DULOXETINE HYDROCHLORIDE capsule, delayed release

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Major Pharmaceuticals

INN (International Name):

DULOXETINE HYDROCHLORIDE

Composition:

DULOXETINE 20 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Duloxetine delayed-release capsules are indicated for the treatment of: 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 [see Dosage and Administration (2.9) and Warnings and Precautions (5.4)] . Risk Summary Data from a postmarketing retrospective cohort study indicate that use of duloxetine in the month before delivery may be associated with an increased risk of postpartum hemorrhage. Dat

Product summary:

Duloxetine Delayed-release Capsules, USP are supplied as: 20 mg capsules: Hard gelatin capsule with a green opaque body and green opaque cap. Imprinted “APO D20” in black ink. Filled with white to off-white granules. Carton of 30 Capsules (10 capsules per blister pack x 3), NDC 0904-6452-04 Cartons of 100 Capsules (10 capsules per blister pack x 10), NDC 0904-6452-61 30 mg capsules : Hard gelatin capsule with a white opaque body and blue opaque cap. Imprinted “APO D30” in green ink. Filled with white to off-white granules.  Cartons of 100 Capsules (10 capsules per blister pack x 10), NDC 0904-6453-61 60 mg capsules : Hard gelatin capsules with a green opaque body and blue opaque cap. Imprinted “APO D60” in white ink. Filled with white to off-white granules.  Cartons of 100 Capsules (10 capsules per blister pack x 10), NDC 0904-6454-61 Store at 20°C to 25°C (68°F to 77°F); excursions permitted from 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature].

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

DULOXETINE HYDROCHLORIDE- DULOXETINE HYDROCHLORIDE CAPSULE, DELAYED
RELEASE
Major Pharmaceuticals
----------
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:
1.
all risks and benefits of treatment with antidepressant medicines
2.
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?
1.
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.
2.
Call your healthcare provider right away to report new or sudden
changes in mood, behavior, thoughts,
or feelings.
1.
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,

Summary of Product characteristics

DULOXETINE HYDROCHLORIDE- 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
WARNING: SUICIDAL THOUGHTS AND BEHAVIORS
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING_.
•
•
RECENT MAJOR CHANGES
Dosage and Administration (2.5) 04/2020
INDICATIONS AND USAGE
Duloxetine delayed-release capsules are a serotonin and norepinephrine
reuptake inhibitor (SNRI)
indicated for the treatment of the following conditions:
6.
7.
8.
9.
10.
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
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 once daily, with or without food. Swallow duloxetine
whole; do not crush or open
capsule (2.1).
DPNP (2.4)
60 mg/day
60 mg/day (once
daily)
60 mg/day
FM (2.5) Adults and
Pediatrics (7 to 17
years of age)
Elderly
Children and
Adolescents (7 to
17 years of age)
330 mg