MIRTAZAPINE tablet, orally disintegrating

Țară: Statele Unite ale Americii

Limbă: engleză

Sursă: NLM (National Library of Medicine)

Ingredient activ:

Mirtazapine (UNII: A051Q2099Q) (Mirtazapine - UNII:A051Q2099Q)

Disponibil de la:

Physicians Total Care, Inc.

INN (nume internaţional):

Mirtazapine

Compoziție:

Mirtazapine 45 mg

Calea de administrare:

ORAL

Tip de prescriptie medicala:

PRESCRIPTION DRUG

Indicații terapeutice:

Mirtazapine Orally Disintegrating 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

Rezumat produs:

Mirtazapine Orally Disintegrating Tablets are supplied as: Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature]. Protect from light and moisture. Use immediately upon opening individual tablet blister.

Statutul autorizaţiei:

New Drug Application Authorized Generic

Prospect

MIRTAZAPINE - MIRTAZAPINE TABLET, ORALLY DISINTEGRATING
Physicians Total Care, Inc.
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MEDICATION GUIDE
Mirtazapine
Orally Disintegrating Tablets
Read the Medication Guide that comes with Mirtazapine Orally
Disintegrating 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 Orally Disintegrating Tablets,
talk to your healthcare provider.
What is the most important information I should know about Mirtazapine
Orally Disintegrating Tablets?
Mirtazapine Orally Disintegrating Tablets and other antidepressant
medicines may cause serious side
effects, including:
1.
Suicidal thoughts or actions:
•
Mirtazapine Orally Disintegrating 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 Orally
Disintegrating
Tablets is 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 i

Caracteristicilor produsului

MIRTAZAPINE - MIRTAZAPINE TABLET, ORALLY DISINTEGRATING
PHYSICIANS TOTAL CARE, INC.
----------
ONCE-A-DAY
MIRTAZAPINE
ORALLY DISINTEGRATING TABLETS
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 ORALLY DISINTEGRATING 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 ORALLY DISINTEGRATING 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 Orally Disintegrating Tablets 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 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
slightly soluble in water.
Mirtazapine Orally Disintegrating Tablets are