage
Contraindications
Warnings & Precautions
Adverse Reactions
Drug Interactions
Use in Specific Populations
Administration & Monitoring
Overdosage
Pharmacology
Clinical Studies
How Supplied
Images
Patient Counseling Information
Precautions with Alcohol
Brand Names
Look-Alike Names

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Chetan Lokhande, M.B.B.S [2]

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Black Box Warning

Black Box warning
See full prescribing information for complete Boxed Warning.
This drug should be administered by adequately trained individuals familiar with its actions, characteristics, and hazards.

Overview

Vecuronium is a skeletal muscle relaxant, neuromuscular blocking drugs that is FDA approved for the prophylaxis of anesthesia, during surgery as an adjunct to general anesthesia to facilitate tracheal intubation or mechanical ventilation; adjunct.. There is a Black Box Warning for this drug as shown here. Common adverse reactions include immunologic: anaphylaxis, hypersensitivity reaction, musculoskeletal: muscle weakness, Prolonged neuromuscular block,respiratory: bronchospasm.

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

  • Dosage must be individualized

Anesthesia, During surgery as an adjunct to general anesthesia to facilitate tracheal intubation or mechanical ventilation; Adjunct

  • Initial
  • 0.08-0.1 mg/kg IV bolus
  • Maintenance
  • 0.01-0.015 mg/kg IV 25-40 min after initial dose, repeat every 12-15 min as needed
  • 1 mcg/kg/min continuous IV infusion 20-40 min after initial intubation dose, after early evidence of spontaneous recovery; then adjust to maintain 90% suppression of twitch response; range 0.8-1.2 mcg/kg/min

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Vecuronium in adult patients.

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of Vecuronium in adult patients.

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

  • Safety and effectiveness not established in pediatric patients 7 weeks of age or younger

Anesthesia, During surgery as an adjunct to general anesthesia to facilitate tracheal intubation or mechanical ventilation; Adjunct

  • (age 8 weeks-1 yr)
  • More sensitive on a mg/kg basis than adults and recovery may take 1.5 times longer
  • (age 1-10 yr)
  • Dosage must be individualized; may require slightly higher initial dose and slightly more frequent supplemental doses than adults
  • (age 10-16 yr)
  • Initial, 0.08-0.1 mg/kg IV bolus
  • Maintenance, 0.01-0.015 mg/kg IV 25-40 min after initial dose, repeat every 12-15 min as needed; may require more frequent supplementation than adults

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Vecuronium in pediatric patients.

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of Vecuronium in pediatric patients.

Contraindications

Vecuronium bromide is contraindicated in patients known to have a hypersensitivity to it.

Warnings

Black Box warning
See full prescribing information for complete Boxed Warning.
This drug should be administered by adequately trained individuals familiar with its actions, characteristics, and hazards.

VECURONIUM SHOULD BE ADMINISTERED IN CAREFULLY ADJUSTED DOSAGE BY OR UNDER THE SUPERVISION OF EXPERIENCED CLINICIANS WHO ARE FAMILIAR WITH ITS ACTIONS AND THE POSSIBLE COMPLICATIONS THAT MIGHT OCCUR FOLLOWING ITS USE. THE DRUG SHOULD NOT BE ADMINISTERED UNLESS FACILITIES FOR INTUBATION, ARTIFICIAL RESPIRATION, OXYGEN THERAPY, AND REVERSAL AGENTS ARE IMMEDIATELY AVAILABLE. THE CLINICIAN MUST BE PREPARED TO ASSIST OR CONTROL RESPIRATION. TO REDUCE THE POSSIBILITY OF PROLONGED NEUROMUSCULAR BLOCKADE AND OTHER POSSIBLE COMPLICATIONS THAT MIGHT OCCUR FOLLOWING LONG-TERM USE IN THE ICU, VECURONIUM OR ANY OTHER NEUROMUSCULAR BLOCKING AGENT SHOULD BE ADMINISTERED IN CAREFULLY ADJUSTED DOSES BY OR UNDER THE SUPERVISION OF EXPERIENCED CLINICIANS WHO ARE FAMILIAR WITH ITS ACTIONS AND WHO ARE FAMILIAR WITH APPROPRIATE PERIPHERAL NERVE STIMULATOR MUSCLE MONITORING TECHNIQUES (see PRECAUTIONS).

In patients who are known to have myasthenia gravis or the myasthenic (Eaton-Lambert) syndrome, small doses of vecuronium may have profound effects. In such patients, a peripheral nerve stimulator and use of a small test dose may be of value in monitoring the response to administration of muscle relaxants.

Anaphylaxis

Severe anaphylactic reactions to neuromuscular blocking agents, including vecuronium bromide, have been reported. These reactions have in some cases been life-threatening and fatal. Due to the potential severity of these reactions, the necessary precautions, such as the immediate availability of appropriate emergency treatment, should be taken. Precautions should also be taken in those individuals who have had previous anaphylactic reactions to other neuromuscular blocking agents since cross-reactivity between neuromuscular blocking agents, both depolarizing and non-depolarizing, has been reported in this class of drugs.

