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pancuronium bromide injection, USP Adverse Reactions

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. (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).

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