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:

Quality Care Products 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 hospitali

Product summary:

Mirtazapine tablets, USP are supplied as: 7.5 mg Tablets – White, biconvex, capsule shaped film coated tablets with “11” debossed on one side and “A” debossed on the other side. 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. 49999-629-30 49999-629-60 30 mg Tablets – Reddish Brown, biconvex, capsule shaped film coated tablets with a score line in between “0” and “9” on one side and “A” debossed on the other side. 45 mg Tablets – White, biconvex, capsule shaped film coated tablets with “10” debossed on one side and “A” debossed on the other side. 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, NJ08810 Manufactured for: Aurobindo Pharma USA, Inc. Dayton, NJ08810 Revised: 03/2012

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

MIRTAZAPINE- mirtazapine tablet, film coated
Quality Care Products LLC
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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
QUALITY CARE PRODUCTS 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)
DISCRIPTION SECTION
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 C17H19N3. 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 film-coated
tablets containing 15