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

Mirtazapin Genericon

Active Ingredient:
Mirtazapine
Origin:
EU

Mirtazapin Genericon (Mirtazapine)

Mirtazapine, the active ingredient in Mirtazapin Genericon, is a NaSSA (noradrenergic and specific serotonergic antidepressant) presented as an oral tablet for oral use. It is indicated for the treatment of major depressive disorder in adult patients and is formulated for once‑daily administration across the European Union.

GNH India supplies Mirtazapin Genericon as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, pharmacies and clinics worldwide, providing reliable bulk shipments and regulatory support for cross‑border procurement. The company adheres to stringent quality standards, ensuring product integrity during storage and transport, and collaborates with regulatory agencies to maintain compliance.

Manufacturer / TM Owner

Genericon Pharma Gesellschaft M.B.H.

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Indications & Clinical Uses

Mirtazapine is an antidepressant that acts on noradrenergic and serotonergic pathways to alleviate depressive symptoms.

  • Major depressive disorder: reduces depressive mood, improves sleep and appetite in adult patients.
  • Treatment‑resistant depression: may be added when first‑line agents are insufficient to achieve remission.
  • Depressive symptoms associated with chronic medical conditions: helps improve mood and quality of life in patients with comorbid illnesses.

How It Works

  • Mirtazapine blocks central presynaptic α2‑adrenergic receptors, increasing norepinephrine release, and selectively antagonizes serotonin 5‑HT2 and 5‑HT3 receptors while strongly inhibiting H1 histamine receptors. This receptor profile enhances serotonergic and noradrenergic neurotransmission and produces sedative and appetite‑stimulating effects, contributing to its antidepressant activity. The combined antagonism leads to increased synaptic concentrations of norepinephrine and serotonin, while H1 blockade accounts for the characteristic sedation and weight gain observed with therapy.

Side Effects

Mirtazapine may be associated with a range of adverse reactions, varying in frequency and severity.

Common Side Effects

  • Sedation or drowsiness
  • Increased appetite leading to weight gain
  • Dry mouth
  • Constipation

Serious or Rare Side Effects

  • Agranulocytosis or severe neutropenia
  • Hepatic dysfunction (elevated transaminases)
  • Suicidal thoughts or behavior, especially early in treatment

Precautions & Warnings

When prescribing mirtazapine, clinicians should consider several safety measures to minimise risk.

  • Assess hepatic function: evaluate liver enzymes before initiation and monitor periodically.
  • Monitor weight: counsel patients about potential weight gain and increased appetite.
  • Screen for suicidal ideation: particularly during the first weeks of therapy.
  • Avoid abrupt discontinuation: taper the dose to reduce risk of withdrawal symptoms.
  • Use caution in elderly patients: increased sensitivity to sedation and orthostatic hypotension.
  • Store at ambient temperature: keep in original packaging, protect from moisture and light.

Avoid Interactions

Mirtazapine can interact with other medicines, altering its efficacy or safety profile.

Major Interactions (Avoid)

  • MAO inhibitors: concurrent use may cause hypertensive crisis; a washout period is required.
  • Potent CYP2D6 inhibitors (e.g., fluoxetine, paroxetine): can raise mirtazapine plasma levels, increasing side‑effect risk.
  • CNS depressants (e.g., benzodiazepines, alcohol): may enhance sedation and respiratory depression.

Moderate Interactions (Monitor Closely)

  • CYP3A4 inducers (e.g., carbamazepine, rifampin): may reduce mirtazapine concentrations, diminishing therapeutic effect.
  • Antihistamines: additive sedation may occur.
  • Lithium: monitor serum lithium levels as mirtazapine may affect renal clearance.

Frequently Asked Questions

Mirtazapin Genericon contains mirtazapine, which is prescribed primarily for the treatment of major depressive disorder in adult patients. It helps alleviate depressive symptoms such as low mood, loss of interest, sleep disturbances, and appetite changes, supporting overall functional recovery.

Mirtazapine works by blocking presynaptic α2‑adrenergic receptors, which increases the release of norepinephrine, and by antagonising serotonin 5‑HT2 and 5‑HT3 receptors while strongly inhibiting H1 histamine receptors. This combined activity enhances noradrenergic and serotonergic neurotransmission and produces sedative and appetite‑stimulating effects that contribute to its antidepressant action.

The appropriate dose of Mirtazapin Genericon is determined by the prescribing healthcare professional based on the individual’s clinical condition, response to therapy, and tolerability. Dosage adjustments are made according to the prescriber’s judgment and local prescribing guidelines.

Safety data for mirtazapine in pregnancy and lactation are limited. The medication should only be used if the potential benefit to the mother outweighs any possible risk to the fetus or infant. Healthcare providers typically evaluate each case individually and may consider alternative treatments when appropriate.

To place an 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 (including any cold‑chain requirements) and the necessary import documentation.

Mirtazapine belongs to the NaSSA class, which differs from selective serotonin reuptake inhibitors (SSRIs) by its combined noradrenergic and serotonergic activity and strong antihistamine effect. Compared with SSRIs, it often causes more sedation and weight gain but may be preferred when patients need sleep improvement or have poor appetite.

Mirtazapin Genericon should be stored at ambient temperature, below 25 °C, in its original packaging. Protect the product from moisture, direct sunlight, and extreme humidity to maintain stability throughout its shelf life.

The medication is taken orally, usually as a tablet, and should be swallowed whole with a glass of water. It is commonly prescribed for once‑daily dosing, but the exact schedule is determined by the prescribing clinician.

Serious adverse events include agranulocytosis or severe neutropenia, hepatic dysfunction indicated by elevated liver enzymes, and the emergence or worsening of suicidal thoughts, particularly during the initial weeks of treatment. Prompt medical attention is required if any of these symptoms occur.

Mirtazapin Genericon is contraindicated in patients with known hypersensitivity to mirtazapine, those currently taking monoamine oxidase inhibitors (MAOIs) without an appropriate washout period, and individuals with severe hepatic impairment. Caution is also advised for patients with a history of bipolar disorder, as it may precipitate manic episodes.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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