MIRTAZAPINE- 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:

REMEDYREPACK INC.

INN (International Name):

MIRTAZAPINE

Composition:

MIRTAZAPINE 45 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Mirtazapine 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 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 mirtazapine tablets i

Product summary:

Mirtazapine Tablets, USP 15 mg are available for oral administration as pale yellow, oval-shaped, scored, film-coated tablets imprinted “APO” on one side and “MI” bisect “15” on the other side. They are supplied as follows: Bottles of 30 NDC 60505-0247-1 Bottles of 100 NDC 60505-0247-3 Bottles of 500 NDC 60505-0247-5 Bottles of 1,000 NDC 60505-0247-8  Mirtazapine Tablets, USP 30 mg are available for oral administration as light pink, oval-shaped, scored, film-coated tablets imprinted “APO” on one side and “MI” bisect “30” on the other side. They are supplied as follows:  Bottles of 30 NDC 60505-0248-1 Bottles of 100 NDC 60505-0248-3 Bottles of 500 NDC 60505-0248-5 Bottles of 1,000 NDC 60505-0248-8  Mirtazapine Tablets, USP 45 mg are available for oral administration as white to off-white, oval-shaped, unscored, film-coated tablets imprinted “APO” on one side and “MI-45” on the other side. They are supplied as follows:  Bottles of 30 NDC 60505-0249-1 Bottles of 100 NDC 60505-0249-3 Bottles of 500 NDC 60505-0249-5 Bottles of 1,000 NDC 60505-0249-8   Store at 20° to 25°C (68° to 77°F); excursions permitted from 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature] Protect from light and moisture.   APOTEX INC. MIRTAZAPINE TABLETS, USP 15 mg, 30 mg and 45 mg Manufactured by                    Manufactured for Apotex Inc.                            Apotex Corp. Toronto, Ontario                     Weston, Florida Canada M9L 1T9                    33326  Revised:  August 2016 Rev. 12

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

MIRTAZAPINE- MIRTAZAPINE TABLET, FILM COATED
REMEDYREPACK INC.
----------
MEDICATION GUIDE
Mirtazapine Tablets, USP
(mir taz’ a peen)
What is the most important information I should know about mirtazapine
tablets, USP?
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 have any of the
following symptoms, or call 911 if an
emergency. Mirtazapine tablets may be associated with these serious
side effects:
2. Manic episodes:
•
greatly increased energy
•
severe trouble sleeping
•
racing thoughts
•
reckless behavior
•
unusually grand ideas
•
excessive happiness or irritability
•
talking more or faster than

Summary of Product characteristics

MIRTAZAPINE- MIRTAZAPINE TABLET, FILM COATED
REMEDYREPACK INC.
----------
MIRTAZAPINE TABLETS, USP
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 TABLETS
ARE 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
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-α] pyrido [2,3-c] [2] benzazepine and
has the molecular formula of C
H
N
. Its molecular weight is 265.36. The structural formula is the
following and it is the racemic
mixture:
Mirtazapine is a white to creamy white crystalline powder, which is
sparingly soluble in water.
Mirtazapine tablets, USP are supplied for oral administration as
scored film-coated tablets containing 15
or 30 mg of