দেশ: মার্কিন যুক্তরাষ্ট্র
ভাষা: ইংরেজি
সূত্র: NLM (National Library of Medicine)
DULOXETINE HYDROCHLORIDE (UNII: 9044SC542W) (DULOXETINE - UNII:O5TNM5N07U)
DIRECT RX
DULOXETINE HYDROCHLORIDE
DULOXETINE 60 mg
ORAL
PRESCRIPTION DRUG
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 D
16.1 How Supplied Duloxetine delayed-release capsules, USP are available in the following strengths, colors, imprints, and presentations: Features Strengths 20 mg* 30 mg* 40 mg* 60 mg* * equivalent to duloxetine base Body color Opaque ochre Opaque white Opaque orange Opaque ochre Cap color Opaque ochre Opaque green Opaque blue Opaque green Cap imprint B B B B Body imprint 746 747 750 748 Presentations and NDC Codes Bottles of 30 NA 51991-747-33 51991-750-33 51991-748-33 Bottles of 60 51991-746-06 NA NA NA Bottles of 90 51991-746-90 51991-747-90 51991-750-90 51991-748-90 Bottles of 500 51991-746-05 NA 51991-750-05 NA Bottles of 1000 NA 51991-747-10 51991-750-10 51991-748-10
Abbreviated New Drug Application
DULOXETINE HYDROCHLORIDE- DULOXETINE HYDROCHLORIDE CAPSULE, DELAYED RELEASE PELLETS DIRECT RX ---------- SPL MEDGUIDE SECTION 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 sleeping • an increase in activity or talking more than what is normal fo সম্পূর্ণ নথি পড়ুন
DULOXETINE HYDROCHLORIDE- DULOXETINE HYDROCHLORIDE CAPSULE, DELAYED RELEASE PELLETS DIRECT RX ---------- DULOXETINE HYDROCHLORIDE BOXED WARNING SECTION WARNING: SUICIDAL THOUGHTS AND BEHAVIORS Antidepressants increased the risk of suicidal thoughts and behavior in children, adolescents, and young adults in short-term studies. These studies did not show an increase in the risk of suicidal thoughts and behavior with antidepressant use in patients over age 24; there was a reduction in risk with antidepressant use in patients aged 65 and older [see Warnings and Precautions (5.1)]. In patients of all ages who are started on antidepressant therapy, monitor closely for worsening, and for emergence of suicidal thoughts and behaviors. Advise families and caregivers of the need for close observation and communication with the prescriber [see Warnings and Precautions (5.1)]. Duloxetine Delayed-release Capsules are not approved for use in pediatric patients [see Use in Specific Populations (8.4)]. WARNINGS SECTION 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: 2004WARNING: SUICIDAL THOUGHTS AND BEHAVIORSSee full prescribing information for complete boxed warning. 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) 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 সম্পূর্ণ নথি পড়ুন