Pancuronium Bromide
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Questions & Answers
Side Effects & Adverse Reactions
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.
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 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 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.
Pancuronium bromide contains benzyl alcohol, which is potentially toxic when administered locally to neural tissue. 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 that received in flush solutions containing benzyl alcohol. Administration of high dosages of medications containing this preservative must take into account the total amount of benzyl alcohol administered. 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 (see WARNINGS and PRECAUTIONS: Pediatric Use).
Legal Issues
There is currently no legal information available for this drug.
FDA Safety Alerts
There are currently no FDA safety alerts available for this drug.
Manufacturer Warnings
There is currently no manufacturer warning information available for this drug.
FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
Uses
Pancuronium bromide injection is indicated as an adjunct to general anesthesia, to facilitate tracheal intubation and to provide skeletal muscle relaxation during surgery or mechanical ventilation.
History
There is currently no drug history available for this drug.
Other Information
Pancuronium bromide injection is a nondepolarizing neuromuscular blocking agent chemically designated as the aminosteroid 2 β, 16 β-dipiperidino-5 α-androstane-3 α, 17-β diol diacetate dimethobromide. The structural formula is:
Pancuronium bromide injection is supplied as a sterile, isotonic, nonpyrogenic solution for injection. Each mL contains: pancuronium bromide 1 mg or 2 mg; sodium acetate, anhydrous, 2 mg; sodium chloride, 4 mg to make isotonic, benzyl alcohol 10 mg (as preservative); water for injection qs; pH is adjusted with acetic acid and/or sodium hydroxide if necessary. pH: 3.8–4.2
Sources
Pancuronium Bromide Manufacturers
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Teva Parenteral Medicines, Inc.
![Pancuronium Bromide Injection, Solution [Teva Parenteral Medicines, Inc.]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Pancuronium Bromide | Teva Parenteral Medicines, Inc.
NOTE: CONTAINS BENZYL ALCOHOL (see CONTRAINDICATIONS, WARNINGS and PRECAUTIONS: Pediatric Use)
Pancuronium bromide injection is for intravenous use only. This drug should be administered by or under the supervision of experienced clinicians familiar with the use of neuromuscular blocking agents. DOSAGE MUST BE INDIVIDUALIZED IN EACH CASE. The dosage information which follows is derived from studies based upon units of drug per unit of body weight and is intended to serve as a guide only. Since potent inhalational anesthetics or prior use of succinylcholine may enhance the intensity and duration of pancuronium bromide (see PRECAUTIONS—Drug Interactions), the lower end of the recommended initial dosage range may suffice when pancuronium bromide is first used after intubation with succinylcholine and/or after maintenance doses of volatile liquid inhalational anesthetics are started. To obtain maximum clinical benefits of pancuronium bromide injection and to minimize the possibility of overdosage, the monitoring of muscle twitch response to a peripheral nerve stimulator is advised.
In adults under balanced anesthesia the initial intravenous dosage range is 0.04 to 0.1 mg/kg. Later incremental doses starting at 0.01 mg/kg may be used. These increments slightly increase the magnitude of the blockade and significantly increase the duration of blockade, because a significant number of myoneural junctions are still blocked when there is clinical need for more drug.
If pancuronium bromide injection is used to provide skeletal muscle relaxation for endotracheal intubation, a bolus dose of 0.06 to 0.1 mg/kg is recommended. Conditions satisfactory in intubation are usually present within 2 to 3 minutes. (SeePRECAUTIONS.)
Dosage in ChildrenDose response studies in children indicate that, with the exception of neonates, dosage requirements are the same as for adults. Due to the potential toxicity of benzyl alcohol in neonates, solutions containing benzyl alcohol must not be used in this patient population (see CONTRAINDICATIONS).
Caesarean SectionThe dosage to provide relaxation for intubation and operation is the same as for general surgical procedures. The dosage to provide relaxation, following usage of succinylcholine for intubation (see PRECAUTIONS—Drug Interactions), is the same as for general surgical procedures.
CompatibilityPancuronium bromide injection is compatible in solution with:
0.9% sodium chloride injection 5% dextrose injection 5% dextrose and sodium chloride injection Lactated Ringer's InjectionParenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.
When mixed with the above solutions in glass or plastic containers, pancuronium bromide injection will remain stable in solution for 48 hours with no alteration in potency or pH; no decomposition is observed and there is no absorption to either the glass or plastic container.
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Hospira, Inc.
Pancuronium Bromide | Hospira, Inc.
Pancuronium Bromide Injection is for intravenous use only. This drug should be administered by or under the supervision of experienced clinicians familiar with the use of neuromuscular blocking agents. DOSAGE MUST BE INDIVIDUALIZED IN EACH CASE. The dosage information which follows is derived from studies based upon units of drug per unit of body weight and is intended to serve as a guide only. Since potent inhalational anesthetics or prior use of succinylcholine may enhance the intensity and duration of pancuronium bromide (see PRECAUTIONS: Drug Interactions), the lower end of the recommended initial dosage range may suffice when pancuronium bromide is first used after intubation with succinylcholine and/or after maintenance doses of volatile liquid inhalational anesthetics are started. To obtain maximum clinical benefits of Pancuronium Bromide Injection and to minimize the possibility of overdosage, the monitoring of muscle twitch response to a peripheral nerve stimulator is advised.
In adults under balanced anesthesia the initial intravenous dosage range is 0.04 to 0.1 mg/kg. Later incremental doses starting at 0.01 mg/kg may be used. These increments slightly increase the magnitude of the blockade and significantly increase the duration of blockade because a significant number of myoneural junctions are still blocked when there is clinical need for more drug.
If Pancuronium Bromide Injection is used to provide skeletal muscle relaxation for endotracheal intubation, a bolus dose of 0.06 to 0.1 mg/kg is recommended. Conditions satisfactory for intubation are usually present within 2 to 3 minutes (see PRECAUTIONS).
Dosage in Children
Dose response studies in children indicate that, with the exception of neonates, dosage requirements are the same as for adults. Neonates are especially sensitive to nondepolarizing neuromuscular blocking agents, such as Pancuronium Bromide Injection, during the first month of life. It is recommended that a test dose of 0.02 mg/kg be given first in this group to measure responsiveness.
Caesarean Section
The dosage to provide relaxation for intubation and operation is the same as for general surgical procedures. The dosage to provide relaxation, following usage of succinylcholine for intubation (see PRECAUTIONS: Drug Interactions), is the same as for general surgical procedures.
Compatibility
Pancuronium Bromide Injection is compatible in solution with:
0.9% sodium chloride injection
5% dextrose injection
5% dextrose and sodium chloride injection
Lactated Ringer’s injection
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.
When mixed with the above solutions in glass or plastic containers, Pancuronium Bromide Injection will remain stable in solution for 48 hours with no alteration in potency or pH; no decomposition is observed and there is no absorption to either the glass or plastic container.
![Pancuronium Bromide Injection, Solution [Hospira, Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=d705382b-8aa0-4893-ed9e-bcf7c7d9d0a2&name=pancuronium-bromide-injection1-figure-2-jRL-2770.jpg)
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