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:

Aurobindo Pharma Limited

INN (Medzinárodný Name):

DULOXETINE HYDROCHLORIDE

Zloženie:

DULOXETINE 20 mg

Spôsob podávania:

ORAL

Typ predpisu:

PRESCRIPTION DRUG

Terapeutické indikácie:

Duloxetine delayed-release capsules are indicated for the treatment of: - Major Depressive Disorder [see Clinical Studies (14.1)] - Generalized Anxiety Disorder [see Clinical Studies (14.2)] - Diabetic Peripheral Neuropathy [see Clinical Studies (14.3)] - Chronic Musculoskeletal Pain [see Clinical Studies (14.5)] Monoamine Oxidase Inhibitors (MAOIs) — 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 also 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 seroto

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 65862-451-60                 Bottles of 1,000                                                   NDC 65862-451-99                 Bottles of 7,000                                                   NDC 65862-451-71                 100 (10 x 10 Unit-dose Capsules)                        NDC 65862-451-78 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 65862-452-30                 Bottles of 90                                                        NDC 65862-452-90                 Bottles of 1,000                                                   NDC 65862-452-99                 Bottles of 5,000                                                   NDC 65862-452-59                 100 (10 x 10 Unit-dose Capsules)                        NDC 65862-452-78 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 65862-453-30                 Bottles of 90                                                       NDC 65862-453-90                 Bottles of 1,000                                                   NDC 65862-453-99                 Bottles of 3,000                                                   NDC 65862-453-39                 100 (10 x 10 Unit-dose Capsules)                        NDC 65862-453-78 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
Aurobindo Pharma Limited
----------
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

Súhrn charakteristických

DULOXETINE - DULOXETINE HYDROCHLORIDE CAPSULE, DELAYED RELEASE
AUROBINDO PHARMA LIMITED
----------
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
None .
INDICATIONS AND USAGE
Duloxetine delayed-release capsules are a serotonin and norepinephrine
reuptake inhibitor (SNRI) indicated for:
Major Depressive Disorder (MDD) (1)
Generalized Anxiety Disorder (GAD) (1)
Diabetic Peripheral Neuropathic Pain (DPNP) (1)
Chronic Musculoskeletal Pain (1)
DOSAGE AND ADMINISTRATION
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)
INDICATION
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
Elderly
Children and Adolescents (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 (2.3)
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
Some patients may benefit from starting at 30 mg once daily (2).
There is no evidence that doses greater than 60 mg/da