DULOXETINE HYDROCHLORIDE- duloxetin hydrochloride capsule, delayed release

Страна: Соединенные Штаты

Язык: английский

Источник: NLM (National Library of Medicine)

Активный ингредиент:

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

Доступна с:

NCS HealthCare of KY, Inc dba Vangard Labs

ИНН (Международная Имя):

DULOXETINE HYDROCHLORIDE

состав:

DULOXETINE 30 mg

Администрация маршрут:

ORAL

Тип рецепта:

PRESCRIPTION DRUG

Терапевтические показания :

        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 establi

Обзор продуктов:

    Duloxetine delayed-release capsules, USP 20 mg are size '4' hard gelatin capsules having light blue cap and body, imprinted as '20 mg' on the body and '1109' on the cap with black ink, containing off white to reddish brown colored pellets.     Duloxetine delayed-release capsules, USP 30 mg are size '3' hard gelatin capsules having blue cap and milky white body, imprinted as '30 mg' on the body with black ink and '1110' on the cap with white ink, containing off white to reddish brown colored pellets. Blistercards of 30                             NDC 0615-7894-39     Duloxetine delayed-release capsules, USP 60 mg are size '1' hard gelatin capsules having opaque blue cap and yellow body, imprinted as '60 mg' on the body and '1111' on the cap with white ink, containing off white to reddish brown colored pellets. Blistercards of 30                             NDC 0615-7895-39     Store at 20°- 25°C (68°-77°); excursions permitted to 15° - 30°C (59° - 86°F) [see USP Controlled Room Temperature].

Статус Авторизация:

Abbreviated New Drug Application

тонкая брошюра

DULOXETINE HYDROCHLORIDE- DULOXETIN HYDROCHLORIDE CAPSULE, DELAYED
RELEASE
NCS HealthCare of KY, Inc dba Vangard Labs
----------
Medication Guide
Duloxetine (doo-LOX-e-teen) Delayed-Release Capsules, USP
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
•
troub

Характеристики продукта

DULOXETINE HYDROCHLORIDE- DULOXETIN HYDROCHLORIDE CAPSULE, DELAYED
RELEASE
NCS HEALTHCARE OF KY, INC DBA VANGARD LABS
----------
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
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 capsule 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 capsule.
(5.7) 08/2012
INDICATIONS AND USAGE
Duloxetine delayed-release capsules, USP are a serotonin and
norepinephrine reuptake inhibitor (SNRI) indicated for: (1)
Major Depressive Disorder (MDD) (1.1)
Generalized Anxiety Disorder (GAD) (1.2)
Diabetic Peripheral Neuropathic Pain (DPNP) (1.3)
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)
INDICATION
STARTING
DOSE
TARGET DOSE
MAXIMUM
DOSE
MDD (2.1,
2.2 )
40mg/day to
60mg/day
Acute Treatment: 40mg/day