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:

Preferred Pharmaceuticals, Inc.

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Mirtazapine tablets are indicated for the treatment of major depressive disorder (MDD) in adults [see Clinical Studies (14)]. Mirtazapine tablets are contraindicated in patients: 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 visiting online at https://womensmentalhealth.org/clinical-and-research-programs/pregnancyregistry/antidepressants/. Risk Summary Prolonged experience with mirtazapine in pregnant women, based on published observational studies and postmarketing reports, has not reliably identified a drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes. There are risks associated with untreated depression in pregnancy (see Clinical Considerations). In animal reproduction studies, oral administration of mirtazpine to pre

Product summary:

Store at 25° C (77° F); excursions permitted to 15° to 30° C (59° to 86° F) [ see USP Controlled Room Temperature] . Protect from light and moisture. Dispense with Medication Guide available at: www.aurobindousa.com/product-medication-guides Distributed by: Aurobindo Pharma USA, Inc. Dayton, NJ 08810 Revised: 03/2018 Repackaged by Preferred Pharmaceuticals, Inc.

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

Preferred Pharmaceuticals, Inc.
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MEDICATION GUIDE
Mirtazapine Tablets, USP for oral use
(mir taz’ a peen)
What is the most important information I should know about mirtazapine
tablets?
Mirtazapine tablets may cause serious side effects, including:
•
Increased risk of suicidal thoughts or actions in some children and
young adults. Mirtazapine 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 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 behavior or mood
What are mirtazapine tablets?
Mirtazapine tablets are prescription medicines used to treat a certain
type o

Summary of Product characteristics

MIRTAZAPINE- MIRTAZAPINE TABLET, FILM COATED
PREFERRED PHARMACEUTICALS, INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
MIRTAZAPINE TABLETS
SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR
MIRTAZAPINE TABLETS.
MIRTAZAPINE TABLETS, FOR ORAL USE
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 TABLETS ARE NOT APPROVED FOR USE IN PEDIATRIC PATIENTS.
(5.1, 8.4)
RECENT MAJOR CHANGES
Contraindications (4) 11/2021
Warnings and Precautions (5.6) 11/2021
INDICATIONS AND USAGE
Mirtazapine tablets are indicated for the treatment of major
depressive disorder (MDD) in adults. (1)
DOSAGE AND ADMINISTRATION
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DOSAGE FORMS AND STRENGTHS
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CONTRAINDICATIONS
•
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WARNINGS AND PRECAUTIONS
•
•
•
•
•
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•
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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)
Reduce dose gradually when discontinuing mirtazapine tablets. (2.6,
5.14)
_Tablets:_ 7.5 mg unscored, 15 mg scored, 30 mg scored and 45 mg
unscored. (3)
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 tablets. (4)
_Agranulocytosis:_ If sore throat, fever, stomatitis or signs of
infection occur, along with a low white
blood cell count, treatment with mirtazapine should be discontinued
and the patient should be closely
monitored. (5.2)
_Serotonin Syndrome:_ Increased risk when co-administered with other
serotonergic drugs (e.g., SSRI,
SNRI, triptans), but also when taken alone.