Pancuronium

Pancuronium
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. Condition Name: THIS DRUG SHOULD BE ADMINISTERED BY ADEQUATELY TRAINED INDIVIDUALS FAMILIAR WITH ITS ACTIONS, CHARACTERISTICS, AND HAZARDS.

Overview

Pancuronium is a skeletal muscle relaxant and neuromuscular blocking drugs that is FDA approved for the {{{indicationType}}} of general anesthesia; adjunct. There is a Black Box Warning for this drug as shown here. Common adverse reactions include musculoskeletal: prolonged neuromuscular block.

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

• Dosage must be individualized
• General anesthesia; Adjunct: initial, 0.04 to 0.1 mg/kg IV (endotracheal intubation, 0.06 to 0.1 mg/kg IV); later incremental doses starting at 0.01 mg/kg may be used

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

Induction of neuromuscular blockade - Percutaneous fetal procedure

       Spasmodic torticollis

Non–Guideline-Supported Use

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

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

Dosage must be individualized General anesthesia; Adjunct: (all ages except neonates) initial, 0.04 to 0.1 mg/kg IV (endotracheal intubation, 0.06 to 0.1 mg/kg IV); later incremental doses starting at 0.01 mg/kg may be used [2] General anesthesia; Adjunct: (neonates) administer a test dose of 0.02 mg/kg IV to measure responsiveness

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

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

Non–Guideline-Supported Use

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

Contraindications

Pancuronium Bromide Injection is contraindicated in patients known to be hypersensitive to the drug.

Warnings

Black Box warning See full prescribing information for complete Boxed Warning. Condition Name: THIS DRUG SHOULD BE ADMINISTERED BY ADEQUATELY TRAINED INDIVIDUALS FAMILIAR WITH ITS ACTIONS, CHARACTERISTICS, AND HAZARDS.

PANCURONIUM BROMIDE INJECTION SHOULD BE ADMINISTERED IN CAREFULLY ADJUSTED DOSES 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.

Anaphylaxis

Severe anaphylactic reactions to neuromuscular blocking agents, including pancuronium 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 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.

In patients who are known to have myasthenia gravis or the myasthenic (Eaton-Lambert) syndrome, small doses of pancuronium bromide 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.

Benzyl alcohol has been reported to be associated with a fatal “gasping syndrome” in premature infants.

Exposure to excessive amounts of benzyl alcohol has been associated with toxicity (hypotension, metabolic acidosis), particularly in neonates, and an increased incidence of kernicterus, particularly in small preterm infants. There have been rare reports of deaths, primarily in preterm infants, associated with exposure to excessive amounts of benzyl alcohol. The amount of benzyl alcohol from medications is usually considered negligible compared to those received in flush solutions containing benzyl alcohol. Administration of high dosages of medications (including pancuronium) containing this preservative must take into account the total amount of benzyl alcohol administered. The recommended dosage range of pancuronium bromide for preterm and term infants includes amounts of benzyl alcohol well below that associated with toxicity; however, the amount of benzyl alcohol at which toxicity may occur is not known. If the patient requires more than the recommended dosages or other medications containing this preservative, the practitioner must consider the daily metabolic load of benzyl alcohol from these combined sources.

Adverse Reactions

Clinical Trials Experience

Neuromuscular

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 respiratory insufficiency or apnea. (See PRECAUTIONS: Pediatric Use).

Inadequate reversal of the neuromuscular blockade is possible with pancuronium bromide as with all curariform drugs. These adverse experiences are managed by manual or mechanical ventilation until recovery is judged adequate.

Prolonged paralysis and/or skeletal muscle weakness have been reported after long-term use to support mechanical ventilation in the intensive care unit.

Cardiovascular

See discussion of circulatory effects in CLINICAL PHARMACOLOGY.

Gastrointestinal

Salivation is sometimes noted during very light anesthesia, especially if no anticholinergic premedication is used.

Skin

An occasional transient rash is noted accompanying the use of pancuronium bromide.

Other

Although histamine release is not a characteristic action of pancuronium bromide, rare hypersensitivity reactions such as bronchospasm, flushing, redness, hypotension, tachycardia and other reactions possibly mediated by histamine release have been reported.

There have been post-marketing reports of severe allergic reactions (anaphylactic and anaphylactoid reactions) associated with use of neuromuscular blocking agents, including pancuronium 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 Pancuronium Postmarketing Experience in the drug label.

Drug Interactions

None known.

Use in Specific Populations

Pregnancy

Pregnancy Category (FDA): C Animal reproduction studies have not been performed. It is not known whether pancuronium bromide can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Pancuronium bromide should be given to a pregnant woman only if the administering clinician decides that the benefits outweigh the risks.

Pancuronium bromide may be used in operative obstetrics (Caesarean Section), but reversal of pancuronium may be unsatisfactory in patients receiving magnesium sulfate for toxemia of pregnancy because magnesium salts enhance neuromuscular blockade. Dosage should usually be reduced, as indicated, in such cases. It is also recommended that the interval between use of pancuronium and delivery be reasonably short to avoid clinically significant placental transfer.
Pregnancy Category (AUS): There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Pancuronium in women who are pregnant.

Labor and Delivery

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

Nursing Mothers

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

Pediatric Use

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

Geriatic Use

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

Gender

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

Race

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

Renal Impairment

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

Hepatic Impairment

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

Females of Reproductive Potential and Males

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

Immunocompromised Patients

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

Administration and Monitoring

Administration

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

Monitoring

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

IV Compatibility

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

Overdosage

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

Mechanism of Action

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

Structure

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

Pharmacodynamics

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

Pharmacokinetics

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

Nonclinical Toxicology

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

Clinical Studies

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

How Supplied

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

Storage

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

Precautions with Alcohol

Alcohol-Pancuronium 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 Pancuronium Brand Names in the drug label.

Look-Alike Drug Names

There is limited information regarding Pancuronium 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.