ATRACURIUM BESYLATE injection, solution

Country: Amerika Syarikat

Bahasa: Inggeris

Sumber: NLM (National Library of Medicine)

Bahan aktif:

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

Boleh didapati daripada:

Sagent Pharmaceuticals

Laluan pentadbiran:

INTRAVENOUS

Jenis preskripsi:

PRESCRIPTION DRUG

Tanda-tanda terapeutik:

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.

Ringkasan produk:

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. Mfd. for SAGENT Pharmaceuticals Schaumburg, IL 60195 (USA) Made in China NOVAPLUS+ NOVAPLUS is a registered trademark of Vizient, Inc. Revised: June 2018

Status kebenaran:

Abbreviated New Drug Application

Ciri produk

ATRACURIUM BESYLATE- ATRACURIUM BESYLATE INJECTION, SOLUTION
SAGENT PHARMACEUTICALS
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ATRACURIUM BESYLATE INJECTION, USP
(FOR INTRAVENOUS INJECTION)
NOVAPLUS
RX 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.
CLINICAL PHARMACOLOGY
Atracurium besylate is a nondepolariz