DULOXETINE- duloxetine hydrochloride capsule, delayed release

Țară: Statele Unite ale Americii

Limbă: engleză

Sursă: NLM (National Library of Medicine)

Ingredient activ:

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

Disponibil de la:

Major Pharmaceuticals

Calea de administrare:

ORAL

Tip de prescriptie medicala:

PRESCRIPTION DRUG

Indicații terapeutice:

Duloxetine delayed-release capsules are indicated for the treatment of: 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 stopping an MAOI intended to treat psychiatric disorders is 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 syndrome [s

Rezumat produs:

Duloxetine Delayed-Release Capsules USP, 20 mg  are green opaque/green opaque, size ‘4’ hard gelatin capsule filled with white to off-white pellets and imprinted with ‘X’ on green opaque cap and ‘01’ on green opaque body with black ink. Carton of 30 Capsules (10 capsules per blister pack x 3), NDC 0904-7043-04 Carton of 100 Capsules (10 capsules per blister pack x 10), NDC 0904-7043-61   Duloxetine Delayed-Release Capsules USP, 30 mg are blue opaque/white opaque, size ‘3’ hard gelatin capsule filled with white to off-white pellets and imprinted with ‘X’ on blue opaque cap and ‘02’ on white opaque body with black ink. Carton of 100 Capsules (10 capsules per blister pack x 10), NDC 0904-7044-61   Duloxetine Delayed-Release Capsules USP, 60 mg are blue opaque/green opaque, size ‘1’ hard gelatin capsule filled with white to off-white pellets and imprinted with ‘X’ on blue opaque cap and ‘03’ on green opaque body with black ink. Carton of 100 Capsules (10 capsules per blister pack x 10), NDC 0904-7045-61 Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].

Statutul autorizaţiei:

Abbreviated New Drug Application

Prospect

DULOXETINE- DULOXETINE HYDROCHLORIDE CAPSULE, DELAYED RELEASE
Major Pharmaceuticals
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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 feelings, especially if
they are new, worse, or

Caracteristicilor produsului

DULOXETINE- DULOXETINE HYDROCHLORIDE CAPSULE, DELAYED RELEASE
MAJOR PHARMACEUTICALS
----------
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
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
•
•
RECENT MAJOR CHANGES
Warnings and Precautions (5.5) 10/2019
INDICATIONS AND USAGE
Duloxetine delayed-release capsules are a serotonin and norepinephrine
reuptake inhibitor (SNRI)
indicated for the treatment of the following conditions:
•
•
•
•
•
DOSAGE AND ADMINISTRATION
•
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)
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
•
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)
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)
Take duloxetine delayed-release capsules once daily, with or without
food. Swallow whole; do not
crush, chew, or open capsule (2.1)
Discontinuing duloxetine delayed-release capsules: Gra