DULOXETINE capsule, delayed release

Kraj: Stany Zjednoczone

Język: angielski

Źródło: NLM (National Library of Medicine)

Składnik aktywny:

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

Dostępny od:

TYA Pharmaceuticals

INN (International Nazwa):

DULOXETINE HYDROCHLORIDE

Skład:

DULOXETINE 60 mg

Droga podania:

ORAL

Typ recepty:

PRESCRIPTION DRUG

Wskazania:

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

Podsumowanie produktu:

NDC:64725-7544-1 in a BOTTLE of 30 CAPSULE, DELAYED RELEASES Duloxetine delayed-release capsules USP are available as follows: 20 mg – a hard gelatin capsule with a light-green cap and light-green body, filled with white to off-white pellets, imprinted on cap with “TEVA” and on body with “7542”, in bottles of 60. 30 mg – a hard gelatin capsule with a light-blue cap and white body, filled with white to off-white pellets, imprinted on cap with “TEVA” and on body with “7543”, in bottles of 30 and 90. 60 mg – a hard gelatin capsule with a light-blue cap and light-green body, filled with white to off-white pellets, imprinted on cap with “TEVA” and on body with “7544”, in bottles of 30 and 1000. Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].

Status autoryzacji:

Abbreviated New Drug Application

Ulotka dla pacjenta

DULOXETINE- DULOXETINE CAPSULE, DELAYED RELEASE
TYA Pharmaceuticals
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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:
•
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 sleeping
•
an increase in activity or ta

Charakterystyka produktu

DULOXETINE- DULOXETINE CAPSULE, DELAYED RELEASE
TYA PHARMACEUTICALS
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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._
RECENT MAJOR CHANGES
Contraindications:
Removed: Uncontrolled Narrow-Angle Glaucoma (4.2)
7/2014
Warnings and Precautions:
Angle-Closure Glaucoma ( ) 5.9
7/2014
INDICATIONS AND USAGE
Duloxetine delayed-release capsules USP are a serotonin and
norepinephrine reuptake inhibitor (SNRI) indicated for:
•
•
•
•
DOSAGE AND ADMINISTRATION
•
INDIC ATIO N
STARTING DOSE
TARGET DOSE
MAXIMUM
DO SE
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
Chronic
Musculoske le tal
Pain ( ) 2.1
30 mg/day
60 mg/day (once daily)
60 mg/day
•
•
•
DOSAGE FORMS AND STRENGTHS
•
CONTRAINDICATIONS
Major Depressive Disorder (MDD) ( ) 1.1
Generalized Anxiety Disorder (GAD) ( ) 1.2
Diabetic Peripheral Neuropathic Pain (DPNP) ( ) 1.3
Chronic Musculoskeletal Pain ( ) 1.5
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
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
Disco