ATRACURIUM BESYLATE INJECTION LIQUID

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

ATRACURIUM BESYLATE

Available from:

SANDOZ CANADA INCORPORATED

ATC code:

M03AC04

INN (International Name):

ATRACURIUM

Dosage:

10MG

Pharmaceutical form:

LIQUID

Composition:

ATRACURIUM BESYLATE 10MG

Administration route:

INTRAVENOUS

Units in package:

10X5ML 10X10ML

Prescription type:

Prescription

Therapeutic area:

MISCELLANEOUS SKELETAL MUSCLE RELAXANTS

Product summary:

Active ingredient group (AIG) number: 0116898001; AHFS:

Authorization status:

CANCELLED PRE MARKET

Authorization date:

2021-03-29

Summary of Product characteristics

Atracurium Besylate Injection
Page 1 of 19
PRODUCT MONOGRAPH
PR
ATRACURIUM BESYLATE INJECTION
10 MG/ML
Skeletal Neuromuscular Blocking Agent
Sandoz Canada Inc.
Date of Revision: March 25, 2013
145 Jules-Léger
Boucherville, QC, Canada
J4B 7K8
CONTROL NO.: 161881
Atracurium Besylate Injection
Page 2 of 19
PR
ATRACURIUM BESYLATE INJECTION
10 MG/ML
THERAPEUTIC CLASSIFICATION
Skeletal Neuromuscular Blocking Agent
ACTIONS AND CLINICAL PHARMACOLOGY
Atracurium besylate is a nondepolarizing, intermediate-duration,
skeletal neuromuscular blocking
agent. Nondepolarizing agents antagonize the neurotransmitter action
of acetylcholine by binding
competitively to cholinergic receptor sites on the motor end-plate.
This antagonism is inhibited, and
neuromuscular block reversed, by acetylcholinesterase inhibitors such
as neostigmine, edrophonium
and pyridostigmine.
The duration of neuromuscular blockade produced by atracurium besylate
is approximately
one-third to one-half the duration seen with d-tubocurarine,
metocurine and pancuronium at
equipotent doses. As with other nondepolarizing neuromuscular
blockers, the time to onset of
paralysis decreases and the duration of maximum effect increases with
increasing atracurium
besylate doses.
The pharmacokinetics of atracurium besylate in man are essentially
linear within the 0.3 to
0.6 mg/kg dose range. The elimination half-life is approximately 20
minutes. The duration of
neuromuscular blockade does not correlate with plasma
pseudocholinesterase levels and is not
altered by the absence of renal function.
INDICATIONS AND CLINICAL USE
Atracurium Besylate Injection is indicated, as an adjunct to general
anaesthesia, to facilitate
endotracheal intubation and to provide skeletal muscle relaxation
during surgery or mechanical
ventilation. It can be used most advantageously if muscle twitch
response to peripheral nerve
stimulation is monitored.
CONTRAINDICATIONS
Atracurium besylate is contraindicated in patients known to have a
hypersensitivity to it.
WARNINGS
ATRACURIUM BESYLATE INJECTION