DULOXETINE capsule, delayed release

Country: Amerika Syarikat

Bahasa: Inggeris

Sumber: NLM (National Library of Medicine)

Bahan aktif:

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

Boleh didapati daripada:

Zydus Pharmaceuticals (USA) Inc.

INN (Nama Antarabangsa):

DULOXETINE HYDROCHLORIDE

Komposisi:

DULOXETINE 20 mg

Laluan pentadbiran:

ORAL

Jenis preskripsi:

PRESCRIPTION DRUG

Tanda-tanda terapeutik:

Duloxetine delayed-release capsules are indicated for the treatment of: -   Major depressive disorder in adults -   Generalized anxiety disorder in adults and pediatric patients 7 years of age and older -   Diabetic peripheral neuropathic pain in adults -   Fibromyalgia in adults -   Chronic musculoskeletal pain in adults Additional pediatric use information is approved for Eli Lilly and Company, Inc.'s CYMBALTA (duloxetine) delayed-release capsules. However, due to Eli Lilly and Company Inc.'s marketing exclusivity rights, this drug product is not labeled with that pediatric information. 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 contraindicated [see Dosage and Administration (2.8) and Warnings and Precautions (5.4)] . Starting duloxetine in a patient who i

Ringkasan produk:

Duloxetine Delayed-Release Capsules, USP equivalent to 20 mg of duloxetine are white to off-white free flowing pellets filled in size '4' hard gelatin capsules with green colored cap printed with "241" in golden ink and white body printed with "20 mg" in golden ink and are supplied as follows: NDC 68382-385-06 in bottle of 30 capsules with child-resistant closure NDC 68382-385-14 in bottle of 60 capsules with child-resistant closure NDC 68382-385-16 in bottle of 90 capsules with child-resistant closure   Duloxetine Delayed-Release Capsules, USP equivalent to 30 mg of duloxetine are white to off-white free flowing pellets filled in size '3' hard gelatin capsules with blue-colored cap printed with "242" in golden ink and green-colored body printed with "30 mg" in golden ink and are supplied as follows: NDC 68382-386-06 in bottle of 30 capsules with child-resistant closure NDC 68382-386-16 in bottle of 90 capsules with child-resistant closure NDC 68382-386-10 in bottle of 1,000 capsules Duloxetine Delayed-Release Capsules, USP equivalent to 60 mg of duloxetine are white to off-white free flowing pellets filled in size '1' hard gelatin capsules with blue-colored cap printed with "243" in golden ink and white-colored body printed with "60 mg" in golden ink and are supplied as follows: NDC 68382-387-06 in bottle of 30 capsules with child-resistant closure NDC 68382-387-16 in bottle of 90 capsules with child-resistant closure NDC 68382-387-10 in bottle of 1,000 capsules Store at 20°C to 25°C (68°F to 77°F) [See USP Controlled Room Temperature]. Dispense in a tight container.

Status kebenaran:

Abbreviated New Drug Application

Risalah maklumat

DULOXETINE- DULOXETINE CAPSULE, DELAYED RELEASE
Zydus Pharmaceuticals (USA) Inc.
----------
Medication Guide
Duloxetine (doo lox' e teen) Delayed-Release Capsules, USP
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 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

Ciri produk

DULOXETINE- DULOXETINE CAPSULE, DELAYED RELEASE
ZYDUS PHARMACEUTICALS (USA) INC.
----------
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
Dosage and Administration (2.5) 04/2020
Warnings and Precautions (5.5)
10/2019
INDICATIONS AND USAGE
Duloxetine is a serotonin and norepinephrine reuptake inhibitor (SNRI)
indicated for the treatment of the following
conditions: (1)
Major Depressive Disorder (MDD) in adults (1)
Generalized Anxiety Disorder (GAD) in adults and pediatric patients 7
years of age and older (1)
Diabetic Peripheral Neuropathic Pain (DPNP) in adults (1)
Fibromyalgia (FM) in adults (1)
Chronic musculoskeletal pain in adults (1)
DOSAGE AND ADMINISTRATION
Take duloxetine delayed-release capsules once daily, with or without
food. Swallow whole; do not crush, chew, or open
capsule (2.1)
INDICATION
STARTING DOSE
TARGET DOSE
MAXIMUM DOSE
MDD (2.2)
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 (2.3)
Adults
60 mg/day
60 mg/day (once daily)
120 mg/day
Ge riatric
30 mg/day
60 mg/day (once daily)
120 mg/day
Pediatrics (7 to 17 years of
age )
30 mg/day
30 to 60 mg/day (once daily)
120 mg/day
DPNP (2.4)
60 mg/day
60 mg/day (once daily)
60 mg/day
FM (2.5)
Adults
30 mg/day
60 mg/day (once daily)
60 mg/day
Chronic Musculoskeletal
Pain (2.6)
30 mg/day
60 mg/day (once daily)
60 mg/day
Discontinuing duloxetine delayed