MIRZAGEN 15/MG FC TAB 30/FC TAB

Indications

Approved Uses

Major depressive disorder (MDD)

Dosage & Administration

Dosing by Condition

Major Depressive Disorder (adults): start 15 mg orally once daily (usually at bedtime); increase in 15 mg increments at ≥1-2 week intervals based on response/tolerability; usual range 15-45 mg/day; maximum 45 mg/day

Initial Dose

15 mg once daily at bedtime

Maintenance Dose

15-45 mg once daily at bedtime

Maximum Dose

45 mg per day

Children's Dosage

Not approved for children or adolescents under 18 years

Dose Adjustment Notes

Increase dose no more frequently than every 1-2 weeks; use caution and consider lower starting dose/slower titration in elderly and in renal or hepatic impairment due to reduced clearance

How to Take

Swallow whole with water; take once daily preferably at bedtime; can 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 nausea, abnormal dreams, tremor, confusion, peripheral edema

Safety & Warnings

Contraindications

Hypersensitivity to mirtazapine; concomitant use with MAO inhibitors or within 14 days of stopping an MAOI; concomitant use with linezolid or intravenous methylene blue.

Warnings & Precautions

Monitor for suicidality and clinical worsening early in therapy and after dose changes (especially <25); watch for infection signs and consider CBC if symptomatic (rare agranulocytosis/neutropenia); risk of serotonin syndrome with serotonergic drugs; caution in bipolar disorder (mania/hypomania), seizure disorders, cardiovascular disease/QT-risk, hepatic/renal impairment, elderly (hyponatremia, falls/sedation); avoid abrupt discontinuation-taper.

Age Restriction

Not approved under 18 years.

Driving Warning

May Cause Drowsiness

Drug Interactions

Drug Interactions

Avoid MAOIs (including linezolid and IV methylene blue); caution with other serotonergic agents (e.g., SSRIs/SNRIs, triptans, tramadol, St. John’s wort) due to serotonin syndrome risk; additive sedation with alcohol/CNS depressants (including benzodiazepines); CYP3A4 inducers (e.g., carbamazepine, rifampicin) may decrease levels and CYP3A4 inhibitors (e.g., ketoconazole) may increase levels; monitor INR if used with warfarin.

Interaction Severity

MAJOR/CONTRAINDICATED: MAO inhibitors (including linezolid and IV methylene blue) due to serotonin syndrome risk; MODERATE: other serotonergic agents (e.g., SSRIs/SNRIs/triptans) (serotonin syndrome risk), CNS depressants including benzodiazepines/alcohol (additive sedation), strong CYP3A4 inhibitors (↑ levels) and inducers (↓ levels); warfarin-monitor INR

Food Interaction

No clinically significant food restriction; may be taken with or without food

Alcohol Interaction

Avoid

Special Populations

Children

Not approved for children or adolescents under 18 years

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

Hepatic impairment: use with caution; consider lower starting dose and slower titration (no fixed adjustment; start low and monitor).

Storage & Patient Advice

Stopping the Medicine

Do not stop abruptly; taper gradually (typically over several weeks, individualized) to minimize discontinuation symptoms.

Overdose

Symptoms commonly include marked drowsiness/sedation, disorientation/confusion, tachycardia and blood pressure changes; severe cases may include CNS depression and cardiac effects. Management is immediate emergency evaluation with supportive care (airway/breathing/circulation, cardiac monitoring) and consideration of activated charcoal if early; no specific antidote.

Patient Counseling

Take once daily (usually at bedtime) due to drowsiness; avoid driving/operating machinery until effects are known; avoid alcohol/CNS depressants; do not stop abruptly-taper with prescriber; improvement may take several weeks; seek urgent care for suicidal thoughts/behavior changes, serotonin syndrome symptoms, or infection signs (fever/sore throat); expect possible increased appetite/weight gain and practice diet/exercise; discuss pregnancy/breastfeeding with clinician

Monitoring Requirements

Monitor for clinical worsening/suicidality (especially early and after dose changes); monitor weight/BMI and metabolic parameters (e.g., lipids as clinically indicated); obtain CBC if signs of infection (fever/sore throat) occur; consider serum sodium in at-risk patients (e.g., elderly, diuretics)

Pharmacology

Mechanism of Action

Noradrenergic and specific serotonergic antidepressant (NaSSA): presynaptic α2-adrenergic antagonist increasing norepinephrine and serotonin release; antagonizes 5‑HT2 and 5‑HT3 receptors and H1 histamine receptors

Onset of Action

Peak plasma concentrations within 2 hours; steady-state levels within 5 days (supports once-daily dosing due to 20-40 hour half-life

Half-Life

20-40 hours.

Excretion

75% renal, 15% fecal

Protein Binding

Approximately 85%.

Product Information

Available Dosage Forms

Film-coated tablet (this product); mirtazapine is also available in some markets as an orodispersible/orally disintegrating tablet

Composition per Dose

Each film-coated tablet: 15 mg mirtazapine

Generic Availability

Yes

Psych Class

Antidepressant-Other (NaSSA)

Controlled Substance

No

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