DULOXETINE HYDROCHLORIDE 20 MG- duloxetine capsule, delayed release DULOXETINE HYDROCHLORIDE 30 MG- duloxetine capsule, delayed

Země: Spojené státy

Jazyk: angličtina

Zdroj: NLM (National Library of Medicine)

Aktivní složka:

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

Dostupné s:

Alembic Pharmaceuticals Limited

INN (Mezinárodní Name):

DULOXETINE HYDROCHLORIDE

Složení:

DULOXETINE 20 mg

Podání:

ORAL

Druh předpisu:

PRESCRIPTION DRUG

Terapeutické indikace:

Duloxetine delayed-release capsules are indicated for the treatment of major depressive disorder (MDD). The efficacy of duloxetine delayed-release capsules were 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 were established in three short-term trials and o

Přehled produktů:

Duloxetine delayed-release capsules are available as delayed release capsules in the following strengths, colors, imprints, and presentations: a equivalent to duloxetine base Store at 25°C (77°F); excursions permitted to 15to30°C (59to86°F) [see USP Controlled Room Temperature].

Stav Autorizace:

Abbreviated New Drug Application

Informace pro uživatele

DULOXETINE HYDROCHLORIDE 20 MG- DULOXETINE CAPSULE, DELAYED RELEASE
DULOXETINE HYDROCHLORIDE 30 MG- DULOXETINE CAPSULE, DELAYED RELEASE
DULOXETINE HYDROCHLORIDE 60 MG- DULOXETINE CAPSULE, DELAYED RELEASE
Alembic Pharmaceuticals Limited
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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 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 wor

Charakteristika produktu

DULOXETINE HYDROCHLORIDE 20 MG- DULOXETINE CAPSULE, DELAYED RELEASE
DULOXETINE HYDROCHLORIDE 30 MG- DULOXETINE CAPSULE, DELAYED RELEASE
DULOXETINE HYDROCHLORIDE 60 MG- DULOXETINE CAPSULE, DELAYED RELEASE
ALEMBIC PHARMACEUTICALS LIMITED
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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 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
ANTIDEPRASSANTS (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 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 capsuleis 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)
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 capsule 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 mix