Duloxetine Delayed-Release: US FDA label indications

Label details

Brand name

Duloxetine Delayed-Release

Generic name

Duloxetine Hydrochloride

Manufacturer

Proficient Rx LP

Route

Oral

Product type

Human Prescription Drug

Substance

Duloxetine Hydrochloride

Application number

ANDA203088

Indications and usage (label excerpt)

1. INDICATIONS AND USAGE Duloxetine Delayed-release Capsules is a serotonin and norepinephrine reuptake inhibitor (SNRI) indicated for: • Major Depressive Disorder (MDD) ( 1.1 ) • Generalized Anxiety Disorder (GAD) ( 1.2 ) • Diabetic Peripheral Neuropathic Pain (DPNP) ( 1.3 ) • Chronic Musculoskeletal Pain ( 1.5 ) 1.1 Major Depressive Disorder Duloxetine Delayed-release Capsules are indicated for the treatment of major depressive disorder (MDD). The efficacy of Duloxetine Delayed-release Capsules was 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. 1.2 Generalized Anxiety Disorder Duloxetine Delayed-release Capsules are indicated for the treatment of generalized anxiety disorder (GAD). The efficacy of Duloxetine Delayed-release Capsules was established in three short-term trials and one maintenance trial in adults [see Clinical Studies (14.2) ] . Generalized anxiety disorder is def…

Warnings (label excerpt)

5. WARNINGS AND PRECAUTIONS • Suicidality: Monitor for clinical worsening and suicide risk ( 5.1 ) • Hepatotoxicity: Hepatic failure, sometimes fatal, has been reported in patients treated with Duloxetine Delayed-release Capsules. Duloxetine Delayed-release Capsules should be discontinued in patients who develop jaundice or other evidence of clinically significant liver dysfunction and should not be resumed unless another cause can be established. Duloxetine Delayed-release Capsules should not be prescribed to patients with substantial alcohol use or evidence of chronic liver disease ( 5.2 ) • Orthostatic Hypotension and Syncope: Cases have been reported with duloxetine therapy ( 5.3 ) • Serotonin Syndrome: Serotonin syndrome has been reported with SSRIs and SNRIs, including with Duloxetine Delayed-release Capsules, both when taken alone, but especially when co-administered with other serotonergic agents (including triptans, tricyclic antidepressants, fentanyl, lithium, tramadol, trypt…

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Trials whose interventions mention this drug

Canadian trials first. A match on the drug name does not mean the trial studied this specific product.