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:

Prasco Laboratories

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: - 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 tablets. Severe skin reactions, including drug reaction with eosinophilia and systemic symptoms (DRESS), Stevens-Johnson syndrome, bullous dermatitis, erythema multiforme and toxic epidermal necrolysis have been reported following the use of mirtazapine tablets [see Warnings and Precautions (5.6), 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 p

Product summary:

Mirtazapine tablets, USP are supplied as: Storage Store at 20° to 25°C (68° to 77°F); excursions permitted 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Protect from light and moisture.

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

Prasco Laboratories
----------
This Medication Guide has been approved by
the U.S. Food and Drug Administration.
Revised
02/2023
MEDICATION GUIDE
MIRTAZAPINE TABLETS
(mir taz' a peen)
Print Medication Guides at:
www.prasco.com/medguide/mirtazapine
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
•
acting on dangerous
commit
suicide
•
acting
aggressive,
being
angry or
violent
•
new or
worse
depression
•
panic
attacks
•
new or
worse
irritability
•
an extreme
increase in
activity or
talking
(mania)
impulses
•
thoughts about
suicide or dying
•
new or worse
anxiety
•
feeling very agitated
or restless
•
trouble sleeping
•
other unusual
change

Summary of Product characteristics

MIRTAZAPINE- MIRTAZAPINE TABLET, FILM COATED
PRASCO LABORATORIES
----------
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
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)
DOSAGE FORMS AND STRENGTHS
_Tablets_: 7.5 mg, 15 mg scored, 30 mg scored, 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 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 tablets 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. If it occurs, discontinue
mirtazapine tablets and initiate
supportive treatment