DRIZALMA SPRINKLE- duloxetine capsule, delayed release

Țară: Statele Unite ale Americii

Limbă: engleză

Sursă: NLM (National Library of Medicine)

Ingredient activ:

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

Disponibil de la:

SUN PHARMACEUTICAL INDUSTRIES, INC.

Calea de administrare:

ORAL

Tip de prescriptie medicala:

PRESCRIPTION DRUG

Indicații terapeutice:

DRIZALMA SPRINKLE is indicated for the treatment of: 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 DRIZALMA SPRINKLE, or within 5 days of stopping treatment with DRIZALMA SPRINKLE, are contraindicated because of an increased risk of serotonin syndrome. The use of DRIZALMA SPRINKLE within 14 days of stopping an MAOI intended to treat psychiatric disorders is contraindicated [see Dosage and Administration (2.10), Warnings and Precautions (5.4), Drug Interactions (7)] . Starting DRIZALMA SPRINKLE in a patient who is being treated with MAOIs such as linezolid or intravenous methylene blue is contraindicated because of an increased risk of serotonin syndrome [see Warnings and Precautions (5.4)] . Pregnancy Exposure Registry There i

Rezumat produs:

Features Strengths 20 mg a 30 mg a 40 mg a 60 mg a Body color Green White White Green Cap color Green Blue White Blue Cap imprint RG53 RG54 RL85 RG55 Body imprint RG53 RG54 RL85 RG55 Presentations and NDC Codes Bottles of 30 47335-616-30 47335-617-30 47335-618-30 47335-619-30 Bottles of 60 47335-616-60 47335-617-60 47335-618-60 47335-619-60 Bottles of 90 47335-616-90 47335-617-90 47335-618-90 47335-619-90 Bottles of 1000 47335-616-10 47335-617-10 47335-618-10 47335-619-10 Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. Dispense in a tightly closed container. For 30, 60, and 90 count bottles only: This package is child-resistant.

Statutul autorizaţiei:

New Drug Application

Prospect

DRIZALMA SPRINKLE- duloxetine capsule, delayed release
SUN PHARMACEUTICAL INDUSTRIES, INC.
----------
Medication Guide
DRIZALMA SPRINKLE (dri zal' mah)
(duloxetine delayed-release capsules)
What is the most important information I should know about DRIZALMA
SPRINKLE?
DRIZALMA SPRINKLE may cause serious side effects, including:
•
Increased risk of suicidal thoughts or actions. DRIZALMA SPRINKLE and
other antidepressant
medicines may increase suicidal thoughts and actions in some people 24
years of age and younger,
especially within the first few months of treatment or when the dose
is changed.
•
Depression and other serious mental illnesses are the most important
causes of suicidal thoughts or
actions.
How can I watch for and try to prevent suicidal thoughts and actions?
o
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.
o
Call your healthcare provider right away to report new or sudden
changes in mood, behavior, thoughts,
or feelings.
o
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 or get emergency help right away if you
or your family member have any
of the following symptoms, especially if they are new, worse, or worry
you:
•
attempts to commit suicide
•
acting on dangerous impulses
•
acting aggressive, being angry, or violent
•
thoughts about suicide or dying
•
new or worse depression
•
new or worse anxiety
•
panic attacks
•
feeling very agitated or restless
•
new or worse irritability
•
trouble sleeping
•
an extreme increase in activity or talking (mania)
•
other unusual changes in behavior or mood
What is DRIZALMA SPRINKLE?
DRIZALMA SPRINKLE is prescription medicine used to treat:
•
A certain type of depression called Major Depressive Disorder (MDD) in
adults
•
Gene

Caracteristicilor produsului

DRIZALMA SPRINKLE- DULOXETINE CAPSULE, DELAYED RELEASE
SUN PHARMACEUTICAL INDUSTRIES, INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
DRIZALMA SPRINKLE
SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR DRIZALMA
SPRINKLE.
DRIZALMA SPRINKLE™ (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
INDICATIONS AND USAGE
DRIZALMA SPRINKLE is a serotonin and norepinephrine reuptake inhibitor
(SNRI) indicated for the
treatment of following conditions: (1)
DOSAGE AND ADMINISTRATION
•
•
•
INDICATION (2)
STARTING DOSE (2) TARGET DOSE (2)
MAXIMUM DOSE (2)
MDD (2.2) (2)
Adults (2)
40 mg/day to (2)
60 mg/day (2)
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 (2)
120 mg/day (2)
GAD (2.3) (2)
Adults (2)
60 mg/day (2)
60 mg/day (once daily) (2)
120 mg/day (2)
Geriatric (2)
30 mg/day (2)
60 mg/day (once daily) (2)
120 mg/day (2)
Pediatrics (7 to 17 years of age)
(2)
30 mg/day (2)
30 to 60 mg/day (once
daily) (2)
120 mg/day (2)
DPNP (2.4) (2)
60 mg/day (2)
60 mg/day (once daily) (2)
60 mg/day (2)
FM (2.5) (2)
30 mg/day (2)
60 mg/day (once daily) (2)
60 mg/day (2)
INCREASED RISK OF SUICIDAL THINKING AND BEHAVIOR IN PEDIATRIC AND
YOUNG ADULT
PATIENTS TAKING ANTIDEPRESSANTS (5.1)
CLOSELY MONITOR ALL ANTIDEPRESSANT-TREATED PATIENTS FOR CLINICAL
WORSENING AND
EMERGENCE OF SUICIDAL THOUGHTS AND BEHAVIORS (5.1)
Indications and Usage; Fibromyalgia (1) 07/2021
Dosage and Administration (2.5, 2.6, 2.12) 07/2021
Warnings and Precautions (5.16) 07/2021
• Major Depressive Disorder (MDD) in adults (1)
• Generalized Anxiety Disorder (GAD) in adults and pediatric
patients ages 7 years of age and older
(1)
• Diabetic Peripheral Neuropathic Pain (DPNP) in adults (1)
• Fibromyalgia (FM) in adults (1)
• Chronic Mu