DULOXETINE- duloxetine hydrochloride capsule, delayed release

País: Estados Unidos

Língua: inglês

Origem: NLM (National Library of Medicine)

Ingredientes ativos:

Duloxetine hydrochloride (UNII: 9044SC542W) (Duloxetine - UNII:O5TNM5N07U)

Disponível em:

Carilion Materials Management

DCI (Denominação Comum Internacional):

Duloxetine hydrochloride

Composição:

Duloxetine 60 mg

Via de administração:

ORAL

Tipo de prescrição:

PRESCRIPTION DRUG

Indicações terapêuticas:

Duloxetine is indicated for the treatment of major depressive disorder (MDD). The efficacy of duloxetine 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 is indicated for the treatment of generalized anxiety disorder (GAD). The efficacy of duloxetine was established in three short-term trials and one maintenance trial in adu

Resumo do produto:

NDC:68151-4727-3 in a PACKAGE of 1 CAPSULE, DELAYED RELEASES Duloxetine is available as delayed release capsules in the following strengths, colors, imprints, and presentations: equivalent to duloxetine base a Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [ USP Controlled Room Temperature]. see

Status de autorização:

New Drug Application Authorized Generic

Folheto informativo - Bula

DULOXETINE- DULOXETINE HYDROCHLORIDE CAPSULE, DELAYED RELEASE
Carilion Materials Management
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Medication Guide
Duloxetine Delayed-Release Capsules
(doo-LOX-e-teen)
Read the Medication Guide that comes with duloxetine 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?
Duloxetine and other antidepressant medicines may cause serious side
effects, including:
1. Suicidal thoughts or actions:
•
in some children, teenagers, or young adults within the Duloxetine and
other antidepressant
medicines may increase suicidal thoughts or actionsfirst 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 is 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 for you
•
other unusual changes in behavior or mood
Call your healthcare pro

Características técnicas

DULOXETINE- DULOXETINE HYDROCHLORIDE CAPSULE, DELAYED RELEASE
CARILION MATERIALS MANAGEMENT
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
DULOXETINE SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING INFORMATION FOR DULOXETINE. DULOXETINE DELAYED-RELEASE
CAPSULES FOR ORAL USE. INITIAL U.S.
APPROVAL: 2004
WARNING: SUICIDALTHOUGHTS AND BEHAVIORS
_SEE 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 IS NOT APPROVED FOR USE IN PEDIATRIC PATIENTS ( ) 8.4
INDICATIONS AND USAGE
Duloxetine 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
Fibromyalgia (FM) ( ) 1.4
Chronic Musculoskeletal Pain ( ) 1.5
DOSAGE AND ADMINISTRATION
Duloxetine should generally be administered once daily without regard
to meals. Duloxetine should be swallowed whole
and should not be chewed or crushed, nor should the capsule be opened
and its contents be sprinkled on food or mixed
with liquids ( ) 2
INDIC ATIO N
STARTING DOSE
TARGET DOSE
MAXIMUM DOSE
MDD ( , ) 2.12.2
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
FM ( ) 2.1
30 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
Some patients may benefit from starting at 30 mg once daily ( ) 2.1
There is no evidence that doses greater than 60 mg/day confers
additional benefit, while some adverse reactions were
observed to be dose-dependent ( ) 2.1
Discontinuing duloxet