DULOXETINE HYDROCHLORIDE- duloxetin hydrochloride 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:

REMEDYREPACK INC.

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 delayed-release capsules or within 5 days of stopping treatment with duloxetine delayed-release capsules is contraindicated because of an increased risk of serotonin syndrome. The use of duloxetine delayed-release capsules 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 delayed-release capsules 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

Product summary:

            Duloxetine delayed-release capsules, USP 20 mg are size '4' hard gelatin capsules having light blue cap and body, imprinted as '20 mg' on the body and '1109' on the cap with black ink, containing off white to reddish brown colored pellets. Bottles of 30                             NDC 13668-109-30 Bottles of 60                             NDC 13668-109-60 Bottles of 100                           NDC 13668-109-01 Bottles of 500                           NDC 13668-109-05  Bottles of 1900                         NDC 13668-109-19 100 Unit dose capsules            NDC 13668-109-74             Duloxetine delayed-release capsules, USP 30 mg are size '3' hard gelatin capsules having blue cap and milky white body, imprinted as '30 mg' on the body with black ink and '1110' on the cap with white ink, containing off white to reddish brown colored pellets. Bottles of 30                             NDC 13668-110-30 Bottles of 100                           NDC 13668-110-01 Bottles of 500                           NDC 13668-110-05  Bottles of 1400                      NDC 13668-110-14 100 Unit dose capsules NDC 13668-110-74             Duloxetine delayed-release capsules, USP 60 mg are size '1' hard gelatin capsules having opaque blue cap and yellow body, imprinted as '60 mg' on the body and '1111' on the cap with white ink, containing off white to reddish brown colored pellets. Bottles of 30                             NDC 13668-111-30 Bottles of 100                           NDC 13668-111-01 Bottles of 500                           NDC 13668-111-05  Bottles of 1000                       NDC 13668-111-10 100 Unit dose capsules NDC 13668-111-74 Store at 20° to 25°C (68° to 77°); 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 HYDROCHLORIDE- DULOXETIN HYDROCHLORIDE CAPSULE, DELAYED
RELEASE
REMEDYREPACK INC.
----------
MEDICATION GUIDE
Medication Guide
Duloxetine (doo-LOX-e-teen) Delayed-Release Capsules, USP
Read the 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 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

Summary of Product characteristics

DULOXETINE HYDROCHLORIDE- DULOXETIN HYDROCHLORIDE CAPSULE, DELAYED
RELEASE
REMEDYREPACK 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 USP, 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, USP are a serotonin and
norepinephrine reuptake inhibitor (SNRI) indicated for: (1)
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 capsule once daily, with or without
food. Swallow duloxetine delayed-release capsule
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 dose