DULOXETINE capsule, delayed release

Country: Сједињене Америчке Државе

Језик: Енглески

Извор: NLM (National Library of Medicine)

Активни састојак:

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

Доступно од:

Inventia Healthcare Private Limited

INN (Међународно име):

DULOXETINE HYDROCHLORIDE

Састав:

DULOXETINE 20 mg

Пут администрације:

ORAL

Тип рецептора:

PRESCRIPTION DRUG

Терапеутске индикације:

Duloxetine is indicated for the treatment of: - Major depressive disorder in adults - Generalized anxiety disorder in adults - Diabetic peripheral neuropathic pain in adults - Fibromyalgia in adults and pediatric patients 13 years of age and older. - 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. Monoamine Oxidase Inhibitors (MAOIs) - 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

Резиме производа:

Duloxetine delayed-release capsules USP are available 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].

Статус ауторизације:

Abbreviated New Drug Application

Информативни летак

DULOXETINE- DULOXETINE CAPSULE, DELAYED RELEASE
Inventia Healthcare Private Limited
----------
Medication
Guide
DULOXETINE (doo-
LOX-e-teen)
delayed-release
capsules USP
Read this Medication Guide before you start taking duloxetine
delayed-release capsule USP 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 capsule USP 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, wor

Карактеристике производа

DULOXETINE- DULOXETINE CAPSULE, DELAYED RELEASE
INVENTIA HEALTHCARE PRIVATE LIMITED
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
DULOXETINE DELAYED
RELEASE CAPSULES, USP SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING
INFORMATION FOR
DULOXETINE DELAYED RELEASE CAPSULES, USP.
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 USP 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 (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 USP 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
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
Discontinui