DULOXETINE HYDROCHLORIDE- duloxetin hydrochloride capsule, delayed release

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Proficient Rx LP

INN (International Name):

DULOXETINE HYDROCHLORIDE

Composition:

DULOXETINE 60 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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 established in three short-

Product summary:

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.             Bottles of 30                             NDC 63187-457-30 Store at 20°- 25°C (68°-77°); excursions permitted to 15° - 30°C (59° - 86°F) [see USP Controlled Room Temperature].

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

DULOXETINE HYDROCHLORIDE- DULOXETIN HYDROCHLORIDE CAPSULE, DELAYED
RELEASE
Proficient Rx LP
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MEDICATION GUIDE
Medication Guide
Duloxetine (doo-LOX-e-teen) Delayed-Release Capsules, USP
Read the Medication Guide before you start taking duloxetine
delayed-release capsules and each time you
get a refill. There may be new information. This information does not
take the place of talking to your
healthcare provider about your medical condition or treatment.
Talk to your healthcare provider about:
•
all risks and benefits of treatment with antidepressant medicines
•
all treatment choices for depression or other serious mental illness
What is the most important information I should know about
antidepressant medicines, depression, other
serious mental illnesses, and suicidal thoughts or actions?
1. 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.
2. Depression and other serious mental illnesses are the most
important causes of suicidal thoughts or
actions. Some people may have a particularly high risk of having
suicidal thoughts or actions. These
include people who have (or have a family history of) bipolar illness
(also called manic-depressive
illness).
3. How can I watch for and try to prevent suicidal thoughts and
actions?
•
Pay close attention to any changes in mood, behavior, actions,
thoughts, or feelings, especially
sudden changes. This is very important when an antidepressant medicine
is started or when the dose
is changed.
•
Call your healthcare provider right away to report new or sudden
changes in mood, behavior,
thoughts, or feelings.
•
Keep all follow-up visits with your healthcare provider as scheduled.
Call your healthcare provider
between visits as needed, especially if you have concerns about
symptoms.
Call your healthcare provider right away if you have any of the
following symptoms, or feelings,
especially i

Summary of Product characteristics

DULOXETINE HYDROCHLORIDE- DULOXETIN HYDROCHLORIDE CAPSULE, DELAYED
RELEASE
PROFICIENT RX LP
----------
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) 07/2014
Warnings and Precautions:
Angle-Closure Glaucoma (5.9) 07/2014
INDICATIONS AND USAGE
Duloxetine delayed-release capsules, USP are a serotonin and
norepinephrine reuptake inhibitor (SNRI) indicated for: (1)
•
•
•
•
DOSAGE AND ADMINISTRATION
•
INDICATION
(2)
STARTING DOSE
(2)
TARGET DOSE
(2)
MAXIMUM DOSE
(2)
MDD (2.1, 2.2)
(2)
40 mg/day to 60 mg/day
(2)
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
(2)
120 mg/day
(2)
GAD (2.1)
(2)
60 mg/day
(2)
60 mg/day (once daily)
(2)
120 mg/day
(2)
DPNP (2.1)
(2)
60 mg/day
(2)
60 mg/day (once daily)
(2)
60 mg/day
(2)
Chronic Musculoskeletal Pain (2.1)
(2)
30 mg/day
(2)
60 mg/day (once daily)
(2)
60 mg/day
(2)
•
•
•
DOSAGE FORMS AND STRENGTHS
20 mg, 30 mg, and 60 mg capsules (3) (3)
CONTRAINDICATIONS
•
WARNINGS AND PRECAUTIONS
•
•
•
•
•
•
•
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)
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 gen