MIRZAGEN 30/MG FC TAB 30/FC TAB

Indications

Approved Uses

Major Depressive Disorder [1, 5]

Dosage & Administration

Dosing by Condition

Major Depressive Disorder: Initial dose 15mg once daily at bedtime. Titrate up every 1-2 weeks based on response. Maintenance dose is 15-45mg once daily. Maximum dose is 45mg/day. [15, 18]

Initial Dose

15 mg once daily at bedtime. [7, 18]

Maintenance Dose

15-45 mg once daily

Maximum Dose

45 mg per day. [7, 15, 18]

Children's Dosage

Not approved for children; safety and effectiveness have not been established. [5, 10]

Dose Adjustment Notes

Dose titration: increase no more frequently than every 1-2 weeks based on response/tolerability; use caution and consider lower starting dose and slower titration in elderly and in moderate-severe hepatic or renal impairment.

How to Take

Oral: swallow the film‑coated tablet whole with water (do not crush/chew unless specifically directed); take once daily, preferably at bedtime due to sedation; may be taken with or without food.

Side Effects

Common Side Effects

Somnolence/drowsiness, increased appetite, weight gain, dry mouth, constipation, dizziness, fatigue/asthenia; less commonly abnormal dreams/confusion and peripheral edema; lipid increases (cholesterol/triglycerides) can occur.

Side Effect Frequency

Very common (≥10%): somnolence/drowsiness, increased appetite, weight gain, dry mouth, constipation. Common (1-10%): dizziness, fatigue/asthenia, headache, nausea, abnormal dreams, confusion, peripheral edema, tremor; laboratory: increased cholesterol/triglycerides and elevated liver enzymes can occur. Rare/uncommon: neutropenia/agranulocytosis, hyponatremia, seizures, serotonin syndrome, QT prolongation, orthostatic hypotension.

Safety & Warnings

Contraindications

Hypersensitivity to mirtazapine, concurrent use with or within 14 days of Monoamine Oxidase Inhibitors (MAOIs), concurrent use with linezolid or intravenous methylene blue.

Warnings & Precautions

Warnings/precautions: suicidality risk in children/adolescents/young adults with close monitoring; sedation and impaired psychomotor performance (avoid alcohol/CNS depressants); agranulocytosis/neutropenia (evaluate infection symptoms); serotonin syndrome with serotonergic drugs/MAOI-related agents; activation of mania/hypomania in bipolar disorder; seizures; hyponatremia (higher risk in elderly/diuretics); QT prolongation/cardiac disease caution; hepatic/renal impairment caution; avoid abrupt discontinuation (taper).

Age Restriction

Not approved under 18 years.

Driving Warning

May Cause Drowsiness

Drug Interactions

Drug Interactions

Key interactions: MAOIs (contraindicated; allow washout), linezolid or IV methylene blue (serotonin syndrome risk), other serotonergic agents (SSRIs/SNRIs/triptans/tramadol/St. John’s wort-serotonin syndrome risk), CNS depressants including benzodiazepines and alcohol (additive sedation), strong CYP3A4 inducers (carbamazepine, phenytoin, rifampin-↓ levels), CYP inhibitors that can ↑ levels (e.g., ketoconazole; cimetidine; fluvoxamine), and warfarin (monitor INR).

Interaction Severity

MAJOR/CONTRAINDICATED: MAOIs (including linezolid and IV methylene blue) due to serotonin syndrome risk; avoid alcohol and other CNS depressants due to additive sedation/impairment (clinically significant). MODERATE: other serotonergic drugs (SSRIs/SNRIs, triptans, tramadol, etc.)-serotonin syndrome risk; strong CYP3A4 inhibitors (e.g., ketoconazole, clarithromycin)-↑ levels; CYP3A4 inducers (e.g., carbamazepine, rifampicin, phenytoin)-↓ levels/efficacy; warfarin-monitor INR. MINOR: no consistent clinically relevant antacid interaction.

Food Interaction

No clinically significant food interaction; may be taken with or without food.

Alcohol Interaction

Avoid

Special Populations

Pregnancy

Not assigned a pregnancy category; use only if potential benefit justifies potential risk to fetus

Children

Not approved for children; safety and effectiveness have not been established. [5, 10]

Elderly

Start at 7.5-15 mg once daily at bedtime; titrate slowly with careful monitoring; elderly patients have reduced clearance and increased sensitivity to sedation and anticholinergic effects

Liver Impairment

Use with caution in hepatic impairment; consider lower starting dose and slower titration (no fixed percentage adjustment).

Storage & Patient Advice

Stopping the Medicine

Do not stop abruptly-taper gradually; a practical taper is over several weeks (often 2-4+ weeks), individualized to dose, duration, and symptoms.

Overdose

Symptoms commonly include marked drowsiness/sedation, confusion/disorientation, tachycardia and blood pressure changes; severe cases may include CNS depression/respiratory depression, seizures, and QT prolongation. Management is supportive (airway/ventilation as needed, cardiac monitoring, activated charcoal if appropriate/early); no specific antidote-seek emergency care.

Patient Counseling

Take once daily at bedtime (may cause marked drowsiness); avoid driving/operating machinery until effects are known; avoid alcohol and other sedatives; take consistently and do not stop abruptly-taper with prescriber; mood improvement may take several weeks; expect possible increased appetite/weight gain (diet/activity advice); seek urgent care for worsening depression/suicidal thoughts, serotonin syndrome symptoms, or signs of infection (fever/sore throat/mouth ulcers); inform clinicians about all medicines and avoid MAOIs.

Monitoring Requirements

Monitor clinical response and suicidality (especially early therapy and dose changes); monitor weight/BMI and appetite; consider lipids (cholesterol/triglycerides) if risk factors or long-term use; CBC if signs of infection (rare neutropenia/agranulocytosis); monitor for serotonin syndrome when combined with serotonergic agents; consider sodium in elderly/high-risk patients; renal/hepatic function as clinically indicated.

Pharmacology

Duration of Effect

Single-dose pharmacologic effects last about 24 hours (supports once-daily dosing). Clinical antidepressant benefit is maintained only with continued daily dosing and may persist for days to weeks after discontinuation due to a 20-40 hour elimination half-life.

Half-Life

Approximately 20-40 hours (longer in elderly and in hepatic/renal impairment).

Bioavailability

Approximately 50%. [4, 11]

Product Information

Available Dosage Forms

For this product (MIRZAGEN): film‑coated tablet (30 mg). Other mirtazapine products may also be available as orodispersible/orally disintegrating tablets, but that is not this SFDA-registered item.

Composition per Dose

Each film-coated tablet: 30 mg mirtazapine

Generic Availability

Yes

OTC Alternatives

No OTC alternative

Psych Class

Antidepressant-Other (NaSSA)

Controlled Substance

No

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