DULOXETINE DELAYED-RELEASE- duloxetine hydrochloride capsule, delayed release pellets

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

NuCare Pharmaceuticals,Inc.

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 delayed-release capsules or within 5 days of stopping treatment with Duloxetine delayed-release capsules are 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 Ad

Product summary:

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

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

DULOXETINE DELAYED-RELEASE- DULOXETINE HYDROCHLORIDE CAPSULE, DELAYED
RELEASE PELLETS
NuCare Pharmaceuticals,Inc.
----------
MEDICATION GUIDE
DULOXETINE (DOO-LOX-E-TEEN)
DELAYED-RELEASE CAPSULES, USP
RX ONLY
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,

Summary of Product characteristics

DULOXETINE DELAYED-RELEASE- DULOXETINE HYDROCHLORIDE CAPSULE, DELAYED
RELEASE PELLETS
NUCARE PHARMACEUTICALS,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 delayed-release capsules are 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 (once d