MIRTAZAPINE- mirtazapine tablet, orally disintegrating

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Amneal Pharmaceuticals of New York LLC

INN (International Name):

MIRTAZAPINE

Composition:

MIRTAZAPINE 15 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Mirtazapine orally disintegrating tablets  are indicated for the treatment of major depressive disorder. The efficacy of 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 effectiveness of mirtazapin

Product summary:

Mirtazapine orally disintegrating tablets, USP are supplied as: 15 mg:       White to off-white, round, flat-faced, beveled-edge, unscored tablet. Debossed with 2 469 on one side and WPI on the other side. Blister package of 30 tablets NDC 0115-1653-08 30 mg:       White to off-white, round, flat-faced, beveled-edge, unscored tablet. Debossed with 2 470 on one side and WPI on the other side. Blister package of 30 tablets NDC 0115-1654-08 45 mg: White to off-white, round, flat-faced, beveled-edge, unscored tablet. Debossed with 2471 on one side and WPI on the other side. Blister package of 30 tablets    NDC 0115-1656-08 Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Protect from light and moisture. Use immediately upon opening individual tablet blister. Manufactured by: Actavis Laboratories FL, Inc. Fort Lauderdale, FL 33314 USA Distributed by: Impax Generics Hayward, CA 94544 Revised: January 2017

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

MIRTAZAPINE- MIRTAZAPINE TABLET, ORALLY DISINTEGRATING
Impax Generics
----------
MEDICATION GUIDE
Mirtazapine (mir-TAZ-a-peen) Orally Disintegrating Tablets, USP
What is the most important information I should know about mirtazapine
orally disintegrating tablets?
Mirtazapine orally disintegrating tablets and other antidepressant
medicines may cause serious side
effects, including:
1. Suicidal thoughts or actions:
•
Mirtazapine orally disintegrating tablets 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 mirtazapine orally
disintegrating tablets are
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. Mirtazapine orally disintegrating tablets may be associated
with these serious side effects:
2. Manic episodes:
•
greatly increased energy
•
severe trouble sleeping
•
racin

Summary of Product characteristics

MIRTAZAPINE- MIRTAZAPINE TABLET, ORALLY DISINTEGRATING
IMPAX GENERICS
----------
MIRTAZAPINE ODT TABLETS
ONCE-A-DAY
MIRTAZAPINE ORALLY DISINTEGRATING TABLETS, USP
Revised: January 2017
RX ONLY
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
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.
MIRTAZAPINE ORALLY DISINTEGRATING TABLETS ARE NOT APPROVED FOR USE IN
PEDIATRIC PATIENTS. (SEE
WARNINGS: CLINICAL WORSENING AND SUICIDE RISK, PRECAUTIONS:
INFORMATION FOR
PATIENTS, AND PRECAUTIONS: PEDIATRIC USE.)
DESCRIPTION
Mirtazapine orally disintegrating tablets, USP are an orally
administered drug. Mirtazapine, USP 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, USP is a white to creamy white crystalline powder which
is slightly solu