DULOXETINE capsule, delayed release

Land: USA

Språk: engelska

Källa: NLM (National Library of Medicine)

Aktiva substanser:

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

Tillgänglig från:

BluePoint Laboratories

INN (International namn):

DULOXETINE HYDROCHLORIDE

Sammansättning:

DULOXETINE 20 mg

Administreringssätt:

ORAL

Receptbelagda typ:

PRESCRIPTION DRUG

Terapeutiska indikationer:

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 or within 5 days of stopping treatment with duloxetine is contraindicated because of an increased risk of serotonin syndrome. The use of duloxetine 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 in a patient who is being t

Produktsammanfattning:

Duloxetine Delayed-release Capsules, USP equivalent to 20 mg of duloxetine are white to off-white free flowing pellets filled in size '4' hard gelatin capsules with green colored cap printed with "241" in golden ink and white body printed with "20 mg" in golden ink and are supplied as follows: NDC 68001-255-06 in bottle of 60 capsules Duloxetine Delayed-release Capsules, USP equivalent to 30 mg of duloxetine are white to off-white free flowing pellets filled in size '3' hard gelatin capsules with blue-colored cap printed with "242" in golden ink and green-colored body printed with "30 mg" in golden ink and are supplied as follows: NDC 68001-256-04 in bottle of 30 capsules NDC 68001-256-05 in bottle of 90 capsules NDC 68001-256-08 in bottle of 1000 capsules Duloxetine Delayed-release Capsules, USP equivalent to 60 mg of duloxetine are white to off-white free flowing pellets filled in size '1' hard gelatin capsules with blue-colored cap printed with "243" in golden ink and white-colored body printed with "60 mg" in golden ink and are supplied as follows: NDC 68001-257-04 in bottle of 30 capsules NDC 68001-257-08 in bottle of 1000 capsules Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Dispense in a tight container.

Bemyndigande status:

Abbreviated New Drug Application

Bipacksedel

DULOXETINE- duloxetine capsule, delayed release
BluePoint Laboratories
----------
Medication Guide
Medication Guide
Duloxetine
(doo-LOX-e-teen)
Delayed-release Capsules, USP
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?
4.
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.
5.
Call your healthcare provider right away to report new or sudden
changes in mood, behavior,
thoughts, or feelings.
6.
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, o

Produktens egenskaper

DULOXETINE- DULOXETINE CAPSULE, DELAYED RELEASE
BLUEPOINT LABORATORIES
----------
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 USP, 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)
INDICATIONS AND USAGE
Duloxetine is 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 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
30mg/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/day confers
additional benefit, while some
adverse reactions were observed to be do