A1,
A2,
B,
C1,
C2,
D,
E,
F,
G-H,
I-K,
L,
M,
N,
O,
P1,
P2,
Q-R,
S,
T,
U-V,
W-Z
Serevent Diskus Online, Description, Chemistry, Ingredients - Salmeterol Xinafoate (inhalation powder)
Serevent Diskus Online, Description, Chemistry, Ingredients - Salmeterol Xinafoate (inhalation powder)
DESCRIPTION
SEREVENT DISKUS (salmeterol xinafoate inhalation
powder) contains salmeterol xinafoate as the racemic
form of the 1-hydroxy-2-naphthoic
acid salt
of salmeterol. The active component
of theformulation is salmeterol base, a highly selective beta2-adrenergic
bronchodilator. The chemical
name of salmeterol xinafoate is;
4-hydroxy-alpha1-[[[6-(4-phenylbutoxy)hexyl]amino]methyl]-1,3-benzenedimethanol,1-
hydroxy-2-naphthalenecarboxylate.
The molecular weight
of salmeterol xinafoate is 603.8, and the empirical
formula is C25H37NO4•C11H8O3.
Salmeterol xinafoate is a white
to off-white powder. It is freely soluble
in methanol; slightly soluble
in ethanol, chloroform, and isopropanol; and sparingly soluble
in water.
SEREVENT DISKUS is a specially designed plastic
device containing a double-foil blister
strip of a powder
formulation of salmeterol xinafoate intended for oral
inhalation only.
Each blister on the
double-foil strip within
the device contains 50
mcg of salmeterol administered as the salmeterol xinafoate salt
in 12.5 mg of formulation containing lactose. When a blister
containing medication is opened by activating the device, the medication
is dispersed into the air stream
created when the patient
inhales through the mouthpiece.
The amount of drug delivered
to the lung will
depend on patient factors
such as inspiratory
flow. Under standardized in vitro testing, SEREVENT DISKUS
delivers 47 mcg when tested
at 60 L/min flow rate
for 3 seconds. In adult
patients with obstructive lung
disease and severely
compromised lung function
(mean forced expiratory
volume in 1 second [FEV1]
0.65 L [range, 0.35 to 0.92 L], 20% to 30% predicted FEV1),
mean peak inspiratory
flow (PIF) through SEREVENT
DISKUS was 82.4 L/min (range, 46.1 to 115.3 L/min). The emitted
dose of salmeterol xinafoate
determined in an in vitro experiment
modeling these patient-generated
flow rates was 46 mcg (range,
45 to 51 mcg).
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