REMERONSOLTAB- mirtazapine tablet, orally disintegrating

Land: Verenigde Staten

Taal: Engels

Bron: NLM (National Library of Medicine)

Werkstoffen:

MIRTAZAPINE (UNII: A051Q2099Q) (MIRTAZAPINE - UNII:A051Q2099Q)

Beschikbaar vanaf:

Organon USA Inc.

INN (Algemene Internationale Benaming):

MIRTAZAPINE

Samenstelling:

MIRTAZAPINE 15 mg

Toedieningsweg:

ORAL

Prescription-type:

PRESCRIPTION DRUG

therapeutische indicaties:

REMERONSolTab (mirtazapine) Orally Disintegrating Tablets are indicated for the treatment of major depressive disorder. The efficacy of REMERON (mirtazapine) Tablets in the treatment of major depressive disorder was established in 6-week controlled trials of outpatients whose diagnoses corresponded most closely to the Diagnostic and Statistical Manual of Mental Disorders – 3rd edition (DSM-III) category of major depressive disorder (see CLINICAL PHARMACOLOGY). A major depressive episode (DSM-IV) implies a prominent and relatively persistent (nearly every day for at least 2 weeks) depressed or dysphoric mood that usually interferes with daily functioning, and includes at least 5 of the following 9 symptoms: depressed mood, loss of interest in usual activities, significant change in weight and/or appetite, insomnia or hypersomnia, psychomotor agitation or retardation, increased fatigue, feelings of guilt or worthlessness, slowed thinking or impaired concentration, a suicide attempt, or suicidal ideation. The ef

Product samenvatting:

REMERONSolTab (mirtazapine) Orally Disintegrating Tablets are supplied as: 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]. Protect from light and moisture. Use immediately upon opening individual tablet blister.

Autorisatie-status:

New Drug Application

Bijsluiter

Organon USA Inc.
----------
This Medication Guide has been approved by the U.S. Food
and Drug Administration
Revised 07/2016
MEDICATION GUIDE
REMERONSolTab® (rĕm' - ĕ - rŏn - sŏl' – tăb)
(mirtazapine)
Orally Disintegrating Tablets
What is the most important information I should know about
REMERONSolTab®?
REMERONSolTab and other antidepressant medicines may cause serious
side effects, including:
1. Suicidal thoughts or actions:
•
REMERONSolTab 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.
•
Depression or other serious mental illnesses are the most important
causes of suicidal thoughts or
actions.
•
Watch for these changes and call your healthcare provider right away
if you notice:
•
New or sudden changes in mood, behavior, actions, thoughts, or
feelings, especially if severe.
•
Pay particular attention to such changes when REMERONSolTab is started
or when the dose
is changed.
Keep all follow-up visits with your healthcare provider and call
between visits if you are worried about
symptoms.
Call your healthcare provider right away if you have any of the
following symptoms, or call 911 if an
emergency, especially if they are new, worse, or worry you:
•
attempts to commit suicide
•
acting on dangerous impulses
•
acting aggressive or violent
•
thoughts about suicide or dying
•
new or worse depression
•
new or worse anxiety or panic attacks
•
feeling agitated, restless, angry or irritable
•
trouble sleeping
•
an increase in activity or talking more than what is normal for you
•
other unusual changes in behavior or mood
Call your healthcare provider right away if you have any of the
following symptoms, or call 911 if an
emergency. REMERONSolTab may be associated with these serious side
effects:
2. Manic episodes:
•
greatly increased
energy
•
reckless behavior
•
talking more or
faster than usual
•
severe trouble sleeping
•
unusual

Productkenmerken

REMERONSOLTAB- MIRTAZAPINE TABLET, ORALLY DISINTEGRATING
ORGANON USA INC.
----------
ONCE-A-DAY
REMERONSOLTAB
(MIRTAZAPINE) ORALLY DISINTEGRATING TABLETS
SUICIDALITY AND ANTIDEPRESSANT DRUGS
ANTIDEPRESSANTS INCREASED THE RISK COMPARED TO PLACEBO OF SUICIDAL
THINKING AND BEHAVIOR
(SUICIDALITY) IN CHILDREN, ADOLESCENTS, AND YOUNG ADULTS IN SHORT-TERM
STUDIES OF MAJOR
DEPRESSIVE DISORDER (MDD) AND OTHER PSYCHIATRIC DISORDERS. ANYONE
CONSIDERING THE USE OF
REMERONSOLTAB (MIRTAZAPINE) ORALLY DISINTEGRATING TABLETS OR ANY OTHER
ANTIDEPRESSANT IN A CHILD, ADOLESCENT, OR YOUNG ADULT MUST BALANCE
THIS RISK WITH THE CLINICAL
NEED. SHORT-TERM STUDIES DID NOT SHOW AN INCREASE IN THE RISK OF
SUICIDALITY WITH
ANTIDEPRESSANTS COMPARED TO PLACEBO IN ADULTS BEYOND AGE 24; THERE WAS
A REDUCTION IN RISK
WITH ANTIDEPRESSANTS COMPARED TO PLACEBO IN ADULTS AGED 65 AND OLDER.
DEPRESSION AND
CERTAIN OTHER PSYCHIATRIC DISORDERS ARE THEMSELVES ASSOCIATED WITH
INCREASES IN THE RISK OF
SUICIDE. PATIENTS OF ALL AGES WHO ARE STARTED ON ANTIDEPRESSANT
THERAPY SHOULD BE MONITORED
APPROPRIATELY AND OBSERVED CLOSELY FOR CLINICAL WORSENING,
SUICIDALITY, OR UNUSUAL CHANGES IN
BEHAVIOR. FAMILIES AND CAREGIVERS SHOULD BE ADVISED OF THE NEED FOR
CLOSE OBSERVATION AND
COMMUNICATION WITH THE PRESCRIBER. REMERONSOLTAB IS NOT APPROVED FOR
USE IN PEDIATRIC
PATIENTS. (SEE WARNINGS: CLINICAL WORSENING AND SUICIDE RISK,
PRECAUTIONS:
INFORMATION FOR PATIENTS, AND PRECAUTIONS: PEDIATRIC USE.)
DESCRIPTION
REMERONSolTab
(mirtazapine) Orally Disintegrating Tablets are an orally administered
drug.
Mirtazapine has a tetracyclic chemical structure and belongs to the
piperazino-azepine group of
compounds. It is designated 1,2,3,4,10,14b-hexahydro-2-methylpyrazino
[2,1-a] pyrido [2,3-c]
benzazepine and has the empirical formula of C
H N . Its molecular weight is 265.36. The structural
formula is the following and it is the racemic mixture:
Mirtazapine is a white to creamy white crystalline powder which is
slightly soluble in water.
REMERONSolTab is available for oral a