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(mirtazapine) Orally Disintegrating Tablets
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® (mirtazapine) is not approved for use in pediatric patients. (See WARNINGS: Clinical Worsening and Suicide Risk, PRECAUTIONS: Information for Patients, and PRECAUTIONS: Pediatric Use)
REMERONSolTab® (mirtazapine) Orally Disintegrating Tablets are an orally administered drug. Mirtazapine has a tetracyclic chemical structure and belongs to the piperazino-azepine group of compounds. It is designated 1,2,3,4,10,14b-hexahydro-2-methylpyrazino [2,1-a] pyrido [2,3-c] benzazepine and has the empirical formula of C17H19N3. Its molecular weight is 265.36. The structural formula is the following and it is the racemic mixture:
Mirtazapine is a white to creamy white crystalline powder which is slightly soluble in water.
REMERONSolTab® (mirtazapine) is available for oral administration as an orally disintegrating tablet containing 15, 30, or 45 mg of mirtazapine. It disintegrates in the mouth within seconds after placement on the tongue allowing its contents to be subsequently swallowed with or without water. REMERONSolTab® (mirtazapine) also contains the following inactive ingredients: aspartame, citric acid, crospovidone, hypromellose, magnesium stearate, mannitol, microcrystalline cellulose, natural and artificial orange flavor, polymethacrylate, povidone, sodium bicarbonate, starch, and sucrose.
What are the possible side effects of mirtazapine (Remeron, Remeron SolTab)?
Get emergency medical help if you have any of these signs of an allergic reaction: skin rash or hives; difficulty breathing; swelling of your face, lips, tongue, or throat.
Report any new or worsening symptoms to your doctor, such as: mood or behavior changes, anxiety, panic attacks, trouble sleeping, or if you feel impulsive, irritable, agitated, hostile, aggressive, restless, hyperactive (mentally or physically), more depressed, or have thoughts about suicide or hurting yourself.
Call your doctor at once if you have a serious side effect such...
What are the precautions when taking mirtazapine (Remeron SolTab)?
Before taking this medication, tell your doctor or pharmacist if you are allergic to it, or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.
Before using this medication, tell your doctor or pharmacist your medical history, especially of: history or family history of psychiatric disorders (e.g., bipolar/manic-depressive disorder), history or family history of suicide attempts, liver disease, kidney disease, seizures, high blood cholesterol or triglyceride levels, heart disease (e.g., recent heart attack, angina), stroke, severe loss of body fluids (dehydration), low blood pressure, personal or family history of glaucoma (angle-closure...
Last reviewed on RxList: 9/28/2007
This monograph has been modified to include the generic and brand name in many instances.
Additional Remeron SolTab Information
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You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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