Mirtazapine (Page 4 of 9)
6.2 Postmarketing Experience
The following adverse reactions have been identified during post-approval use of mirtazapine tablets. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Cardiac disorders: ventricular arrhythmia (Torsades de Pointes)
Endocrine disorders: hyperprolactinemia (and related symptoms, e.g., galactorrhea and gynecomastia)
Musculoskeletal and connective tissue disorders: increased creatine kinase blood levels and rhabdomyolysis
Psychiatric disorders: somnambulism (ambulation and other complex behaviors out of bed)
Reproductive system and breast disorders: priapism
Skin and subcutaneous tissue disorders: severe skin reactions, including DRESS, Stevens-Johnson syndrome, bullous dermatitis, erythema multiforme and toxic epidermal necrolysis
To report SUSPECTED ADVERSE REACTIONS contact AvKARE at 1-855-361-3993; email drugsafety@avkare.com; or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
7 DRUG INTERACTIONS
Table 5 includes clinically important drug interactions with mirtazapine tablets [see Clinical Pharmacology (12.3)].
Table 5: Clinically Important Drug Interactions with Mirtazapine Tablets
| Monoamine Oxidase Inhibitors (MAOIs) | |
| Clinical Impact | The concomitant use of serotonergic drugs, including mirtazapine tablets, and MAOIs increases the risk of serotonin syndrome. |
| Intervention | Mirtazapine tablets are 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 mirtazapine tablets 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 mirtazapine tablets and/or concomitant serotonergic drugs [see Warnings and Precautions (5.3)]. |
| Examples | SSRIs, SNRIs, triptans, tricyclic antidepressants, fentanyl, lithium, amphetamines, St. John’s Wort, tramadol, tryptophan, buspirone |
| Strong CYP3A Inducers | |
| Clinical Impact | The concomitant use of strong CYP3A inducers with mirtazapine tablets decreases the plasma concentration of mirtazapine [see Clinical Pharmacology (12.3)]. |
| Intervention | Increase the dose of mirtazapine tablets if needed with concomitant CYP3A inducer use. Conversely, a decrease in dosage of mirtazapine tablets may be needed if the CYP3A inducer is discontinued [see Dosage and Administration (2.5)]. |
| Examples | phenytoin, carbamazepine, rifampin |
| Strong CYP3A Inhibitors | |
| Clinical Impact | The concomitant use of strong CYP3A inhibitors with mirtazapine tablets may increase the plasma concentration of mirtazapine [see Clinical Pharmacology (12.3)]. |
| Intervention | Decrease the dose of mirtazapine tablets if needed with concomitant strong CYP3A inhibitor use. Conversely, an increase in dosage of mirtazapine tablets may be needed if the CYP3A inhibitor is discontinued [see Dosage and Administration (2.5)]. |
| Examples | itraconazole, ritonavir, nefazodone |
| Cimetidine | |
| Clinical Impact | The concomitant use of cimetidine, a CYP1A2, CYP2D6, and CYP3A inhibitor, with mirtazapine tablets may increase the plasma concentration of mirtazapine [see Clinical Pharmacology (12.3)]. |
| Intervention | Decrease the dose of mirtazapine tablets if needed with concomitant cimetidine use. Conversely, an increase in dosage of mirtazapine tablets may be needed if cimetidine is discontinued [see Dosage and Administration (2.5)]. |
| Benzodiazepines and Alcohol | |
| Clinical Impact | The concomitant use of benzodiazepines or alcohol with mirtazapine tablets increases the impairment of cognitive and motor skills produced by mirtazapine tablets alone. |
| Intervention | Avoid concomitant use of benzodiazepines and alcohol with mirtazapine tablets [see Warnings and Precautions (5.8),Clinical Pharmacology (12.3)]. |
| Examples | diazepam, alprazolam, alcohol |
| Drugs that Prolong QTc Interval | |
| Clinical Impact | The concomitant use of other drugs which prolong the QTc interval with mirtazapine tablets, increase the risk of QT prolongation and/or ventricular arrhythmias (e.g., Torsades de Pointes). |
| Intervention | Use caution when using mirtazapine tablets concomitantly with drugs that prolong the QTc interval [see Warnings and Precautions (5.5),Clinical Pharmacology (12.3)]. |
| Warfarin | |
| Clinical Impact | The concomitant use of warfarin with mirtazapine tablets may result in an increase in INR [see Clinical Pharmacology (12.3)]. |
| Intervention | Monitor INR during concomitant use of warfarin with mirtazapine tablets. |
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