DULOXETINE DELAYED-RELEASE- duloxetine hydrochloride capsule, delayed release pellets

Страна: США

мова: англійська

Джерело: NLM (National Library of Medicine)

Активний інгредієнт:

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

Доступна з:

Preferred Pharmaceuticals Inc.

Адміністрація маршрут:

ORAL

Тип рецепту:

PRESCRIPTION DRUG

Терапевтичні свідчення:

Duloxetine delayed-release capsules are indicated for the treatment of: 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 [see Dosage and Administration (2.9) and Warnings and Precautions (5.4)] . Pregnancy Category C Risk Summary — There are no adequate and well-controlled studies of duloxetine administration in pregnant women. In animal studies with duloxetine, fetal weights were decreased but there was no evidence of teratogenicity in pregnant rats and rabbits at oral doses administered during the period of organogenesis up to 4 and 7 times the maximum recommended human dose (MRHD) of 120 mg/day, respectively. When duloxetine was administered orally to pregnant rats throughout gestation and lactation, pup weights at birth and pup survival to 1 day postpartum were decreased at a dose 2 times the MRHD. At this dose, pup behaviors consistent with i

Огляд продуктів:

Duloxetine delayed-release capsules, USP are available as delayed release capsules in the following strengths, colors, imprints, and presentations: Body color Opaque ochre Cap color Opaque green Cap imprint B Body imprint 748 Presentations and NDC Codes Bottles of 6 68788-7399-0 Bottles of 10 68788-7399-1 Bottles of 20 68788-7399-2 Bottles of 30 68788-7399-3 Bottles of 60 68788-7399-6 Bottles of 90 68788-7399-9 Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature].

Статус Авторизація:

Abbreviated New Drug Application

інформаційний буклет

DULOXETINE DELAYED-RELEASE- DULOXETINE HYDROCHLORIDE CAPSULE, DELAYED
RELEASE PELLETS
Preferred Pharmaceuticals Inc.
----------
MEDICATION GUIDE
Duloxetine (doo-LOX-e-teen)
Delayed-Release Capsules, USP
Rx Only
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 feelin

Характеристики продукта

DULOXETINE DELAYED-RELEASE- DULOXETINE HYDROCHLORIDE CAPSULE, DELAYED
RELEASE
PELLETS
PREFERRED 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._
3.
4.
RECENT MAJOR CHANGES
None
INDICATIONS AND USAGE
Duloxetine delayed-release capsules are a serotonin and norepinephrine
reuptake inhibitor (SNRI) indicated for:
5.
6.
7.
8.
DOSAGE AND ADMINISTRATION
•
INDIC ATIO N
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
Elde rly
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
•
•
•
•
•
DOSAGE FORMS AND STRENGTHS
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) (1)
Generalized Anxiety Disorder (GAD) (1)
Diabetic Peripheral Neuropathic Pain (DPNP) (1)
Chronic Musculoskeletal Pain (1)
Take Duloxetine delayed-release capsules once daily, with or without
food. Swallow Duloxetine delayed-release
capsules 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)
Some patients may b