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:

Cipla USA Inc.

INN (International Name):

DULOXETINE HYDROCHLORIDE

Composition:

DULOXETINE 20 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Duloxetine is 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 Precautions (5.4)]. Pregnancy Category C Risk Summary

Product summary:

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

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

DULOXETINE- DULOXETINE CAPSULE, DELAYED RELEASE
Cipla USA Inc.
----------
SPL MEDGUIDE
DULOXETINE (doo-LOX-e-teen)
delayed-release capsules USP
Read this Medication Guide before you start taking duloxetine
delayed-release capsule USPand 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 capsule USPand 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 em

Summary of Product characteristics

DULOXETINE- DULOXETINE CAPSULE, DELAYED RELEASE
CIPLA USA INC.
----------
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, 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)
INDICATIONS AND USAGE
Duloxetine delayed-release capsules USP is 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 USP once daily, with or
without food. Swallow duloxetine delayed-release
capsules USP 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 USP 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
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
additional benefit, while some adverse reactions were
observed to be dose-dependent (2)
Discontinuing duloxetine delayed-release capsule USP: Gradually reduce
dosage to a