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:

Aidarex Pharmaceuticals LLC

INN (International Name):

MIRTAZAPINE

Composition:

MIRTAZAPINE 15 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Mirtazapine tablets, USP are indicated for the treatment of major depressive disorder.  The efficacy of mirtazapine 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 mirtazapine in hospital

Product summary:

Mirtazapine tablets, USP are supplied as: 15 mg Tablets – Yellow, biconvex, capsule shaped film coated tablets with a score line in between “0” and “8” on one side and “A” debossed on the other side. Bottles of 30                                                    NDC 33261-0073-30 Bottles of 60                                                    NDC 33261-0073-60 Bottles of 90                                                    NDC 33261-0073-90 Storage Store at 25° C (77° F); excursions permitted to 15° to 30° C (59° to 86° F) [ see USP Controlled Room Temperature] . Protect from light and moisture. Manufactured by: Aurolife Pharma LLC Dayton, NJ 08810   Manufactured for: Aurobindo Pharma USA, Inc. Dayton, NJ 08810   Repackaged By : Aidarex Pharmaceuticals LLC, Corona, CA 92880 Revised: 01/2013

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

MIRTAZAPINE- MIRTAZAPINE TABLET, FILM COATED
Aidarex Pharmaceuticals LLC
----------
MEDICATION GUIDE
Mirtazapine Tablets, USP
Read the Medication Guide that comes with mirtazapine tablets before
you start taking them and each
time you get a refill. There may be new information. This Medication
Guide does not take the place of
talking to your healthcare provider about your medical condition or
treatment. If you have any questions
about mirtazapine tablets, talk to your healthcare provider.
What is the most important information I should know about mirtazapine
tablets?
Mirtazapine tablets and other antidepressant medicines may cause
serious side effects, including:
1. Suicidal thoughts or actions:
•
Mirtazapine 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 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

Summary of Product characteristics

MIRTAZAPINE- MIRTAZAPINE TABLET, FILM COATED
AIDAREX PHARMACEUTICALS LLC
----------
MIRTAZAPINE TABLETS, USP
7.5 MG, 15 MG, 30 MG, AND 45 MG
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 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 IS NOT
APPROVED FOR USE IN PEDIATRIC PATIENTS. (SEE WARNINGS: CLINICAL
WORSENING AND SUICIDE
RISK, PRECAUTIONS: INFORMATION FOR PATIENTS, AND PRECAUTIONS:
PEDIATRIC USE).
DESCRIPTION
Mirtazapine 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 tablets, USP are supplied for oral administration as
scored film-coated tablets containin