DULOXETINE- duloxetine hydrochloride capsule, delayed release

Krajina: Spojené štáty

Jazyk: angličtina

Zdroj: NLM (National Library of Medicine)

Aktívna zložka:

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

Dostupné z:

BluePoint

Spôsob podávania:

ORAL

Typ predpisu:

PRESCRIPTION DRUG

Terapeutické indikácie:

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 and pediatric patients 13 years of age and older - 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 stopping an MAOI intended to treat psychiatric disorders is contraindicated

Prehľad produktov:

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. Bottles of 60                                           NDC 68001-413-06 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. Bottles of 30                                           NDC 68001-414-04 Bottles of 90                                           NDC 68001-414-05 Bottles of 1,000                                      NDC 68001-414-08   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. Bottles of 30                                           NDC 68001-415-04 Bottles of 90                                           NDC 68001-415-05 Bottles of 1,000                                      NDC 68001-415-08 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].

Stav Autorizácia:

Abbreviated New Drug Application

Príbalový leták

DULOXETINE- DULOXETINE HYDROCHLORIDE CAPSULE, DELAYED RELEASE
BluePoint
----------
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 worry you. I

Súhrn charakteristických

DULOXETINE- DULOXETINE HYDROCHLORIDE CAPSULE, DELAYED RELEASE
BLUEPOINT
----------
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: SUIDAL THOUGHTS AND BEHAVIOURS
_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)
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 and pediatric patients 13 years of age and
older ( 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)
Adults and Pediatrics (13
30 mg/day
60 mg/day (once daily)
60 mg/day
Adults and Pediatrics (13
to 17 years of age)
30 mg/day
60 mg/day (once daily)
60 mg/day
Chronic Musculoskeletal
Pain (