DULOXETINE- duloxetine capsule, delayed release pellets

מדינה: ארצות הברית

שפה: אנגלית

מקור: NLM (National Library of Medicine)

מרכיב פעיל:

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

זמין מ:

Preferred Pharmaceuticals, Inc.

INN (שם בינלאומי):

DULOXETINE HYDROCHLORIDE

הרכב:

DULOXETINE 30 mg

מסלול נתינה (של תרופות):

ORAL

סוג מרשם:

PRESCRIPTION DRUG

סממני תרפויטית:

Duloxetine delayed-release capsules are indicated for the treatment of major depressive disorder (MDD). The efficacy of duloxetine 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 was established in three short-term trials and one maintenance trial in adults [see CLINICAL STUDIES

leaflet_short:

Duloxetine delayed-release capsules USP, 30 mg are white to off-white spherical enteric coated pellets filled in size '3' hard gelatin capsules with opaque blue coloured cap and opaque white colored body, imprinted 'RDY609' on cap and '30mg' on body with golden yellow ink. Bottle of 6 - 68788-9370-0 Bottle of 10 - 68788-9370-1 Bottle of 20 - 68788-9370-2 Bottle of 30 - 68788-9370-3 Bottle of 60 - 68788-9370-6 Bottle of 90 - 68788-9370-9 Store at 20°-25°C (68° - 77°F); [See USP Controlled Room Temperature].

מצב אישור:

Abbreviated New Drug Application

עלון מידע

DULOXETINE- DULOXETINE CAPSULE, DELAYED RELEASE PELLETS
Preferred Pharmaceuticals, Inc.
----------
MEDICATION GUIDE
DULOXETINE [doh-LOCKS-ah-teen]
(Duloxetine Delayed-Release Capsules USP)
Read the Medication Guide that comes with duloxetine 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 and other antidepressant medicines may cause serious side
effects, including:
1. Suicidal thoughts or actions:
•
Duloxetine 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 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 worse depression
•
new or worse anxiety or panic attacks
•
feeling agitated, restless, angry or irritable
•
trouble sleeping
•
an increase in activity or talking more than what is normal for you
•
other unusual changes in beh

מאפייני מוצר

DULOXETINE- DULOXETINE CAPSULE, DELAYED RELEASE PELLETS
PREFERRED PHARMACEUTICALS, INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
DULOXETINE SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING INFORMATION FOR DULOXETINE .
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 IS NOT APPROVED FOR USE IN PEDIATRIC PATIENTS (8.4)
RECENT MAJOR CHANGES
Contraindications:
Removed: Uncontrolled Narrow-Angle Glaucoma (4.2) 00/0000
Warnings and Precautions:
Angle-Closure Glaucoma (5.9) 00/0000
INDICATIONS AND USAGE
Duloxetine delayed-release capsules are 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
•
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
Musculoskeletal Pain
(2.1)
30 mg/day
60 mg/day (once daily)
60 mg/day
•
•
•
DOSAGE FORMS AND STRENGTHS
20 mg, 30 mg, and 60 mg capsules (3)
CONTRAINDICATIONS
•
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 mixe