REMERON 30 mg/1
MIRTAZAPINE · TABLET, FILM COATED · Organon LLC
REMERON is a tablet, film coated containing mirtazapine at 30 mg/1, taken oral. Manufactured by Organon LLC.
Key Facts
- Brand Name
- REMERON
- Generic Name
- MIRTAZAPINE
- NDC Code (Product)
78206-161- Manufacturer
- Organon LLC
- Strength
- 30 mg/1
- Dosage Form
- TABLET, FILM COATED
- Route
- ORAL
- Marketing Status
- Application #
- NDA020415
- Marketing Start
- 06/01/2021
Recall History
No Recall HistorySide Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
1 INDICATIONS AND USAGE REMERON/REMERONSolTab are indicated for the treatment of major depressive disorder (MDD) in adults [see Clinical Studies (14) ] . REMERON/REMERONSolTab is indicated for the treatment of major depressive disorder (MDD) in adults. ( 1 )
Dosage & Administration
2 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 , 5.14 ) 2.1 Recommended Dosage The recommended starting dose of REMERON/REMERONSolTab is 15 mg once daily, administered orally, preferably in the evening prior to sleep. If patients do not have an adequate response to the initial 15 mg dose, increase the dose up to a maximum of 45 mg per day. Dose changes should not be made in intervals of less than 1 to 2 weeks to allow sufficient time for evaluation of response to a given dose [see Clinical Pharmacology (12.3) ] . 2.2 Administration of REMERONSolTab The tablet should remain in the blister pack until the patient is ready to take it. The patient or caregiver should use dry hands to open the blister. As soon as the blister is opened, the tablet should be removed and placed on the patient's tongue. Use REMERONSolTab immediately after removal from its blister; once removed, it c…
Contraindications
4 CONTRAINDICATIONS REMERON/REMERONSolTab is 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 REMERON/REMERONSolTab . 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 REMERON/REMERONSolTab [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 REMERON/REMERONSolTab. ( 4 )
Drug Interactions
7 DRUG INTERACTIONS Table 5 includes clinically important drug interactions with REMERON/REMERONSolTab [see Clinical Pharmacology (12.3) ]. Table 5: Clinically Important Drug Interactions with REMERON/REMERONSolTab Monoamine Oxidase Inhibitors (MAOIs) Clinical Impact The concomitant use of serotonergic drugs, including REMERON/REMERONSolTab, and MAOIs increases the risk of serotonin syndrome. Intervention REMERON/REMERONSolTab is contraindicated in patients taking MAOIs, including MAOIs such as linezolid or intravenous methylene blue [see Dosage and Administration (2.4) , Contraindications (4) , Warnings and Precautions (5.3) ]. Examples selegiline, tranylcypromine, isocarboxazid, phenelzine, linezolid, methylene blue Other Serotonergic Drugs Clinical Impact The concomitant use of serotonergic drugs with REMERON/REMERONSolTab increases the risk of serotonin syndrome. Intervention Monitor patients for signs and symptoms of serotonin syndrome, particularly during treatment initiation and dosage increases. If serotonin syndrome occurs, consider discontinuation of REMERON/REMERONSolTab and/or concomitant serotonergic drugs [see Warnings and Precautions (5.3) ]. Examples SSRIs, SNRIs, t…
Adverse Reactions
6 ADVERSE REACTIONS The following adverse reactions are described in more detail in other sections of the prescribing information: Hypersensitivity [see Contraindications (4) ] Suicidal Thoughts and Behaviors [see Warnings and Precautions (5.1) ] Agranulocytosis [see Warnings and Precautions (5.2) ] Serotonin Syndrome [see Contraindications (4) , Warnings and Precautions (5.3) , Drug Interactions (7) ] Angle-Closure Glaucoma [see Warnings and Precautions (5.4) ] QT Prolongation and Torsades de Pointes [see Warnings and Precautions (5.5) ] Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) [see Warnings and Precautions (5.6) ] Increased Appetite and Weight Gain [see Warnings and Precautions (5.7) ] Somnolence [see Warnings and Precautions (5.8) ] Activation of Mania or Hypomania [see Warnings and Precautions (5.9) ] Seizures [see Warnings and Precautions (5.10) ] Elevated Cholesterol and Triglycerides [see Warnings and Precautions (5.11) ] Hyponatremia [see Warnings and Precautions (5.12) ] Transaminase Elevations [see Warnings and Precautions (5.13) ] Discontinuation Syndrome [see Warnings and Precautions (5.14) ] Use in Patients with Concomitant Illness [see Warnings an…
Frequently Asked Questions
What is REMERON used for?
REMERON contains MIRTAZAPINE. It is a tablet, film coated taken oral. Consult your doctor for specific uses.
Is REMERON a controlled substance?
REMERON is not classified as a controlled substance by the DEA.
What is the generic name for REMERON?
The generic name for REMERON is MIRTAZAPINE. There are 11 other brand versions of MIRTAZAPINE.
What is the NDC code for REMERON 30 mg/1?
The NDC (National Drug Code) for REMERON 30 mg/1 is 78206-161, listed by Organon LLC.