FDA label 0dbf8441-1ea7-49fd-9806-d98505d92016

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

WARNINGS 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 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 ).

ADVERSE REACTIONS 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. 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. Post-Marketing There have been post-marketing reports of severe allergic reactions (anaphylactic and anaphylactoid reactions) associated with the 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 ) .