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:

DIRECT RX

INN (International Name):

DULOXETINE HYDROCHLORIDE

Composition:

DULOXETINE 20 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Duloxetine delayed-release capsules USP 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 Precautions

Product summary:

16.1 How Supplied Duloxetine delayed-release capsules USP are available in the following strengths, colors, imprints, and presentations: Features Strengths 20 mg 30 mg 60 mg Body color Green White Green Cap color Green Blue Blue Cap imprint 381 382 383 Body imprint 381 382 383 Capsule Size 4 3 1 Presentations and NDC Codes Bottles of 30 CRC 47335-381-83 47335-382-83 47335-383-83 Bottles of 60 CRC 47335-381-86 - - Bottles of 90 CRC - 47335-382-81 - Bottles of 100 CRC 47335-381-88 47335-382-88 47335-383-88 Bottles of 100 NCRC 47335-381-08 47335-382-08 47335-383-08 Bottles of 1000 NCRC 47335-381-18 47335-382-18 47335-383-18 Unit dose blisters of 100 47335-381-61 47335-382-61 47335-383-61 16.2 Storage and Handling Store duloxetine delayed-release capsules USP at 20° to 25°C (68° to 77°F); excursions permitted between 15° and 30°C (59° and 86°F) [see USP Controlled Room Temperature]. Dispense in a tightly closed container.

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

DULOXETINE- DULOXETINE CAPSULE, DELAYED RELEASE
DIRECT RX
----------
Duloxetine
(doo-LOX-e-teen)
Delayed-release Capsules USP
Read this Medication Guide before you start taking duloxetine
delayed-release capsulesand 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,
especially if they are new, worse, or worry you. In an emergency, call
911.
attempts to commit suicide

Summary of Product characteristics

DULOXETINE- DULOXETINE CAPSULE, DELAYED RELEASE
DIRECT RX
----------
DULOXETINE
WARNING: SUICIDAL THOUGHTS AND BEHAVIORS
Antidepressants increased the risk of suicidal thoughts and behavior
in children, adolescents, and
young adults in short-term studies. These studies did not show an
increase in the risk of suicidal
thoughts and behavior with antidepressant use in patients over age 24;
there was a reduction in
risk with antidepressant use in patients aged 65 and older [see
Warnings and Precautions (5.1)].
In patients of all ages who are started on antidepressant therapy,
monitor closely for worsening,
and for emergence of suicidal thoughts and behaviors. Advise families
and caregivers of the need
for close observation and communication with the prescriber [see
Warnings and Precautions
(5.1)].
Duloxetine delayed-release capsules USP 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)]
Swallow duloxetine delayed-release capsules whole. Do not chew or
crush. Do not open the capsule
and sprinkle its contents on food or mix with liquids. All of these
might affect the enteric coating.
Duloxetine delayed-release capsules can be given without regard to
meals. If a dose of duloxetine
delayed-release capsule is missed, take the missed dose as soon as it
is remembered. If it is almost time
for the next dose, skip the missed dose and take the next dose at the
regular time. Do not take two doses
of duloxetine delayed-release capsules at the same time.
2.1 Dosage for Treatment of Major Depressive Disorder
Administer duloxetine delayed-release capsules at a total dose of 40
mg/day (given as 20 mg twice
daily) to 60 mg/day (given either once daily or as 30 mg twice daily).
For some patients, it may be
desirable to start at 30 mg once daily for 1 week, to allow patients
to adjust to the medication before
increasing