VECURONIUM BROMIDE injection powder lyophilized for solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

VECURONIUM BROMIDE (UNII: 7E4PHP5N1D) (VECURONIUM - UNII:5438723848)

Available from:

Cardinal Health

INN (International Name):

VECURONIUM BROMIDE

Composition:

VECURONIUM BROMIDE 1 mg in 1 mL

Prescription type:

PRESCRIPTION DRUG

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

VECURONIUM BROMIDE- VECURONIUM BROMIDE INJECTION, POWDER, LYOPHILIZED,
FOR SOLUTION
CARDINAL HEALTH
----------
RX ONLY
BOXED WARNING
THIS DRUG SHOULD BE ADMINISTERED BY ADEQUATELY TRAINED INDIVIDUALS
FAMILIAR WITH ITS ACTIONS, CHARACTERISTICS, AND HAZARDS.
DESCRIPTION
Vecuronium Bromide for Injection is a nondepolarizing neuromuscular
blocking agent of intermediate
duration, chemically designated as
1-(3α,17β-Dihydroxy-2β-piperidino-5α-androstan-16β,5α-yl)-1-
methylpiperidinium bromide, diacetate. The structural formula is:
Its chemical formula is C
H BrN O with molecular weight 637.75.
Vecuronium Bromide for Injection is supplied as a sterile nonpyrogenic
freeze-dried buffered cake of
very fine microscopic crystalline particles for intravenous injection
only. Each vial contains 10 mg or
20 mg of vecuronium bromide, USP. In addition, each 10 mg vial
contains 20.75 mg citric acid
anhydrous, 16.25 mg dibasic sodium phosphate anhydrous, 97 mg mannitol
(to adjust tonicity), sodium
hydroxide and/or phosphoric acid to buffer and adjust to a pH range of
3.5 to 4.5. Each 20 mg vial
contains 41.5 mg citric acid anhydrous, 32.5 mg dibasic sodium
phosphate anhydrous, 194 mg mannitol
(to adjust tonicity), sodium hydroxide and/or phosphoric acid to
buffer and adjust to a pH range of 3.5 to
4.5.
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CLINICAL PHARMACOLOGY
Vecuronium is a nondepolarizing neuromuscular blocking agent
possessing all of the characteristic
pharmacological actions of this class of drugs (curariform). It acts
by competing for cholinergic
receptors at the motor end-plate. The antagonism to acetylcholine is
inhibited and neuromuscular block
is reversed by acetylcholinesterase inhibitors such as neostigmine,
edrophonium, and pyridostigmine.
Vecuronium is about 1/3 more potent than pancuronium; the duration of
neuromuscular blockade
produced by vecuronium is shorter than that of pancuronium at
initially equipotent doses. The time to
onset of paralysis decreases and the duration of maximum effect
increases with increasing vecuronium
doses. The