DULOXETINE capsule, delayed release

Pajjiż: Stati Uniti

Lingwa: Ingliż

Sors: NLM (National Library of Medicine)

Ingredjent attiv:

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

Disponibbli minn:

Quality Care Products LLC

INN (Isem Internazzjonali):

DULOXETINE HYDROCHLORIDE

Kompożizzjoni:

DULOXETINE 30 mg

Rotta amministrattiva:

ORAL

Tip ta 'preskrizzjoni:

PRESCRIPTION DRUG

Indikazzjonijiet terapewtiċi:

Duloxetine delayed-release capsules are indicated for the treatment of: - Major Depressive Disorder [see Clinical Studies ( 14.1 )] . - Generalized Anxiety Disorder [see Clinical Studies ( 14.2 )] . - Diabetic Peripheral Neuropathy [see Clinical Studies ( 14.3 )] . - Chronic Musculoskeletal Pain [see Clinical Studies ( 14.5 )] .          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 also 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

Sommarju tal-prodott:

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

L-istatus ta 'awtorizzazzjoni:

Abbreviated New Drug Application

Fuljett ta 'informazzjoni

DULOXETINE- DULOXETINE CAPSULE, DELAYED RELEASE
Quality Care Products LLC
----------
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
aboutantidepressant 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.

Karatteristiċi tal-prodott

DULOXETINE- DULOXETINE CAPSULE, DELAYED RELEASE
QUALITY CARE PRODUCTS 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
None.
INDICATIONS AND USAGE
Duloxetine delayed-release capsules are a serotonin and norepinephrine
reuptake inhibitor (SNRI)
indicated for:
Major Depressive Disorder (MDD) (1)
Generalized Anxiety Disorder (GAD) (1)
Diabetic Peripheral Neuropathic Pain (DPNP) (1)
Chronic Musculoskeletal Pain (1)
DOSAGE AND ADMINISTRATION
Take duloxetine delayed-release capsules once daily, with or without
food. Swallow duloxetine delayed-
release capsules whole; do not crush or chew, do not open capsule.
Take a missed dose as soon as it is
remembered. Do not take two doses of duloxetine delayed-release
capsules at the same time. (2)
INDICATION
STARTING
DOSE
TARGET DOSE
MAXIMUM
DOSE
MDD (2.1)
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 (2.2)
Adults
60 mg/day
60 mg/day (once daily)
120 mg/day
Elderly
30 mg/day
60 mg/day (once daily)
120 mg/day
Children and Adolescents
(7 to 17 years of age)
30 mg/day
30 to 60 mg/day (once daily)
120 mg/day
DPNP (2.3)
60 mg/day
60 mg/day (once daily)
60 mg/day
Chronic
Musculoskeletal
Pain (2.5)
30 mg/day
60 mg/day (once daily)
60 mg/day
Some patients may benefit from starting at 30 mg once daily (2)
There is no evidence that doses greater than 60 mg/day confers
addit