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:

Rebel Distributors Corp

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 six week controlled trials of outpatients whose diagnoses corresponded most closely to the Diagnostic and Statistical Manual of Mental Disorders-3rd edition (DSM-lll) category of major depressive disorder (see CLINICAL PHARMACOLOGY ). A major depressive episode (DSM-lV) 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 in hospitalized dep

Product summary:

Mirtazapine Tablets USP are supplied as: 15 mg tablet: White to off-white, oval, biconvex, scored on one side, film-coated tablet, debossed 11 on left side and 17 on right side of score, and WPI on the plain side, in bottles of 30, 60 and 90. 30 mg tablet: Yellow, oval, biconvex, scored on one side, film-coated tablet, debossed WPI on upper perimeter and 1118 on lower perimeter of the plain side, in bottles of 30 and 60. Store at 20°-25°C (68°-77°F). [See USP Controlled Room Temperature.] Protect from light and moisture. Manufactured for: Watson Laboratories, Inc. Corona, CA 92880 USA Manufactured by: Patheon Pharmaceuticals Inc. Cincinnati, OH 45237 USA Revised: December 2010 Repackaged by: Rebel Distributors Corp Thousand Oaks, CA 91320

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

MIRTAZAPINE- MIRTAZAPINE TABLET, FILM COATED
Rebel Distributors Corp
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MEDICATION GUIDE
Antidepressant Medicines, Depression and other Serious Mental
Illnesses,and Suicidal Thoughts or
Actions
Read the Medication Guide that comes with you or your family
member’s antidepressant medicine. This
Medication Guide is only about the risk of suicidal thoughts and
actions with antidepressant medicines.
Talk to your, or your family member’s, healthcare provider about:
all risks and benefits of treatment with antidepressant medicines
all treatment choices for depression or other serious mental illness
What is the most important information I should know about
antidepressant medicines, depression and
other serious mental illnesses, and suicidal thoughts or actions?
Antidepressant medicines may increase suicidal thoughts or actions in
some children, teenagers, and
young adults within the first few months of treatment.
Depression and other serious mental illnesses are the most important
causes of suicidal thoughts and
actions. Some people may have a particularly high risk of having
suicidal thoughts or actions. These
include people who have (or have a family history of) bipolar illness
(also called manic-depressive
illness) or suicidal thoughts or actions.
How can I watch for and try to prevent suicidal thoughts and actions
in myself or a family member?
Pay close attention to any changes, especially sudden changes, in
mood, behaviors, thoughts,
or feelings. This is very important when an antidepressant medicine is
started or when the
dose is changed.
Call the healthcare provider right away to report new or sudden
changes in mood, behavior,
thoughts, or feelings.
Keep all follow-up visits with the healthcare provider as scheduled.
Call the healthcare
provider between visits as needed, especially if you have concerns
about symptoms.
Call a healthcare provider right away if you or your family member has
any of the following symptoms,
especially if they are new, worse, or worry you:
thoughts about suicide or dying
att

Summary of Product characteristics

MIRTAZAPINE- MIRTAZAPINE TABLET, FILM COATED
REBEL DISTRIBUTORS CORP
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MIRTAZAPINE TABLETS USP
REVISED: JUNE 2008
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 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 molecular formula of
C
H N . Its molecular weight is 265.35. The structural formula is the
following and it is the racemic
mixture:
Mirtazapine is a white to creamy white crystalline powder which is
slightly soluble in water.
Mirtazapine is supplied for oral administration as scored, film-coated
tablets containing 15 mg, 30 mg or
45 mg mirtazapine.