REMERON- mirtazapine tablet, film coated REMERONSOLTAB- mirtazapine tablet, orally disintegrating

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Organon USA Inc.

INN (International Name):

MIRTAZAPINE

Composition:

MIRTAZAPINE 45 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

REMERON/REMERONSolTab are indicated for the treatment of major depressive disorder (MDD) in adults [see Clinical Studies (14)] . REMERON/REMERONSolTab is 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 REMERON/REMERONSolTab. Severe skin reactions, including Stevens-Johnson syndrome, bullous dermatitis, erythema multiforme and toxic epidermal necrolysis have been reported following the use of REMERON/REMERONSolTab [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 encouraged to register patients by calling the National Pregnancy Registry for Antidepressants at 1-844-405-6185 or

Product summary:

REMERON tablets are supplied as: Storage Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. Protect from light and moisture. REMERONSolTab orally disintegrating tablets are supplied as: Storage Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. Protect from light and moisture. Use immediately upon opening individual tablet blister.

Authorization status:

New Drug Application

Patient Information leaflet

REMERONSOLTAB- mirtazapine tablet, orally disintegrating
Organon USA Inc.
Reference Label Set Id: 31f48378-27db-424f-a4c5-82584a553c35
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MEDICATION GUIDE
REMERON® (rĕm' - ĕ – rŏn)
(mirtazapine)
tablets, for oral use
REMERONSolTab® (rĕm' - ĕ - rŏn - sŏl' – tăb)
(mirtazapine)
orally disintegrating tablets, for oral use
This Medication Guide has been approved by the U.S. Food and Drug
Administration
Revised: 4/2020
What is the most important information I should know about REMERON and
REMERONSolTab?
REMERON and REMERONSolTab may cause serious side effects, including:
•
Increased risk of suicidal thoughts or actions in some children and
young adults. REMERON,
REMERONSolTab, 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. REMERON and REMERONSolTab 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 aggressive, being
angry or violent
•
new or worse depression
•
panic attacks
•
new or worse irritability
•
an extreme incr

Summary of Product characteristics

REMERON- MIRTAZAPINE TABLET, FILM COATED
REMERONSOLTAB- MIRTAZAPINE TABLET, ORALLY DISINTEGRATING
ORGANON USA INC.
REFERENCE LABEL SET ID: 31F48378-27DB-424F-A4C5-82584A553C35
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
REMERON/REMERONSOLTAB SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING
INFORMATION FOR
REMERON/REMERONSOLTAB.
REMERON (MIRTAZAPINE) TABLETS, FOR ORAL USE
REMERONSOLTAB (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.
REMERON/REMERONSOLTAB IS NOT APPROVED FOR USE IN PEDIATRIC PATIENTS.
(5.1, 8.4)
INDICATIONS AND USAGE
REMERON/REMERONSolTab is 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 REMERONSolTab immediately after removal from blister pack.
(2.2)
Reduce dose gradually when discontinuing REMERON/REMERONSolTab. (2.6,
5.13)
DOSAGE FORMS AND STRENGTHS
_Tablets_: 15 mg scored and 30 mg scored. (3)
_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
REMERON/REMERONSolTab. (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 REMERON/REMERONSolTab should be
discontinued and the patient should be
closely monitored. (5.2)
_S