ATRACURIUM BESYLATE injection solution

Země: Spojené státy

Jazyk: angličtina

Zdroj: NLM (National Library of Medicine)

Aktivní složka:

ATRACURIUM BESYLATE (UNII: 40AX66P76P) (ATRACURIUM - UNII:2GQ1IRY63P)

Dostupné s:

Aurobindo Pharma Limited

INN (Mezinárodní Name):

ATRACURIUM BESYLATE

Složení:

ATRACURIUM BESYLATE 50 mg in 5 mL

Podání:

INTRAVENOUS

Druh předpisu:

PRESCRIPTION DRUG

Stav Autorizace:

Abbreviated New Drug Application

Charakteristika produktu

ATRACURIUM BESYLATE - ATRACURIUM BESYLATE INJECTION, SOLUTION
AUROBINDO PHARMA LIMITED
----------
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 . Atracurium besylate USP
is white to almost white solid and hygroscopic. 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, clear,
colorless aqueous solution free
from visible particles. Each mL contains 10 mg atracurium besylate USP
(equivalent to 7.47 mg
atracurium). The pH is adjusted to 3.00 to 3.65 with benzenesulfonic
acid. 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 nonde