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Duloxetine HCl

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Duloxetine HCl

HOME >> Pharmaceuticals API List 1 >> Duloxetine Hcl >> Drug Description

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

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