DULOXETINE HYDROCHLORIDE capsule, delayed release pellets

Země: Spojené státy

Jazyk: angličtina

Zdroj: NLM (National Library of Medicine)

Aktivní složka:

DULOXETINE HYDROCHLORIDE (UNII: 9044SC542W) (DULOXETINE - UNII:O5TNM5N07U)

Dostupné s:

DIRECT RX

INN (Mezinárodní Name):

DULOXETINE HYDROCHLORIDE

Složení:

DULOXETINE 60 mg

Podání:

ORAL

Druh předpisu:

PRESCRIPTION DRUG

Terapeutické indikace:

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

Přehled produktů:

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

Stav Autorizace:

Abbreviated New Drug Application

Informace pro uživatele

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

Charakteristika produktu

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