DULOXETINE 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:

Solco Healthcare US, LLC

INN (International Name):

DULOXETINE HYDROCHLORIDE

Composition:

DULOXETINE 20 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Duloxetine delayed-release capsules, USP are indicated for the treatment of: The use of MAOIs intended to treat psychiatric disorders with duloxetine delayed-release capsules or within 5 days of stopping treatment with duloxetine delayed-release capsules is contraindicated because of an increased risk of serotonin syndrome. The use of duloxetine delayed-release capsules within 14 days of stopping an MAOI intended to treat psychiatric disorders is contraindicated [see Dosage and Administration (2.8) and Warnings and Precautions (5.4)] . Starting duloxetine delayed-release capsules in a patient who is being treated with MAOIs such as linezolid or intravenous methylene blue is also contraindicated because of an increased risk of serotonin syndrome [see Dosage and Administration (2.9) and Warnings and Precautions (5.4)] . Risk Summary Data from a postmarketing retrospective cohort study indicate that use of duloxetine in the month before delivery may be associated with an increased risk of postpartum hemorrhage.

Product summary:

Duloxetine delayed-release capsules, USP are available as delayed release capsules in the following strengths, colors, imprints, and presentations: Features Strengths 20 mg a 30 mg a 60 mg a Body color Opaque white Opaque light green Opaque dark blue Cap color Opaque white Opaque white Opaque white Cap imprint 557 558 559 Body imprint 20mg 30mg 60mg Capsule number Coni-Snap Coni-Snap Coni-Snap Presentations and NDC Codes Bottles of 30 43547-379-03 43547-380-03 43547-381-03 Bottles of 60 43547-379-06 - - Bottles of 90    43547-379-09 43547-380-09 43547-381-09 Bottles of 1000 43547-379-11 43547-380-11 43547-381-11 a equivalent to duloxetine base Store at 20 o C to 25o C (68 o F to 77o F); excursions permitted between 15 o C to 30o C (59 o F to 86o F) [See USP Controlled Room Temperature].

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

DULOXETINE- DULOXETINE CAPSULE, DELAYED RELEASE
Solco Healthcare US, LLC
----------
MEDICATION GUIDE
Dispense with Medication Guide available at:
www.solcohealthcare.com/medguide/duloxetine-dr-
capsules.pdf
Duloxetine delayed-release capsules, USP
(Doo-Lox-e-teen)
Read this 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 aw

Summary of Product characteristics

DULOXETINE- DULOXETINE CAPSULE, DELAYED RELEASE
SOLCO HEALTHCARE US, LLC
----------
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._
•
•
INDICATIONS AND USAGE
Duloxetine is a serotonin and norepinephrine reuptake inhibitor (SNRI)
indicated for the treatment of the
following conditions:
•
•
•
•
•
DOSAGE AND ADMINISTRATION
•
INDICATION
STARTING DOSE
TARGET DOSE
MAXIMUM DOSE
MDD (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 (2.3) Adults
Geriatric Pediatrics
(7 to 17 years of age)
60 mg/day
30 mg/day
30 mg/day
60 mg/day (once daily)
60 mg/day (once daily)
30 to 60 mg/day (once
daily)
120 mg/day
120 mg/day
120 mg/day
DPNP (2.4)
60 mg/day
60 mg/day (once daily)
60 mg/day
FM (2.5) Adults and
Pediatrics (13 to 17 years
of age)
30 mg/day
60 mg/day (once daily)
60 mg/day
Chronic Musculoskeletal
Pain (2.6)
30 mg/day
60 mg/day (once daily)
60 mg/day
•
DOSAGE FORMS AND STRENGTHS
Delayed-release capsules: 20 mg, 30 mg, and 60 mg (3)
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)
Major depressive disorder (MDD) in adults (1)
Generalized Anxiety Disorder (GAD) in adults and pediatric patients 7
years of age and older (1)
Diabetic Peripheral Neuropathic Pain (DPNP) in adults (1)
Fibromyalgia (FM) in adults and pediatric patients 13 years of age and
older (1)
Chronic musculoskeletal pain in adult (1)
Take duloxetine delayed-release capsules once daily, with or without
food.