MIRTAZAPINE tablet, orally disintegrating

מדינה: ארצות הברית

שפה: אנגלית

מקור: NLM (National Library of Medicine)

מרכיב פעיל:

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

זמין מ:

Cadila Healthcare Limited

INN (שם בינלאומי):

MIRTAZAPINE

הרכב:

MIRTAZAPINE 15 mg

מסלול נתינה (של תרופות):

ORAL

סוג מרשם:

PRESCRIPTION DRUG

סממני תרפויטית:

Mirtazapine orally disintegrating tablets are indicated for the treatment of major depressive disorder (MDD) in adults [see Clinical Studies (14)] . Mirtazapine orally disintegrating tablets are contraindicated in patients: - Taking, or within 14 days of stopping, MAOIs (including the MAOIs linezolid and intravenous methylene blue) because of an increased risk of serotonin syndrome [see Warnings and Precautions (5.3), Drug Interactions (7)]. - With a known hypersensitivity to mirtazapine or to any of the excipients in mirtazapine orally disintegrating tablets. Severe skin reactions, including Stevens-Johnson syndrome, bullous dermatitis, erythema multiforme and toxic epidermal necrolysis have been reported following the use of mirtazapine orally disintegrating tablets[see Adverse Reactions 6.2]. Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to antidepressants during pregnancy. Healthcare providers are encourag

leaflet_short:

Mirtazapine orally disintegrating tablets USP, 15 mg are white to off-white colored, round shaped, beveled edged, uncoated tablets, debossed with '677' on upper face and plain on other side and are supplied as follows: NDC 70771-1072-4 in unit-dose blister cartons of 30 (5 x 6) unit-dose tablets Mirtazapine orally disintegrating tablets USP, 30 mg are white to off-white colored, round shaped, beveled edged, uncoated tablets, debossed with '676' on upper face and plain on other side and are supplied as follows: NDC 70771-1073-4 in unit-dose blister cartons of 30 (5 x 6) unit-dose tablets Mirtazapine orally disintegrating tablets USP, 45 mg are white to off-white colored, round shaped, beveled edged, uncoated tablets, debossed with '679' on upper face and plain on other side and are supplied as follows: NDC 70771-1074-4 in unit-dose blister cartons of 30 (5 x 6) unit-dose tablets Storage Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Protect from light and moisture. Use immediately upon opening individual tablet blister.

מצב אישור:

Abbreviated New Drug Application

עלון מידע

Cadila Healthcare Limited
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MEDICATION GUIDE
MEDICATION GUIDE
Mirtazapine (mir TAZ a peen)
Orally Disintegrating Tablets, USP
for oral use
What is the most important information I should know about mirtazapine
orally
disintegrating tablets? Mirtazapine orally disintegrating tablets may
cause serious side
effects, including:
•
Increased risk of suicidal thoughts or actions in some children and
young adults.
Mirtazapine orally disintegrating tablets, and other antidepressant
medicines may
increase suicidal thoughts or actions in some people 24 years of age
and younger,
especially within the first few months of treatment or when the dose
is changed.
Mirtazapine orally disintegrating tablets are not for use in children.
•
Depression or other serious mental illnesses are the most important
causes of
suicidal thoughts or actions.
How can I watch for and try to prevent suicidal thoughts and actions?
•
Pay close attention to any changes, especially sudden changes in mood,
behavior,
thoughts, or feelings, or if you develop suicidal thoughts or actions.
This is very
important when an antidepressant medicine is started or when the dose
is changed.
•
Call your healthcare provider right away to report new or sudden
changes in
mood, behavior, thoughts, or feelings.
•
Keep all follow-up visits with your healthcare provider as scheduled.
Call your
healthcare provider between visits as needed, especially if you have
concerns
about symptoms.
Call your healthcare provider or get emergency medical help right away
if you or your
family member have any of the following symptoms, especially if they
are new, worse, or
worry you:
•
attempts to commit suicide
•
acting on dangerous impulses
•
acting aggressive, being angry or
violent
•
thoughts about suicide or dying
•
new or worse depression
•
new or worse anxiety
•
panic attacks
•
feeling very agitated or restless
•
new or worse irritability
•
trouble sleeping
•
an extreme increase in activity or
talking (mania)
•
other unusual changes in behavi

מאפייני מוצר

MIRTAZAPINE- MIRTAZAPINE TABLET, ORALLY DISINTEGRATING
CADILA HEALTHCARE LIMITED
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
MIRTAZAPINE ORALLY DISINTEGRATING
TABLETS
SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR
MIRTAZAPINE ORALLY DISINTEGRATING
TABLETS.
MIRTAZAPINE ORALLY DISINTEGRATING TABLETS
INITIAL U.S. APPROVAL: 1996
WARNING: SUICIDAL THOUGHTS AND BEHAVIORS
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
INCREASED RISK OF SUICIDAL THOUGHTS AND BEHAVIOR IN PEDIATRIC AND
YOUNG ADULT PATIENTS TAKING
ANTIDEPRESSANTS. CLOSELY MONITOR ALL ANTIDEPRESSANT-TREATED PATIENTS
FOR CLINICAL WORSENING AND
EMERGENCE OF SUICIDAL THOUGHTS AND BEHAVIORS.
MIRTAZAPINE ORALLY DISINTEGRATING TABLETS ARE NOT APPROVED FOR USE IN
PEDIATRIC PATIENTS. (5.1, 8.4)
INDICATIONS AND USAGE
Mirtazapine orally disintegrating tablets are indicated for the
treatment of major depressive disorder (MDD) in adults. (1)
DOSAGE AND ADMINISTRATION
Starting dose: 15-mg once daily; may increase up to maximum
recommended dose of 45 mg once daily. (2.1)
Administer orally once daily, preferably in the evening prior to
sleep. (2.1)
Administer mirtazapine orally disintegrating tablets immediately after
removal from blister pack. (2.2)
Reduce dose gradually when discontinuing mirtazapine orally
disintegrating tablets (2.6,5.13)
DOSAGE FORMS AND STRENGTHS
_Orally disintegrating tablets_ : 15 mg, 30 mg, and 45 mg. (3)
CONTRAINDICATIONS
Concomitant use of monoamine oxidase inhibitors (MAOIs) or use within
14 days of stopping MAOIs. (2.4,4, 7)
Known hypersensitivity to mirtazapine or any of the excipients in
mirtazapine orally disintegrating tablets. (4)
WARNINGS AND PRECAUTIONS
_Agranulocytosis_ : If sore throat, fever, stomatitis or signs of
infection occur, along with a low white blood cell count,
treatment with mirtazapine orally disintegrating tablets should be
discontinued and the patient should be closely
monitored. (5.2)
_Serotonin Syndrome_ : Increased r