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Remeron/RemeronSolTab

Generic Name: Mirtazapine
Drug Category: Tetracyclic Antidepressant
Litigation Alert Level: High
This drug has been approved for use by males and females over the age of 18 years old for a maximum duration of 40 weeks.

Approved Uses

Indicated for the treatment of major depressive disorder.

The effectiveness of REMERON/REMERONSolTab in hospitalized depressed patients have not been adequately studied.

REMERON/REMERONSolTab are not approved for use in treating bipolar depression.

REMERON/REMERONSolTab are not approved for use in pediatric patients.

Prior to initiating treatment with an antidepressant, patients with depressive symptoms should be adequately screened to determine if they are at risk for bipolar disorder; such screening should include a detailed psychiatric history, including a family history of suicide, bipolar disorder, and depression.

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. 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.

Patients who are to receive REMERON/REMERONSolTab should be warned about the risk of developing agranulocytosis. Patients should be advised to contact their physician if they experience any indication of infection such as fever, chills, sore throat, mucous membrane ulceration, or other possible signs of infection.

REMERON/REMERONSolTab may trigger an angle-closure attack in a patient with anatomically narrow angles who does not have a patent iridectomy.

During the postmarketing use of mirtazapine, cases of QT prolongation, Torsades de Pointes, ventricular tachycardia, and sudden death, have been reported.

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.

Patients should be advised to avoid alcohol while taking mirtazapine.

The clearance of mirtazapine is reduced in elderly patients and in patients with moderate to severe renal or hepatic impairment.

Hyponatremia has been reported very rarely with the use of mirtazapine.

Reported increased appetite and weight gain.

Nonfasting cholesterol increases to ≥20% above the upper limits of normal were observed in patients treated with REMERON/REMERONSolTab.

 REMERON/REMERONSolTab should be used with caution in patients with impaired hepatic function.

REMERON/REMERONSolTab should be prescribed with caution in patients with a seizure disorder.

Mania/hypomania occurred in REMERON/REMERONSolTab-treated patients.

Phenylalanine can be harmful to patients with phenylketonuria (PKU). REMERONSolTab contain phenylalanine, a component of aspartame.

REMERON/REMERONSolTab should be used with caution in patients with known cardiovascular or cerebrovascular disease that could be exacerbated by hypotension (history of myocardial infarction, angina, or ischemic stroke) and conditions that would predispose patients to hypotension (dehydration, hypovolemia, and treatment with antihypertensive medication).

There have been reports of adverse reactions upon the discontinuation of REMERON/REMERONSolTab (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.

Because of the potentially significant effects of REMERON/REMERONSolTab on impairment of performance, patients should be cautioned about engaging in activities requiring alertness until they have been able to assess the drug’s effect on their own psychomotor performance.

Severe skin reactions, including Stevens-Johnson syndrome, bullous dermatitis, erythema multiforme and toxic epidermal necrolysis have been reported following the use of REMERON/REMERONSolTab.

The use of monoamine oxidase inhibitors (MAOIs) intended to treat psychiatric disorders with  REMERON/REMERONSolTab or within 14 days of stopping treatment with REMERON/REMERONSolTab  is contraindicated because of an increased risk of serotonin syndrome. The use of REMERON/REMERONSolTab within 14 days of stopping an MAOI intended to treat psychiatric disorders is also contraindicated.

The development of a potentially life-threatening serotonin syndrome has been reported with SNRIs and SSRIs, including REMERON/REMERONSolTab, alone but particularly with concomitant use of other serotonergic drugs (including triptans, tricyclic antidepressants, fentanyl, lithium, tramadol, tryptophan, buspirone, and St. John’s wort), and with drugs that impair metabolism of serotonin (in particular, MAOIs, both those intended to treat psychiatric disorders and also others, such as linezolid and intravenous methylene blue).

Avoid diazepam and other similar drugs while taking REMERON/REMERONSolTab.

An increase in dosage of REMERON/REMERONSolTab may be needed with concomitant strong CYP3A
inducer (e.g., carbamazepine, phenytoin, rifampin) use. Conversely, a decrease in dosage of REMERON/REMERONSolTab may be needed if the CYP3A inducer is discontinued.