Adverse Reactions

Clinical Trials Experience

The most frequent adverse reaction to nondepolarizing blocking agents as a class consists of an extension of the drug's pharmacological action beyond the time period needed. This may vary from skeletal muscle weakness to profound and prolonged skeletal muscle paralysis resulting in respiration insufficiency or apnea.

Inadequate reversal of the neuromuscular blockade is possible with vecuronium bromide as with all curariform drugs. These adverse reactions are managed by manual or mechanical ventilation until recovery is judged adequate. Little or no increase in intensity of blockade or duration of action with vecuronium bromide is noted from the use of thiobarbiturates, narcotic analgesics, nitrous oxide, or droperidol. See OVERDOSAGE for discussion of other drugs used in anesthetic practice which also cause respiratory depression.

Prolonged to profound extensions of paralysis and/or muscle weakness as well as muscle atrophy have been reported after long-term use to support mechanical ventilation in the intensive care unit (see PRECAUTIONS). The administration of vecuronium bromide has been associated with rare instances of hypersensitivity reactions (bronchospasm, hypotension and/or tachycardia, sometimes associated with acute urticaria or erythema); (see also CLINICAL PHARMACOLOGY).

There have been post-marketing reports of severe allergic reactions (anaphylactic and anaphylactoid reactions) associated with use of neuromuscular blocking agents, including vecuronium bromide. These reactions, in some cases, have been life-threatening and fatal. Because these reactions were reported voluntarily from a population of uncertain size, it is not possible to reliably estimate their frequency (See WARNINGS and PRECAUTIONS).

Postmarketing Experience

There is limited information regarding Vecuronium Postmarketing Experience in the drug label.

Drug Interactions

There is limited information regarding Vecuronium Drug Interactions in the drug label.

Use in Specific Populations

Pregnancy

Pregnancy Category (FDA): There is no FDA guidance on usage of Vecuronium in women who are pregnant.
Pregnancy Category (AUS): There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Vecuronium in women who are pregnant.

Labor and Delivery

There is no FDA guidance on use of Vecuronium during labor and delivery.

Nursing Mothers

There is no FDA guidance on the use of Vecuronium in women who are nursing.

Pediatric Use

There is no FDA guidance on the use of Vecuronium in pediatric settings.

Geriatic Use

There is no FDA guidance on the use of Vecuronium in geriatric settings.

Gender

There is no FDA guidance on the use of Vecuronium with respect to specific gender populations.

Race

There is no FDA guidance on the use of Vecuronium with respect to specific racial populations.

Renal Impairment

There is no FDA guidance on the use of Vecuronium in patients with renal impairment.

Hepatic Impairment

There is no FDA guidance on the use of Vecuronium in patients with hepatic impairment.

Females of Reproductive Potential and Males

There is no FDA guidance on the use of Vecuronium in women of reproductive potentials and males.

Immunocompromised Patients

There is no FDA guidance one the use of Vecuronium in patients who are immunocompromised.

Administration and Monitoring

Administration

There is limited information regarding Vecuronium Administration in the drug label.

Monitoring

There is limited information regarding Vecuronium Monitoring in the drug label.

IV Compatibility

There is limited information regarding the compatibility of Vecuronium and IV administrations.

Overdosage

There is limited information regarding Vecuronium overdosage. If you suspect drug poisoning or overdose, please contact the National Poison Help hotline (1-800-222-1222) immediately.

Pharmacology

There is limited information regarding Vecuronium Pharmacology in the drug label.

Mechanism of Action

There is limited information regarding Vecuronium Mechanism of Action in the drug label.

Structure

There is limited information regarding Vecuronium Structure in the drug label.

Pharmacodynamics

There is limited information regarding Vecuronium Pharmacodynamics in the drug label.

Pharmacokinetics

There is limited information regarding Vecuronium Pharmacokinetics in the drug label.

Nonclinical Toxicology

There is limited information regarding Vecuronium Nonclinical Toxicology in the drug label.

Clinical Studies

There is limited information regarding Vecuronium Clinical Studies in the drug label.

How Supplied

There is limited information regarding Vecuronium How Supplied in the drug label.

Storage

There is limited information regarding Vecuronium Storage in the drug label.

Images

Drug Images

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Package and Label Display Panel

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Patient Counseling Information

There is limited information regarding Vecuronium Patient Counseling Information in the drug label.

Precautions with Alcohol

Alcohol-Vecuronium interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.

Brand Names

There is limited information regarding Vecuronium Brand Names in the drug label.

Look-Alike Drug Names

There is limited information regarding Vecuronium Look-Alike Drug Names in the drug label.

Drug Shortage Status

Price

References

The contents of this FDA label are provided by the National Library of Medicine.