VECURONIUM BROMIDE- 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:

Akorn - Strides LLC

INN (International Name):

VECURONIUM BROMIDE

Composition:

VECURONIUM 1 mg in 1 mL

Administration route:

INTRAVENOUS

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Vecuronium bromide is indicated as an adjunct to general anesthesia, to facilitate endotracheal intubation and to provide skeletal muscle relaxation during surgery or mechanical ventilation. Vecuronium bromide is contraindicated in patients known to have a hypersensitivity to it.

Product summary:

Vecuronium Bromide for Injection is supplied as follows: 10 mg vecuronium bromide, NDC 23360-160-08 Box of 10. 20 mg vecuronium bromide, NDC 23360-160-10 Box of 10. Store dry powder at 20o to 25o C (68o to 77o F) [see USP Controlled Room Temperature]. Protect from light. Retain in carton until time of use. Akorn-Strides, LLC Lake Forest, IL 60045 Made in India STVE00N Revision: August 2008

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

VECURONIUM BROMIDE - VECURONIUM BROMIDE INJECTION, POWDER,
LYOPHILIZED, FOR SOLUTION
AKORN - STRIDES LLC
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VECURONIUM BROMIDE FOR INJECTION
VECURONIUM BROMIDE FOR INJECTION
RX ONLY
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. In addition, each 10 mg vial contains
20.75 mg citric acid anhydrous,
16.25 mg sodium phosphate dibasic 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 sodium phosphate dibasic 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.
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
incre