Mirtazapine

Remeron and RemeronSolTab are indicated for major depressive disorder in adults. Pediatric MDD safety/effectiveness have not been established and pediatric use is not approved.

The selected label does not establish insomnia, appetite stimulation, nausea or other off-label regimens. Before treating depression, screen personal and family history for bipolar disorder, mania or hypomania; antidepressant treatment can trigger a mixed/manic episode.

Keep RemeronSolTab in the blister until the dose is due. With dry hands, open the blister and place the whole tablet on the tongue immediately; allow it to dissolve in saliva and swallow. Do not split, crush or chew it, and do not store an unwrapped tablet. Water is not required. Food has minimal influence on mirtazapine absorption; follow the prescribed consistent daily schedule.

Strong CYP3A inducers may require a higher mirtazapine dose during treatment and a lower dose when stopped. Strong CYP3A inhibitors or cimetidine may require a lower dose during treatment and reassessment upward when stopped. Adjust by response/tolerability within the labeled regimen; no universal adjustment factor or permission to exceed 45 mg/day is supplied.

Known hypersensitivity to mirtazapine or any excipient; taking an MAOI or within 14 days of stopping one, including linezolid or IV methylene blue, because of serotonin-syndrome risk. If urgent MAOI treatment is necessary, the treating team must stop mirtazapine before the MAOI and manage monitoring; do not improvise concurrent administration.

Short-term antidepressant studies found increased suicidal thoughts/behaviors in pediatric and young adult patients. Monitor all treated patients for worsening and emergent suicidality. Mirtazapine is not approved for pediatric use; lack of an increased signal in older groups does not eliminate individual suicide risk.

Common trial effects include somnolence, increased appetite, weight gain, dizziness, dry mouth and constipation. Reported serious reactions include severe skin/systemic allergy, cytopenias, hyponatremia and arrhythmia; postmarketing reports also include rhabdomyolysis, hyperprolactinemia, sleepwalking and priapism. Overdose can produce drowsiness, disorientation, impaired memory and tachycardia; serious/fatal mixed or high-dose overdoses and QT/torsades have occurred. Obtain urgent medical/Poison Help advice; no specific antidote is known.

MAOIs are contraindicated with the required 14-day antidepressant washouts. SSRIs/SNRIs, triptans, tramadol, fentanyl, lithium, buspirone, amphetamines, tryptophan and St. John’s wort can increase serotonin-syndrome risk; monitor when combined for a clinical reason. Avoid alcohol and benzodiazepines because cognitive/motor impairment is additive.

Strong CYP3A inducers (e.g., carbamazepine, phenytoin, rifampin) lower mirtazapine exposure; strong CYP3A inhibitors (e.g., ketoconazole, clarithromycin, ritonavir) and cimetidine can raise it. Reassess dose when added or removed. Other QT-prolonging drugs increase arrhythmia risk; use caution. Warfarin coadministration can increase INR: monitor INR when used together.

Moderate/severe renal or hepatic impairment reduces clearance and may require a lower dose. Selected PK studies found about 30% lower clearance at GFR 11–39 mL/min/1.73 m² and about 50% lower below 10, and about 30% lower after a 15 mg dose in hepatic impairment; these exposure findings are not dose-reduction formulas. Older adults can have reduced clearance, confusion/oversedation, orthostasis and hyponatremia; select conservatively based on organ function and co-medication.

Published observational/postmarketing experience has not reliably identified a drug-associated major-birth-defect, miscarriage or adverse maternal/fetal risk; absence of a signal is not proof of no risk. Consider relapse and untreated-depression risks when changing treatment; the antidepressant pregnancy registry is available. Low levels occur in human milk; most reported cases have no infant adverse effect, with limited data and no milk-production data. Discuss maternal need, feeding benefits and potential infant effects.

Pediatric MDD studies did not establish safety/effectiveness, and substantial weight gain was observed; no approved pediatric regimen is supplied. PKU requires assessing SolTab phenylalanine content and other sources; conventional tablets and other manufacturers’ excipients must be checked separately.

The antidepressant mechanism is not fully understood. Central presynaptic alpha2 antagonism may enhance noradrenergic/serotonergic activity. Serotonin 5-HT2/5-HT3, histamine H1 and peripheral alpha1 receptor antagonism contributes to the pharmacologic profile; H 1/alpha1 effects help explain sedation/orthostasis.

Absorption / food

Oral bioavailability about 50%; peak about 2 hours. Food has minimal effect.

Half-life / steady state

Approximately 20–40 hours; steady state within 5 days.

Protein binding

Approximately 85%.

Metabolism

Extensive demethylation/hydroxylation and conjugation; CYP2D6, CYP1A2 and CYP3A pathways.

Elimination

Drug and metabolites: about 75% urinary,15% fecal; reduced clearance in renal/hepatic impairment.

Assess mood/suicide risk and bipolar history before treatment and closely after initiation/dose changes. Review sedation, falls/orthostasis, appetite/weight, metabolic effects and medication changes. Check CBC for infection/neutropenia symptoms, sodium for symptoms or increased risk, liver tests when clinically indicated, and ECG/electrolyte assessment when QT risk warrants it. Follow renal/hepatic status and INR with warfarin. No universal scheduled CBC/ECG/lab interval is specified by this label.

Take the evening dose as prescribed; improvement and tolerability need follow-up rather than rapid self-titration. Avoid alcohol, discuss sedatives, and delay driving/hazardous activities until effects are known. Report suicidal thoughts, mania, fever/sore throat, severe rash, syncope/palpitations, eye pain/visual change or confusion promptly. Do not stop abruptly; arrange taper and discuss pregnancy/feeding plans. Read exact ODT handling and PKU excipients.

Ingredient / route

Mirtazapine 15 mg · oral film-coated tablet.

Appearance / imprint

Yellow oval, scored; MSD / T3Z.

Labeler / example NDC

Organon · 78206-160-01,30-tablet bottle.

U.S. status

Prescription NDA antidepressant; no DEA schedule.

Selected Remeron tablets

15 mg yellow MSD/T3Z; 30 mg red-brown MSD/T5Z; both scored.

Selected RemeronSolTab ODT

15,30,45 mg white round tablets; T1Z,T2Z,T4Z respectively. Example 45 mg NDC 78206-159-01.

Formulation scope

Generic conventional/ODT products may have other strengths, imprints or excipients. No injectable, extended-release or labeled sleep/appetite regimen is inferred.

Store 20–25°C (excursions 15–30°C), protected from light/moisture. Leave each SolTab sealed until use; open with dry hands and use immediately without splitting/chewing/crushing or storing an unwrapped tablet. Keep out of children’s reach.