DULOXETINE capsule, delayed release DULOXETINE- 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:

Camber Pharmaceuticals, Inc.

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 • Fibromya lgia 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 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 stopp

Ringkasan produk:

Duloxetine Delayed-Release Capsules USP, 20 mg are Opaque green cap/Opaque green body size ‘4’ hard gelatin capsule imprinted with ‘H’ on cap and ‘190’ on body, filled with white to off white colored pellets. Bottles of 30 Capsules (NDC 31722-168-30) Bottles of 60 Capsules (NDC 31722-168-60) Bottles of 100 Capsules (NDC 31722-168-01) Bottles of 1000 Capsules (NDC 31722-168-10) Blister Card of 7 Unit-Dose Capsules (NDC 31722-168-31) Blister Pack of 105 (15x7) Unit-Dose Capsules (NDC 31722-168-32) Duloxetine Delayed-Release Capsules USP, 30 mg are Opaque blue cap/Opaque white body size ‘3’ hard gelatin capsule imprinted with ‘H’ on cap and ‘191’ on body, filled with white to off white colored pellets. Bottles of 30 Capsules (NDC 31722-169-30) Bottles of 90 Capsules (NDC 31722-169-90) Bottles of 100 Capsules (NDC 31722-169-01) Bottles of 1000 Capsules (NDC 31722-169-10) Blister Card of 7 Unit-Dose Capsules (NDC 31722-169-31) Blister Pack of 105 (15x7) Unit-Dose Capsules (NDC 31722-169-32) Duloxetine Delayed-Release Capsules USP, 60 mg are Opaque blue cap/Opaque green body size ‘1’ hard gelatin capsule imprinted with ‘H’ on cap and ‘192’ on body, filled with white to off white colored pellets. Bottles of 30 Capsules (NDC 31722-170-30) Bottles of 100 Capsules (NDC 31722-170-01) Bottles of 1000 Capsules (NDC 31722-170-10) Blister Card of 10 Unit-Dose Capsules (NDC 31722-170-31) Blister Pack of 90 (9x10) Unit-Dose Capsules (NDC 31722-170-32) Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].

Status kebenaran:

Abbreviated New Drug Application

Risalah maklumat

DULOXETINE- DULOXETINE CAPSULE, DELAYED RELEASE
DULOXETINE - DULOXETINE CAPSULE, DELAYED RELEASE
Camber Pharmaceuticals, Inc.
----------
MEDICATION GUIDE
Duloxetine Delayed-Release Capsules, USP
(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 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 fee

Ciri produk

DULOXETINE- DULOXETINE CAPSULE, DELAYED RELEASE
DULOXETINE - DULOXETINE CAPSULE, DELAYED RELEASE
CAMBER PHARMACEUTICALS, 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
Warnings and Precautions Sexual Dysfunction ( 5.16) 07/2021
INDICATIONS AND USAGE
Duloxetine delayed-release capsules are a serotonin and norepinephrine
reuptake inhibitor (SNRI)
indicated for the treatment of the following conditions:
• 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
Geriatric
Pediatrics
(7 to 17 years
of age)
60
mg/day
30
mg/day
30
mg/day
60 mg/day (once daily)
60 mg/day (once daily)
30 to 60 mg/day (once daily)
120
mg/day
120
mg/day
120
mg/day
DPNP (2.4)
60
mg/day
60 mg/day (once daily)
60 mg/day
FM (2.5)
FM (2.5)
Adults
30
mg/day
60 mg/day (once daily)
60 mg/day
Chronic
Musculoskeletal