Duloxetine Hydrochloride 20 Mg Recall
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FDA Labeling Changes
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Duloxetine delayed-release capsules are indicated for the treatment of major depressive disorder (MDD). The efficacy of duloxetine delayed-release capsules were established in four short term and one maintenance trial in adults [see Clinical Studies (14.1)].
A major depressive episode (DSM-IV) implies a prominent and relatively persistent (nearly every day for at least 2 weeks) depressed or dysphoric mood that usually interferes with daily functioning, and includes at least 5 of the following 9 symptoms: depressed mood, loss of interest in usual activities, significant change in weight and/or appetite, insomnia or hypersomnia, psychomotor agitation or retardation, increased fatigue, feelings of guilt or worthlessness, slowed thinking or impaired concentration, or a suicide attempt or suicidal ideation.
Duloxetine delayed-release capsules are indicated for the treatment of generalized anxiety disorder (GAD). The efficacy of duloxetine delayed-release capsules were established in three short-term trials and one maintenance trial in adults [see Clinical Studies (14.2)].
Generalized anxiety disorder is defined by the DSM-IV as excessive anxiety and worry, present more days than not, for at least 6 months. The excessive anxiety and worry must be difficult to control and must cause significant distress or impairment in normal functioning. It must be associated with at least 3 of the following 6 symptoms: restlessness or feeling keyed up or on edge, being easily fatigued, difficulty concentrating or mind going blank, irritability, muscle tension, and/or sleep disturbance.
Duloxetine delayed-release capsules are indicated for the management of neuropathic pain (DPNP) associated with diabetic peripheral neuropathy [see Clinical Studies (14.3)].
Duloxetine delayed-release capsule is indicated for the management of chronic musculoskeletal pain. This has been established in studies in patients with chronic low back pain (CLBP) and chronic pain due to osteoarthritis [see Clinical Studies (14.5)].
There is currently no drug history available for this drug.
Duloxetine hydrochloride is 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. The structural formula is:
Duloxetine hydochloride USP is a white to off-white powder, which is freely soluble in methanol and 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 sugar spheres, hypromellose, talc, sucrose, hypromellose phthalate, triethyl citrate, FD&C Blue No.2, titanium dioxide, gelatine and sodium lauryl sulfate. The 20 and 60 mg capsules also contain iron oxide yellow, Ink contains following ingradients:
20 mg: shellac, black iron oxide, potassium hydroxide, propylene glycol, strong ammonia solution
30 mg: shellac, titanium dioxide, yellow iron oxide, FD&C Blue No. 2 Aluminium Lake, propylene glycol, strong ammonia solution
60 mg: shellac, potassium hydroxide, titanium dioxide, propylene glycol, strong ammonia solution.