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U.S. Department of Health and Human Services

Safety

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Remeron (mirtazapine) tablets and RemeronSolTab (mirtazapine) orally disintegrating tablets

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) – May 2010

 

Summary View

 

CONTRAINDICATIONS

Monoamine Oxidase Inhibitors
  • The concomitant use of Remeron Tablets and a monoamine oxidase (MAO) inhibitor is contraindicated. Remeron should not be used within 14 days of initiating or discontinuing therapy with a monoamine oxidase inhibitor (MAOI)

WARNINGS

Serotonin Syndrome
  • On rare occasions serotonin syndrome has occurred in association with treatment of Remeron tablets, particularly when given in combination with other serotonergic drugs. As serotonin syndrome may result in potentially life-threatening conditions, treatment with Remeron should be discontinued if patients develop a combination of symptoms possibly including hyperthermia, rigidity, myoclonus, autonomic instability with possible rapid fluctuations of vital signs, mental status changes including confusion, irritability, extreme agitation progressing to delirium and coma, and supportive symptomatic treatment should be initiated. Due to the risk of serotonin syndrome, Remeron should not be used in combination with MAO inhibitors or serotonin-precursors (such as L-tryptophan and oxitriptan) and should be used with caution in patients receiving other serotonergic drugs (e.g., triptans, lithium, tramadol, St. John’s wort, and most tricyclic antidepressants)

PRECAUTIONS

Discontinuation Symptoms
  • There have been reports of adverse reactions upon the discontinuation of Remeron (mirtazapine) Tablets (particularly when abrupt), including but not limited to the following: dizziness, abnormal dreams, sensory disturbances (including paresthesia and electric shock sensations), agitation, anxiety, fatigue, confusion, headache, tremor, nausea, vomiting, and sweating, or other symptoms which may be of clinical significance. The majority of the reported cases are mild and self-limiting. Even though these have been reported as adverse reactions, it should be realized that these symptoms may be related to underlying disease.
  • Patients currently taking Remeron should NOT discontinue treatment abruptly, due to risk of discontinuation symptoms. At the time that a medical decision is made to discontinue treatment with Remeron, a gradual reduction in the dose, rather than an abrupt cessation, is recommended.
Akathisia/Psychomotor Restlessness
  • The use of antidepressants has been associated with the development of akathisia, characterized by a subjectively unpleasant or distressing restlessness and need to move, often accompanied by an inability to sit or stand still. This is most likely to occur within the first few weeks of treatment. In patients who develop these symptoms, increasing the dose may be detrimental.
Hyponatremia
  • Hyponatremia has been reported very rarely with the use of mirtazapine. Caution should be exercised in patients at risk, such as elderly patients or patients concomitantly treated with medications known to cause hyponatremia.

ADVERSE REACTIONS

Other Adverse Events Observed During Postmarketing Evaluation
  • Cases of severe skin reactions, including Stevens-Johnson Syndrome, bullous dermatitis, erythema multiforme and toxic epidermal necrolysis have also been reported