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

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

TYA Pharmaceuticals

INN (International Name):

DULOXETINE HYDROCHLORIDE

Composition:

DULOXETINE 30 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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

Product summary:

NDC:64725-0747-1 in a BOTTLE of 90 CAPSULE, DELAYED RELEASE PELLETSS Duloxetine Delayed-release Capsules are available as delayed release capsules in the following strengths, colors, imprints, and presentations: Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature].

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

DULOXETINE DELAYED-RELEASE- DULOXETINE HYDROCHLORIDE CAPSULE, DELAYED
RELEASE PELLETS
TYA Pharmaceuticals
----------
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:
•
in some children, teenagers, or young adults within the Duloxetine
Delayed-release Capsules 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
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 s

Summary of Product characteristics

DULOXETINE DELAYED-RELEASE- DULOXETINE HYDROCHLORIDE CAPSULE, DELAYED
RELEASE
PELLETS
TYA PHARMACEUTICALS
----------
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._
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 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:
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 DOSE
TARGET DOSE
MAXIMUM DOSE
MDD ( , ) 2.12.2
40 mg/day to