MIRTAZAPINE tablet, film coated

Država: Združene države Amerike

Jezik: angleščina

Source: NLM (National Library of Medicine)

Aktivna sestavina:

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

Dostopno od:

NCS HealthCare of KY, Inc dba Vangard Labs

Pot uporabe:

ORAL

Tip zastaranja:

PRESCRIPTION DRUG

Terapevtske indikacije:

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 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

Povzetek izdelek:

Mirtazapine Tablets, USP are available containing 15 mg, 30 mg and 45 mg of mirtazapine, USP. The 15 mg tablets are beige film-coated, round, scored tablets debossed with M over 515 on one side of the tablet and bisected by a score on the other side. They are available as follows: NDC 0615-5527-39 blistercards of 30 tablets NDC 0615-5527-05 blistercards of 15 tablets The 30 mg tablets are beige film-coated, round, scored tablets debossed with M over 530 on one side of the tablet and bisected by a score on the other side. They are available as follows: NDC 0615-5573-39 blistercards of 30 tablets NDC 0615-5573-05 blistercards of 15 tablets The 45 mg tablets are beige film-coated, round, unscored tablets debossed with M over 545 on one side of the tablet and blank on the other side. 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 using a child-resistant closure. PHARMACIST: Dispense a Medication Guide with each prescription.

Status dovoljenje:

Abbreviated New Drug Application

Navodilo za uporabo

MIRTAZAPINE- MIRTAZAPINE TABLET, FILM COATED
NCS HealthCare of KY, Inc dba Vangard Labs
----------
MEDICATION GUIDE
MIRTAZAPINE TABLETS, USP
(MIR TAZ' A PEEN)
15 MG, 30 MG AND 45 MG
Read the Medication Guide that comes with mirtazapine tablets 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, 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 m

Lastnosti izdelka

MIRTAZAPINE- MIRTAZAPINE TABLET, FILM COATED
NCS HEALTHCARE OF KY, INC DBA VANGARD LABS
----------
MIRTAZAPINE TABLETS 15MG AND 30MG-5572-5573
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 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).
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 265.36. 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 are supplied for oral administration as scored
film-coated tablets containing 15 mg
or 30 mg of mirtazap