TAZMERON 15MG F.C.TAB 30 FILM-COATED TAB

Indications

Approved Uses

Major depressive disorder (MDD)

Off-Label Uses

Commonly used off‑label for insomnia (especially with comorbid depression/anxiety) and for anxiety disorders (e.g., GAD, panic disorder, PTSD); sometimes used to stimulate appetite/weight gain in chronic illness-evidence varies by indication.

Dosage & Administration

Dosing by Condition

Major Depressive Disorder: Initial 15mg once daily at bedtime; Maintenance 15-45mg once daily at bedtime; Maximum 45mg once 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

Increase dose no more frequently than every 1-2 weeks based on response/tolerability; use caution and consider lower doses in elderly patients and in moderate-severe hepatic or renal impairment.

How to Take

Swallow the film‑coated tablet whole with water; take once daily, preferably in the evening/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, dizziness, constipation; fatigue is also common.

Side Effect Frequency

Very common (≥10%): somnolence/drowsiness, increased appetite, weight gain, dry mouth. Common (1-10%): dizziness, constipation, nausea, fatigue/asthenia, headache, peripheral edema. Uncommon/Rare (≤1%): orthostatic hypotension, tremor, confusion/abnormal dreams, hyponatremia (SIADH), seizures, serotonin syndrome, severe skin reactions (e.g., SJS/TEN), blood dyscrasias including agranulocytosis/neutropenia.

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: monitor for clinical worsening/suicidality (especially early and in <25); avoid MAOIs and monitor for serotonin syndrome with serotonergic agents; sedation and impaired psychomotor performance (caution driving/CNS depressants); weight gain/increased appetite; orthostatic hypotension; rare agranulocytosis (evaluate infection symptoms); caution in bipolar disorder/mania risk, seizure disorders, hepatic/renal impairment, cardiovascular disease/QT risk factors, angle-closure glaucoma/urinary retention; taper to discontinue.

Age Restriction

Not approved/recommended for use in patients <18 years (pediatric safety/efficacy not established).

Driving Warning

May Cause Drowsiness

Drug Interactions

Drug Interactions

Key interactions: MAOIs (contraindicated; require washout), linezolid/IV methylene blue (avoid-serotonin syndrome risk), other serotonergic drugs (e.g., SSRIs/SNRIs/triptans/tramadol/St. John’s wort-serotonin syndrome risk), CNS depressants/alcohol/benzodiazepines (additive sedation), strong CYP3A4 inducers (carbamazepine, phenytoin, rifampin-↓ levels), CYP inhibitors (e.g., cimetidine; azole antifungals such as ketoconazole-may ↑ levels), warfarin (monitor INR).

Interaction Severity

MAJOR/Contraindicated: MAO inhibitors (and within 14 days), linezolid, IV methylene blue (serotonin syndrome risk). MODERATE: other serotonergic drugs (SSRIs/SNRIs/triptans, etc.)-serotonin syndrome risk; CNS depressants including alcohol/benzodiazepines-additive sedation; strong CYP3A4 inhibitors (e.g., ketoconazole)-↑ levels; CYP inducers (e.g., carbamazepine, rifampicin, phenytoin)-↓ levels/efficacy; warfarin-possible ↑ INR/bleeding risk. QT‑prolonging drugs: use caution in at‑risk patients.

Food Interaction

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

Alcohol Interaction

Avoid

Special Populations

Pregnancy

Consult Doctor

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; elderly patients may have reduced clearance and increased sensitivity to sedation and orthostatic hypotension

Kidney Impairment

Moderate to severe renal impairment: use with caution; consider lower starting dose and slower titration (clearance reduced, especially when CrCl <40 mL/min).

Liver Impairment

Hepatic impairment: use with caution; consider lower starting dose and slower titration (no single fixed adjustment, but reduced clearance is expected).

Storage & Patient Advice

Storage Conditions

Store below 30°C, in a dry place, protected from light

Missed Dose

If remembered the same night/evening, take it then; if it is close to the next scheduled dose (e.g., next day), skip the missed dose and resume the regular schedule-do not double.

Stopping the Medicine

Do not stop abruptly; taper gradually over several weeks (individualize based on dose/duration and symptoms).

Overdose

Overdose: commonly marked sedation, disorientation, tachycardia and blood pressure changes; serious toxicity is uncommon alone but can include arrhythmias/QT effects especially with co-ingestants; management is supportive (airway/ventilation as needed, activated charcoal if appropriate, cardiac/vital sign monitoring); no specific antidote-seek emergency care.

Patient Counseling

Take once daily in the evening/at bedtime; may cause 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; report worsening mood/suicidal thoughts; report fever/sore throat/mouth ulcers (possible neutropenia); expect possible increased appetite/weight gain and consider diet/weight monitoring; inform clinicians about all medicines, especially MAOIs/linezolid/serotonergic drugs and warfarin.

Monitoring Requirements

Monitor clinical response and worsening depression/suicidal ideation (especially early); monitor weight/BMI and metabolic parameters (lipids; consider glucose if risk); consider CBC if signs of infection occur (rare agranulocytosis/neutropenia); consider sodium in elderly or those at hyponatremia risk; monitor for sedation and falls risk.

Pharmacology

Mechanism of Action

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

Onset of Action

Sedation and appetite effects may occur within days; antidepressant effect typically begins within 1-2 weeks with clearer benefit by 2-4 weeks; full effect may take 4-6 weeks.

Duration of Effect

Single-dose pharmacologic effects last about 24 hours (supports once-daily dosing). Antidepressant therapeutic effect is maintained only with continued daily dosing; after discontinuation, clinical benefit may persist for days to weeks depending on response and tapering.

Half-Life

20-40 hours.

Bioavailability

Approximately 50%.

Metabolism

Extensive hepatic metabolism primarily via CYP1A2, CYP2D6, and CYP3A4 (e.g., demethylation/hydroxylation) to metabolites.

Excretion

Eliminated mainly as metabolites in urine (~75%) and feces (~15%).

Protein Binding

Approximately 85%.

Product Information

Available Dosage Forms

For this product: film‑coated tablet (oral). Mirtazapine is also available in some markets as an orally disintegrating/orodispersible tablet, but that is a different dosage form than this SFDA-registered product.

Composition per Dose

Each film-coated tablet: 15mg mirtazapine

Generic Availability

Yes

OTC Alternatives

No OTC alternative

Psych Class

Antidepressant-Other (NaSSA)

Controlled Substance

No

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