DULOXETINE DELAYED-RELEASE- duloxetine hydrochloride capsule, delayed release pellets

Country: Amerika Syarikat

Bahasa: Inggeris

Sumber: NLM (National Library of Medicine)

Bahan aktif:

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

Boleh didapati daripada:

Proficient Rx LP

Laluan pentadbiran:

ORAL

Jenis preskripsi:

PRESCRIPTION DRUG

Tanda-tanda terapeutik:

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

Ringkasan produk:

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 green Cap imprint B Body imprint 748 Presentations and NDC Codes Bottles of 30 63187-735-30 Bottles of 60 63187-735-60 Bottles of 90 63187-735-90 Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature].

Status kebenaran:

Abbreviated New Drug Application

Risalah maklumat

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:
o
New or sudden changes in mood, behavior, actions, thoughts, or
feelings, especially if severe.
o
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

Ciri produk

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
•
INDICATION
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
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) (1.3)
Chronic Musculoskeletal Pain (1.5)
Duloxetine Delayed-release Capsules should generally be administered
once daily without regard to
meals. Duloxetine Delayed-release Capsules should b