DULOXETINE- duloxetine capsule, delayed release DULOXETINE capsule, delayed release

Quốc gia: Hoa Kỳ

Ngôn ngữ: Tiếng Anh

Nguồn: NLM (National Library of Medicine)

Thành phần hoạt chất:

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

Sẵn có từ:

Asclemed USA, Inc.

Tuyến hành chính:

ORAL

Loại thuốc theo toa:

PRESCRIPTION DRUG

Chỉ dẫn điều trị:

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 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 P

Tóm tắt sản phẩm:

Duloxetine delayed-release capsules are available in the following strengths, colors, imprints, and presentations: Features Strengths 20 mg a 30 mg a 40 mg a 60 mg a Body color White Blue Pink White Cap color Blue Blue Blue Blue Cap imprint ap ap ap ap Body imprint DLX20 DLX30 DLX40 DLX60 Presentations and NDC Codes Bottles of 30’s pack 76420-633-30 (repackaged from NDC 27241-097-xx) 76420-634-30 (repackaged from NDC 27241-098-xx) 76420-636-30 (repackaged from NDC 27241-164-xx) 76420-623-30 (repackaged from NDC 27241-099-xx) Bottles of 60’s pack 76420-633-60 (repackaged from NDC 27241-097-xx) 76420-634-60 (repackaged from NDC 27241-098-xx) Not Applicable 76420-623-60 (repackaged from NDC 27241-099-xx) Bottles of 90’s pack 76420-633-90 (repackaged from NDC 27241-097-xx) 76420-634-90 (repackaged from NDC 27241-098-xx) 76420-636-90 (repackaged from NDC 27241-164-xx) 76420-623-90 (repackaged from NDC 27241-099-xx) Bottles of 100’s pack 76420-633-01 (repackaged from NDC 27241-097-xx) 76420-634-01 (repackaged from NDC 27241-098-xx) 76420-636-01 (repackaged from NDC 27241-164-xx) 76420-623-01 (repackaged from NDC 27241-099-xx) a equivalent to duloxetine base Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [ see USP Controlled Room Temperature].

Tình trạng ủy quyền:

Abbreviated New Drug Application

Tờ rơi thông tin

DULOXETINE - DULOXETINE CAPSULE, DELAYED RELEASE
DULOXETINE- DULOXETINE CAPSULE, DELAYED RELEASE
Asclemed USA, Inc.
----------
MEDICATION GUIDE
Duloxetine Delayed-Release Capsules
(doo lox’ e teen)
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,
especia

Đặc tính sản phẩm

DULOXETINE - DULOXETINE CAPSULE, DELAYED RELEASE
DULOXETINE- DULOXETINE CAPSULE, DELAYED RELEASE
ASCLEMED USA, 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 ( 5.4, 5.5)
08/2023
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 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,
or 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 years 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 and Pediatrics (13
years to 17 years of age)
30 mg/day
60 mg/