Product image of Mirtazapin Hexal (Mirtazapine) supplied by GNH India

Mirtazapin Hexal

Active Ingredient:
Mirtazapine
Origin:
EU

Mirtazapin Hexal (Mirtazapine)

Mirtazapine, the active ingredient in Mirtazapin Hexal, is a NaSSA (noradrenergic and specific serotonergic antidepressant) presented as an oral tablet for systemic use. It is prescribed for the treatment of major depressive disorder in adult patients, helping to improve mood, sleep and appetite where other agents have been insufficient.

GNH India supplies Mirtazapin Hexal as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, pharmacies and clinics worldwide.

Manufacturer / TM Owner

Hexal Ag

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Indications & Clinical Uses

Mirtazapine is indicated for depressive disorders and works by modulating noradrenergic and serotonergic pathways.

  • Major depressive disorder: alleviates depressive symptoms and improves overall mood in adult patients.

How It Works

  • Mirtazapine antagonizes central presynaptic α2‑adrenergic receptors, increasing norepinephrine and serotonin release. It also blocks 5‑HT2 and 5‑HT3 receptors, enhancing serotonergic transmission via 5‑HT1 receptors, and acts as a potent H1‑receptor antagonist, contributing to its sedative and appetite‑stimulating effects.

Side Effects

Common Side Effects

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

Serious or Rare Side Effects

  • Severe neutropenia or agranulocytosis
  • Serotonin syndrome, especially when combined with other serotonergic agents
  • Severe hypersensitivity reactions (e.g., Stevens‑Johnson syndrome)
  • Emergence or worsening of suicidal thoughts, particularly early in treatment

Precautions & Warnings

Before initiating therapy, consider the following precautions:

  • Assess psychiatric history: evaluate for suicidal thoughts and mood instability.
  • Monitor weight: patients may experience increased appetite and weight gain.
  • Check liver function: use caution in hepatic impairment.
  • Avoid abrupt discontinuation: taper under medical supervision to prevent withdrawal symptoms.
  • Pregnancy and lactation: safety not established; weigh benefits against potential risks.
  • Store at ambient temperature: keep below 25 °C, protect from moisture and light in the original packaging.

Avoid Interactions

Major Interactions (Avoid)

  • Monoamine oxidase inhibitors (MAOIs): risk of hypertensive crisis and serotonin syndrome.
  • Selective serotonin reuptake inhibitors (SSRIs) and other serotonergic agents: increased risk of serotonin syndrome.
  • CYP2D6 inhibitors (e.g., fluoxetine, paroxetine): may raise mirtazapine plasma levels.
  • Alcohol: additive central nervous system depression and sedation.

Moderate Interactions (Monitor Closely)

  • CNS depressants (benzodiazepines, opioids): enhanced sedative effect.
  • Anticholinergic drugs: may worsen dry mouth and constipation.
  • Warfarin: possible alteration of INR; monitor coagulation parameters.

Frequently Asked Questions

Mirtazapin Hexal contains mirtazapine, which is prescribed for the treatment of major depressive disorder in adult patients. It helps to alleviate depressive symptoms, improve sleep quality, and increase appetite when other antidepressants have not provided adequate relief.

Mirtazapine works by blocking presynaptic α2‑adrenergic receptors, which leads to increased release of norepinephrine and serotonin. It also antagonizes 5‑HT2 and 5‑HT3 receptors while stimulating 5‑HT1 receptors, and blocks H1 histamine receptors, producing its antidepressant and sedative effects.

The dose of Mirtazapin Hexal is individualized by the prescribing clinician based on the patient’s clinical condition, response, and tolerability. The prescriber determines the appropriate starting dose and any subsequent adjustments.

Safety of mirtazapine in pregnancy and lactation has not been definitively established. Clinicians should weigh the potential benefits against possible risks and consider alternative therapies when treating pregnant or nursing individuals.

To order, 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.

Mirtazapine belongs to the NaSSA class, differing from SSRIs and SNRIs that primarily inhibit serotonin or serotonin‑norepinephrine reuptake. Its strong antihistamine activity often results in sedation and weight gain, which can be advantageous for patients with insomnia or loss of appetite, whereas SSRIs are generally less sedating.

Store the tablets at ambient temperature, preferably below 25 °C. Keep them in the original container, protect from moisture and light, and keep out of reach of children. Do not store in humid or excessively hot environments.

Mirtazapin Hexal is taken orally, usually once daily in the evening due to its sedative effect. It may be swallowed with or without food, but consistent administration with respect to meals helps maintain stable absorption.

Serious risks include the emergence or worsening of suicidal thoughts, especially early in treatment, serotonin syndrome when combined with other serotonergic drugs, severe neutropenia or agranulocytosis, and rare hypersensitivity reactions such as Stevens‑Johnson syndrome.

Mirtazapin Hexal should be avoided in patients with known hypersensitivity to mirtazapine, those currently taking monoamine oxidase inhibitors, or individuals with severe hepatic impairment unless the prescriber decides the benefit outweighs the risk.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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