duloxetine 60 MG Delayed Release Oral Capsule
1 INDICATIONS AND USAGE Duloxetine delayed-release capsule 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 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. 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 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. 1.3 Diabetic Peripheral Neuropathic Pain Duloxetine delayed-release capsules are indicated for the management of neuropathic pain (DPNP) associated with Diabetic peripheral Neuropathy [see Clinical Studies (14.3)] . 1.5 Chronic Musculoskeletal Pain 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)].
Alembic Pharmaceuticals Limited
CAPSULE BLUE 158 A
158 A CAPSULE BLUE
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16 HOW SUPPLIED/STORAGE AND HANDLING 16.1 How Supplied Duloxetine delayed-release capsules are available as delayed release capsules in the following strengths, colors, imprints, and presentations: Features Strengths 20 mg a 30 mg a 60 mg a Body color Opaque green Opaque white Opaque green Cap color Opaque green Opaque blue Opaque blue Cap imprint A A A Body imprint 156 157 158 Presentations and NDC Codes Bottles of 30 46708-128-30 46708-129-30 46708-130-30 Bottles of 60 46708-128-60 NA NA Bottles of 90 NA 46708-129-90 46708-130-90 Bottles of 1000 46708-128-91 46708-129-91 46708-130-91 Carton of 100 46708-128-10 46708-129-10 46708-130-10 a equivalent to duloxetine base 16.2 Storage Store at 25°C (77°F); excursions permitted to 15to30°C (59to86°F) [ see USP Controlled Room Temperature].
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