REMERON- mirtazapine tablet, film coated

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

REMEDYREPACK INC.

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

REMERON (mirtazapine) Tablets are indicated for the treatment of major depressive disorder. The efficacy of REMERON 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 effectiveness of REMERON in hospitalize

Product summary:

REMERON (mirtazapine) Tablets are supplied as: 15 mg Tablets — oval, scored, yellow, coated, with "Organon" debossed on 1 side and " T 3 Z " on the other side. 15 mg Tablets — oval, scored, yellow, coated, with "MSD" debossed on 1 side and " T 3 Z " on the other side. 30 mg Tablets — oval, scored, red-brown, coated, with "Organon" debossed on 1 side and " T 5 Z " on the other side. 30 mg Tablets — oval, scored, red-brown, coated, with "MSD" debossed on 1 side and " T 5 Z " on the other side. 45 mg Tablets — oval, white, coated, with "Organon" debossed on 1 side and " T 7 Z " on the other side. 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.

Authorization status:

New Drug Application

Patient Information leaflet

REMEDYREPACK INC.
----------
This Medication Guide has been approved by the U.S. Food and Drug
Administration
Revised: 05/2018
MEDICATION GUIDE
REMERON® (rĕm' - ĕ – rŏn)
(mirtazapine)
Tablets
What is the most important information I should know about REMERON®?
REMERON and other antidepressant medicines may cause serious side
effects, including:
1. Suicidal thoughts or actions:
•
REMERON 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 REMERON 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. REMERON 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
•
unusually grand
ideas
•
racing thoughts
•
excessive happiness or irritabil

Summary of Product characteristics

REMERON- MIRTAZAPINE TABLET, FILM COATED
REMEDYREPACK INC.
----------
REMERON
(MIRTAZAPINE) 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
REMERON (MIRTAZAPINE) 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.
REMERON IS NOT APPROVED FOR USE IN PEDIATRIC PATIENTS. (SEE WARNINGS:
CLINICAL
WORSENING AND SUICIDE RISK, PRECAUTIONS: INFORMATION FOR PATIENTS, AND
PRECAUTIONS: PEDIATRIC USE)
DESCRIPTION
REMERON
(mirtazapine) 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.
REMERON is supplied for oral administration as scored film-coated
tablets containing 15 or 30 mg of
mirtazapine, and unscored film-coated tablets containi