DULOXETINE- duloxetine hydrochloride capsule, delayed release

Country: Сједињене Америчке Државе

Језик: Енглески

Извор: NLM (National Library of Medicine)

Активни састојак:

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

Доступно од:

Lake Erie Medical DBA Quality Care Products LLC

INN (Међународно име):

DULOXETINE HYDROCHLORIDE

Састав:

DULOXETINE 60 mg

Пут администрације:

ORAL

Тип рецептора:

PRESCRIPTION DRUG

Терапеутске индикације:

Duloxetine delayed-release capsules USP are indicated for the treatment of major depressive disorder (MDD). The efficacy of duloxetine delayed-release capsules USP 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 USP are indicated for the treatment of generalized anxiety disorder (GAD). The efficacy of duloxetine delayed-release capsules USP was established in three short

Резиме производа:

Duloxetine Delayed-Release Capsules USP, 20 mg are green opaque/green opaque, size ‘4’ hard gelatin capsule filled with white to off-white pellets and imprinted with ‘X’ on green opaque cap and ‘01’ on green opaque body with black ink. Duloxetine Delayed-Release Capsules USP, 30 mg are blue opaque/white opaque, size ‘3’ hard gelatin capsule filled with white to off-white pellets and imprinted with ‘X’ on blue opaque cap and ‘02’ on white opaque body with black ink. Duloxetine Delayed-Release Capsules USP, 60 mg are blue opaque/green opaque, size ‘1’ hard gelatin capsule filled with white to off-white pellets and imprinted with ‘X’ on blue opaque cap and ‘03’ on green opaque body with black ink. Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].

Статус ауторизације:

Abbreviated New Drug Application

Информативни летак

DULOXETINE- DULOXETINE HYDROCHLORIDE CAPSULE, DELAYED RELEASE
Lake Erie Medical DBA Quality Care Products LLC
----------
MEDICATION GUIDE
Duloxetine Delayed-Release Capsules USP
(doo lox' e teen)
Read the Medication Guide that comes with duloxetine delayed-release
capsules before you start
taking them 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

Карактеристике производа

DULOXETINE- DULOXETINE HYDROCHLORIDE CAPSULE, DELAYED RELEASE
LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
DULOXETINE DELAYED-RELEASE
CAPSULES USP SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION
FOR DULOXETINE DELAYED-RELEASE CAPSULES
USP.
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._
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
Contraindications:
Removed: Uncontrolled Narrow-Angle Glaucoma (4.2) 07/2014
Warnings and Precautions:
Angle-Closure Glaucoma (5.9) 07/2014
INDICATIONS AND USAGE
Duloxetine delayed-release capsules USP are 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)
Chronic Musculoskeletal Pain (1.5)
DOSAGE AND ADMINISTRATION
Duloxetine delayed-release capsules should generally be administered
once daily without regard to meals. Duloxetine
delayed-release capsules 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
DO SE
TARGET DOSE
MAXIMUM
DO SE
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
Musculoske le tal
Pain (2.1)
30 mg/day
60 mg/day (once daily)
60