ATRACURIUM BESYLATE injection, solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

atracurium besylate (UNII: 40AX66P76P) (atracurium - UNII:2GQ1IRY63P)

Available from:

Sagent Pharmaceuticals

INN (International Name):

atracurium besylate

Composition:

atracurium besylate 10 mg in 1 mL

Administration route:

INTRAVENOUS

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Atracurium besylate injection is indicated, as an adjunct to general anesthesia, to facilitate endotracheal intubation and to provide skeletal muscle relaxation during surgery or mechanical ventilation. Atracurium besylate is contraindicated in patients known to have a hypersensitivity to it. Use of atracurium besylate from multiple dose vials containing benzyl alcohol as a preservative is contraindicated in patients with a known hypersensitivity to benzyl alcohol.

Product summary:

Atracurium Besylate Injection, USP is supplied as follows: Store between 2° and 8°C (36° and 46°F) to preserve potency. Upon removal from refrigeration to room temperature storage conditions (25°C/77°F), use Atracurium Besylate Injection within 14 days even if re-refrigerated. Protect from light. Retain in carton until time of use. Do not freeze. Sterile, Nonpyrogenic. The container closure is not made with natural rubber latex. SAGENT® Mfd. for SAGENT Pharmaceuticals Schaumburg, IL 60195 (USA) Made in China ©2018 Sagent Pharmaceuticals, Inc. Revised: June 2018  SAGENT Pharmaceuticals®

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

ATRACURIUM BESYLATE- ATRACURIUM BESYLATE INJECTION, SOLUTION
SAGENT PHARMACEUTICALS
----------
ATRACURIUM BESYLATE INJECTION, USP
(FOR INTRAVENOUS INJECTION)
SAGENT
R only
This drug should be used only by adequately trained individuals
familiar with its actions,
characteristics, and hazards.
DESCRIPTION
Atracurium besylate is an intermediate-duration, nondepolarizing,
skeletal muscle
relaxant for intravenous administration. Atracurium besylate is
designated as 2-(2-
Carboxyethyl)-1, 2, 3,
4-tetrahydro-6,7-dimethoxy-2-methyl-1-veratrylisoquinolinium
benzenesulfonate, pentamethylene ester. It has a molecular weight of
1243.49, and its
molecular formula is C
H
N O
S . The structural formula is:
Atracurium besylate is a complex molecule containing four sites at
which different
stereochemical configurations can occur. The symmetry of the molecule,
however,
results in only ten, instead of sixteen, possible different isomers.
The manufacture of
atracurium besylate results in these isomers being produced in unequal
amounts but
with a consistent ratio. Those molecules in which the methyl group
attached to the
quaternary nitrogen projects on the opposite side to the adjacent
substituted-benzyl
moiety predominate by approximately 3:1.
Atracurium Besylate Injection, USP is a sterile, non-pyrogenic aqueous
solution. Each mL
contains 10 mg atracurium besylate. The pH is adjusted to 3.25 to 3.65
with
benzenesulfonic acid. The multiple dose vial contains 0.9% benzyl
alcohol added as a
preservative. Atracurium besylate injection slowly loses potency with
time at the rate of
approximately 6% per _year_ under refrigeration (5°C). Atracurium
besylate injection
should be refrigerated at 2° to 8°C (36° to 46°F) to preserve
potency. Rate of loss in
potency increases to approximately 5% per _month_ at 25°C (77°F).
Upon removal from
refrigeration to room temperature storage conditions (25°C / 77°F),
use atracurium
besylate injection within 14 days even if re-refrigerated.
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CLINICAL PHARMACOLOGY
Atracurium besyla