Mirtazapine OD Tabs45 mg / 5 √ó 6 unit dosage forms
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Brand name: Remeron SolTab®
Mirtazapine Orally Disintegrating Tablets, USP are indicated for the treatment of major depressive disorder.
For more information please see the prescribing information.
Suicidality and Antidepressant Drugs: Antidepressants increased the risk compared to placebo of suicidal thinking and behavior (suicidality) in children, adolescents, and young adults in short-term studies of major depressive disorder (MDD) and other psychiatric disorders. Anyone considering the use of mirtazapine orally disintegrating tablets or any other antidepressant in a child, adolescent, or young adult must balance this risk with the clinical need. Short-term studies did not show an increase in the risk of suicidality with antidepressants compared to placebo in adults beyond age 24; there was a reduction in risk with antidepressants compared to placebo in adults aged 65 and older. Depression and certain other psychiatric disorders are themselves associated with increases in the risk of suicide. Patients of all ages who are started on antidepressant therapy should be monitored appropriately and observed closely for clinical worsening, suicidality, or unusual changes in behavior. Families and caregivers should be advised of the need for close observation and communication with the prescriber. Mirtazapine orally disintegrating tablets are not approved for use in pediatric patients. (See WARNINGS: Clinical Worsening and Suicide Risk, PRECAUTIONS: Information for Patients, and PRECAUTIONS: Pediatric Use)
For more information please see the prescribing information on DailyMed.
|Product Name||Mirtazapine OD Tabs|
|Dosage Form||Orally Disintegrating Tablets|
|Pack Size||5 √ó 6 unit dosage forms|
|Shape||Round (Embossed Circular Edge)|
|Gluten||Free from Gluten|
|Lactose||This product contains Lactose as an inactive ingredient in the formulation and is derived from animal milk|
|Sweeteners||Free from Sweeteners|
|Soy||Free from Soy|
|Gelatin||Free from Gelatin|
|Allergen Info||Free from Allergen|
|Other Product Info||Contains Lactose as an inactive ingredient in the formulation and is derived from animal milk|
mannitol, aspartame, natural and artificial peppermint flavor, strawberry guarana flavor, crospovidone, magnesium stearate, colloidal silicon dioxide, and microcrystalline cellulose
Store at 20°C – 25°C (68°F – 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].
|Product Shelf Life||36 months|
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