DULOXETINE HYDROCHLORIDE- duloxetin hydrochloride capsule, delayed release

Negara: Amerika Serikat

Bahasa: Inggris

Sumber: NLM (National Library of Medicine)

Bahan aktif:

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

Tersedia dari:

Torrent Pharmaceuticals Limited

INN (Nama Internasional):

DULOXETINE HYDROCHLORIDE

Komposisi:

DULOXETINE 20 mg

Rute administrasi :

ORAL

Jenis Resep:

PRESCRIPTION DRUG

Indikasi Terapi:

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 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 delayed-release capsules or within 5 days of stopping treatment with duloxetine delayed-release capsules is 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 ser

Ringkasan produk:

Duloxetine delayed-release capsules, USP 20 mg are size '4' hard gelatin capsules having light blue cap and body, imprinted as '20 mg' on the body and '1109' on the cap with black ink, containing off white to reddish brown colored pellets. Bottles of 30                           NDC 13668-109-30 Bottles of 60                           NDC 13668-109-60 Bottles of 100                         NDC 13668-109-01 Bottles of 500                         NDC 13668-109-05 Duloxetine delayed-release capsules, USP 30 mg are size '3' hard gelatin capsules having blue cap and milky white body, imprinted as '30 mg' on the body with black ink and '1110' on the cap with white ink, containing off white to reddish brown colored pellets. Bottles of 30                           NDC 13668-110-30 Bottles of 100                         NDC 13668-110-01 Bottles of 500                         NDC 13668-110-05 Duloxetine delayed-release capsules, USP 60 mg are size '1' hard gelatin capsules having opaque blue cap and yellow body, imprinted as '60 mg' on the body and '1111' on the cap with white ink, containing off white to reddish brown colored pellets. Bottles of 30                           NDC 13668-111-30 Bottles of 100                         NDC 13668-111-01 Bottles of 500                         NDC 13668-111-05 Store at 20° to 25°C (68° to 77°); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].

Status otorisasi:

Abbreviated New Drug Application

Selebaran informasi

DULOXETINE HYDROCHLORIDE- DULOXETIN HYDROCHLORIDE CAPSULE, DELAYED
RELEASE
Torrent Pharmaceuticals Limited
----------
MEDICATION GUIDE
Medication Guide
Duloxetine (doo-LOX-e-teen) Delayed-Release Capsules, USP
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 somechildren, teenagers, oryoung 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,

Karakteristik produk

DULOXETINE HYDROCHLORIDE- DULOXETIN HYDROCHLORIDE CAPSULE, DELAYED
RELEASE
TORRENT PHARMACEUTICALS LIMITED
----------
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 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 and pediatric patients 13 years of age
older (1)
Chronic musculoskeletal pain in adults (1)
DOSAGE AND ADMINISTRATION
Take duloxetine delayed-release capsule 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 Musculos