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:

Preferred Pharmaceuticals Inc.

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Duloxetine delayed-release capsules are indicated for the treatment of: 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 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 [s

Product summary:

Duloxetine delayed-release capsules, USP are available in the following strengths, colors, imprints, and presentations: Body color Opaque ochre Cap color Opaque ochre Cap imprint B Body imprint 746 Presentations and NDC Codes Bottles of 30 68788-7897-3 Bottles of 60 68788-7897-6 Bottles of 90 68788-7897-9 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
Preferred Pharmaceuticals Inc.
----------
MEDICATION GUIDE
DULOXETINE (DOO-LOX-E-TEEN)
DELAYED-RELEASE CAPSULES, USP
RX ONLY
Dispense with Medication Guide available at:
www.bpirx.com/products/patientinformation
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?
o
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.
o
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

Summary of Product characteristics

DULOXETINE DELAYED-RELEASE- DULOXETINE HYDROCHLORIDE CAPSULE, DELAYED
RELEASE PELLETS
PREFERRED 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._
•
•
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:
•
•
•
•
•
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
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 daily)
60 mg/day
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 (1)
Chronic musculoskeletal pain in adults (1)
Take Duloxetine delayed-release capsules once daily, with or without
food. Swallow whole; do no