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:

Cardinal Health 107, LLC

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

Product summary:

Mirtazapine Orally Disintegrating Tablets, USP are supplied as: 15 mg Tablets – White, round tablets debossed with ‘36’ on one side and ‘A’ on the other side with an embossed circular edge.  Overbagged with 6 tablets per bag, NDC 55154-8335-6 Storage Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Protect from light and moisture. The tablet should be used immediately after removal from its blister or container. Keep the container tightly closed.  Distributed by: Aurobindo Pharma USA, Inc. 279 Princeton-Hightstown Road East Windsor, NJ 08520 Manufactured by: Aurobindo Pharma Limited Hyderabad-500 038, India Distributed By: Cardinal Health Dublin, OH 43017 L53162601019 Revised: 09/2019 Dispense with Medication Guide available at: www.aurobindousa.com/product-medication-guides

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

MIRTAZAPINE- MIRTAZAPINE TABLET, ORALLY DISINTEGRATING
Cardinal Health 107, LLC
----------
MEDICATION GUIDE
Mirtazapine Orally Disintegrating Tablets, USP
(mir taz' a peen)
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 sleepin

Summary of Product characteristics

MIRTAZAPINE- MIRTAZAPINE TABLET, ORALLY DISINTEGRATING
CARDINAL HEALTH 107, LLC
----------
ONCE-A-DAY
MIRTAZAPINE ORALLY DISINTEGRATING TABLETS, USP
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 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:
17
19
3
Mirtazapine USP is a white to creamy white crystalline powder which is
slightly soluble in
water.
Mirtazapine Orally