REMERON 30/MG 30/FC TAB

Indications

Approved Uses

Major depressive disorder (MDD)

Off-Label Uses

Common off-label uses include insomnia (particularly with comorbid depression/anxiety), anxiety disorders (e.g., GAD, panic disorder, PTSD, social anxiety), and appetite/weight stimulation in selected patients (e.g., cancer/HIV-related anorexia/cachexia).

Dosage & Administration

Dosing by Condition

Major Depressive Disorder: Initial 15mg daily at bedtime, titrate up every 1-2 weeks based on response to a usual maintenance dose of 15-45mg daily. Maximum dose is 45mg daily.

Initial Dose

15mg once daily at bedtime.

Maintenance Dose

15-45mg once daily at bedtime

Maximum Dose

45mg per day.

Children's Dosage

Not approved for children or adolescents under 18 years

Dose Adjustment Notes

Titrate based on response/tolerability, generally no more frequently than every 1-2 weeks; consider lower starting dose and/or slower titration in elderly and in renal or hepatic impairment (especially moderate-severe).

How to Take

Oral film‑coated tablet: take once daily, preferably at bedtime; swallow whole with water; may be taken with or without food.

Side Effects

Common Side Effects

Somnolence/drowsiness, increased appetite, weight gain, dry mouth, constipation, dizziness, fatigue/asthenia; metabolic changes such as increased cholesterol/triglycerides can occur.

Side Effect Frequency

Very common (≥10%): somnolence/drowsiness, dry mouth, increased appetite, weight gain, constipation. Common (1-10%): dizziness, headache, fatigue/asthenia, peripheral edema, abnormal dreams, confusion, tremor, nausea. Rare/serious: neutropenia/agranulocytosis, serotonin syndrome (esp. with serotonergic/MAOI exposure), hyponatremia/SIADH, seizures, mania/hypomania, QT prolongation (risk-dependent), hepatic injury.

Safety & Warnings

Contraindications

Contraindicated with: (1) hypersensitivity to mirtazapine; (2) concomitant use with MAOIs or within 14 days of stopping an MAOI (and vice versa); (3) concomitant use with linezolid or intravenous methylene blue (or require washout/close monitoring due to serotonin syndrome risk).

Warnings & Precautions

Key warnings/precautions: monitor for clinical worsening and suicidality (especially ≤24 years); avoid MAOIs/linezolid/IV methylene blue (serotonin syndrome); monitor for infection signs due to severe neutropenia/agranulocytosis; risk of serotonin syndrome with serotonergic drugs; activation of mania/hypomania; seizure risk; angle-closure glaucoma; hyponatremia (esp. elderly/diuretics); sedation/impairment (avoid alcohol/CNS depressants); caution in cardiovascular disease/QT risk; taper to discontinue.

Age Restriction

Not approved for use in pediatric patients (<18 years); safety and effectiveness have not been established.

Driving Warning

Avoid Driving

Drug Interactions

Drug Interactions

Major interactions include: MAOIs (including linezolid and IV methylene blue) (serotonin syndrome), other serotonergic drugs (serotonin syndrome), CNS depressants/benzodiazepines and alcohol (additive sedation), CYP3A4 inhibitors (↑ mirtazapine), CYP3A4 inducers (↓ mirtazapine), strong CYP1A2/2D6 inhibition (e.g., fluvoxamine) (↑ mirtazapine), cimetidine (↑ mirtazapine), and warfarin (monitor INR).

Interaction Severity

MAJOR/contraindicated: MAOIs (including linezolid and IV methylene blue) due to risk of serotonin syndrome; avoid concomitant use and observe appropriate washout. MODERATE: other CNS depressants (including alcohol, benzodiazepines) due to additive sedation; strong CYP3A4 inducers (e.g., carbamazepine, rifampin) may decrease effect; strong CYP inhibitors (e.g., ketoconazole; fluvoxamine can markedly increase exposure) may increase levels; warfarin-monitor INR. MINOR/other: cimetidine may increase mirtazapine exposure; additive hypotension with antihypertensives may occur.

Food Interaction

No restriction.

Alcohol Interaction

Avoid

Special Populations

Pregnancy

Category C

Breastfeeding

Caution

Children

Not approved for children or adolescents under 18 years

Elderly

Start at 7.5-15mg once daily at bedtime; titrate slowly with careful monitoring for sedation, orthostatic hypotension, and hyponatremia; standard maximum dose applies but lower doses may be effective

Kidney Impairment

Renal impairment: use with caution; consider lower starting dose and slower titration particularly when CrCl <40 mL/min, and use extra caution in severe impairment (e.g., <10 mL/min).

Liver Impairment

Hepatic impairment: use with caution; consider a lower starting dose and slower titration (often ~50% lower in moderate-severe impairment) based on clinical response and tolerability.

Storage & Patient Advice

Stopping the Medicine

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

Overdose

Overdose commonly causes CNS depression (drowsiness/sedation, disorientation), tachycardia and blood pressure changes; severe toxicity is uncommon but can include seizures and QT prolongation/arrhythmias-management is supportive with airway/ventilation as needed, activated charcoal if appropriate, and cardiac/vital sign monitoring; seek emergency care.

Patient Counseling

Take once daily at bedtime due to drowsiness; avoid driving/operating machinery until effects are known; avoid alcohol and other sedatives unless advised; do not stop abruptly-taper with prescriber; improvement may take several weeks; seek urgent help for suicidal thoughts/behavior changes; report fever/sore throat/mouth ulcers (possible neutropenia); expect possible increased appetite/weight gain and consider diet/exercise; inform clinicians about all medicines, especially MAOIs/linezolid/methylene blue and other antidepressants.

Monitoring Requirements

Monitor clinical response and worsening depression/suicidality (especially early and after dose changes); monitor weight/BMI and appetite; consider lipid profile periodically; obtain CBC if signs of infection (e.g., fever, sore throat) occur; consider serum sodium in elderly or those at hyponatremia risk; monitor for mania/hypomania in bipolar risk.

Pharmacology

Mechanism of Action

Noradrenergic and specific serotonergic antidepressant (NaSSA): antagonizes central presynaptic α2 autoreceptors/heteroreceptors increasing norepinephrine and serotonin release; antagonizes 5‑HT2 and 5‑HT3 receptors (shifting signaling toward 5‑HT1A); also blocks H1 receptors (sedation/weight gain).

Onset of Action

Sedation may occur within hours after the first dose; antidepressant effect typically begins within 1-2 weeks (full effect 4-6 weeks).

Duration of Effect

Sedative effects may last ~8-12 hours; antidepressant effect persists with continued once-daily dosing (therapeutic effect maintained over 24 hours between doses; full clinical benefit may take 4-6 weeks).

Half-Life

20-40 hours.

Bioavailability

Approximately 50%.

Metabolism

Extensive hepatic metabolism primarily via CYP3A4 with contributions from CYP2D6 and CYP1A2; metabolites include desmethylmirtazapine and mirtazapine N‑oxide (among others).

Excretion

Renal (75%) and fecal (15%).

Protein Binding

Approximately 85%.

Product Information

Available Dosage Forms

For this product: film‑coated tablet (oral). Other marketed mirtazapine forms may include orally disintegrating tablets (ODT/SolTab) depending on country/brand, but they are not this SFDA-registered product.

Composition per Dose

Each film-coated tablet: 30mg mirtazapine

Generic Availability

Yes

OTC Alternatives

No OTC alternative

Psych Class

Antidepressant-Other (NaSSA)

Controlled Substance

No

Reviewed by Al Mujtama Pharmacy Medical Review Team. Last reviewed 29-08-2026