A decrease in dosage of REMERON/REMERONSolTab may be needed with concomitant use of strong CYP3A4 inhibitors (e.g., ketoconazole, clarithromycin). Conversely, an increase in dosage of REMERON/REMERONSolTab may be needed if the CYP3A4 inhibitor is discontinued.

A decrease in dosage of REMERON/REMERONSolTab may be needed with concomitant use of
cimetidine. Conversely, an increase in dosage of REMERON/REMERONSolTab may be needed if cimetidine is discontinued.

Caution should be exercised when co-administering mirtazapine with potent CYP3A4 inhibitors, HIV protease inhibitors, azole antifungals, erythromycin, or nefazodone.

The concomitant use of other drugs which prolong the QTc interval with REMERON/REMERONSolTab, increase the risk of QTc prolongation and/or ventricular arrhythmias (e.g., Torsades de Pointes).

It is advisable to monitor the INR in case of concomitant treatment of warfarin with mirtazapine.

There are no adequate and well-controlled studies in pregnant women. Animal studies: increase in postimplantation losses.

Mirtazapine may be excreted in breast milk. Exercise caution when administering REMERON/REMERONSolTab to nursing women.

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Off-label Uses

• Dosage greater than 45 mg per day. GoToSource

• Panic disorder. GoToSource

• Bipolar depression. GoToSource  

• Social phobia, obsessive-compulsive disorder, dysthymia, menopausal depression, post-stroke depression, depression as a result of infection with human immunodeficiency virus, elderly depression, methylenedioxymethamphetamine (MDMA)-induced depression, hot flashes, sexual disorders, cancer pain, fibromyalgia, chronic fatigue, arthritis, lupus and irritable bowel syndrome. GoToSource

• Tremors. GoToSource

• Post-traumatic stress disorder. GoToSource

• Generalized anxiety disorders. GoToSource

• Neuropathic pain. GoToSource

• Substance abuse and addiction. GoToSource

• Adjunctive use for cognitive enhancement in schizophrenia. GoToSource

• Tension-type headache. GoToSource 

• Treatment and prophylaxis of migraine headache. GoToSource

• Nausea induced by serotonin reuptake inhibitors. GoToSource

• Preventing intrathecal morphine-induced nausea and vomiting after orthopedic surgery. GoToSource

• Charles bonnet syndrome. GoToSource

• Progressive multifocal leukoencephalopathy. GoToSource

• Obstructive sleep apnea syndrome. GoToSource 

• Pruritus. GoToSource

Adverse Events

Sudden hearing loss. GoToSource

Agranulocytosis (bone marrow does not produce enough white blood cells). GoToSource

Increased risk of suicidal thinking and behavior (suicidality). GoToSource

Significant weight gain. GoToSource

Serotonin syndrome (life-threatening drug interaction). GoToSource

Increased risk of hip fractures in elderly patients. GoToSource

Liver injury. GoToSource 

Hyponatremia (low sodium level in the blood). GoToSource

Withdrawal symptoms. GoToSource

Akathisia (movement disorder), GoToSource

Stevens-johnson syndrome, bullous dermatitis, erythema multiforme and toxic epidermal necrolysis (severe skin reaction). GoToSource

Pisa syndrome (neurological disorder). GoToSource

Periodic leg movements. GoToSource

Auditory, musical and visual hallucinations. GoToSource

Spontaneous abortions. GoToSource 

Neutropenia (abnormally low count of neutrophils, a type of white blood cell). GoToSource

Elevated cholesterol and triglyceride levels. GoToSource 

Angle-closure glaucoma. GoToSource

Litigation

Lawsuits filed for birth defects, suicides, blood and bone marrow abnormalities and death in patients with coronary artery disease. 

The material contained in GoToPills is for informational purposes only and not intended to replace the judgment, evaluation and treatment of physicians, pharmacists and other healthcare providers. GoToPills does not provide medical advice, diagnoses or treatment. Always seek the advice of your physician or other qualified health provider regarding a medical condition or treatment.

 

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Site Last Updated March 28, 2024