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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