DULOXETINE HYDROCHLORIDE- duloxetine hydrochloride 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:

Lake Erie Medical DBA Quality Care Products LLC

INN (Tên quốc tế):

DULOXETINE HYDROCHLORIDE

Thành phần:

DULOXETINE 20 mg

Tuyến hành chính:

ORAL

Loại thuốc theo toa:

PRESCRIPTION DRUG

Chỉ dẫn điều trị:

Duloxetine delayed-release capsules USP, are indicated for the treatment of major depressive disorder (MDD). The efficacy of duloxetine delayed-release capsules, USP was established in four short-term and one maintenance trial in adults [see Clinical Studies (14.1)] . A major depressive episode (DSM-IV) implies a prominent and relatively persistent (nearly every day for at least 2 weeks) depressed or dysphoric mood that usually interferes with daily functioning, and includes at least 5 of the following 9 symptoms: depressed mood, loss of interest in usual activities, significant change in weight and/or appetite, insomnia or hypersomnia, psychomotor agitation or retardation, increased fatigue, feelings of guilt or worthlessness, slowed thinking or impaired concentration, or a suicide attempt or suicidal ideation. Duloxetine delayed-release capsules, USP are indicated for the treatment of generalized anxiety disorder (GAD). The efficacy of duloxetine delayed-release capsules, USP was established in three short-

Tóm tắt sản phẩm:

Duloxetine Delayed-Release Capsules, USP are supplied as: 20 mg capsules: Hard gelatin capsule with a green opaque body and green opaque cap. Imprinted “APO D20” in black ink. Filled with white to off-white granules. 55700-435-30 30 mg capsules : Hard gelatin capsule with a white opaque body and blue opaque cap. Imprinted “APO D30” in green ink. Filled with white to off-white granules.  Store at 20° to 25°C (68° to 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 HYDROCHLORIDE- DULOXETINE HYDROCHLORIDE CAPSULE, DELAYED
RELEASE
Lake Erie Medical DBA Quality Care Products LLC
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17 PATIENT COUNSELING INFORMATION
See FDA-approved patient labeling (Medication Guide).
17.1 INFORMATION ON MEDICATION GUIDE
Prescribers or other health professionals should inform patients,
their families, and their caregivers about
the benefits and risks associated with treatment with duloxetine
delayed-release capsules and should
counsel them in its appropriate use. A patient Medication Guide is
available for duloxetine delayed-
release capsules. The prescriber or health professional should
instruct patients, their families, and their
caregivers to read the Medication Guide before starting duloxetine
delayed-release capsules and each time
their prescription is renewed, and should assist them in understanding
its contents. Patients should be
given the opportunity to discuss the contents of the Medication Guide
and to obtain answers to any
questions they may have. The complete text of the Medication Guide is
reprinted at the end of this
document.
Patients should be advised of the following issues and asked to alert
their prescriber if these occur while
taking duloxetine delayed-release capsules.
17.2 SUICIDAL THOUGHTS AND BEHAVIORS
Patients, their families, and their caregivers should be encouraged to
be alert to the emergence of anxiety,
agitation, panic attacks, insomnia, irritability, hostility,
aggressiveness, impulsivity, akathisia
(psychomotor restlessness), hypomania, mania, other unusual changes in
behavior, worsening of
depression, and suicidal ideation, especially early during
antidepressant treatment and when the dose is
adjusted up or down. Families and caregivers of patients should be
advised to observe for the emergence
of such symptoms on a day-to-day basis, since changes may be abrupt.
Such symptoms should be
reported to the patient's prescriber or health professional,
especially if they are severe, abrupt in onset, or
were not part of the patient's presenting sym

Đặc tính sản phẩm

DULOXETINE HYDROCHLORIDE- DULOXETINE HYDROCHLORIDE CAPSULE, DELAYED
RELEASE
LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC
----------
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, USP FOR ORAL USE.
INITIAL U.S. APPROVAL: 2004
WARNING: SUICIDAL THOUGHTS AND BEHAVIORS
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING_.
•
•
•
RECENT MAJOR CHANGES
Contraindications:
Removed Uncontrolled Narrow-Angle Glaucoma (4.2) 09/2014
Warnings and Precautions:
Angle-Closure Glaucoma (5.9) 09/2014
INDICATIONS AND USAGE
Duloxetine delayed-release capsules, USP are a serotonin and
norepinephrine reuptake inhibitor (SNRI) indicated for:
1.
2.
3.
4.
DOSAGE AND ADMINISTRATION
•
INDICATION
STARTING DOSE
TARGET DOSE
MAXIMUM
DOSE
MDD (2.1, 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 (2.1)
60 mg/day
60 mg/day (once daily)
120 mg/day
DPNP (2.1)
60 mg/day
60 mg/day (once daily)
60 mg/day
Chronic Musculoskeletal
Pain (2.1)
30 mg/day
60 mg/day (once daily)
60 mg/day
•
•
•
DOSAGE FORMS AND STRENGTHS
20 mg, 30 mg, and 60 mg capsules (3)
CONTRAINDICATIONS
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)
DULOXETINE DELAYED-RELEASE CAPSULES ARE NOT APPROVED FOR USE IN
PEDIATRIC PATIENTS (8.4)
Major Depressive Disorder (MDD) (1.1)
Generalized Anxiety Disorder (GAD) (1.2)
Diabetic Peripheral Neuropathic Pain (DPNP) (1.3)
Chronic Musculoskeletal Pain (1.5)
Duloxetine delayed- release capsules, USP should generally be
administered once daily without regard to meals.
Duloxetine delayed- release capsules, USP should be s