INDICATION AND USES:
REMERON/REMERONSolTab is indicated for the treatment of major depressive disorder (MDD) in adults. (1)
DOSAGE AND ADMINISTRATION
- Starting dose: 15-mg once daily; may increase up to maximum recommended dose of 45 mg once daily. (2.1)
- Administer orally once daily, preferably in the evening prior to sleep. (2.1)
- Administer REMERONSolTab immediately after removal from blister pack. (2.2)
- Reduce dose gradually when discontinuing REMERON/REMERONSolTab. (2.6, 5.13)
SIDE EFFECTS:
Most common adverse reactions (≥5% or greater and twice placebo) were somnolence, increased appetite, weight gain, and dizziness. (6.1)
CONTRAINDICATIONS:
- 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 REMERON/REMERONSolTab. (4)
WARNINGS AND PRECAUTIONS:
- Agranulocytosis: If sore throat, fever, stomatitis or signs of infection occur, along with a low white blood cell count, treatment with REMERON/REMERONSolTab 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 REMERON/REMERONSolTab 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 REMERON/REMERONSolTab with caution in patients with risk factors for QT prolongation. (5.5, 7)
- Increased Appetite/Weight Gain: REMERON/REMERONSolTab has been associated with increased appetite and weight gain. (5.6)
- Somnolence: May impair judgment, thinking and/or motor skills. Use with caution when engaging in activities requiring alertness, such as driving or operating machinery. (5.7, 7)
- Activation of Mania/Hypomania: Screen patients for bipolar disorder prior to initiating treatment. (2.3, 5.8)
- Seizures: Use with caution in patients with a seizure disorder. (5.9)
- Elevated Cholesterol/Triglycerides: Has been reported with REMERON use. (5.10)
- Hyponatremia: May occur as a result of treatment with serotonergic antidepressants, including REMERON/REMERONSolTab. (5.11)
- Transaminase Elevations: Clinically significant elevations have occurred. Use with caution in patients with impaired hepatic function. (5.12)
DRUG INTERACTIONS:
- Strong CYP3A inducers: Dosage increase may be needed for REMERON/REMERONSolTab with concomitant use of strong CYP3A inducers. (2.5, 7)
- Strong CYP3A inhibitors: Dosage decrease may be needed when REMERON/REMERONSolTab is coadministered with strong CYP3A inhibitors. (2.5, 7)
- Cimetidine: Dosage decrease may be needed when REMERON/REMERONSolTab is coadministered with cimetidine. (2.5, 7)
- Warfarin: Monitor INR during concomitant use. (7)
OVERDOSE:
In premarketing clinical studies, there were reports of REMERON overdose alone or in combination with other pharmacological agents. Signs and symptoms reported in association with overdose included disorientation, drowsiness, impaired memory, and tachycardia. Based on postmarketing reports, serious outcomes (including fatalities) may occur at dosages higher than the recommended doses, especially with mixed overdoses. In these cases, QT prolongation and Torsades de Pointes have also been reported [see Warnings and Precautions (5.5), Adverse Reactions (6.2), and Drug Interactions (7)].
Overdose Management: No specific antidotes for mirtazapine are known. Contact Poison Control (1-800-222-1222) for the latest recommendations.
- Uses
-
INDICATION AND USES:
REMERON/REMERONSolTab is indicated for the treatment of major depressive disorder (MDD) in adults. (1)
DOSAGE AND ADMINISTRATION
- Starting dose: 15-mg once daily; may increase up to maximum recommended dose of 45 mg once daily. (2.1)
- Administer orally once daily, preferably in the evening prior to sleep. (2.1)
- Administer REMERONSolTab immediately after removal from blister pack. (2.2)
- Reduce dose gradually when discontinuing REMERON/REMERONSolTab. (2.6, 5.13)
- Side Effects
-
SIDE EFFECTS:
Most common adverse reactions (≥5% or greater and twice placebo) were somnolence, increased appetite, weight gain, and dizziness. (6.1)
- Precautions
-
CONTRAINDICATIONS:
- 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 REMERON/REMERONSolTab. (4)
WARNINGS AND PRECAUTIONS:
- Agranulocytosis: If sore throat, fever, stomatitis or signs of infection occur, along with a low white blood cell count, treatment with REMERON/REMERONSolTab 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 REMERON/REMERONSolTab 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 REMERON/REMERONSolTab with caution in patients with risk factors for QT prolongation. (5.5, 7)
- Increased Appetite/Weight Gain: REMERON/REMERONSolTab has been associated with increased appetite and weight gain. (5.6)
- Somnolence: May impair judgment, thinking and/or motor skills. Use with caution when engaging in activities requiring alertness, such as driving or operating machinery. (5.7, 7)
- Activation of Mania/Hypomania: Screen patients for bipolar disorder prior to initiating treatment. (2.3, 5.8)
- Seizures: Use with caution in patients with a seizure disorder. (5.9)
- Elevated Cholesterol/Triglycerides: Has been reported with REMERON use. (5.10)
- Hyponatremia: May occur as a result of treatment with serotonergic antidepressants, including REMERON/REMERONSolTab. (5.11)
- Transaminase Elevations: Clinically significant elevations have occurred. Use with caution in patients with impaired hepatic function. (5.12)
- Interactions
-
DRUG INTERACTIONS:
- Strong CYP3A inducers: Dosage increase may be needed for REMERON/REMERONSolTab with concomitant use of strong CYP3A inducers. (2.5, 7)
- Strong CYP3A inhibitors: Dosage decrease may be needed when REMERON/REMERONSolTab is coadministered with strong CYP3A inhibitors. (2.5, 7)
- Cimetidine: Dosage decrease may be needed when REMERON/REMERONSolTab is coadministered with cimetidine. (2.5, 7)
- Warfarin: Monitor INR during concomitant use. (7)
- Overdose
-
OVERDOSE:
In premarketing clinical studies, there were reports of REMERON overdose alone or in combination with other pharmacological agents. Signs and symptoms reported in association with overdose included disorientation, drowsiness, impaired memory, and tachycardia. Based on postmarketing reports, serious outcomes (including fatalities) may occur at dosages higher than the recommended doses, especially with mixed overdoses. In these cases, QT prolongation and Torsades de Pointes have also been reported [see Warnings and Precautions (5.5), Adverse Reactions (6.2), and Drug Interactions (7)].
Overdose Management: No specific antidotes for mirtazapine are known. Contact Poison Control (1-800-222-1222) for the latest recommendations.