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:

American Health Packaging

INN (International Name):

DULOXETINE HYDROCHLORIDE

Composition:

DULOXETINE 20 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Duloxetine delayed-release capsules 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 also contraindicated [see Dosage and Administration (2.9) and Warnings and Precautions (5.4)]. Starting duloxetine in a patient

Product summary:

Duloxetine is available as delayed-release capsules in the following strengths, colors, imprints, and presentations: Features Strengths 20 mg * 30 mg * 60 mg * Body color Green White Green Cap color Green Dark Blue Dark Blue Cap imprint ‘LU’ ‘LU’ ‘LU’ Body imprint ‘Q01’ ‘Q02’ ‘Q03’ Capsule number 4 3 1 20 mg supplied in unit dose packages of 30 (3 x 10) NDC 68084-675-21 30 mg supplied in unit dose packages of 100 (10 x 10) NDC 68084-683-01 60 mg supplied in unit dose packages of 100 (10 x 10) NDC 68084-692-01 Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. FOR YOUR PROTECTION: Do not use if blister is torn or broken.

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

DULOXETINE- DULOXETINE CAPSULE, DELAYED RELEASE
American Health Packaging
----------
MEDICATION GUIDE
8267521/0522
Duloxetine (doo-LOX-e-teen) Delayed-release Capsules
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 have any of the
following symptoms or feelings,
especially if they are new, worse, or

Summary of Product characteristics

DULOXETINE- DULOXETINE CAPSULE, DELAYED RELEASE
AMERICAN HEALTH PACKAGING
----------
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 delayed-release capsule 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 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 (onc