Mirtazapine

DEA Class;  Rx

Common Brand Names; Remeron, Remeron SolTab

Hypersensitivity

Within 14 days of administration of MAOIs (serotonin syndrome)

Patients receiving linezolid or methylene blue IV

• Somnolence (54%)
• Weight gain (>7% increase in <49% of pediatric patients)
• Xerostomia (25%)
• Increased appetite (17%)
• Constipation (13%)
• Asthenia (8%)
• Weakness (8%)
• Weight gain (>7% increase in 8% of adults)
• Dizziness (7%)
• Serum TGs increased (6%)
• Dream disorder (4%)
• Disturbance in thinking (3%)
• ALT increased (2%)
• Peripheral edema (2%)
• Myalgia (2%)
• Confusion (2%)
• Urinary frequency (2%)
• Tremor (2%)
• Back pain (2%)
• Dyspnea (1%)
• Mania (0.2%)
• Grand mal seizure (less than 0.1%)
• Depression exacerbation
• Status epilepticus
• Suicidal thoughts, suicide (rare)
• Agranulocytosis
• Neutropenia
• Arrythmia Torsades de Pointes
• Hyperprolactenemia and related symptoms galactorrhea and gynecomastia
• Sonambulism (complex behaviors)

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

Screen for bipolar disorder; MDD episode may be the initial presentation of bipolar disorder; generally believed (though not established in controlled trials) that treating such an episode with an antidepressant alone may increase precipitation of mixed/manic episode in patients at risk for bipolar disorder

Rare reports of activation of mania/hypomania

Agranulocytosis reported; if sign/symptoms develop (eg, sore throat, fever, stomatitis, infection with low WBC count), discontinue mirtazapine and closely monitor

Potentially life-threatening serotonin syndrome reported with SNRIs and SSRIs alone, but also if coadministered with other serotonergic drugs

Pupillary dilation that occurs with antidepressant drugs may trigger an angle-closure attack in patients with anatomically narrow angles who have not had iridectomy

Upon discontinuation (particularly when abrupt), the following symptoms may occur: dizziness, abnormal dreams, sensory disturbances (including paresthesia and electric shock sensations), agitation, anxiety, fatigue, confusion, headache, tremor, nausea, vomiting, and sweating

Akathisia, characterized by subjectively unpleasant or distressing restlessness and need to move, often accompanied by an inability to sit or stand still; most likely to occur within first few weeks; increasing dose may be detrimental

Hyponatremia (rare) reported

Somnolence reported in ~50% of patients

Dizziness, increased appetite/weight gain, and transaminase elevations reported

Postmarketing reports of QT prolongation, torsades de pointes, ventricular tachycardia, and sudden death; majority reported in association with overdose or in patients with other risk factors for QT prolongation, including concomitant use of QTc-prolonging medicines

A pregnancy exposure registry monitors pregnancy outcomes in women exposed to antidepressants during pregnancy

Data from published literature report presence of drug in human milk at low levels with relative infant doses ranging between 0.6 and 2.8% of the maternal weight-adjusted dose; no adverse effects on breastfed infant reported in most cases of maternal use of drug