DULOXETINE capsule, delayed release

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Proficient Rx LP

INN (International Name):

DULOXETINE HYDROCHLORIDE

Composition:

DULOXETINE 20 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Duloxetine delayed-release capsules are indicated for the treatment of:          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 Precautions (5.4)].          Pregnancy Category C          Risk Summary — There are no adequate and well-controlled studies of duloxetine administration in pregnant women. In animal studies with duloxetine, fetal weights were decreased but there was no evi

Product summary:

         Duloxetine delayed-release capsules are available in the following strengths, colors, imprints, and presentations: Features Strength 20 mga Body color White Cap color Blue Cap imprint ap Body imprint DLX20 Presentations and NDC Codes Bottles of 30’s pack 71205-005-30 Bottles of 60’s pack 71205-005-60 Bottles of 90’s pack 71205-005-90          Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

DULOXETINE- DULOXETINE CAPSULE, DELAYED RELEASE
Proficient Rx LP
----------
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 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?
1.
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.
2.
Call your healthcare provider right away to report new or sudden
changes in mood, behavior,
thoughts, or feelings.
1.
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.
•
attemp

Summary of Product characteristics

DULOXETINE- DULOXETINE CAPSULE, DELAYED RELEASE
PROFICIENT RX LP
----------
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
•
•
RECENT MAJOR CHANGES
None.
INDICATIONS AND USAGE
Duloxetine delayed-release capsules are a serotonin and norepinephrine
reuptake inhibitor (SNRI)
indicated for:
•
•
•
•
DOSAGE AND ADMINISTRATION
•
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
•
•
•
•
•
DOSAGE FORMS AND STRENGTHS
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)
Major Depressive Disorder (MDD) (1)
Generalized Anxiety Disorder (GAD) (1)
Diabetic Peripheral Neuropathic Pain (DPNP) (1)
Chronic Musculoskeletal Pain (1)
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)
Some patients may benefit from starting at 30 mg once daily (2)
There is no evidence that doses greater than 60 mg/day confers
additional benefit, while some
adverse react