DULOXETINE capsule, delayed release

Država: Združene države Amerike

Jezik: angleščina

Source: NLM (National Library of Medicine)

Aktivna sestavina:

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

Dostopno od:

Ascend Laboratories, LLC

INN (mednarodno ime):

DULOXETINE HYDROCHLORIDE

Sestava:

DULOXETINE 20 mg

Pot uporabe:

ORAL

Tip zastaranja:

PRESCRIPTION DRUG

Terapevtske indikacije:

Duloxetine is 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 and pediatric patients 13 years of age and older - Chronic musculoskeletal pain in adults 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 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 postm

Povzetek izdelek:

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

Status dovoljenje:

Abbreviated New Drug Application

Navodilo za uporabo

DULOXETINE - DULOXETINE CAPSULE, DELAYED RELEASE
Ascend Laboratories, LLC
----------
MEDICATION GUIDE
Duloxetine Delayed-Release Capsules USP
(doo-LOX-e-teen)
Read this Medication Guide before you start taking duloxetine 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 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 worry you. In an emergency, call
911.
•
attempts to commit

Lastnosti izdelka

DULOXETINE - DULOXETINE CAPSULE, DELAYED RELEASE
ASCEND LABORATORIES, 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._
•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 (5.4, 5.5) 8/2023
INDICATIONS AND USAGE
Duloxetine hydrochloride 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 and pediatric patients 13 years of age and
older (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 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