Product image of Mirtazapine supplied by GNH India

Mirtazapine

Active Ingredient:
Mirtazapine
Origin:
EU

Mirtazapine

Mirtazapine, the active ingredient in Mirtazapine, is a tetracyclic antidepressant presented as an oral tablet for oral use. It is prescribed to alleviate symptoms of major depressive disorder in adult patients and may be used as part of a comprehensive treatment plan that includes psychotherapy.

GNH India supplies Mirtazapine as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, pharmacies and clinics worldwide. The company adheres to stringent quality standards and provides regulatory documentation for each batch, ensuring reliable and traceable supply.

Manufacturer / TM Owner

Krka, D.D., Novo Mesto

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Indications & Clinical Uses

Mirtazapine is a tetracyclic antidepressant used primarily in the management of depressive disorders.

  • Major depressive disorder: reduces depressive symptoms and improves mood in adult patients.
  • Depressive episodes in bipolar disorder: used as an adjunct to stabilize mood when other agents are insufficient.
  • Treatment‑resistant depression: considered when first‑line antidepressants have not achieved adequate response.

How It Works

  • Mirtazapine blocks central presynaptic alpha‑2 adrenergic receptors, enhancing norepinephrine release, and antagonizes 5‑HT2, 5‑HT3 and H1 histamine receptors, which together increase serotonergic transmission and produce its antidepressant and sedative effects.

Side Effects

Mirtazapine may cause a range of adverse reactions that vary in frequency and severity.

Common Side Effects

  • Sedation or drowsiness
  • Increased appetite and weight gain
  • Dry mouth
  • Constipation
  • Dizziness
  • Orthostatic hypotension

Serious or Rare Side Effects

  • Agranulocytosis or severe neutropenia
  • Anaphylactic or severe allergic reactions
  • Serotonin syndrome, especially with other serotonergic agents
  • Suicidal thoughts or worsening depression
  • Hepatic dysfunction or jaundice

Precautions & Warnings

Before initiating therapy, clinicians should evaluate specific risk factors and monitor patients closely.

  • Assess psychiatric history: monitor for worsening depression or emergent suicidal ideation.
  • Evaluate hepatic function: consider dose adjustment in severe liver impairment.
  • Caution in elderly: increased risk of sedation, falls and orthostatic changes.
  • Avoid abrupt discontinuation: taper under medical supervision to prevent withdrawal symptoms.
  • Store at ambient temperature: keep below 25°C in the original packaging, protect from moisture.

Avoid Interactions

Mirtazapine can interact with several drug classes, requiring careful management.

Major Interactions (Avoid)

  • Monoamine oxidase inhibitors (MAOIs): risk of hypertensive crisis or serotonin syndrome.
  • Strong CYP2D6 inhibitors (e.g., fluoxetine, paroxetine): may raise mirtazapine plasma concentrations.

Moderate Interactions (Monitor Closely)

  • Central nervous system depressants (e.g., benzodiazepines, alcohol): additive sedation.
  • Anticholinergic agents: increased anticholinergic burden.
  • Warfarin: potential alteration of INR, requiring coagulation monitoring.

Frequently Asked Questions

Mirtazapine is prescribed primarily for the treatment of major depressive disorder in adult patients. It may also be used as an adjunct in bipolar depression and in cases where first‑line antidepressants have not provided sufficient relief.

Mirtazapine enhances norepinephrine and serotonin neurotransmission by blocking presynaptic alpha‑2 adrenergic receptors and antagonizing specific serotonin (5‑HT2, 5‑HT3) and histamine (H1) receptors, which together improve mood and produce a calming effect.

The appropriate dose of Mirtazapine is determined by the prescribing clinician based on the individual’s clinical condition, response, and tolerability. Patients should follow the dosage instructions provided by their healthcare professional.

Safety data for Mirtazapine in pregnancy and lactation are limited. Prescribers should weigh potential benefits against risks and consider alternative therapies when treating pregnant or nursing individuals.

To request Mirtazapine, submit an enquiry on the product page at gnhindia.com specifying the required quantity. GNH India works with hospitals, pharmacies and procurement teams worldwide, verifies trade or institutional credentials, and then provides pricing, availability, shipping details and any necessary import documentation.

Compared with selective serotonin reuptake inhibitors, Mirtazapine has a distinct receptor profile that often results in greater sedation and weight gain but may be advantageous for patients with insomnia or poor appetite. Its efficacy in depression is comparable, though individual response varies.

Mirtazapine tablets should be stored at ambient temperature, preferably below 25 °C, in their original packaging to protect from moisture and light. Keep the product out of reach of children.

Mirtazapine is taken orally, usually once daily in the evening due to its sedative effect. It should be swallowed whole with water and not crushed or chewed unless specifically instructed by a healthcare professional.

Serious risks include agranulocytosis, severe allergic reactions, serotonin syndrome (especially when combined with other serotonergic drugs), and worsening depression or emergence of suicidal thoughts. Prompt medical attention is required if any of these occur.

Mirtazapine is contraindicated in patients with known hypersensitivity to the drug, those currently taking monoamine oxidase inhibitors, or individuals with severe hepatic impairment without appropriate dose adjustment. Clinicians should also exercise caution in patients with a history of bipolar disorder or seizure disorders.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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