미르타자핀

Mirtazapine tablets are indicated for the treatment of major depressive disorder (MDD) in adults [see Clinical Studies (14) ] . Mirtazapine tablets are indicated for the treatment of major depressive disorder (MDD) in adults. ( 1 )

Mirtazapine tablets are contraindicated in patients: Taking, or within 14 days of stopping, MAOIs (including the MAOIs linezolid and intravenous methylene blue) because of an increased risk of serotonin syndrome [see Warnings and Precautions (5.3) , Drug Interactions (7) ] . With a known hypersensitivity to mirtazapine or to any of the excipients in mirtazapine tablets . Severe skin reactions, including drug reaction with eosinophilia and systemic symptoms (DRESS), Stevens-Johnson syndrome, bullous dermatitis, erythema multiforme and toxic epidermal necrolysis have been reported following the use of mirtazapine tablets [see Warnings and Precautions (5.6) , Adverse Reactions (6.2 )]. Concomitant use of monoamine oxidase inhibitors (MAOIs) or use within 14 days of stopping MAOIs. ( 2.4 , 4 , 7 ) Known hypersensitivity to mirtazapine or any of the excipients in mirtazapine tablets. ( 4 )

Agranulocytosis: If sore throat, fever, stomatitis or signs of infection occur, along with a low white blood cell count, treatment with mirtazapine tablets should be discontinued and the patient should be closely monitored. ( 5.2 ) Serotonin Syndrome: Increased risk when co-administered with other serotonergic drugs (e.g., SSRI, SNRI, triptans), but also when taken alone. If it occurs, discontinue mirtazapine tablets and initiate supportive treatment. ( 2.4 , 4 , 5.3 , 7 ) Angle-Closure Glaucoma: Angle closure glaucoma has occurred in patients with untreated anatomically narrow angles treated with antidepressants. ( 5.4 ) QT Prolongation: Use mirtazapine tablets with caution in patients with risk factors for QT prolongation. ( 5.5 , 7 ) Drug Reaction with Eosinophilia and System Symptoms (DRESS): Discontinue mirtazapine tablets if DRESS is suspected. ( 5.6 ) Increased Appetite/Weight Gain: Mirtazapine tablets have been associated with increased appetite and weight gain. ( 5.7 ) Somnolence: May impair judgment, thinking and/or motor skills. Use with caution when engaging in activities requiring alertness, such as driving or operating machinery. ( 5.8 , 7 ) Activation of Mania/Hypomania: Screen patients for bipolar disorder prior to initiating treatment. ( 2.3 , 5.9 ) Seizures: Use with caution in patients with a seizure disorder. ( 5.10 ) Elevated Cholesterol/Triglycerides: Has been reported with mirtazapine use. ( 5.11 ) Hyponatremia: May occur as a result of treatment with …

8.1 Pregnancy Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to antidepressants during pregnancy. Healthcare providers are encouraged to register patients by calling the National Pregnancy Registry for Antidepressants at 1-844-405-6185 or visiting online at https://womensmentalhealth.org/clinical-and-research-programs/pregnancyregistry/antidepressants/. Risk Summary Prolonged experience with mirtazapine in pregnant women, based on published observational studies and postmarketing reports, has not reliably identified a drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes. There are …