|
|
DRUG DESCRIPTION
Duloxetine HCl
CAS number 136434-34-9
Duloxetine Hydrochlorideis a selective serotonin and norepinephrine
reuptake inhibitor (SSNRI) for oral administration. Its chemical designation
is (+)-(S)-N-methyl-γ-(1-naphthyloxy)-2-thiophenepropylamine hydrochloride.
The empirical formula is C18H19NOS•HCl, which corresponds to a molecular
weight of 333.88.
Duloxetine hydrochloride is a white to slightly brownish white solid, which
is slightly soluble in water.
Each capsule contains enteric-coated pellets of 22.4, 33.7, or 67.3 mg of
duloxetine hydrochloride equivalent to 20, 30, or 60 mg of duloxetine,
respectively. These enteric-coated pellets are designed to prevent
degradation of the drug in the acidic environment of the stomach. Inactive
ingredients include FD&C Blue No. 2, gelatin, hypromellose, hydroxypropyl
methylcellulose acetate succinate, sodium lauryl sulfate, sucrose, sugar
spheres, talc, titanium dioxide, and triethyl citrate. The 20 and 60 mg
capsules also contain iron oxide yellow.
Duloxetine HCl is used to treat major depression—a disorder marked by
continuing, serious, and overwhelming feelings of depression that interfere
with daily functioning. Symptoms may include major changes in appetite or
sleep habits; lack of interest in social or work life; feelings of sadness,
guilt, or worthlessness; fatigue; difficulty concentrating or making
decisions; and suicidal thoughts or attempted suicide.
Duloxetine HCl is also used to treat diabetic peripheral neuropathy, a
painful nerve disorder associated with diabetes that affects the hands,
legs, and feet.
Duloxetine HCl is thought to work by correcting an imbalance of two brain
chemicals known to influence mood—serotonin and norepinephrine. It belongs
to a class of antidepressants called selective serotonin and norepinephrine
reuptake inhibitors

|