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:

Apotex Corp.

INN (International Name):

MIRTAZAPINE

Composition:

MIRTAZAPINE 15 mg

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 pat

Product summary:

Mirtazapine tablets are supplied as: Mirtazapine Tablets, USP 15 mg are available for oral administration as pale yellow, oval-shaped, scored, film-coated tablets imprinted “APO” on one side and “MI” bisect “15” on the other side. They are supplied as follows: Bottles of 30 NDC 60505-0247-1 Bottles of 1,000 NDC 60505-0247-8  Mirtazapine Tablets, USP 30 mg are available for oral administration as light pink, oval-shaped, scored, film-coated tablets imprinted “APO” on one side and “MI” bisect “30” on the other side. They are supplied as follows:  Bottles of 30 NDC 60505-0248-1 Bottles of 1,000 NDC 60505-0248-8  Mirtazapine Tablets, USP 45 mg are available for oral administration as white to off-white, oval-shaped, unscored, film-coated tablets imprinted “APO” on one side and “MI-45” on the other side. They are supplied as follows:  Bottles of 30 NDC 60505-0249-1 Bottles of 1,000 NDC 60505-0249-8   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.

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

MIRTAZAPINE- MIRTAZAPINE TABLET, FILM COATED
Apotex Corp.
----------
MEDICATION GUIDE
Mirtazapine Tablets, USP
(mir taz’ a peen)
Medication Guide available at www1.apotex.com/products/us
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.
o 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?
o 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.
o Call your healthcare provider right away to report new or sudden
changes in mood, behavior, thoughts,
or feelings.
o 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 increase in activity or talking (mania)
• acting on dangerous impulses
• thoughts about suicide or dying
• new or worse anxiety
• feeling very agitated or restless
• trouble sleeping
• other unusual changes in behavior or mood
What are mirtazapine tablets?
Mirtazapine ta

Summary of Product characteristics

MIRTAZAPINE- MIRTAZAPINE TABLET, FILM COATED
APOTEX CORP.
----------
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 IS NOT
APPROVED FOR USE IN PEDIATRIC PATIENTS. (5.1, 8.4)
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: _15 mg scored and 30 mg scored. (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. (2.4, 4, 5.3, 7)
_Angle-Closure Glaucoma: _Angle closure glaucoma has occurred in
patients with untreated anatom