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:

Teva Pharmaceuticals USA, Inc.

INN (International Name):

MIRTAZAPINE

Composition:

MIRTAZAPINE 15 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 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 tablets in hospitali

Product summary:

Mirtazapine tablets USP are supplied as: 15 mg Tablets — Yellow, round, film-coated tablet. One side of the tablet is scored in half and debossed with the number “9” on one side of the score and the number “3” on the other. The other side of the tablet is debossed with the number “7206”. They are available in bottles of 30. NDC 0093-7206-56 30 mg Tablets — Red-brown, round, film-coated tablet. One side of the tablet is scored in half and debossed with the number “9” on one side of the score and the number “3” on the other. The other side of the tablet is debossed with the number “7207”. They are available in bottles of 30. NDC 0093-7207-56 45 mg Tablets — White to off-white, round, film-coated tablet. One side of the tablet is debossed with the number “93”. The other side of the tablet is debossed with the number “7208”. They are available in bottles of 30. NDC 0093-7208-56 Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Protect from light and moisture. Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required). KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN. Manufactured In Israel By: Teva Pharmaceutical Ind. Ltd. Jerusalem, 9777402, Israel Manufactured For: Teva Pharmaceuticals USA, Inc. North Wales, PA 19454 Rev. AD 9/2017

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

MIRTAZAPINE- MIRTAZAPINE TABLET, FILM COATED
Teva Pharmaceuticals USA, Inc.
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MEDICATION GUIDE
Mirtazapine (mir taz’ a peen)
Tablets USP
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 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 faste

Summary of Product characteristics

MIRTAZAPINE- MIRTAZAPINE TABLET, FILM COATED
TEVA PHARMACEUTICALS USA, 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,
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. The
structural formula is the following
and it is the racemic mixture:
C
H N M.W. 265.35
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
or 30 mg of mirtazapine, USP, and unscored, film-coate