REMERONSolTab®

Life Without Depression

REMERONSolTab® has been approved by the Food and Drug Administration for the treatment of major depressive disorders in adults.

The Medication Guide and the Full Prescribing Information with Medication Guide are helpful reading for anyone using or thinking of using REMERONSolTab®.

These documents are available in Adobe's Portable Document Format (PDF), and can be opened with the free Adobe Acrobat Reader. If you don't already have this software installed on your computer, you can download it by clicking on the graphic link below.

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Important Safety Information about REMERONSolTab®

In US controlled clinical trials of 6-week duration, the most commonly reported adverse events associated with REMERON® (mirtazapine) Tablets therapy were: somnolence (54%), increased appetite (17%), weight gain (12%), and dizziness (7%).  In short-term clinical trials, 10.4 % of patients discontinued therapy due to somnolence.  In a pool of premarketing US studies, including patients in long-term, open-label treatment, 8% of patients discontinued therapy due to weight gain.

Coadministration with a monoamine oxidase inhibitor (MAOI) or use within 14 days of initiating or discontinuing therapy with an MAOI is not recommended.  (See WARNINGS in full prescribing information.)  In premarketing clinical trials, two out of 2796 patients developed agranulocytosis, and a third patient developed severe neutropenia.  All patients recovered after discontinuation of therapy. (See WARNINGS in full prescribing information.)

REMERONSolTab® is indicated for the treatment of major depressive disorder (MDD) in adults.  REMERONSolTab® is not approved for use in pediatric patients, including children and teenagers.

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 REMERONSolTab® (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. REMERONSolTab® is not approved for use in pediatric patients. (See WARNINGS: Clinical Worsening and Suicide Risk, PRECAUTIONS: Information for Patients, and PRECAUTIONS: Pediatric Use of the package insert)

WARNINGS
Clinical Worsening and Suicide Risk
Patients with major depressive disorder (MDD), both adult and pediatric, may experience worsening of their depression and/or the emergence of suicidal ideation and behavior (suicidality) or unusual changes in behavior, whether or not they are taking antidepressant medications, and this risk may persist until significant remission occurs. Suicide is a known risk of depression and certain other psychiatric disorders, and these disorders themselves are the strongest predictors of suicide. There has been a long-standing concern, however, that antidepressants may have a role in inducing worsening of depression and the emergence of suicidality in certain patients during the early phases of treatment. Pooled analyses of short-term placebo-controlled trials of antidepressant drugs (SSRIs and others) showed that these drugs increase the risk of suicidal thinking and behavior (suicidality) in children, adolescents, and young adults (ages 18-24) with major depressive disorder (MDD) and other psychiatric disorders. 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 with antidepressants compared to placebo in adults aged 65 and older.

All patients being treated with antidepressants for any indication should be monitored appropriately and observed closely for clinical worsening, suicidality, and unusual changes in behavior, especially during the initial few months of a course of drug therapy, or at times of dose changes, either increases or decreases.

Consideration should be given to changing the therapeutic regimen, including possibly discontinuing the medication, in patients whose depression is persistently worse, or who are experiencing emergent suicidality or symptoms that might be precursors to worsening depression or suicidality, especially if these symptoms are severe, abrupt in onset, or were not part of the patient's presenting symptoms. 

Families and caregivers of patients being treated with antidepressants for major depressive disorder or other indications, both psychiatric and nonpsychiatric, should be alerted about the need to monitor patients for the emergence of agitation, irritability, unusual changes in behavior, and the other symptoms described above, as well as the emergence of suicidality, and to report such symptoms immediately to healthcare providers. Such monitoring should include daily observation by families and caregivers. Prescriptions for REMERONSolTab® (mirtazapine) Orally Disintegrating Tablets should be written for the smallest quantity of tablets consistent with good patient management, in order to reduce the risk of overdose.

PRESCRIBING INFORMATION and MEDICATION GUIDE FOR REMERONSolTab®
Antidepressant Prescribing Information and Medication Guide for REMERONSolTab® is provided in Adobe's Portable Document Format (PDF). To view these documents you will need Adobe Acrobat Reader; if you do not have it, follow the link to download a copy.

PRESCRIBING INFORMATION and MEDICATION GUIDE FOR REMERON®Tablets
Antidepressant Prescribing Information and Medication Guide for REMERON® Tablets, is provided in Adobe's Portable Document Format (PDF). To view these documents you will need Adobe Acrobat Reader; if you do not have it, follow the link to download a copy.

Get Adobe Acrobat Reader
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