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:

Sun Pharmaceutical Industries, Inc.

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:  - • Major depressive disorder in adults  - • Generalized anxiety disorder in adults and pediatric patients 7 years of age and older  - • Diabetic peripheral neuropathic pain in adults - • Fibromyalgia in adults   - • Chronic musculoskeletal pain in adults  Additional pediatric use information is approved for Eli Lilly and Company, Inc.’s CYMBALTA (duloxetine) delayed-release capsules. However, due to Eli Lilly and Company Inc.’s marketing exclusivity rights, this drug product is not labeled with that pediatric information. The use of MAOIs intended to treat psychiatric disorders with duloxetine or within 5 days of stopping treatment with duloxetine is contraindicated because of an increased risk of serotonin syndrome. The use of duloxetine 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 in a pat

Product summary:

Duloxetine delayed-release capsules USP are available in the following strengths, colors, imprints, and presentations: Store duloxetine delayed-release capsules USP at 20° to 25°C (68° to 77°F); excursions permitted between 15° and 30°C (59° and 86°F) [see USP Controlled Room Temperature]. Dispense in a tightly closed container.

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

DULOXETINE - duloxetine capsule, delayed release
Sun Pharmaceutical Industries, Inc.
----------
MEDICATION GUIDE
Dispense with Medication Guide available at:
https://www.sunpharma.com/usa/products
Duloxetine
(doo-LOX-e-teen)
Delayed-release Capsules USP
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 away if you h

Summary of Product characteristics

DULOXETINE - DULOXETINE CAPSULE, DELAYED RELEASE
SUN PHARMACEUTICAL INDUSTRIES, INC.
----------
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.
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)
RECENT MAJOR CHANGES
Warnings and Precautions, Sexual Dysfunction (5.16) 07/2021
INDICATIONS AND USAGE
Duloxetine is a serotonin and norepinephrine reuptake inhibitor (SNRI)
indicated for the treatment of the
following conditions:
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 (1)
Chronic musculoskeletal pain in adults (1)
DOSAGE AND ADMINISTRATION
Take duloxetine delayed-release capsules once daily, with or without
food. Swallow whole; do not crush,
chew, or open capsule (2.1)
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
60 mg/day
60 mg/day (once daily)
120 mg/day
Geriatric
30 mg/day
60 mg/day (once daily)
120 mg/day
Pediatrics (7 to 17 years of
age)
30 mg/day
30 mg/day to 60 mg/day
(once daily)
120 mg/day
DPNP (2.4)
60 mg/day
60 mg/day (once daily)
60 mg/day
FM (2.5)
Adults
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
Discontinuing duloxetine delayed-release capsul