Country: United States
Language: English
Source: NLM (National Library of Medicine)
DULOXETINE HYDROCHLORIDE (UNII: 9044SC542W) (DULOXETINE - UNII:O5TNM5N07U)
Proficient Rx LP
DULOXETINE HYDROCHLORIDE
DULOXETINE 20 mg
ORAL
PRESCRIPTION DRUG
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. 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
Duloxetine Delayed-release Capsules are available as delayed release capsules in the following strengths, colors, imprints, and presentations: Body color Opaque ochre Cap color Opaque ochre Cap imprint B Body imprint 746 Presentations and NDC Codes Bottles of 30 63187-720-30 Bottles of 60 63187-720-60 Bottles of 90 63187-720-90 Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature].
Abbreviated New Drug Application
DULOXETINE DELAYED-RELEASE- DULOXETINE HYDROCHLORIDE CAPSULE, DELAYED RELEASE PELLETS Proficient Rx LP ---------- MEDICATION GUIDE DULOXETINE (DOO-LOX-E-TEEN) DELAYED-RELEASE CAPSULES, USP RX ONLY Read the Medication Guide that comes with Duloxetine Delayed-release Capsules before you start taking it and each time you get a refill. There may be new information. This Medication Guide does not take the place of talking to your healthcare provider about your medical condition or treatment. Talk with your healthcare provider if there is something you do not understand or want to learn more about. What is the most important information I should know about Duloxetine Delayed-release Capsules? Duloxetine Delayed-release Capsules and other antidepressant medicines may cause serious side effects, including: 1. Suicidal thoughts or actions: • Duloxetine Delayed-release Capsules and other antidepressant medicines may increase suicidal thoughts or actions in some children, teenagers, or young adults within the first few months of treatment or when the dose is changed. • Depression or other serious mental illnesses are the most important causes of suicidal thoughts or actions. • Watch for these changes and call your healthcare provider right away if you notice: • New or sudden changes in mood, behavior, actions, thoughts, or feelings, especially if severe. • Pay particular attention to such changes when Duloxetine Delayed-release Capsules are started or when the dose is changed. Keep all follow-up visits with your healthcare provider and call between visits if you are worried about symptoms. Call your healthcare provider right away if you have any of the following symptoms, or call 911 if an emergency, especially if they are new, worse, or worry you: • attempts to commit suicide • acting on dangerous impulses • acting aggressive or violent • thoughts about suicide or dying • new or worse depression • new or worse anxiety or panic attacks • feeling agitated, restless, angry or irritable • trouble slee Read the complete document
DULOXETINE DELAYED-RELEASE- DULOXETINE HYDROCHLORIDE CAPSULE, DELAYED RELEASE PELLETS PROFICIENT RX LP ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE DULOXETINE DELAYED-RELEASE CAPSULES SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR DULOXETINE DELAYED-RELEASE CAPSULES. DULOXETINE DELAYED-RELEASE CAPSULES USP FOR ORAL USE. INITIAL U.S. APPROVAL: 2004 WARNING: SUICIDAL THOUGHTS AND BEHAVIORS _SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._ • • • RECENT MAJOR CHANGES Dosage and Administration: Switching a Patient To or From a Monoamine Oxidase Inhibitor (MAOI) Intended to Treat Psychiatric Disorders (2.5) 10/2012 Use of Duloxetine Delayed-release Capsules with Other MAOIs such as Linezolid or Methylene Blue (2.6) 10/2012 Contraindications – Monoamine Oxidase Inhibitors (4.1) 10/2012 Warnings and Precautions: Serotonin Syndrome (5.4) 10/2012 Discontinuation of Treatment with Duloxetine Delayed-release Capsules (5.7) 08/2012 INDICATIONS AND USAGE Duloxetine Delayed-release Capsules is a serotonin and norepinephrine reuptake inhibitor (SNRI) indicated for: • • • • DOSAGE AND ADMINISTRATION • INDIC ATIO N STARTING DOSE TARGET DOSE MAXIMUM DOSE MDD (2.1, 2.2) 40 mg/day to 60 mg/day Acute Treatment: 40 mg/day (20 mg twice daily) to 60 mg/day (once daily or as 30 mg twice daily); Maintenance Treatment: 60 mg/day 120 mg/day GAD (2.1) 60 mg/day 60 mg/day (once daily) 120 mg/day DPNP (2.1) 60 mg/day 60 mg/day (once daily) 60 mg/day Chronic Musculoskeletal Pain (2.1) 30 mg/day 60 mg/day (once daily) 60 mg/day INCREASED RISK OF SUICIDAL THINKING AND BEHAVIOR IN CHILDREN, ADOLESCENTS, AND YOUNG ADULTS TAKING ANTIDEPRESSANTS (5.1) MONITOR FOR WORSENING AND EMERGENCE OF SUICIDAL THOUGHTS AND BEHAVIORS (5.1) DULOXETINE DELAYED-RELEASE CAPSULES ARE NOT APPROVED FOR USE IN PEDIATRIC PATIENTS (8.4) Major Depressive Disorder (MDD) (1.1) Generalized Anxiety Disorder (GAD) (1.2) Diabetic Peripheral Neuropathic Pain (DPNP) (1. Read the complete document