MIRTAZAPINE tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

NCS HealthCare of KY, LLC dba Vangard Labs

INN (International Name):

MIRTAZAPINE

Composition:

MIRTAZAPINE 7.5 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 six 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 five of the following nine 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 tablets, USP are supplied as: 7.5 mg tablets -Yellow colored, circular, biconvex, film coated tablets with "C" debossed on one side and plain on the other side. 7.5 mg Blistercards of 30               NDC 0615-8078-39 7.5 mg Blistercards of 15               NDC 0615-8078-05 15 mg tablets -Yellow colored, oval, biconvex, film coated tablets with "499" debossed on one side and scored on the other side.    30 mg tablets -Reddish-brown colored, oval, biconvex, film coated tablets with "500" debossed on one side and scored on the other side.     45 mg tablets -White to off-white colored, oval, biconvex, film coated tablets with "501" debossed on one side and plain on the other side. Storage Store at 20° to 25°C (68° to 77°F); excursions permitted 15° to 30°C (59° to 86°F). [see USP Controlled Room Temperature]. Protect from light and moisture. Rx only    Manufactured by: ALKALOIDA Chemical Company Zrt. 4440 Tiszavasvári Kabay János u. 29. Hungary   Distributed by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512   Revision date: 01/2016

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

MIRTAZAPINE- MIRTAZAPINE TABLET
NCS HealthCare of KY, Inc dba Vangard Labs
----------
SPL MEDGUIDE
Medication Guide
Mirtazapine (mir taz’ a peen) tablets, USP
Read the Medication Guide that comes with Mirtazapine tablets, USP
before you start taking it 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, USP, talk to your healthcare provider.
What is the most important information I should know about Mirtazapine
tablets, USP?
Mirtazapine tablets, USP and other antidepressant medicines may cause
serious side effects, including:
1. Suicidal thoughts or actions:
•
Mirtazapine tablets, USP 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, USP
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 be

Summary of Product characteristics

MIRTAZAPINE- MIRTAZAPINE TABLET
NCS HEALTHCARE OF KY, INC DBA VANGARD LABS
----------
MIRTAZAPINE TABLETS, USP 7.5 MG, 15 MG, 30 MG AND 45 MG
BOXED WARNING
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 TABLETS,
USP IS NOT APPROVED FOR USE IN PEDIATRIC PATIENTS. (SEE WARNINGS:
CLINICAL WORSENING AND
SUICIDE RISK, PRECAUTIONS: INFORMATION FOR PATIENTS, AND PRECAUTIONS:
PEDIATRIC
US E)
DESCRIPTION
Mirtazapine 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 soluble in water.
Mirtazapine tablets, USP are supplied for oral administration as
scored tablets conta