REMERONSolTab®
About DepressionAbout REMERONSolTabCaregiver InformationFAQsPrescribing Information & Medication Guide

Life Without Depression

Feeling sad? Tired? Lacking interest in life? Problems with sleeping? You may be experiencing symptoms of a common condition called depression, an illness that can be treated.

This site will help you to learn more about depression and treatment with REMERONSolTab® (mirtazapine) Orally Disintegrating Tablets.

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.

Clinical Worsening and Suicide Risk: Patients, their families, and their caregivers should be encouraged to be alert to the emergence of anxiety, agitation, panic attacks, insomnia, irritability, hostility, aggressiveness, impulsivity, akathisia (psychomotor restlessness), hypomania, mania, other unusual changes in behavior, worsening of depression, and suicidal ideation, especially early during antidepressant treatment and when the dose is adjusted up or down. Families and caregivers of patients should be advised to observe for the emergence of such symptoms on a day-to-day basis, since changes may be abrupt. Such symptoms should be reported to the patient's prescriber or health professional, especially if they are severe, abrupt in onset, or were not part of the patient's presenting symptoms. Symptoms such as these may be associated with an increased risk for suicidal thinking and behavior and indicate a need for very close monitoring and possibly changes in the medication. Please see Prescribing Information and Medication Guide.

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.

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